Estate & Priorities
Value Map & Prioritization
Every tracked surface in the estate, scored for the value of keeping it live, then plotted on an owner-tunable magic quadrant. Personal / Family / Career excluded. Modeled estimates.
Prioritization quadrant toggle the axes
Feature sets, ranked click a header to sort
Every component, ranked
Composite (0–100) = 0.34·org-value + 0.18·reach + 0.20·risk-reduction + 0.13·readiness + 0.15·differentiation; effort is the second quadrant axis. Tiers: P1 ≥75 · P2 60–75 · P3 <60. Modeled, owner-tunable.
Estate & Priorities
Program Magic Quadrant
Live development programs by strategic value against effort, risk and readiness, with the rationale for each placement. Modeled from PDT baselines and the May portfolio RAG history.
Why each program sits where it does
Portfolio Decision Team
PDT Executive Dashboard
The monthly Portfolio Decision Team at a glance — decisions, action-item aging, session cadence, baselines and engagement. From the PDT record, May 2026 forward.
Decisions log May 15 inaugural PDT
Action items aged to 16 Jun 2026
Session cadence
Program baselines locked at Phase B
Engagement
Estate · Insulet core
PMO Ops Board (live app)
Hub A · 1 components · 1 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet core
PMO & EPMO Command Centers
Hub B · 19 components · 12 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet core
Clarity Hub
Hub C · 11 components · 10 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet enable
Operating Manual Hub
Hub E · 12 components · 10 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet core
Governance & Strategy
Hub G · 4 components · 3 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet core
PDT Hub
Hub D · 9 components · 6 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet enable
Learning Shelf
Hub H · 7 components · 7 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Insulet enable
Roles Atlas
Hub F · 7 components · 5 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Platform
Agent-Facing Layer
Hub L · 10 components · 9 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Platform
Apps & OS
Hub K · 13 components · 2 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Platform
Design Systems
Hub I · 7 components · 6 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Gap
Gaps / Scaffold (potential)
Hub N · 2 components · 0 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
Estate · Adjacent
Research & Situation Room
Hub J · 11 components · 4 live. Value, effort, reach and risk for this feature set, every component ranked, and why it sits where it does.
PMO · Product Delivery & Operational Excellence
Empower teams to deliver with excellence.
The PMO Center of Excellence unifies and elevates how we deliver across platforms and products — fostering collaboration, continuous improvement, and innovation.
Insulet purposeBorn of empathy, driven by ingenuity, and proven by science, we transform the lives of people with diabetes.
The PMO turns that purpose into delivery — aligning teams, governance, and AI so every release reaches the people who wear the Pod.
01 · PMO Mission
Empower teams across product, platform, and enterprise functions through operational excellence, agile delivery, and strong governance — accelerating delivery and creating meaningful impact for the business.
02 · PMO Vision
Scaled operational excellence, enabled with AI — strengthening systems, governance, and processes across product delivery, compliant by design and architected for an agentic future.
PMO · Purpose
Aligned by purpose, powered by AI, proven by execution — we help every team deliver what matters most.
01PMO Mission
To empower teams across product, platform, and enterprise functions through operational excellence, agile delivery, and strong governance that enable scalable, high-quality, and customer-centered solutions. Through standardized ways of working, strategic alignment, and a people-first culture, we accelerate delivery and create meaningful impact for the business.
02PMO Vision
Scaled operational excellence, enabled with AI — strengthening systems, governance, and processes across product delivery, compliant by design and architected for an agentic future.
PMO · Purpose
We exist so the teams behind Omnipod can focus on the people who wear it.
PeopleQualityVelocityAI-enabled
01 — Mission
Empower teams to deliver with excellence
Operational excellence, agile delivery, and strong governance across product, platform, and enterprise functions — standardized ways of working and a people-first culture that accelerate delivery and create meaningful impact.
02 — Vision
Scaled operational excellence, enabled with AI
Strengthening systems, governance, and processes across product delivery — compliant by design and architected for an agentic future.
Operating pillars
Strengthening systems, governance, and processes — with AI as the enabler.
01 · Systems
Optimized systems: connected, compliant, efficient, effective, flexible.
02 · Governance
Tailored, adaptable, effective — Business Governance, Agile Delivery, Quality System.
03 · Processes
Codified and agentic — compliant by design, architected for an agentic future.
Quick access
Jump to any section.
Command Center
Comprehensive observability into portfolio & performance, relative to governance, as measured by our KPIs.
▦
Ops Board
Operations board — priorities, operating cadence, and platform health at a glance
⏱ liveOpen →
◉
Portfolio
Health matrix, programs, risk command, master register, watchlist, trends, deep analytics + the ten-insight narrative
⏱ May 2026Open →
▤
Metrics
33 metrics across the 8 PMBOK-7 domains + Agile + Contract — one source per metric, trended monthly
⏱ Apr 2026Open →
⚠
Risk Register
The 92-item master RAID register — risks, issues & opportunities, deduped, normalized & owned (native)
⏱ May 2026Open →
◷
Milestones
Investor-Day milestone commitment — met vs missed by quarter, trend, FY26 launches
⏱ May 2026Open →
◫
PDT
Portfolio Decision Team — May 15 decisions, action items, attendance, charter, next-PDT bar (native)
⏱ May 2026Open →
◷
Stakeholders
PDT seat ownership — 32 members by group, seats, May-15 attendance (native)
⏱ May 2026Open →
◳
AOP
FY27 plan simulator (scenario, Monte Carlo, capacity, builder) + reconciliation (Clarity vs FP&A vs baseline)
⏱ FY27 planOpen →
◑
Resource & Capacity
Critical gaps, plan-vs-actual, scenario planner, geo-shift + full-year demand vs capacity
⏱ May 2026Open →
▦
Program Gantt
GPDP phase timeline — program bars, RAG, milestone gates, Today line (rebuilt native)
⏱ Jun 2026Open →
▰
Agile Metrics
PI-objective health, releases, defects & test progress across the four platforms (26Q2-5)
⏱ 26Q2-5Open →
Center of Excellence
What we do and how we do it. Best-practice focused.
★
Best-Practices Playbook
Decision playbook, RACI, anti-patterns, PMBOK-7 crosswalk, watermelon detector
⏱ May 2026Open →
◷
Roles & Responsibilities
Every charter & team role at the product-delivery edge
⏱ 2026Open →
⛁
Data Dictionary
The agentic data-management foundation — MAS, knowledge graphs
⏱ 2026Open →
▢
Deliverables
Design-control deliverables by phase gate + AI deliverable creation engine
⏱ Jun 2026Open →
Initiatives
CoE initiatives led by the leadership team — blank canvases ready to build.
✦
PI Planning Optimization
Led by Paula Davis
Blank canvasOpen →
✦
Tool Optimization
Led by Anitha Athipathy
Blank canvasOpen →
✦
Performance Optimization
Led by Carlos Lopez
Blank canvasOpen →
✦
Enterprise Agile & Scrum Training
Led by Scott Desatnick
Blank canvasOpen →
✦
Metrics Standardization
Led by Evelyn Betances Topete
Blank canvasOpen →
✦
Operations Excellence
Led by Travis Picou
Blank canvasOpen →
Governance
The three systems that govern how we work — quality, business, and delivery.
✚
Quality Management System
Design controls, ISO 13485 / 21 CFR 820, IEC 62304, gate reviews, DHF, CAPA
QualityOpen →
⚖
Business Governance
PDT decision rights, stage-gates A–F, AOP, portfolio governance, milestones
BusinessOpen →
⟳
Agile Ways of Working
PI planning cadence, team composition, charter roles, sprint flow, RACI
DeliveryOpen →
Tools
The systems we use to run product delivery.
◦
Clarity
Portfolio, demand & resource management — the FY26 operating plan.
ToolOpen →
◦
Smartsheet
Status reporting & milestone rollups.
ToolOpen →
◦
Jira
Agile delivery — epics, sprints, velocity & defect flow.
ToolOpen →
◦
Jira Product Discovery
Idea & opportunity backlog; product discovery and prioritization.
ToolOpen →
◦
Confluence
Documentation, runbooks & decision logs.
ToolOpen →
◦
Microsoft Teams
Collaboration, meetings & channels.
ToolOpen →
◦
Arena PLM
PLM — BOM, change & document control.
ToolOpen →
AI
Personal AI experiments — what's live, what's emerging, what we're learning. Not an official program.
✦
AI Best Practices
A working notebook of the AI experiments — situational awareness, mindset, my initiatives, and the team toolkit
⏱ Jun 2026Open →
✦
Agents
The AI agent fleet — deliverable drafting, review, and risk analysis
⏱ Jun 2026Open →
Observability
Command Center
Comprehensive observability into portfolio & performance, relative to governance, as measured by our KPIs.
◉
Portfolio
Health matrix, programs, risk command, master register, watchlist, trends, deep analytics + the ten-insight narrative
⏱ May 2026Open →
▤
Metrics
33 metrics across the 8 PMBOK-7 domains + Agile + Contract — one source per metric, trended monthly
⏱ Apr 2026Open →
⚠
Risk Register
The 92-item master RAID register — risks, issues & opportunities, deduped, normalized & owned (native)
⏱ May 2026Open →
◷
Milestones
Investor-Day milestone commitment — met vs missed by quarter, trend, FY26 launches
⏱ May 2026Open →
◫
PDT
Portfolio Decision Team — May 15 decisions, action items, attendance, charter, next-PDT bar (native)
⏱ May 2026Open →
◷
Stakeholders
PDT seat ownership — 32 members by group, seats, May-15 attendance (native)
⏱ May 2026Open →
◳
AOP
FY27 plan simulator (scenario, Monte Carlo, capacity, builder) + reconciliation (Clarity vs FP&A vs baseline)
⏱ FY27 planOpen →
◑
Resource & Capacity
Critical gaps, plan-vs-actual, scenario planner, geo-shift + full-year demand vs capacity
⏱ May 2026Open →
▦
Program Gantt
GPDP phase timeline — program bars, RAG, milestone gates, Today line (rebuilt native)
⏱ Jun 2026Open →
Practice & Standards
Center of Excellence
What we do and how we do it. Best-practice focused.
★
Best-Practices Playbook
Decision playbook, RACI, anti-patterns, PMBOK-7 crosswalk, watermelon detector
⏱ May 2026Open →
◷
Roles & Responsibilities
Every charter & team role at the product-delivery edge
⏱ 2026Open →
⛁
Data Dictionary
The agentic data-management foundation — MAS, knowledge graphs
⏱ 2026Open →
Toolchain
Tools
The systems we use to run product delivery. Open one for links, SOPs, and usage notes.
◦
Clarity
Portfolio, demand & resource management — the FY26 operating plan.
ToolOpen →
◦
Smartsheet
Status reporting & milestone rollups.
ToolOpen →
◦
Jira
Agile delivery — epics, sprints, velocity & defect flow.
ToolOpen →
◦
Jira Product Discovery
Idea & opportunity backlog; product discovery and prioritization.
ToolOpen →
◦
Confluence
Documentation, runbooks & decision logs.
ToolOpen →
◦
Microsoft Teams
Collaboration, meetings & channels.
ToolOpen →
◦
Arena PLM
PLM — BOM, change & document control.
ToolOpen →
Personal AI
AI
Personal AI experiments — what's live, what's emerging, what we're learning. Not an official program.
✦
AI Best Practices
A working notebook of the AI experiments — situational awareness, mindset, my initiatives, and the team toolkit
⏱ Jun 2026Open →
Governance · Quality
The Quality Management System.
How Insulet proves the product is safe, effective, and compliant — the design-control spine that every program runs on, from concept through commercial release.
ISO 13485
QMS standard
21 CFR 820
FDA QSR
IEC 62304
SW lifecycle
A–F
Phase gates
What it governs
The objects of evidence the QMS keeps honest across the lifecycle.
Design Controls
Design history file (DHF)
User needs → design inputs → outputs → verification → validation, fully traceable. Design reviews at each gate, with independent reviewers.
Risk
ISO 14971 risk management
Hazard analysis, risk controls, and benefit-risk — maintained as a living file, not a one-time deliverable. Feeds labeling and post-market surveillance.
Software
IEC 62304 lifecycle
Module decomposition, interface specs, SOUP/OTS analysis, and verification mapped to the software safety class. Cybersecurity threat modeling integrated.
CAPA
MasterControl quality system
Corrective & preventive action, nonconformance, and audit findings tracked to closure with effectiveness checks. Feeds the quality dashboards.
Gate model
Phase gates A–F — each gate has entry criteria, required deliverables, and a named approver. No gate skips.
A · Concept→
B · Feasibility→
C · Development→
D · Verification→
E · Validation→
F · Launch
Go deeper
The detailed roles, DRIs, and process steps live in these surfaces — this page is the map, not a copy.
◷
QMS roles & DRIs
Core Team / PDT function DRIs, gate & specialist roles — who owns which quality artifact
CatalogOpen →
⛁
Data Dictionary
The agentic management data model behind the quality records
ReferenceOpen →
Governance · Business
How the business decides and steers.
Decision rights, portfolio governance, and the annual operating plan — the system that turns strategy into committed, funded, milestone-bearing work.
PDT
Decision body
AOP
Annual plan
Clarity
PPM system
FP&A
Finance partner
What it governs
The forums and instruments that allocate capital, people, and commitments.
Decision rights
Portfolio Decision Team
The PDT owns portfolio trade-offs — start/stop/continue, rebalancing, and escalations. Decisions are logged with owners and due dates.
Planning
Annual Operating Plan
FY27 plan built from capacity, demand, and milestone commitments. Scenario-simulated and reconciled to Clarity and FP&A before commit.
Commitments
Investor-Day milestones
Launch-flagged milestones tracked met-vs-missed by quarter. The single source of truth for what the company told the street.
Spend
Capex / Opex & R&D credit
Classification that is defensible to audit — a three-way reconciliation between Clarity PPM, the FP&A plan, and the baseline.
Decision cadence
A predictable rhythm so decisions land where the data is freshest.
Weekly · Program review→
Monthly · PDT→
Quarterly · Portfolio & scorecard→
Annual · AOP
Go deeper
The live instruments behind this system — linked, not duplicated.
◫
PDT
Decisions, action items, attendance, charter, and the next-PDT bar
LiveOpen →
◳
AOP
FY27 simulator (scenario, Monte Carlo, capacity) + 3-way reconciliation
PlanOpen →
◉
Portfolio
Health matrix, risk command, watchlist, trends, and the insight narrative
LiveOpen →
◷
Milestones
Investor-Day commitment — met vs missed by quarter, with launch flags
LiveOpen →
Governance · Delivery
Our Agile Ways of Working.
How teams are composed, how they plan, and how work flows — the delivery operating model that connects strategy to sprints without losing the thread.
PI Planning
Cadence anchor
Charter
Role definitions
RACI
PI cycle events
Jira
Flow system
What it governs
The structures that make agile predictable at portfolio scale.
Roles
Charter roles
Product Owner, Scrum Master, RTE, and team roles defined with mission, responsibilities, and interfaces — not titles, but accountabilities.
Teams
Team composition
How cross-functional teams are formed and sized — the standard pod, its skills mix, and its dependencies on shared services.
Planning
PI planning & cycle
The increment cadence, planning events, and the RACI that says who plans, who commits, and who clears dependencies.
Flow
Sprint & flow metrics
Velocity, defect flow, and epic status feeding portfolio health — honest signals, surfaced early, owned by name.
Increment rhythm
A steady heartbeat from planning to review.
PI Planning→
Sprints→
System demo→
Inspect & adapt
Go deeper
The detailed catalogs and best practices — linked from here.
◷
Roles & Responsibilities
Charter roles, team composition, and the PI-cycle RACI in full
CatalogOpen →
★
Best-Practices Playbook
Scope discipline, schedule, and how to spot a watermelon status
PracticeOpen →
Governance
Governance
The three systems that govern how we work — quality, business, and delivery. Standards, decision rights, and cadence, each with a single map.
✚
Quality Management System
Design controls, ISO 13485 / 21 CFR 820, IEC 62304, gate reviews, DHF, CAPA
QualityOpen →
⚖
Business Governance
PDT decision rights, stage-gates A–F, AOP, portfolio governance, milestones
BusinessOpen →
⟳
Agile Ways of Working
PI planning cadence, team composition, charter roles, sprint flow, RACI
DeliveryOpen →
Center of Excellence · Practice
The Best-Practices Playbook.
Our process flow charts, merged into one place: the AI-augmented operating model and the four standing PMO processes with their control gates.
Operating model — one trigger, two human stops
The owner starts it; agents research and assemble; a human makes the judgment call; a human executes. Agents never send, spend, or mutate a system of record.
TRIGGER
Owner asks
A real question enters the board.
›
AUTO
Research
Fleet fans out, gathers witnessed facts.
›
◆ STOP 1
Judgment gate
A blank to fill, not a paragraph to rubber-stamp.
›
AUTO
Assemble + draft
Ops builds, Comms drafts in your voice.
›
◆ STOP 2
Final review
Confirm or regenerate. Trace links light up.
›
HUMAN
Execute
Send · gate · commit. Never an agent.
PR-SAFE
No send, post, spend, or system-of-record mutation by an agent. Drafts and staging only.
Cost-disciplined
A loop that never changes the output is a loop you cut. Every step earns its keep.
The four PMO process flows
Four standing processes · 34 documented steps · 8 control gates · one Process-Steward contract.
PROCESS 01
PDT Prep
Cadence: T-10 to T+3 around PDT
Lead: PMO Ops with VP of PMO + chairs
Exit: Pre-read sent, PDT run, minutes signed, actions logged
Feeds: Decision/action ledger, monthly status inputs, portfolio memory
PROCESS 02
PMO Monthly Status Report
Cadence: ME-4 to the 1st
Lead: PMO Ops, PMs, and reporting engine
Exit: Monthly report, tracker, data pack, and MoM log archived
Feeds: Command Center, quarterly status, resource & risk routines
PROCESS 03
PMO Quarterly Status Update
Cadence: BD5 to BD10 after quarter close
Lead: PMO Ops with VP of PMO confirmation
Exit: Executive tracker PDF, data pack, follow-up note, carried actions
Feeds: AOP/FY planning, executive decision history, monthly carry-forward
PROCESS 04
Clarity Monthly Closeout
Cadence: MC-1, one day before month close
Lead: PMO Ops
Exit: VP email sent with PowerBI report link and approval action
Feeds: Time-card approval escalation before close
How the four-process rhythm connects
The processes hand off to each other on a monthly/quarterly heartbeat.
1
Clarity triggers the closeout escalation
Process 04 sends the VP-level PowerBI time-card compliance report one day before close.
2
Monthly Status publishes the portfolio story
Process 02 turns PM updates and clean data into the monthly report and pack.
3
PDT Prep turns status into decisions
Process 01 moves the portfolio story into the meeting, decisions, minutes, and ledger.
4
Quarterly Status packages executive trajectory
Process 03 uses monthly history and PDT decisions to carry the quarter forward.
Control gates register
What must be true to pass — and the failure path if it is not.
| Process | Gate | Criteria | Evidence | If it fails |
|---|---|---|---|---|
| PDT Prep | T-3 update-readiness | All presenting program updates are in the working deck; agenda risk is visible. | Working Teams deck, presenter list, late-slide log. | Chase same day; escalate to chair if agenda is at risk. |
| PDT Prep | VP pre-read review | Pre-read is reviewed before it goes to T1/T2/Cross-Segment members. | Reviewed deck, version marker, send list. | Fix in place; do not send until reviewed. |
| PDT Prep | Minutes sign-off | Decisions/actions are in approved format and logged before distribution. | Signed minutes, attendance, action/decision log. | Hold distribution; resolve owner/date gaps first. |
| Monthly Status | ME-2 PM update gate | PM sections are current enough for the compressed final-week build. | Deck sections, stale-date scan, gap list. | Chase same day; build starts Monday regardless. |
| Monthly Status | Engine exit OK | Standing reporting engine completed without a failed exit line. | Engine output folder, XLSX pack, Command Center sync. | Fix input issue and rerun; do not patch output by hand. |
| Monthly Status | ME accuracy gate | Report read end-to-end and spot-checked against source. | Read-through notes, 3-program spot checks, RAG/date exceptions. | Correct source or deck, then rerun/re-export. |
| Quarterly Status | BD7 accuracy gate | Milestones, launches, and quarter RAG are evidenced at source. | Smartsheet export, PDT minutes, trend.json, gap-analysis. | Correct source and regenerate; no hand-editing output. |
| Quarterly Status | Recipient confirmation | Distribution audience confirmed before the executive packet is sent. | VP of PMO confirmation, PDF, data pack, follow-up note. | Hold distribution until audience is settled. |
Command Center · Agile
Agile Metrics Command Center.
PI-objective health, releases, defects, and test progress across the four platforms — from the 26Q2-5 syncs. Open a platform for the full detail.
4
Platforms
283
Objectives complete
42
At risk
26Q2-5
Reporting period
Platform scorecards
Click a platform for teams, releases, defects, and test progress.
◉ Pod
58 slides →
5 releases · 7 at risk · 69 complete
Open detail →
◫ Data Cloud
33 slides →
45% Complete · 27 at risk · 82 complete
Open detail →
◐ iOS
42 slides →
9 releases · 4 at risk · 99 complete
Open detail →
◑ Android Classic
28 slides →
135 bugs fixed · 4 at risk · 33 complete
Open detail →
Scrum Team Delivery Metrics
Per-team agile health from Jira — throughput (resolved, last 90 days), work in progress, backlog, overall resolved rate, and bug share. Live snapshot.
Pod SoftwareOP5POD · 181 active
423
Throughput 90d
159
In progress
1207
Backlog
32%
Resolved
3%
Bugs
Mobile · iOSPDMI · 159 active
500
Throughput 90d
121
In progress
860
Backlog
41%
Resolved
17%
Bugs
Mobile · ModernMODB · 75 active
178
Throughput 90d
80
In progress
488
Backlog
32%
Resolved
7%
Bugs
Cloud PlatformMBCLD · 213 active
1725
Throughput 90d
147
In progress
827
Backlog
65%
Resolved
54%
Bugs
Discover / DataINSIGHT · 48 active
247
Throughput 90d
43
In progress
50
Backlog
73%
Resolved
0%
Bugs
Algorithm / SmartAdjustALGO · 30 active
59
Throughput 90d
35
In progress
70
Backlog
43%
Resolved
3%
Bugs
DSCX · NextGen CRMNGCRMI · 77 active
484
Throughput 90d
140
In progress
329
Backlog
59%
Resolved
3%
Bugs
System TestSYS · 97 active
18
Throughput 90d
138
In progress
544
Backlog
4%
Resolved
5%
Bugs
Center of Excellence · Artifacts
Deliverables & RACI.
The audit-ready deliverables of the design-control lifecycle — components, gate criteria, and full R/A/C/I across 25 DRI functions — plus an AI engine that drafts any of them.
Uses the Claude connection from Settings. ◌ Supabase
149
Deliverables
6
Phase gates
52
Gate-required
25
DRI functions
Deliverable cards & components
By phase gate. Expand a card for acceptance criteria and standards references.
Phase A Concept · 20 deliverables
Phase A◆ Gate
Product Concept Document
Defines the product vision, target user, problem statement, and proposed solution at a high level. Serves as the North Star for Phase A exploration.
Components
Executive SummaryProblem Statement & Unmet NeedTarget User ProfileProposed Solution OverviewKey Assumptions & HypothesesSuccess MetricsCompetitive Differentiation
Acceptance criteria & references
Acceptance criteria
- Clear articulation of the user problem being solved
- Identified target patient/HCP population
- Preliminary competitive positioning
- Alignment with Insulet strategic priorities
- Endorsed by Product Management and Commercial
References
- ISO 13485:2016 §7.3.2 — Design & Development Planning
- Insulet Product Delivery Phase A Gate Criteria
Phase A
Customer Insights Report
Synthesizes primary and secondary research on target users — needs, pain points, behaviors, and willingness to adopt. Forms the evidence base for the product concept.
Components
Research MethodologyPatient Insights (Jobs, Pains, Gains)HCP Insights (Prescribing Drivers)Payer Insights (Coverage/Value)Unmet Needs PrioritizationCompetitive User Experience AssessmentRecommendations
Acceptance criteria & references
Acceptance criteria
- Minimum N=30 patient interviews or survey responses
- HCP input from ≥5 endocrinologists/CDEs
- Clear prioritization of needs with evidence weighting
- Validated problem-solution fit hypothesis
References
- VoC Best Practices
- Kano Model
- MaxDiff Analysis
Phase A◆ Gate
Preliminary Business Case
Rough financial model justifying investment in Phase B. Includes TAM/SAM/SOM, revenue projections, cost estimates, and NPV/IRR at ±50% confidence.
Components
Market Sizing (TAM/SAM/SOM)Revenue Projections (5-year)COGS & Gross Margin EstimatesR&D Investment RequiredNPV / IRR AnalysisKey Financial AssumptionsSensitivity AnalysisInvestment Ask
Acceptance criteria & references
Acceptance criteria
- Financial model reviewed by Finance
- Revenue assumptions sourced from market data
- COGS estimates validated with Manufacturing
- NPV positive under base-case scenario
- Risk-adjusted projections included
References
- Insulet Financial Model Template
- Capital Expenditure Request (CER) Process
Phase A
Draft Program Charter
Establishes the program identity — scope boundaries, team structure, governance tier, key milestones, and preliminary budget. Authorizes the program to enter Phase B.
Components
Program Name & DescriptionBusiness Objectives & Success CriteriaScope Statement (In/Out)Core Team Roster & DRI AssignmentsGovernance Tier & Review CadencePreliminary Schedule & Key MilestonesBudget Estimate (±50%)Key Risks & DependenciesStakeholder Map
Acceptance criteria & references
Acceptance criteria
- Scope boundaries clearly defined (in-scope vs. out-of-scope)
- Core team identified with all 15 DRI functions
- Governance tier determined via Scaling Calculator
- Milestone dates aligned with portfolio roadmap
- PDT endorsement for Phase B entry
References
- Insulet Program Charter Template
- Product Delivery Tier Scaling Calculator
Phase A
Preliminary Risk Assessment
Initial identification of product, process, and program risks. Establishes the risk management framework and identifies top hazards requiring feasibility investigation.
Components
Risk Management Plan (Draft)Hazard IdentificationPreliminary Severity & Probability RatingsTop 10 Risk ItemsFeasibility Investigation PlanRisk Acceptability CriteriaRisk Control Strategy
Acceptance criteria & references
Acceptance criteria
- ISO 14971 risk management plan initiated
- Top risks identified with preliminary severity/probability
- Feasibility investigation plan for high-risk items
- Risk acceptability criteria defined per Insulet policy
References
- ISO 14971:2019 — Medical Device Risk Management
- IEC 62366-1 — Usability Engineering
- Insulet Risk Management SOP
Phase A◆ Gate
Technical Feasibility Assessment
Evaluates whether the proposed product concept is technically achievable within the target timeline, cost, and quality constraints. Covers hardware, software, algorithm, and manufacturing feasibility.
Components
Technology Readiness AssessmentCore Technical ChallengesHardware Feasibility (Mechanical, Electrical, Fluidics)Software Feasibility (Algorithm, Connectivity, Cybersecurity)Manufacturing Feasibility (Process, Scale, Yield)Key Technical Risks & UnknownsFeasibility Investigation PlanResource & Timeline EstimateGo/No-Go Recommendation
Acceptance criteria & references
Acceptance criteria
- All critical technical challenges identified with feasibility paths
- Technology readiness level (TRL) assessed for each subsystem
- Manufacturing process conceptually validated
- Key technical risks documented with mitigation strategies
- Engineering leadership sign-off on feasibility conclusion
References
- NASA TRL Scale
- IEC 62304 — SW Lifecycle
- ISO 13485 §7.3.2 — Design Planning
Phase A◆ Gate
Market Feasibility Assessment
Validates that a viable market exists for the product concept. Covers addressable market sizing, competitive landscape, customer willingness to adopt, and commercial viability.
Components
Total Addressable Market (TAM/SAM/SOM)Target Customer Segments & PersonasCompetitive Landscape AnalysisCustomer Needs Validation (VOC Summary)Willingness to Pay / AdoptDistribution Channel AssessmentReimbursement LandscapeCommercial Viability ConclusionKey Market Risks
Acceptance criteria & references
Acceptance criteria
- Market sizing based on credible data sources
- At least one validated customer segment with unmet need
- Competitive differentiation articulated
- Preliminary pricing/reimbursement feasibility confirmed
- Product Management sign-off on market opportunity
References
- Insulet Market Research Guidelines
- Payer Landscape Database
- Competitive Intelligence Reports
Phase A◆ Gate
Regulatory Pathway Assessment
Comprehensive regulatory landscape assessment performed at concept stage. Scans regulatory precedents, determines device classification, selects the submission pathway, identifies applicable standards and clinical evidence requirements, estimates the regulatory timeline, and flags key risks. This single deliverable replaces the need for separate preliminary and draft regulatory documents.
Components
Device Classification (US Class I/II/III, EU Class I/IIa/IIb/III, ROW)Regulatory Precedent Scan (similar cleared/approved devices)Predicate / Equivalent Device AnalysisSubmission Pathway (510(k), De Novo, PMA, CE Technical File)Applicable Standards & Guidance DocumentsClinical Evidence Requirements & Gap AssessmentInternational Filing StrategyRegulatory Timeline EstimateKey Regulatory Risks & Red FlagsImpact on Program Scope & ResourcesPost-Market Obligations Preview
Acceptance criteria & references
Acceptance criteria
- Device classification confirmed with regulatory precedent
- At least 3 regulatory precedents identified
- Submission pathway selected with rationale
- Applicable standards identified and mapped to deliverables
- Clinical evidence gaps assessed
- Timeline aligned with overall program plan
- Key regulatory risks documented with mitigation approach
- Regulatory Affairs sign-off on pathway viability
References
- FDA Product Classification Database
- EUDAMED Database
- 21 CFR 860 — Device Classification
- FDA Guidance: Choosing a Regulatory Pathway
- EU MDR 2017/745 Annex VIII
- Insulet Regulatory Strategy Template
Phase A◆ Gate
Business Needs Assessment
Defines what Insulet needs to deliver this product — resource requirements, capability gaps, infrastructure needs, partnership dependencies, and organizational readiness.
Components
Resource Requirements (FTE by Function)Capability Gap AnalysisInfrastructure & Tooling NeedsPartnership / Supplier DependenciesOrganizational Readiness AssessmentBudget Requirements (R&D + Capital)Timeline Dependencies & ConstraintsCross-Program Resource ConflictsInvestment Decision Framework
Acceptance criteria & references
Acceptance criteria
- Resource plan reviewed by all DRI function leads
- Capability gaps identified with acquisition/build plans
- Budget estimate within ±50% confidence
- Key dependencies and constraints documented
- EPM and Finance sign-off on delivery feasibility
References
- Insulet Resource Planning Model
- Capacity Management Dashboard
- Capital Expenditure Request (CER) Process
Phase A◆ Gate
Competitive Analysis
Maps the competitive landscape — identifying direct and indirect competitors, their product capabilities, market positioning, pricing, and vulnerabilities — to define Insulet’s differentiation strategy.
Components
Competitor Identification (Direct & Indirect)Product Feature Comparison MatrixTechnology & Patent LandscapeMarket Share & Revenue BenchmarkingPricing & Reimbursement ComparisonStrengths / Weaknesses AnalysisCompetitive Differentiation StrategyThreat Assessment & Response PlanCompetitive Intelligence Sources
Acceptance criteria & references
Acceptance criteria
- All major competitors identified with product details
- Feature comparison matrix completed with verified data
- Clear differentiation strategy articulated
- Competitive threats ranked by severity and probability
- Product Management sign-off on competitive positioning
References
- Insulet Competitive Intelligence Database
- FDA 510(k) Database (Predicates)
- Patent Search Tools
- Industry Analyst Reports
Phase A◆ Gate
User Needs Assessment
Captures and validates the needs of target users — patients, healthcare professionals, and caregivers — through primary and secondary research to form the evidence base for design inputs.
Components
Target User PopulationsUse Environment AnalysisUser Needs Elicitation (Interviews, Observation, Surveys)Needs Prioritization (Critical vs. Important vs. Nice-to-Have)Patient Journey MappingHCP Workflow Integration NeedsCaregiver & Support NeedsAccessibility RequirementsUnmet Needs Gap AnalysisNeeds Traceability to Concept
Acceptance criteria & references
Acceptance criteria
- Minimum N=20 user research participants across target populations
- Critical user needs identified with supporting evidence
- Needs prioritized using structured methodology
- User needs traceable to product concept features
- Human Factors sign-off on user needs completeness
References
- IEC 62366-1:2015 — Usability Engineering
- FDA Guidance: Applying Human Factors
- ISO 14971:2019 §5 — Use-Related Risk
Phase A◆ Gate
Rough Project Estimate
Provides a high-level investment estimate (±50% confidence) for the full program lifecycle — from Phase B through launch — to enable informed go/no-go decisions at concept stage.
Components
Scope Summary & Key AssumptionsR&D Investment Estimate (by Phase)Capital Expenditure RequirementsHeadcount & Resource Cost EstimateExternal Costs (Testing, Consultants, Clinical)Tooling & Manufacturing Setup CostsRegulatory & Clinical Trial CostsTotal Program Investment RangeTimeline to RevenueKey Cost Drivers & Sensitivities
Acceptance criteria & references
Acceptance criteria
- Estimate covers all phases B through F
- Confidence range explicitly stated (±50%)
- Key assumptions documented and sourced
- Reviewed by Finance and Engineering leadership
- Investment range supports business case NPV analysis
References
- Insulet Program Estimation Framework
- Capital Expenditure Request (CER) Process
- Historical Program Cost Database
Phase A◆ Gate
Target Product Profile (TPP)
The capstone Phase A deliverable that synthesizes all concept-stage assessments — technical feasibility, market feasibility, competitive analysis, user needs, regulatory pathway, and business needs — into a single product definition document. Defines minimum acceptable and ideal product attributes across every dimension. The TPP is the North Star aligning R&D, Commercial, and Regulatory through all subsequent phases.
Components
Executive Summary (Concept Synthesis)Clinical Performance TargetsUser Needs Summary (from User Needs Assessment)Usability & Form Factor RequirementsTechnical Feasibility Summary (from Technical Feasibility Assessment)Market Opportunity Summary (from Market Feasibility Assessment)Competitive Positioning (from Competitive Analysis)Regulatory Pathway Summary (from Regulatory Pathway Assessment)Connectivity & Digital FeaturesEconomic Value PropositionInvestment Summary (from Rough Project Estimate)Attribute Weighting & Trade-offsTPP Evolution Plan (A→F)Go/No-Go Recommendation
Acceptance criteria & references
Acceptance criteria
- Min/target/ideal specified for each product attribute
- All Phase A assessments synthesized and cross-referenced
- Trade-off analysis documented with rationale
- Competitive differentiation clearly articulated
- Investment requirements aligned with business case
- Endorsed by Product, R&D, Regulatory, Commercial, and Finance
- IC/PDT endorsement for Phase B entry
References
- Insulet TPP Template
- ISO 13485 §7.3.2
- Phase A Assessment Documents
Phase A
Competitive Benchmarking
Systematic comparison of competitive products across features, clinical outcomes, pricing, market share, and user experience.
Components
Competitor IdentificationFeature Comparison MatrixClinical Outcome ComparisonPricing & Reimbursement ComparisonMarket Share AnalysisUX & Satisfaction BenchmarksCompetitive Gaps & Opportunities
Acceptance criteria & references
Acceptance criteria
- All major competitors included
- Data sources cited
- Gaps mapped to product strategy
- Updated quarterly
References
- Insulet Competitive Intelligence SOP
Phase A
Design Controls Framework
Establishes the design control framework for the program — procedures, roles, review points, and DHF structure.
Components
Design Control PlanDHF Structure & IndexDesign Review ScheduleChange Control ProcessDocument Control RequirementsQuality PlanningAudit Schedule
Acceptance criteria & references
Acceptance criteria
- Design control plan approved
- DHF structure established
- Review milestones defined
- Change control process active
References
- 21 CFR 820.30
- ISO 13485 §7.3
- FDA Design Control Guidance
Phase A
Regulatory Strategy & Pathway
Comprehensive regulatory strategy covering classification, submission pathway, standards applicability, and international filing plan.
Components
Device ClassificationPredicate AnalysisSubmission Type (510k/PMA/De Novo/CE)Standards Gap AnalysisRegulatory TimelinePre-Submission StrategyInternational Filing Sequence
Acceptance criteria & references
Acceptance criteria
- Classification confirmed
- Predicate(s) identified
- Timeline within program plan
- Pre-Sub meeting planned
References
- 21 CFR 860
- EU MDR 2017/745
- FDA Guidance Documents
Phase A
Rough Business Case
Preliminary financial model at ±50% confidence justifying Phase B investment. TAM/SAM/SOM and rough NPV/IRR.
Components
Market Sizing (TAM/SAM/SOM)Revenue Projections (5yr)COGS EstimatesR&D Investment RequiredNPV/IRR AnalysisKey AssumptionsSensitivity Analysis
Acceptance criteria & references
Acceptance criteria
- Financial model reviewed by Finance
- Revenue assumptions sourced
- NPV positive under base case
- Risk-adjusted projections included
References
- Insulet Business Case Template
- CER Process
Phase A
IP Landscape Scan
Patent landscape analysis identifying relevant patents, white space opportunities, and potential infringement risks in the design space.
Components
Search Strategy & KeywordsPatent Landscape VisualizationKey Patent ClustersWhite Space OpportunitiesPotential Infringement RisksCompetitor IP Portfolio AnalysisRecommendations
Acceptance criteria & references
Acceptance criteria
- Comprehensive search documented
- Key patents analyzed
- White space mapped
- Infringement risks flagged
- Reviewed by IP counsel
References
- Insulet IP SOP
Phase A
Trade Secret Protection
Plan for protecting proprietary know-how, algorithms, and manufacturing processes as trade secrets.
Components
Trade Secret InventoryClassification CriteriaAccess Control MeasuresNDA RequirementsEmployee AgreementsVisitor ProtocolsDigital Security MeasuresBreach Response Plan
Acceptance criteria & references
Acceptance criteria
- Trade secrets identified and classified
- Access controls implemented
- NDA coverage confirmed
- Employee agreements current
References
- Insulet Trade Secret SOP
- DTSA
Phase A◆ Gate
Stage Exit Presentation — Phase A (Concept)
Formal presentation deck delivered to the Pipeline Decision Team (PDT) summarizing Phase A outcomes, concept viability, and requesting authorization to proceed to Phase B (Feasibility). Follows Insulet Stage Exit Review format.
Components
Program Identity & Governance TierExecutive Summary (1-slide)Problem Statement & Unmet NeedProduct Concept OverviewTechnical Feasibility SummaryMarket Feasibility SummaryRegulatory Pathway AssessmentPreliminary Risk Profile (Top 5)Preliminary Business Case (TAM/SAM, NPV range)Resource & Timeline EstimatePhase A Exit Criteria Compliance MatrixDRI Sign-Off StatusOpen Items & RisksGO / NO-GO Recommendation Request
Acceptance criteria & references
Acceptance criteria
- All Phase A exit criteria addressed with evidence
- DRI sign-off status current (15 functions)
- Top risks identified with mitigations
- Financial viability confirmed at ±50% confidence
- PDT presentation rehearsed with core team
- Presentation ≤25 slides plus appendix
References
- SOP-003 — Design Control
- QSP-122 — Design & Development Planning
- Phase A Exit Criteria Matrix
- PDT Review Protocol
Phase B Feasibility · 27 deliverables
Phase B◆ Gate
Design Input Requirements (CRS/PRS/HRS)
Formal design inputs that define WHAT the product must do. Includes customer requirements (CRS), product requirements (PRS), and hardware requirements (HRS) with full traceability.
Components
Functional RequirementsPerformance RequirementsSafety RequirementsRegulatory RequirementsEnvironmental & Durability RequirementsInterface RequirementsUsability RequirementsCybersecurity RequirementsLabeling RequirementsTraceability Matrix (Input → Output)
Acceptance criteria & references
Acceptance criteria
- All requirements uniquely identified and traceable
- Requirements reviewed by all 15 DRI functions
- Ambiguity audit completed (no TBDs remaining)
- Design Input Review (DIR) meeting minutes documented
- Requirements frozen and under change control
References
- 21 CFR 820.30(c) — Design Input
- ISO 13485:2016 §7.3.3
- FDA Guidance: Design Control
Phase B◆ Gate
Integrated Program Plan (IPP)
Master schedule integrating all functional workstreams, dependencies, milestones, and resource allocations. Baselined at Phase B exit.
Components
Master Schedule (Gantt/Timeline)Critical Path AnalysisFunctional Workstream PlansResource Allocation MatrixDependency Map (Cross-Program)Risk-Adjusted ScheduleBudget BaselineCommunication PlanChange Control Process
Acceptance criteria & references
Acceptance criteria
- All functional leads have contributed their workstream schedules
- Critical path identified with float analysis
- Resource conflicts resolved
- Dependencies mapped and owners assigned
- Schedule baselined in project management tool
References
- Insulet IPP Template
- SAFe PI Planning
- Clarity PPM
Phase B
Business Case — Final
Definitive financial justification for full program investment. Refined from Phase A with ±25% confidence. Locked as part of the Program Contract.
Components
Market Opportunity UpdateRevenue Model (Units × ASP × Mix)COGS & Margin AnalysisR&D & CapEx Investment5-Year P&L ProjectionNPV / IRR / Payback PeriodScenario Analysis (Best/Base/Worst)Competitive SensitivityResource RequirementsGo/No-Go Recommendation
Acceptance criteria & references
Acceptance criteria
- NPV positive under base-case scenario
- IRR exceeds Insulet hurdle rate
- COGS validated by Manufacturing Engineering
- Revenue model endorsed by Commercial
- Finance sign-off on all assumptions
References
- Insulet Business Case Template
- CER Process
- Portfolio Prioritization Framework
Phase B
Program Contract
Formal agreement between the program team and PDT/IC on scope, budget, timeline, and success criteria. The contract is the baseline against which execution is measured.
Components
Program Scope Statement (Final)Committed Milestones & DatesBudget AuthorizationResource Commitments by FunctionSuccess Criteria & KPIsRisk Tolerance & Escalation TriggersChange Control ThresholdsGovernance Review ScheduleSign-Off Page
Acceptance criteria & references
Acceptance criteria
- All 15 DRI leads have signed off
- PDT has approved scope, budget, and timeline
- Success criteria are measurable and time-bound
- Change control thresholds defined
- Escalation triggers clearly stated
References
- Insulet Program Contract Template
- Product Delivery Governance Framework
Phase B◆ Gate
Program Scope Statement
Defines the boundaries of the program — what is in scope and what is explicitly out of scope. Establishes the baseline for change control and prevents scope creep.
Components
Program Overview & ObjectivesIn-Scope Features & FunctionsOut-of-Scope Items (Explicit Exclusions)Target Users & Use EnvironmentsGeographic & Regulatory ScopePlatform & Technology BoundariesIntegration PointsAssumptions & ConstraintsScope Change Control Process
Acceptance criteria & references
Acceptance criteria
- In-scope/out-of-scope boundaries clearly defined
- All 15 DRI functions reviewed and agreed
- PDT approved
- Under change control
- Referenced in Program Contract
References
- Insulet Program Scope Template
- SOP-003
- Product Delivery Governance Framework
Phase B◆ Gate
IP Assessment
Comprehensive intellectual property assessment covering freedom-to-operate, patentability of novel features, competitive IP landscape, and licensing requirements.
Components
IP Landscape ScanFreedom-to-Operate (FTO) AnalysisPatentability AssessmentCompetitive Patent ReviewLicensing RequirementsTrade Secret IdentificationIP Risk Mitigation StrategyPatent Filing Recommendations
Acceptance criteria & references
Acceptance criteria
- FTO analysis completed for all key design features
- Patentability opinion obtained for novel innovations
- IP risks identified with mitigation plan
- Legal/IP sign-off obtained
- Filing strategy aligned with program timeline
References
- Insulet IP Assessment Template
- FTO Analysis Framework
Phase B◆ Gate
Risk Management Plan
Complete risk management plan covering all identified hazards, severity/probability ratings, risk control strategy, and residual risk evaluation framework. The Design FMEA (dFMEA) is baselined in Phase C after design outputs are sufficiently mature.
Components
Risk Management Plan (Final)Intended Use & Foreseeable MisuseHazard AnalysisRisk Evaluation (Severity × Probability)Risk Control StrategyResidual Risk Acceptability CriteriaRisk-Benefit Analysis FrameworkRisk Management Review Schedule
Acceptance criteria & references
Acceptance criteria
- All known hazards identified and analyzed
- Risk acceptability criteria defined per Insulet policy
- Risk control strategy documented for all unacceptable risks
- Risk management plan reviewed and approved by Quality
References
- ISO 14971:2019
- IEC 60812 — FMEA Techniques
- 21 CFR 820.30(g)
- Insulet Risk Management SOP
Phase B◆ Gate
Preliminary Go-to-Market Plan
Initial commercial launch strategy establishing target segments, positioning hypothesis, pricing strategy, channel approach, and preliminary Year 1 revenue targets. Refined into the Final GTM Plan by Phase D exit.
Components
Target Market SegmentsPositioning & Messaging FrameworkPricing & Reimbursement StrategyChannel & Distribution PlanSales Enablement & Training PlanLaunch Timeline & MilestonesKOL Engagement StrategyMarketing BudgetYear 1 Revenue TargetsCompetitive Response Plan
Acceptance criteria & references
Acceptance criteria
- Target segments validated by market research
- Pricing aligned with value proposition and payer landscape
- Channel strategy confirmed with distribution partners
- Sales team training curriculum designed
- Year 1 targets endorsed by Commercial leadership
References
- Insulet GTM Template
- Launch Playbook
Phase B
Backlog Prioritization
Prioritized product backlog connecting user needs to development work items. Uses WSJF or MoSCoW to rank features by value, risk, and effort.
Components
Backlog Items with User StoriesPriority Ranking (WSJF/MoSCoW)Sprint/PI AssignmentAcceptance Criteria per ItemDependencies MapCapacity Alignment
Acceptance criteria & references
Acceptance criteria
- All items traced to user needs
- Priority rationale documented
- Capacity validated with engineering
- Top items ready for sprint planning
References
- SAFe WSJF Framework
- Insulet Agile WoW
Phase B
System Architecture Diagram
High-level system architecture showing all subsystems, interfaces, data flows, and external system connections.
Components
System Context DiagramBlock DiagramData Flow DiagramCommunication ArchitecturePower ArchitectureSafety ArchitectureDeployment Architecture
Acceptance criteria & references
Acceptance criteria
- All subsystems represented
- Interfaces documented
- Reviewed by HW, SW, and Systems
- Maintained under version control
References
- Insulet Systems Architecture Template
Phase B
Acceptance Criteria
Measurable acceptance criteria for each design output, defining pass/fail thresholds for verification and validation testing.
Components
Performance Acceptance CriteriaSafety Acceptance CriteriaUsability Acceptance CriteriaReliability Acceptance CriteriaEnvironmental Acceptance CriteriaStatistical Basis for Sample Sizes
Acceptance criteria & references
Acceptance criteria
- All criteria measurable and objective
- Statistical rationale documented
- Aligned with design inputs
- Reviewed by Quality
References
- ISO 13485 §7.3.4
- 21 CFR 820.30(d)
Phase B
Standards Gap Analysis
Analysis of applicable consensus standards (IEC, ISO, ASTM) and identification of gaps in current design/test coverage.
Components
Applicable Standards ListClause-by-Clause AssessmentCompliance Status (Full/Partial/Gap)Gap Closure PlanTest RequirementsTimeline for Compliance
Acceptance criteria & references
Acceptance criteria
- All applicable standards identified
- Gaps documented with closure plans
- Test requirements defined
- Timeline aligned with program schedule
References
- FDA Recognized Consensus Standards
- EU Harmonized Standards
Phase B
Pre-Submission Packages
Pre-Submission (Q-Sub) meeting request package for FDA feedback on regulatory pathway, testing strategy, or clinical requirements.
Components
Meeting Request LetterDevice DescriptionProposed Regulatory PathwaySpecific Questions for FDAProposed Testing StrategySupporting DataProposed Labeling Concepts
Acceptance criteria & references
Acceptance criteria
- Focused questions (max 5-7)
- Supporting data included
- Internal review completed
- Submitted 75 days before desired meeting
References
- FDA Q-Sub Guidance
- Insulet Pre-Sub SOP
Phase B
Medical Affairs Guidance
Medical affairs input on clinical positioning, KOL engagement, medical education strategy, and scientific communication plan.
Components
Clinical Positioning StatementKOL Identification & Engagement PlanMedical Education StrategyScientific Publication PlanAdvisory Board PlanMedical Information Response Plan
Acceptance criteria & references
Acceptance criteria
- Clinical positioning aligned with evidence
- KOL list prioritized
- Publication plan timeline set
- Medical information responses prepared
References
- Insulet Medical Affairs SOP
Phase B
Refined Business Case (Finance Review)
Definitive financial justification at ±25% confidence. Locked as part of Program Contract.
Components
Revenue Model (Units × ASP × Mix)COGS & Margin AnalysisR&D & CapEx Investment5-Year P&LNPV/IRR/PaybackScenario AnalysisCompetitive SensitivityGo/No-Go Recommendation
Acceptance criteria & references
Acceptance criteria
- NPV positive under base case
- IRR exceeds hurdle rate
- COGS validated by Manufacturing
- Finance sign-off obtained
References
- Insulet Business Case Template
Phase B
Pricing & Reimbursement Strategy
Pricing strategy and reimbursement pathway analysis covering commercial, Medicare, Medicaid, and international markets.
Components
Pricing Research ResultsRecommended Price PointPayer LandscapeCoding Strategy (CPT/HCPCS)Coverage Determination PlanPrior Authorization WorkflowInternational Pricing
Acceptance criteria & references
Acceptance criteria
- Pricing supported by research
- Payer coverage pathway defined
- Coding strategy confirmed
- Finance concurrence on margin
References
- Insulet Pricing SOP
Phase B
KOL Engagement Plan
Key Opinion Leader identification, engagement strategy, and advisory board plan to drive clinical adoption.
Components
KOL Identification & TieringEngagement Strategy by TierAdvisory Board PlanSpeaker BureauClinical Champion DevelopmentCongress StrategyCompliance Guidelines
Acceptance criteria & references
Acceptance criteria
- KOL list prioritized
- Engagement activities planned
- Advisory board chartered
- Compliance review completed
References
- Insulet KOL Engagement SOP
Phase B
Task Analysis & Use Scenarios
Detailed task analysis defining user tasks, steps, decision points, and potential use errors for each use scenario.
Components
Use Scenario DefinitionsTask DecompositionCritical Task IdentificationUser Decision PointsPotential Use ErrorsHazardous SituationsTask Frequency & Criticality
Acceptance criteria & references
Acceptance criteria
- All use scenarios covered
- Critical tasks identified
- Use errors mapped to hazards
- Reviewed by Quality/Risk
References
- IEC 62366-1 §5.3
- Insulet UE SOP
Phase B
Threat Model (STRIDE/DREAD)
Systematic threat modeling using STRIDE/DREAD methodology to identify cybersecurity threats to the medical device system.
Components
System Architecture (DFD)Trust BoundariesSTRIDE Analysis per ComponentDREAD Risk ScoringThreat Mitigation StrategiesResidual Risk AssessmentThreat Model Maintenance Plan
Acceptance criteria & references
Acceptance criteria
- All components analyzed
- Trust boundaries defined
- Threats scored and prioritized
- Mitigations assigned
- Reviewed by security team
References
- IEC 81001-5-1
- FDA Cybersecurity Guidance (2023)
- AAMI TIR57
Phase B
Learning Strategy & Curriculum
Training strategy and curriculum design for all stakeholder groups — sales, clinical, patient, and internal teams.
Components
Training Needs AnalysisCurriculum DesignLearning ObjectivesDelivery MethodsAssessment StrategyTimelineResource Requirements
Acceptance criteria & references
Acceptance criteria
- All stakeholder groups covered
- Learning objectives measurable
- Delivery methods appropriate
- Assessment criteria defined
References
- Insulet Training SOP
- ADDIE Model
Phase B
Freedom-to-Operate (FTO) Analysis
Formal freedom-to-operate opinion assessing whether the product design infringes third-party patents.
Components
Design Feature AnalysisRelevant Patent IdentificationClaim Chart AnalysisInfringement Risk AssessmentDesign-Around OptionsFTO OpinionRisk Mitigation Recommendations
Acceptance criteria & references
Acceptance criteria
- All key features analyzed
- Claim charts completed
- Risk level assigned
- Design-around options identified
- IP counsel sign-off
References
- Insulet FTO Process
Phase B
Patent Filing Strategy
Strategy for protecting innovative features through provisional and utility patent filings.
Components
Inventive Features IdentificationPrior Art AssessmentFiling Priority & TimingProvisional vs. Utility DecisionInternational Filing Strategy (PCT)Inventor IdentificationBudget & Timeline
Acceptance criteria & references
Acceptance criteria
- Inventive features identified with inventors
- Prior art reviewed
- Filing timeline set
- Budget approved
References
- Insulet Patent Filing SOP
Phase B◆ Gate
Project Design & Development Plan (PDDP)
Master planning artifact defining milestones, resources, PI alignment, and phase gate target dates. Primary exit criteria for Phase B gate per SDLC Blueprint.
Components
Program Scope & ObjectivesPhase Gate Target DatesResource Allocation MatrixPI Planning AlignmentFunctional Workstream PlansDesign Control Checklist ReferenceRisk-Adjusted ScheduleCritical Path AnalysisBudget Baseline
Acceptance criteria & references
Acceptance criteria
- All functional leads have contributed workstream plans
- PI timing coordinated with Systems Engineering
- Phase gate dates aligned with portfolio roadmap
- PDDP approved by PDT
- Design Control Checklist initiated per QWI-397
References
- QSP-122 — Design & Development Planning
- SOP-003 — Design & Development Control
- SDLC Blueprint: Phase A-F Lifecycle
Phase B
Usability Engineering Plan
Defines the usability engineering process for the product per IEC 62366-1 including formative studies, summative validation, and use error risk analysis.
Components
Intended Use & User ProfilesUse Environment SpecificationKnown Use ProblemsUsability Goals & CriteriaFormative Evaluation PlanSummative Evaluation PlanUse Error Risk Analysis ApproachHuman Factors Validation StrategyUser Interface Design Principles
Acceptance criteria & references
Acceptance criteria
- Intended users and use environments defined
- Usability goals measurable
- Formative and summative study plans approved
- UERA approach aligned with QSP-257
- Human Factors lead sign-off
References
- QSP-044 — Usability Engineering
- IEC 62366-1:2015
- FDA Human Factors Guidance
Phase B
Cybersecurity Risk Assessment
Systematic evaluation of cybersecurity risks for the product including threat modeling, vulnerability assessment, and security control identification per Section 524B of FD&C Act.
Components
Threat Model (STRIDE/DREAD)Attack Surface AnalysisVulnerability AssessmentCybersecurity Risk MatrixSecurity Controls & MitigationsSBOM BaselinePenetration Testing PlanIncident Response ReadinessCoordinated Vulnerability Disclosure Plan
Acceptance criteria & references
Acceptance criteria
- Threat model completed with all attack vectors
- Risk matrix populated with cybersecurity-specific hazards
- Security controls mapped to threats
- SBOM baseline established
- Product Security sign-off
References
- QSP-049 — Cybersecurity Risk Analysis
- FDA Cybersecurity Guidance
- IEC 81001-5-1
Phase B
Design Control Checklist (DCC)
Living checklist tracking all design control deliverables throughout the development lifecycle. Created at Phase B entry and maintained through Phase F.
Components
Design Input ChecklistDesign Output ChecklistDesign Review RecordsVerification Evidence TrackingValidation Evidence TrackingDesign Transfer ChecklistDHF Completeness TrackingChange Control Log
Acceptance criteria & references
Acceptance criteria
- All Phase B design control items checked off
- Design input review documented
- Design review schedule established
- DCC under revision control
- Program Manager sign-off
References
- QWI-397 — Design Control Checklist
- QSP-122 — Design & Development Planning
- SOP-003
Phase B◆ Gate
Stage Exit Presentation — Phase B (Feasibility)
Formal presentation to PDT summarizing Phase B outcomes including frozen design inputs, integrated program plan, baselined business case, and Program Contract. Requests authorization to enter Phase C (Design & Development).
Components
Program Identity & Contract SummaryExecutive Summary (1-slide)Design Input Requirements StatusArchitecture & Design ConceptRisk Management Plan SummaryRegulatory Strategy UpdateBusiness Case — Final (NPV/IRR)Integrated Program Plan & Critical PathProgram Contract (Scope, Budget, Timeline)Go-to-Market Strategy OverviewResource Allocation & GapsPhase B Exit Criteria Compliance MatrixDRI Sign-Off StatusKey Risks & MitigationsInvestment Decision Request
Acceptance criteria & references
Acceptance criteria
- Design inputs frozen and under change control
- Program Contract endorsed by all DRI leads
- Business case NPV positive under base-case
- Risk management plan approved by Quality
- IPP baselined with critical path identified
- Presentation ≤30 slides plus appendix
References
- SOP-003 — Design Control
- QSP-122 — Design & Development Planning
- QSP-123 — Design Input
- Phase B Exit Criteria Matrix
- Program Contract Template
Phase C Development · 40 deliverables
Phase C◆ Gate
Design Output Specifications
Formal design outputs defining HOW the product meets design inputs. Includes hardware specs, software architecture, system integration specs, and acceptance criteria.
Components
Hardware Design SpecificationsElectrical Schematic & PCB LayoutMechanical Design (CAD/BOM)Software Design SpecificationSystem Interface SpecificationsDesign Output Acceptance CriteriaTraceability (Output → Input)Drawing Package
Acceptance criteria & references
Acceptance criteria
- Every design input has a corresponding design output
- Output specifications are measurable and verifiable
- BOM is locked and under change control
- Traceability matrix complete (input ↔ output)
- Design output review completed
References
- 21 CFR 820.30(d) — Design Output
- ISO 13485:2016 §7.3.4
- Insulet Design Control SOP
Phase C◆ Gate
Software Architecture (IEC 62304)
Software architecture document per IEC 62304, including SW classification (A/B/C), SOUP analysis, module decomposition, and interface specifications.
Components
Software Safety ClassificationArchitecture Overview & DiagramsModule DecompositionInterface SpecificationsSOUP/OTS Component AnalysisData Flow & State DiagramsError Handling StrategyCybersecurity ArchitectureTraceability (SW Req → Architecture)
Acceptance criteria & references
Acceptance criteria
- SW classification justified per IEC 62304 §4.3
- Architecture reviewed by SW team and Systems
- SOUP risks analyzed per IEC 62304 §8
- All interfaces documented
- Cybersecurity threats modeled
References
- IEC 62304:2006+A1:2015
- FDA Guidance: Content of Premarket Submissions for Software
- IEC 81001-5-1 — Health SW Cybersecurity
Phase C
System Integration Design
Defines how subsystems (HW, SW, sensors, connectivity) integrate into the complete system. Includes interface control documents and integration test strategy.
Components
System Block DiagramInterface Control Documents (ICDs)Integration Test StrategyCommunication ProtocolsPower Management DesignEMC/EMI ConsiderationsEnvironmental Stress AnalysisSystem-Level FMEA Inputs
Acceptance criteria & references
Acceptance criteria
- All subsystem interfaces formally documented
- Integration test plan covers all critical interfaces
- EMC/EMI pre-compliance testing planned
- System architecture review completed
References
- ISO 13485 §7.3
- IEC 60601-1
- Insulet Systems Engineering SOP
Phase C
Prototype Build
Engineering prototype(s) for formative testing, design verification planning, and stakeholder review. Documents build configuration, deviations, and lessons learned.
Components
Build Configuration & BOMPrototype ObjectivesBuild Quantity & DistributionDeviations from Design SpecsTest Results SummaryUser Feedback (Formative)Lessons LearnedRecommendations for Next Build
Acceptance criteria & references
Acceptance criteria
- Prototype meets minimum functional requirements
- Build deviations documented and risk-assessed
- Formative feedback captured and analyzed
- Design iteration plan created
References
- Insulet Prototype Build Procedure
Phase C
Formative Usability Study
Iterative usability evaluation with representative users to identify use errors and optimize the user interface before design freeze.
Components
Study ProtocolParticipant Recruitment CriteriaTask Scenarios & Success CriteriaData Collection MethodsUse Error AnalysisFindings & Severity ClassificationDesign RecommendationsStudy Report
Acceptance criteria & references
Acceptance criteria
- Minimum 5-8 representative participants per round
- Critical tasks tested with measurable success criteria
- Use errors identified and classified by severity
- Design changes recommended for critical findings
- Report suitable for regulatory submission
References
- IEC 62366-1:2015 §5.7
- FDA Guidance: Applying Human Factors
- Insulet Usability Engineering SOP
Phase C
Early Design Reviews
Formal and peer design reviews of subsystem designs at defined milestones during Phase C. Documents review findings, action items, and approvals.
Components
Review Type & ScopeReview Team & IndependenceDesign Artifacts ReviewedEvaluation CriteriaReview FindingsAction Items & OwnersDisposition (Approved / Conditional / Rejected)DHF Record
Acceptance criteria & references
Acceptance criteria
- Review team includes independent reviewer(s)
- All action items assigned with due dates
- Findings classified by severity
- Review record added to DHF
- All critical findings resolved before Phase D
References
- 21 CFR 820.30(e) — Design Review
- ISO 13485:2016 §7.3.5
- Insulet Design Review SOP
Phase C
Manufacturing Process Design
Design of the manufacturing process, including DFM/DFA analysis, process flow, equipment specifications, and preliminary process FMEA (pFMEA).
Components
Process Flow DiagramDFM/DFA AnalysisEquipment & Tooling SpecificationsProcess FMEA (pFMEA)Critical Process ParametersIn-Process ControlsPreliminary Validation StrategyYield & Cycle Time Targets
Acceptance criteria & references
Acceptance criteria
- DFM/DFA review completed with R&D
- pFMEA risk scores acceptable
- Critical process parameters identified
- Equipment/tooling specifications approved
- Pilot production plan defined
References
- 21 CFR 820.75 — Process Validation
- Insulet Manufacturing SOP
Phase C
Supplier Selection & Qualification
Selection and qualification of critical component suppliers, including quality agreements, incoming inspection plans, and dual-source strategies.
Components
Supplier Evaluation CriteriaSupplier Audit ResultsQuality AgreementIncoming Inspection PlanFirst Article Inspection (FAI)Dual-Source StrategySupply Chain Risk AssessmentApproved Supplier List Update
Acceptance criteria & references
Acceptance criteria
- Supplier audited and approved
- Quality agreement executed
- Incoming inspection procedures defined
- Dual-source identified for single-source risks
- ASL updated
References
- ISO 13485:2016 §7.4 — Purchasing
- Insulet Supplier Quality SOP
Phase C
BOM & Sourcing
Final Bill of Materials with sourcing decisions, cost targets, and component lifecycle risk assessment.
Components
Full BOM with Part NumbersComponent Cost BreakdownSourcing Decisions (Make/Buy)Component Lifecycle AssessmentObsolescence Risk AnalysisTarget COGS vs. ActualAlternate Part Strategy
Acceptance criteria & references
Acceptance criteria
- BOM locked and under change control
- All components sourced with confirmed lead times
- COGS within target margin
- Obsolescence risks mitigated
- BOM review completed with cross-functional team
References
- Insulet BOM Management SOP
Phase C
FMEA Updates
Updated dFMEA and new pFMEA reflecting detailed design decisions, test results, and manufacturing process insights from Phase C.
Components
dFMEA Updates (New Failure Modes)pFMEA (Process FMEA)Risk Score TrendingNew Risk Control MeasuresVerification of Risk ControlsResidual Risk UpdateRisk Management Report Update
Acceptance criteria & references
Acceptance criteria
- All new failure modes from Phase C captured
- pFMEA completed for manufacturing process
- Risk scores trending downward
- New mitigations verified effective
- Risk management file updated
References
- ISO 14971:2019
- IEC 60812
- Insulet FMEA SOP
Phase C
Hardware BOM
Complete Bill of Materials for the hardware design including all mechanical, electrical, and packaging components with part numbers, suppliers, and costs.
Components
Top-Level AssemblyMechanical ComponentsElectrical Components (PCB, Connectors)Packaging & Labeling MaterialsRaw MaterialsSupplier & Lead TimeUnit Cost BreakdownAlternate Parts
Acceptance criteria & references
Acceptance criteria
- All components have approved part numbers
- Dual-source for critical items
- Cost within target COGS
- BOM under change control
References
- Insulet BOM Management SOP
- ISO 13485 §7.5.3
Phase C
DFM/DFA Analysis
Design for Manufacturing and Design for Assembly analysis ensuring the product can be reliably and cost-effectively manufactured at scale.
Components
Manufacturability AssessmentAssembly Sequence AnalysisTolerance Stack-Up AnalysisMaterial Selection RationaleTooling RequirementsProcess Capability EstimatesCost Impact AnalysisDFM/DFA Recommendations
Acceptance criteria & references
Acceptance criteria
- All critical tolerances analyzed
- Assembly sequence validated
- Tooling approach confirmed
- Manufacturing concurrence obtained
References
- Insulet DFM/DFA Checklist
Phase C
Thermal & Structural Analysis
FEA/CFD analysis of thermal management and structural integrity under expected use conditions, drop, and environmental stress.
Components
Thermal Model & Boundary ConditionsTemperature Distribution ResultsStructural Load CasesStress/Strain AnalysisDrop Test SimulationSafety Margin CalculationsDesign Optimization Recommendations
Acceptance criteria & references
Acceptance criteria
- Thermal limits within IEC 60601 requirements
- Structural safety factors adequate
- Drop survival criteria met
- Analysis validated against prototype test data
References
- IEC 60601-1 §11
- Insulet Simulation SOP
Phase C
SW Architecture Document (R&D SW)
Software architecture document defining module decomposition, interfaces, data flows, and SOUP analysis per IEC 62304 software lifecycle standard.
Components
SW Safety Classification (A/B/C)Architecture DiagramsModule DecompositionInterface SpecificationsSOUP/OTS AnalysisData Flow DiagramsError Handling & RecoveryCybersecurity Architecture
Acceptance criteria & references
Acceptance criteria
- Classification justified per §4.3
- SOUP risks analyzed per §8
- All interfaces documented
- Architecture peer-reviewed
References
- IEC 62304:2006+A1:2015
- FDA SW Guidance
Phase C
Code Quality & Static Analysis
Static analysis reports, coding standard compliance, and code quality metrics demonstrating software implementation rigor.
Components
Coding Standard (MISRA-C / CERT-C)Static Analysis Tool & ConfigurationFindings SummaryCritical Finding ResolutionCode Coverage MetricsComplexity MetricsPeer Review Summary
Acceptance criteria & references
Acceptance criteria
- No critical static analysis findings open
- Code coverage meets target (e.g. ≥80%)
- Coding standard compliance documented
- Peer reviews completed for all modules
References
- IEC 62304 §5.5
- MISRA C:2012
- Insulet SW Development SOP
Phase C
Automated Test Suite
Comprehensive automated test suite including unit tests, integration tests, and system tests with traceability to software requirements.
Components
Test Strategy & FrameworkUnit Test CoverageIntegration Test CasesSystem Test CasesRegression Test SuiteTraceability (Req → Test → Result)CI/CD Pipeline ConfigurationTest Execution Reports
Acceptance criteria & references
Acceptance criteria
- All SW requirements covered by tests
- Unit test coverage ≥80%
- Integration tests passing
- CI/CD pipeline green
- Traceability complete
References
- IEC 62304 §5.7
- Insulet SW V&V SOP
Phase C
CI/CD Pipeline
Continuous Integration/Continuous Deployment pipeline configuration ensuring automated build, test, and deployment with quality gates.
Components
Pipeline ArchitectureBuild ConfigurationAutomated Test GatesCode Quality GatesArtifact ManagementDeployment StrategyRollback ProceduresPipeline Monitoring
Acceptance criteria & references
Acceptance criteria
- Pipeline fully automated
- All quality gates enforced
- Build artifacts versioned
- Rollback tested
References
- Insulet DevOps SOP
Phase C
API Design & Integration
API specifications for device-to-cloud, app-to-device, and third-party integrations including FHIR health data exchange.
Components
API Specification (OpenAPI/Swagger)Authentication & AuthorizationData Models & SchemasFHIR Resource MappingRate Limiting & ThrottlingError HandlingVersioning StrategyIntegration Test Plan
Acceptance criteria & references
Acceptance criteria
- API spec reviewed by all consumers
- Security review completed
- FHIR compliance validated
- Integration tests passing
References
- HL7 FHIR R4
- Insulet API Standards
Phase C◆ Gate
Software Requirements Specification (SRS)
Complete system-level requirements derived from user needs and design inputs, covering functional, performance, safety, and interface requirements.
Components
Functional RequirementsPerformance RequirementsSafety RequirementsInterface RequirementsEnvironmental RequirementsRegulatory RequirementsCybersecurity RequirementsTraceability to User Needs
Acceptance criteria & references
Acceptance criteria
- All requirements uniquely identified
- No TBDs remaining
- Reviewed by all DRI functions
- Traceability complete
- Under change control
References
- ISO 13485 §7.3.3
- 21 CFR 820.30(c)
- Insulet Systems Eng SOP
Phase C
Interface Control Documents
Formal specification of all interfaces between subsystems — electrical, mechanical, software, and communication protocols.
Components
Interface Identification MatrixElectrical InterfacesMechanical InterfacesSoftware InterfacesCommunication ProtocolsData FormatsInterface Verification Plan
Acceptance criteria & references
Acceptance criteria
- All interfaces documented
- Both sides of each interface agree
- Interface tests defined
- Under configuration control
References
- Insulet ICD Template
Phase C
Integration Test Reports
System integration test results confirming subsystems work together correctly per interface specifications.
Components
Integration Test PlanTest ConfigurationInterface Test ResultsEnd-to-End Test ResultsPerformance Under LoadFailure Mode TestingDeviation SummaryIntegration Test Report
Acceptance criteria & references
Acceptance criteria
- All interfaces tested
- End-to-end scenarios passing
- Performance within spec
- Deviations resolved
References
- Insulet Integration Test SOP
Phase C
Study Protocols & CRFs
Clinical study protocol and case report forms for any prospective clinical investigation.
Components
Study Objectives & EndpointsStudy DesignPatient Population & Inclusion/ExclusionSample Size JustificationData Collection (CRFs)Safety MonitoringStatistical Analysis PlanEthics/IRB Approval
Acceptance criteria & references
Acceptance criteria
- Protocol reviewed by biostatistics
- IRB/EC approval obtained
- CRFs validated
- Safety monitoring plan in place
References
- ISO 14155:2020
- 21 CFR 812
- GCP ICH E6
Phase C
Process Design & PFMEA
Manufacturing process design with Process FMEA identifying potential failure modes, effects, and control measures.
Components
Process Flow DiagramProcess FMEACritical Process ParametersIn-Process ControlsSPC PlanEquipment SpecificationsEnvironmental Controls
Acceptance criteria & references
Acceptance criteria
- All process steps analyzed in pFMEA
- Critical parameters identified
- Controls defined for high-RPN items
- Equipment specs approved
References
- 21 CFR 820.75
- IEC 60812
- Insulet Manufacturing SOP
Phase C
Quality Agreements
Formal quality agreements with critical suppliers defining quality requirements, change notification, and audit rights.
Components
Quality RequirementsChange Notification ObligationsAudit RightsComplaint HandlingCAPA RequirementsRecord RetentionRegulatory RequirementsTermination Conditions
Acceptance criteria & references
Acceptance criteria
- Agreement signed by both parties
- All quality requirements specified
- Change notification triggers defined
- Audit schedule agreed
References
- ISO 13485 §7.4.1
- 21 CFR 820.50
Phase C
BOM Cost Tracking
Ongoing BOM cost tracking against COGS targets with variance analysis and cost reduction opportunities.
Components
Component Cost BreakdownTarget vs. Actual COGSVariance AnalysisCost Reduction OpportunitiesMaterial Price TrendsCurrency Impact Analysis
Acceptance criteria & references
Acceptance criteria
- All components priced
- COGS within target margin
- Variances explained
- Reduction opportunities identified
References
- Insulet Cost Management SOP
Phase C
Supply Chain Risk Mitigation
Risk assessment and mitigation plan for supply chain vulnerabilities including single-source, geopolitical, and logistics risks.
Components
Risk IdentificationSingle-Source AnalysisGeopolitical Risk AssessmentLogistics VulnerabilityMitigation StrategiesBusiness Continuity PlanMonitoring & Triggers
Acceptance criteria & references
Acceptance criteria
- All critical risks identified
- Mitigation strategies defined
- Business continuity plan tested
- Monitoring in place
References
- Insulet Supply Chain Risk SOP
Phase C
Earned Value Management
EVM tracking of program budget performance — planned value, earned value, actual cost, and variance analysis.
Components
Work Breakdown StructurePlanned Value (PV) BaselineEarned Value (EV) TrackingActual Cost (AC) TrackingSchedule Variance (SV)Cost Variance (CV)CPI & SPI IndicesEstimate at Completion (EAC)
Acceptance criteria & references
Acceptance criteria
- WBS aligned with IPP
- Baseline approved
- Monthly EVM reporting active
- Variances explained with corrective actions
References
- Insulet EVM SOP
- PMI PMBOK
Phase C
Program Budget Tracking
Monthly budget tracking report comparing planned vs. actual spend across all cost categories.
Components
Labor CostsNon-Labor CostsCapEx SpendTravel & External CostsTotal Spend vs. PlanVariance AnalysisForecast to CompleteBudget Change Requests
Acceptance criteria & references
Acceptance criteria
- Aligned with Clarity PPM data
- Variances explained
- Forecast updated monthly
- Change requests documented
References
- Insulet Financial Reporting SOP
- Clarity PPM
Phase C
Formative Usability Program (DCX)
Iterative usability evaluations with representative users to identify use errors and optimize UI design.
Components
Study ProtocolParticipant CriteriaTask ScenariosData CollectionUse Error AnalysisFindings & ClassificationDesign RecommendationsStudy Report
Acceptance criteria & references
Acceptance criteria
- 5-8 participants per round
- Critical tasks tested
- Use errors classified
- Design changes for critical findings
References
- IEC 62366-1 §5.7
- FDA Human Factors Guidance
Phase C
UI/UX Design Specifications
Complete UI/UX design specifications for device interfaces, mobile apps, and connected experiences.
Components
Design System & Component LibraryInteraction Design PatternsVisual Design SpecificationsAccessibility Requirements (WCAG)Responsive Design RulesAnimation & Transition SpecsIconography & Typography
Acceptance criteria & references
Acceptance criteria
- Design system documented
- Accessibility audit completed
- All screens specified
- Design review approved
References
- WCAG 2.1
- Insulet Design System
Phase C
Security Architecture
Cybersecurity architecture defining defense-in-depth controls, authentication, encryption, and network security measures.
Components
Security Architecture DiagramAuthentication & AuthorizationEncryption (At Rest/In Transit)Network Security ControlsSecure Boot & UpdateLogging & MonitoringIncident Response Design
Acceptance criteria & references
Acceptance criteria
- Defense-in-depth implemented
- Encryption meets standards
- Secure update mechanism designed
- Architecture reviewed by security team
References
- IEC 81001-5-1
- NIST Cybersecurity Framework
- FDA Cybersecurity Guidance
Phase C
Secure Coding Review
Security-focused code review using SAST/DAST tools and manual review against secure coding standards.
Components
SAST Tool ResultsDAST Tool ResultsManual Code Review FindingsOWASP Top 10 AssessmentCWE Coverage AnalysisRemediation TrackingSecure Coding Compliance Score
Acceptance criteria & references
Acceptance criteria
- No critical security defects open
- OWASP Top 10 addressed
- CWE coverage meets target
- Secure coding standard compliance documented
References
- IEC 81001-5-1
- CERT C
- OWASP ASVS
Phase C
Licensing & Partnership Review
Review of licensing requirements, partnership agreements, and technology transfer terms for any third-party IP used in the product.
Components
Third-Party IP InventoryLicense Terms & ConditionsRoyalty ObligationsSublicensing RightsTechnology Transfer RequirementsTermination ProvisionsCompliance Monitoring
Acceptance criteria & references
Acceptance criteria
- All third-party IP identified
- License terms reviewed by Legal
- Royalty obligations budgeted
- Compliance monitoring in place
References
- Insulet Licensing SOP
Phase C◆ Gate
System Hazard Analysis (SHA)
Identifies hazards, hazardous situations, and associated risks at the system level. Evaluates each hazard using Severity, P1, P2 criteria and provides inputs to the RRR and Risk Management Report.
Components
Hazard IdentificationHazardous Situation AnalysisSeverity ClassificationP1 (Probability of Hazardous Situation) ScoringP2 (Probability of Harm) ScoringRisk Estimation MatrixRisk Evaluation vs. Acceptability CriteriaRisk Control MeasuresTraceability to dFMEACybersecurity-Originating Hazards
Acceptance criteria & references
Acceptance criteria
- All foreseeable hazards identified at system level
- Severity/P1/P2 scoring completed per SOP-048
- Risk acceptability evaluated per Insulet criteria
- Cybersecurity hazards included
- Risk management team sign-off
References
- QSP-140 — System Hazard Analysis Procedure
- ISO 14971:2019
- SOP-048 — Risk Management
Phase C◆ Gate
Design FMEA (dFMEA)
Design Failure Mode and Effects Analysis including severity/occurrence/detection scoring, RPN calculation, and mitigation tracking.
Components
Function & Requirement MappingPotential Failure ModesFailure Effects AnalysisSeverity ScoringOccurrence ScoringDetection ScoringRPN CalculationRisk Mitigation ActionsResidual RPN VerificationTraceability to SHA
Acceptance criteria & references
Acceptance criteria
- All design functions mapped to potential failure modes
- S/O/D scoring completed per QSP-246 scale
- High-RPN items have mitigation actions assigned
- Residual risk evaluated post-mitigation
- DFMEA owner sign-off
References
- QSP-246 — Design FMEA
- IEC 60812
- SOP-048 — Risk Management
Phase C
Software Build Report (SBR)
Generated upon PR merge containing all approved pull requests, establishing unbroken traceability from Jira defects through code review to integration.
Components
Build Version & ConfigurationApproved Pull RequestsCode Review RecordsJira Issue LinkageUnit Test ResultsStatic Analysis ResultsIntegration Test StatusKnown Issues & Waivers
Acceptance criteria & references
Acceptance criteria
- All PRs linked to Jira issues
- Minimum 3 participants per review (author + 2 reviewers)
- Unit tests passing
- Static analysis clean
- Build configuration documented
References
- QSP-280 — Code Review
- QWI-456 — SW Integration Testing
- SDLC Blueprint: Defect Tracking Pipeline
Phase C◆ Gate
Critical Design Outputs (CS/CP)
Identifies and classifies design outputs as Critical to Safety (CS) or Critical to Performance (CP) based on risk management per SOP-048.
Components
Critical Output IdentificationCS Classification CriteriaCP Classification CriteriaRisk-Based JustificationTraceability to SHA/dFMEAVerification Requirements per OutputAcceptance CriteriaDHF Filing Location
Acceptance criteria & references
Acceptance criteria
- All critical outputs identified from risk analysis
- CS/CP classification justified by risk data
- Verification approach defined per output
- Traceability to hazard analysis confirmed
- Quality sign-off
References
- QSP-257 — Critical Design Outputs
- QSP-124 — Design Output
- SOP-048 — Risk Management
Phase C
Use Error Risk Analysis (UERA)
Identifies and mitigates use errors across hardware, software, systems, and consumables. Tracked in Codebeamer alongside the Cybersecurity Risk Register.
Components
Use Scenario AnalysisPotential Use ErrorsError Severity AssessmentError Probability AssessmentRisk EstimationRisk Control MeasuresResidual Use Error RiskTraceability to Usability StudiesFormative Study Findings Integration
Acceptance criteria & references
Acceptance criteria
- All foreseeable use errors identified
- Severity/probability scored per methodology
- Risk controls defined for unacceptable use errors
- Traceable to formative usability findings
- Human Factors + Quality sign-off
References
- QSP-257 — UERA Procedure
- QSP-044 — Usability Engineering
- IEC 62366-1:2015
Phase C◆ Gate
SRS Trace Matrices
Bidirectional traceability matrices linking system requirements to design outputs, verification evidence, and validation results. Managed in Codebeamer ALM.
Components
Requirements to Design OutputsDesign Outputs to VerificationVerification to Test ResultsValidation LinkageGap AnalysisCoverage MetricsOrphan Requirements Check
Acceptance criteria & references
Acceptance criteria
- 100% forward traceability from requirements
- 100% backward traceability to verification
- No orphan requirements
- Coverage metrics meet threshold
- Systems Engineering sign-off
References
- QSP-123 — Design Input
- QWI-214 — Codebeamer Work Instructions
- QSP-081 — DHF
Phase C◆ Gate
Stage Exit Presentation — Phase C (Design & Development)
Formal presentation to PDT summarizing Phase C design completion, verification readiness, and requesting authorization to enter Phase D (Verification & Validation). Covers design outputs, prototyping results, and verification protocol readiness.
Components
Program Status & Contract VarianceExecutive Summary (1-slide)Design Output Summary (HW, SW, Mechanical)Design Output → Input TraceabilityVerification Protocol ReadinessPrototype Build & Test ResultsSoftware Development Status (IEC 62304)Risk Management Update (dFMEA status)Process Design & pFMEA PreviewUsability Formative Study ResultsSupplier Qualification StatusCybersecurity Threat Model StatusPhase C Exit Criteria Compliance MatrixDRI Sign-Off StatusSchedule & Budget VarianceKey Risks & Path Forward
Acceptance criteria & references
Acceptance criteria
- Design outputs traceable to all design inputs
- Verification protocols ready for execution
- Prototype test data supports design feasibility
- Software architecture documented per IEC 62304
- dFMEA updated with current design
- All critical suppliers qualified or on track
- Presentation ≤30 slides plus appendix
References
- SOP-003 — Design Control
- QSP-098 — Design Output
- QSP-122 — Design & Development Planning
- IEC 62304 — SW Lifecycle
- Phase C Exit Criteria Matrix
Phase D Verification & Validation · 27 deliverables
Phase D◆ Gate
Design Verification (DVT)
Formal verification testing confirming design outputs meet design inputs. Includes test protocols, results, and traceability.
Components
Verification Test PlanTest Protocol per RequirementTest Setup & ConfigurationTest Results & DataPass/Fail AnalysisDeviations & InvestigationsTraceability Matrix (Input → Output → Test)DVT Summary Report
Acceptance criteria & references
Acceptance criteria
- All design inputs verified with documented test results
- Test protocols approved before execution
- All deviations investigated and dispositioned
- Traceability matrix complete
- DVT report approved by Quality
References
- 21 CFR 820.30(f) — Design Verification
- ISO 13485:2016 §7.3.6
- Insulet V&V SOP
Phase D◆ Gate
Design Validation Results
Validation testing confirming the product meets user needs and intended use under actual or simulated use conditions.
Components
Validation Test PlanUse Condition DefinitionTest Configuration (Production-Equivalent)Clinical Study Results (if applicable)User Acceptance ResultsValidation Test ResultsTraceability (User Need → Validation)Validation Summary Report
Acceptance criteria & references
Acceptance criteria
- Testing performed on production-equivalent units
- User needs validated under actual/simulated conditions
- Clinical evidence sufficient for submission
- All validation protocols passed
- Report suitable for regulatory submission
References
- 21 CFR 820.30(g) — Design Validation
- ISO 13485:2016 §7.3.7
- FDA Guidance: Design Validation
Phase D◆ Gate
DHF Completion
Design History File audit confirming all design control documents are indexed, approved, and complete for regulatory submission.
Components
DHF Index & Document ListDesign Input RecordsDesign Output RecordsDesign Review RecordsDesign Verification RecordsDesign Validation RecordsDesign Transfer RecordsDesign Change RecordsRisk Management FileDHF Completeness Audit
Acceptance criteria & references
Acceptance criteria
- All required documents present and approved
- No open action items from design reviews
- Traceability matrix complete end-to-end
- Risk management file current
- DHF audit passed with no critical findings
References
- 21 CFR 820.30(j) — Design History File
- ISO 13485:2016 §4.2.4
- Insulet DHF SOP
Phase D◆ Gate
Regulatory Submission Dossier
Complete regulatory submission package — 510(k), PMA, De Novo, or CE Technical File — ready for filing with regulatory authority.
Components
Submission Cover LetterDevice DescriptionPredicate Comparison (510(k))Performance Data SummaryBiocompatibility DataElectrical Safety (IEC 60601)EMC Data (IEC 60601-1-2)Software Documentation (IEC 62304)Cybersecurity DocumentationClinical EvidenceLabelingRisk Analysis Summary
Acceptance criteria & references
Acceptance criteria
- All required sections complete per FDA/NB guidance
- Clinical evidence meets submission pathway requirements
- Biocompatibility per ISO 10993
- Software documentation per IEC 62304
- Internal regulatory review passed
References
- 21 CFR 807 — 510(k)
- FDA eCopy Guidance
- EU MDR Technical Documentation (Annex II/III)
Phase D◆ Gate
Clinical Evidence Package
Complete clinical evidence supporting safety and effectiveness — clinical evaluation report, study data, literature review, and post-market clinical follow-up plan.
Components
Clinical Evaluation Report (CER)Clinical Study ProtocolsClinical Study ResultsLiterature Review & AppraisalSubstantial Equivalence AnalysisBenefit-Risk AnalysisPost-Market Clinical Follow-Up PlanClinical Expert Statement
Acceptance criteria & references
Acceptance criteria
- CER comprehensive and current
- Clinical data supports intended use claims
- Literature review systematic and unbiased
- Benefit-risk favorable
- PMCF plan adequate
References
- MEDDEV 2.7/1 Rev 4
- MDR Annex XIV
- 21 CFR 860
- FDA Clinical Evidence Guidance
Phase D◆ Gate
Summative Usability Report
Final validation usability study confirming safe and effective use by intended users under simulated use conditions. Required for regulatory submission.
Components
Study Protocol & IRB ApprovalParticipant DemographicsTask Scenarios & Use EnvironmentResults by Critical TaskUse Error Analysis & Root CauseResidual Use Risk EvaluationKnowledge Task ResultsStudy Report & Conclusions
Acceptance criteria & references
Acceptance criteria
- Minimum 15 participants per user group
- All critical tasks evaluated
- No new critical use errors discovered
- Residual use risk acceptable
- Report formatted for regulatory submission
References
- IEC 62366-1:2015 §5.9
- FDA Guidance: Applying Human Factors
- AAMI HE75
Phase D◆ Gate
Process Validation Protocol
IQ/OQ/PQ validation protocols demonstrating the manufacturing process consistently produces product meeting specifications.
Components
Validation Master PlanInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Statistical Rationale (Sample Sizes)Acceptance CriteriaEquipment Calibration RecordsProtocol Approval Signatures
Acceptance criteria & references
Acceptance criteria
- Validation strategy approved by Quality
- Statistical rationale documented
- Acceptance criteria aligned with design specs
- IQ/OQ/PQ protocols reviewed and approved
- Worst-case conditions defined
References
- 21 CFR 820.75 — Process Validation
- FDA Process Validation Guidance
- GHTF SG3 N99-10
Phase D
Launch Readiness Plan
Cross-functional launch readiness checklist and timeline covering commercial, regulatory, manufacturing, supply chain, and support readiness.
Components
Launch Readiness Checklist (All Functions)Regulatory Approval StatusManufacturing ReadinessSupply Chain & InventoryCommercial ReadinessTraining ReadinessCustomer Support ReadinessPost-Market Surveillance PlanLaunch Go/No-Go Criteria
Acceptance criteria & references
Acceptance criteria
- All functional areas report readiness
- Regulatory filing on track
- Manufacturing validated and production-ready
- Commercial materials approved
- Support infrastructure operational
References
- Insulet Launch Readiness Template
- Product Delivery Phase D Gate Criteria
Phase D◆ Gate
Go-to-Market Plan — Final
Finalized commercial launch strategy with confirmed pricing, channel commitments, sales enablement readiness, launch timeline, and Year 1 revenue targets validated against business case assumptions.
Components
Finalized Target Segments & SizingPositioning & Messaging (Validated)Pricing & Reimbursement (Confirmed)Channel & Distribution (Committed)Sales Enablement & Training (Ready)Launch Timeline & MilestonesKOL & Advisory Board EngagementMarketing Budget (Approved)Year 1 Revenue Targets (Committed)Competitive Response PlanCommercial Readiness Checklist
Acceptance criteria & references
Acceptance criteria
- Pricing confirmed and approved by Commercial leadership
- Channel partners committed with signed agreements
- Sales training curriculum finalized and scheduled
- Launch timeline locked and resourced
- Year 1 revenue targets validated against final business case
References
- Insulet GTM Template
- Launch Playbook
- Commercial Readiness Checklist
Phase D
DVT Reports
Design Verification Testing reports documenting that hardware design outputs meet design input requirements through objective evidence.
Components
Test Matrix (Input → Test)Environmental Testing (Temp, Humidity, Vibration)Electrical Safety TestingMechanical Stress TestingBiocompatibility TestingEMC/EMI TestingTest Results & DataDeviation Analysis
Acceptance criteria & references
Acceptance criteria
- All design inputs verified
- Test protocols pre-approved
- Pass/fail criteria met
- Deviations investigated and closed
References
- 21 CFR 820.30(f)
- IEC 60601-1
- ISO 10993
Phase D
SW Validation Report
Software validation report confirming the software meets user needs and intended use under representative conditions.
Components
Validation PlanTest Environment ConfigurationValidation Test ResultsAnomaly SummaryTraceability AnalysisResidual Anomaly Risk AssessmentValidation Conclusion
Acceptance criteria & references
Acceptance criteria
- All validation tests executed
- Anomalies dispositioned
- Traceability complete
- Validation conclusion approved by Quality
References
- IEC 62304 §5.8
- FDA SW Validation Guidance
Phase D◆ Gate
Traceability Matrix
Bidirectional traceability from user needs → design inputs → design outputs → verification → validation, ensuring complete coverage.
Components
User Needs → Design InputsDesign Inputs → Design OutputsDesign Outputs → Verification TestsDesign Inputs → Validation TestsGap AnalysisCoverage Summary
Acceptance criteria & references
Acceptance criteria
- 100% forward traceability
- 100% backward traceability
- No orphan requirements
- No untested outputs
- Matrix tool-maintained
References
- 21 CFR 820.30
- ISO 13485 §7.3
- FDA Design Control Guidance
Phase D
CAPA Management
Corrective and Preventive Action process for addressing nonconformities discovered during V&V and production.
Components
CAPA Identification & SourceRoot Cause AnalysisCorrective Action PlanPreventive Action PlanEffectiveness VerificationCAPA Closure CriteriaTrend Analysis
Acceptance criteria & references
Acceptance criteria
- Root cause identified
- Corrective actions implemented
- Effectiveness verified
- CAPA closed within timeline
References
- 21 CFR 820.90
- ISO 13485 §8.5.2/§8.5.3
Phase D
Process Validation Protocol Suite (QA)
IQ/OQ/PQ protocols for validating manufacturing processes that cannot be fully verified by inspection.
Components
Validation Master PlanIQ ProtocolOQ ProtocolPQ ProtocolStatistical RationaleAcceptance CriteriaEquipment CalibrationRevalidation Triggers
Acceptance criteria & references
Acceptance criteria
- Protocols approved by Quality
- Statistical basis documented
- Acceptance criteria defined
- Worst-case conditions identified
References
- 21 CFR 820.75
- FDA Process Validation Guidance (2011)
Phase D
Submission Dossier (510(k)/PMA/CE)
Complete regulatory submission package ready for filing with FDA, Notified Body, or other regulatory authority.
Components
Cover LetterDevice DescriptionPredicate ComparisonPerformance DataBiocompatibilityEMC/Electrical SafetySoftware DocumentationCybersecurityClinical EvidenceLabelingRisk Summary
Acceptance criteria & references
Acceptance criteria
- All sections complete
- Internal review passed
- Clinical evidence sufficient
- Filing timeline confirmed
References
- 21 CFR 807
- FDA eCopy Guidance
- MDR Annex II/III
Phase D◆ Gate
Clinical Evaluation Report (CER)
Systematic and comprehensive analysis of clinical data confirming the device meets safety and performance requirements.
Components
Device Description & Intended PurposeClinical Background & State of the ArtLiterature Review & AppraisalClinical Investigation DataPost-Market DataBenefit-Risk AnalysisConclusionsQualifications of Evaluators
Acceptance criteria & references
Acceptance criteria
- All available clinical data considered
- Literature search reproducible
- Benefit-risk conclusion justified
- Evaluator qualifications documented
References
- MEDDEV 2.7/1 Rev 4
- MDR Annex XIV Part A
Phase D
Safety Monitoring Reports
Ongoing safety reports from clinical investigations including adverse events, SAEs, and DSMB reviews.
Components
Adverse Event SummarySerious Adverse Event DetailsDSMB Meeting MinutesRisk-Benefit ReassessmentProtocol Deviation SummarySafety Signal Analysis
Acceptance criteria & references
Acceptance criteria
- All AEs documented within 24 hours
- SAEs reported within regulatory timelines
- DSMB recommendations addressed
- No safety signals unresolved
References
- ISO 14155 §10
- 21 CFR 812.150
Phase D
Incoming Inspection Procedures
Incoming quality inspection procedures for critical components to ensure supplier conformance.
Components
Inspection Plan by ComponentSampling Plan (AQL)Inspection Methods & EquipmentAccept/Reject CriteriaNCR ProcessSkip-Lot QualificationInspection Records
Acceptance criteria & references
Acceptance criteria
- All critical components covered
- Sampling plans statistically justified
- Methods validated
- Inspectors trained
References
- ISO 13485 §7.4.3
- ANSI/ASQ Z1.4
Phase D
Summative Validation (IEC 62366)
Final validation usability study confirming safe and effective use under simulated conditions. Required for submission.
Components
Protocol & IRB ApprovalParticipant DemographicsTask ScenariosResults by Critical TaskUse Error Root CauseResidual Risk EvaluationKnowledge TasksStudy Report
Acceptance criteria & references
Acceptance criteria
- ≥15 participants per user group
- All critical tasks evaluated
- No new critical use errors
- Report submission-ready
References
- IEC 62366-1 §5.9
- AAMI HE75
Phase D
Human Factors Engineering Report
Comprehensive human factors engineering report summarizing the entire UE process from use specification through summative validation.
Components
Use SpecificationUser ProfilesUse EnvironmentsTask AnalysisKnown Use ProblemsFormative Study SummariesSummative Study ResultsResidual Use RiskHFE Conclusions
Acceptance criteria & references
Acceptance criteria
- Complete UE process documented
- All use-related risks addressed
- Residual risk acceptable
- Report suitable for regulatory submission
References
- IEC 62366-1
- FDA HFE Guidance
- AAMI HE75
Phase D
Accessibility Compliance
Accessibility compliance assessment ensuring digital interfaces meet WCAG 2.1 AA and Section 508 requirements.
Components
WCAG 2.1 AA AuditAssistive Technology TestingColor Contrast AnalysisKeyboard Navigation TestingScreen Reader CompatibilityRemediation PlanCompliance Declaration
Acceptance criteria & references
Acceptance criteria
- WCAG 2.1 AA criteria met
- Tested with major assistive technologies
- Remediation items closed
- Compliance declaration issued
References
- WCAG 2.1
- Section 508
- EN 301 549
Phase D
Vulnerability & Penetration Testing
Security testing including vulnerability scanning, penetration testing, and fuzz testing of the medical device system.
Components
Test Scope & MethodologyVulnerability Scan ResultsPenetration Test ResultsFuzz Testing ResultsFindings Classification (CVSS)Remediation PlanRetest ResultsSecurity Test Report
Acceptance criteria & references
Acceptance criteria
- No critical/high vulnerabilities unresolved
- Penetration test by independent team
- All findings classified and dispositioned
- Retest confirms remediation
References
- IEC 81001-5-1 §8
- OWASP
- CVSS v3.1
Phase D
SBOM (Software Bill of Materials)
Complete software bill of materials listing all software components, versions, licenses, and known vulnerabilities.
Components
Component InventoryVersion InformationLicense AnalysisKnown Vulnerabilities (CVE)Patch StatusEnd-of-Life AssessmentSBOM Format (SPDX/CycloneDX)Update Plan
Acceptance criteria & references
Acceptance criteria
- All components inventoried
- CVEs assessed
- Critical vulnerabilities patched
- SBOM in standard format
- Update plan defined
References
- FDA Cybersecurity Guidance (2023)
- EO 14028
- NTIA SBOM Minimum Elements
Phase D
Contract Compliance
Compliance review of all program contracts — supplier agreements, clinical trial agreements, licensing, and partnership terms.
Components
Contract InventoryCompliance Status ReviewObligation TrackingMilestone DeliverablesFinancial ObligationsIP ProvisionsRegulatory ObligationsNon-Compliance Risks
Acceptance criteria & references
Acceptance criteria
- All contracts inventoried
- Obligations tracked
- No non-compliance issues open
- Financial obligations budgeted
References
- Insulet Contract Management SOP
Phase D◆ Gate
Residual Risk Report (RRR)
Evaluates and documents overall residual risk acceptability after all mitigations are applied, including cybersecurity-originating hazards. Required before Phase E entry.
Components
Overall Residual Risk SummaryIndividual Hazard Residual RiskCybersecurity Residual RiskRisk-Benefit AnalysisRisk Acceptability DeterminationUnresolved Risk ItemsPost-Market Risk Monitoring PlanTraceability to SHA, dFMEA, UERA
Acceptance criteria & references
Acceptance criteria
- All identified risks evaluated post-mitigation
- Overall residual risk acceptable per SOP-048 criteria
- Cybersecurity risks included
- Risk-benefit analysis completed
- Risk Management + Quality sign-off
References
- QSP-146 — Residual Risk Report
- QSP-150 — Risk Management Plan
- ISO 14971:2019 §8
Phase D◆ Gate
DHF Traceability Closure
Confirms the Design History File is complete with all design control documents indexed, approved, and traceable across Systems, App, and Cloud configuration levels.
Components
DHF Index & Completeness CheckSystems Level DocumentsApp Level DocumentsCloud Level DocumentsCross-Reference VerificationMissing Document ResolutionALM/PLM Storage ConfirmationArchival Plan
Acceptance criteria & references
Acceptance criteria
- DHF index 100% populated
- All design control documents approved and filed
- Traceability verified across all configuration levels
- No unresolved gaps
- Design Quality sign-off
References
- QSP-081 — Design History File
- QWI-214 — Codebeamer
- SDLC Blueprint: DHF Traceability Hierarchy
Phase D◆ Gate
Stage Exit Presentation — Phase D (Verification & Validation)
Formal presentation to PDT summarizing Phase D verification and validation results, regulatory submission readiness, and requesting authorization to enter Phase E (Transfer & Launch Prep). This is typically the most evidence-intensive gate review.
Components
Program Status & Contract VarianceExecutive Summary (1-slide)Verification Test Results SummaryValidation Test Results SummaryDesign Verification → Input Traceability MatrixSoftware V&V Results (IEC 62304)Summative Usability Study ResultsBiocompatibility Testing StatusEMC/Electrical Safety TestingSterility & Shelf Life ValidationClinical Evidence SummaryRisk Management File Status (Residual Risk)Regulatory Submission ReadinessCybersecurity Testing ResultsPhase D Exit Criteria Compliance MatrixDRI Sign-Off StatusOutstanding NCRs / DeviationsSchedule & Budget VarianceKey Risks & Path to Submission
Acceptance criteria & references
Acceptance criteria
- All verification tests executed with results documented
- Validation protocols completed or justified deferrals
- Summative usability study meets acceptance criteria
- Risk management file updated with residual risk assessment
- Regulatory submission package ≥90% complete
- All critical NCRs dispositioned
- Presentation ≤35 slides plus appendix
References
- SOP-003 — Design Control
- QSP-127 — Design Validation
- QSP-044 — Usability Engineering
- 21 CFR 820.30(f)(g) — V&V
- Phase D Exit Criteria Matrix
Phase E Transfer & Launch · 19 deliverables
Phase E◆ Gate
Process Validation Report
Final IQ/OQ/PQ validation reports demonstrating manufacturing process consistency and capability.
Components
IQ Report & ResultsOQ Report & ResultsPQ Report & ResultsCpk / Ppk AnalysisDeviation SummaryValidation ConclusionRevalidation TriggersApproval Signatures
Acceptance criteria & references
Acceptance criteria
- All IQ/OQ/PQ protocols executed successfully
- Cpk ≥ 1.33 for critical parameters
- Deviations investigated and closed
- Validation conclusion approved by Quality
- Revalidation triggers defined
References
- 21 CFR 820.75
- FDA Process Validation Guidance (2011)
Phase E
Pilot Production & Yield
Pilot production run results demonstrating yield rates, cycle times, and production quality at target volumes.
Components
Pilot Run ConfigurationProduction Volume & DurationYield Rate AnalysisDefect ClassificationCycle Time AnalysisEquipment PerformanceCorrective ActionsScale-Up Recommendations
Acceptance criteria & references
Acceptance criteria
- Yield rate meets target (typically ≥95%)
- Cycle time within target
- Defect rate acceptable
- Equipment performing to specification
- Scale-up plan confirmed
References
- Insulet Manufacturing SOP
Phase E◆ Gate
Design Transfer Documents
Formal transfer of design outputs to manufacturing, including drawings, specs, procedures, and acceptance criteria.
Components
Design Transfer ChecklistDrawing Package (Released)Manufacturing SpecificationsWork InstructionsAcceptance Criteria & Test ProceduresTraining RequirementsTransfer Acceptance Sign-Off
Acceptance criteria & references
Acceptance criteria
- All design outputs transferred to production
- Manufacturing specs reviewed and accepted
- Work instructions validated
- Production team trained
- Transfer acceptance signed
References
- 21 CFR 820.30(h) — Design Transfer
- ISO 13485 §7.3.8
Phase E
First Article Inspection
Inspection of first production units confirming they meet all design output specifications.
Components
Inspection PlanDimensional MeasurementsFunctional Test ResultsVisual InspectionMaterial VerificationComparison to Design SpecsDispositionFAI Report
Acceptance criteria & references
Acceptance criteria
- All critical dimensions within tolerance
- Functional tests passing
- Visual inspection acceptable
- Materials verified per BOM
- FAI report approved
References
- Insulet FAI Procedure
- AS9102 (Reference)
Phase E◆ Gate
Labeling & IFU
Final labeling, Instructions for Use (IFU), and packaging materials — regulatory-approved and production-ready.
Components
Product Label (Inner/Outer)Instructions for Use (IFU)Quick Start GuideUnique Device Identifier (UDI)Translations (if applicable)Regulatory Compliance ReviewPrint Specifications
Acceptance criteria & references
Acceptance criteria
- Labeling reviewed and approved by Regulatory
- UDI assigned and registered
- IFU tested with representative users
- Translations verified
- Print specs confirmed with vendor
References
- 21 CFR 801 — Labeling
- EU MDR Annex I Chapter III
- FDA UDI Rule
Phase E◆ Gate
Post-Market Surveillance Plan
Plan for monitoring product safety and performance after market release — complaint handling, MDR reporting, trend analysis, and PMCF.
Components
Complaint Handling ProcessMDR / Adverse Event ReportingTrend Analysis PlanPost-Market Clinical Follow-Up (PMCF)Periodic Safety Update Report (PSUR)Field Safety Corrective ActionsCustomer Feedback LoopSurveillance Metrics & KPIs
Acceptance criteria & references
Acceptance criteria
- Complaint handling process validated
- MDR reporting procedures in place
- Trend analysis methodology defined
- PMCF plan approved
- Surveillance metrics established
References
- EU MDR Articles 83-86
- 21 CFR 803 — MDR
- MEDDEV 2.12 Rev 8
Phase E
SPC Implementation
Statistical Process Control implementation plan for monitoring critical process parameters during production.
Components
Critical Parameters SelectionControl Chart TypesSampling PlanControl Limits CalculationOut-of-Control Action PlanTrend Analysis RulesSPC Training Plan
Acceptance criteria & references
Acceptance criteria
- Critical parameters identified
- Control limits calculated from PQ data
- Sampling plan statistically justified
- Operators trained
References
- 21 CFR 820.250
- ISO 13485 §8.2.4
Phase E
IQ/OQ/PQ Validation Reports
Installation, Operational, and Performance Qualification reports demonstrating process capability and consistency.
Components
IQ Report (Equipment Installed Correctly)OQ Report (Process Operates Within Parameters)PQ Report (Process Produces Consistent Product)Cpk/Ppk AnalysisDeviation SummaryValidation Conclusion
Acceptance criteria & references
Acceptance criteria
- All protocols executed per plan
- Cpk ≥ 1.33 for critical parameters
- Deviations investigated and closed
- Conclusion approved by Quality
References
- 21 CFR 820.75
- FDA Process Validation Guidance
Phase E
Pilot Production Analysis (Mfg)
Results from pilot production runs demonstrating manufacturing readiness at target volumes.
Components
Run ConfigurationVolume & DurationYield AnalysisDefect ParetoCycle Time AnalysisEquipment OEELessons LearnedScale-Up Plan
Acceptance criteria & references
Acceptance criteria
- Yield ≥95% target
- Cycle time within target
- Major defect modes addressed
- Scale-up plan confirmed
References
- Insulet Pilot Production SOP
Phase E
Design Transfer Package (Mfg)
Complete package transferring design to manufacturing including specs, procedures, training, and acceptance criteria.
Components
Drawing PackageManufacturing SpecificationsWork InstructionsInspection ProceduresTraining RecordsTransfer Acceptance ChecklistSign-Off
Acceptance criteria & references
Acceptance criteria
- All drawings released
- Work instructions validated
- Operators trained
- Transfer acceptance signed by R&D and Manufacturing
References
- 21 CFR 820.30(h)
- ISO 13485 §7.3.8
Phase E
Scale-Up & Demand Plan
Supply chain scale-up plan ensuring capacity to meet Year 1 and Year 2 demand forecasts.
Components
Demand Forecast (Y1-Y3)Supplier Capacity AssessmentLead Time AnalysisSafety Stock CalculationsLogistics & Distribution PlanRisk Mitigation Plan
Acceptance criteria & references
Acceptance criteria
- Demand forecast aligned with Commercial
- Supplier capacity confirmed
- Safety stock levels set
- Logistics validated
References
- Insulet S&OP Process
Phase E
PSIRT Readiness Plan
Product Security Incident Response Team readiness plan for handling post-market cybersecurity vulnerabilities and incidents.
Components
PSIRT Charter & RolesVulnerability Intake ProcessTriage & Severity ClassificationCoordinated Disclosure PolicyPatch Development & TestingCustomer Communication PlanRegulatory Notification ProcessTabletop Exercise Plan
Acceptance criteria & references
Acceptance criteria
- PSIRT team identified
- Intake process operational
- Disclosure policy published
- Tabletop exercise completed
- Regulatory notification triggers defined
References
- IEC 81001-5-1
- FDA Postmarket Cybersecurity Guidance
- ISO/IEC 29147
Phase E
Training Content (Multi-Modal)
Training content developed across multiple modalities — eLearning, instructor-led, simulation, and field-based.
Components
eLearning ModulesInstructor-Led MaterialsSimulation/Hands-On LabsQuick Reference GuidesVideo ContentAssessment QuestionsCertification Requirements
Acceptance criteria & references
Acceptance criteria
- Content reviewed by SMEs
- Pilot tested with target audience
- Assessment questions validated
- Multi-modal coverage complete
References
- Insulet Training Content SOP
Phase E
Clinical Educator Programs
Clinical educator training program for CDEs, nurses, and HCPs who will train patients on device use.
Components
Educator Selection CriteriaTrain-the-Trainer CurriculumClinical Competency AssessmentPatient Teaching MethodologyTroubleshooting GuideEducator CertificationOngoing Support Resources
Acceptance criteria & references
Acceptance criteria
- Educator competency validated
- Patient teaching methodology reviewed by HFE
- Troubleshooting guide comprehensive
- Certification process documented
References
- Insulet Clinical Educator SOP
Phase E
User Education Materials
Patient and caregiver education materials supporting safe and effective device use — aligned with IFU and usability findings.
Components
Getting Started GuideVideo TutorialsFAQ DocumentTroubleshooting GuideCaregiver GuideMultilingual VersionsDigital Support Resources
Acceptance criteria & references
Acceptance criteria
- Materials tested with representative users
- Aligned with IFU and labeling
- Reading level appropriate
- Multilingual versions verified
- Regulatory review completed
References
- IEC 62366-1
- Insulet Patient Education SOP
Phase E◆ Gate
ECO / CDP Execution
Engineering Change Order or Change Development Plan fully executed per SOP-069 for pre-production and post-production design changes. Primary Phase E exit criteria.
Components
Change Description & JustificationImpact AssessmentAffected Documents & DrawingsVerification of ChangeValidation of ChangeTRB Review RecordApproval SignaturesImplementation TimelineDHF Update
Acceptance criteria & references
Acceptance criteria
- ECO/CDP fully executed per SOP-069
- All affected documents updated
- Change verification completed
- TRB review documented
- Change Control sign-off
References
- SOP-069 — Change Management
- QSP-098 — Design Transfer
- SDLC Blueprint: Phase E Exit Criteria
Phase E◆ Gate
Device Master Record (DMR)
Complete set of procedures and specifications required to manufacture a finished medical device including BOM, process instructions, labeling, packaging, and quality acceptance criteria.
Components
Device SpecificationsBOM (Bill of Materials)Process InstructionsLabeling SpecificationsPackaging RequirementsQuality Acceptance CriteriaEquipment & Tooling RequirementsEnvironmental RequirementsDrawing Package
Acceptance criteria & references
Acceptance criteria
- All specifications complete and approved
- BOM released to production status
- Process instructions validated via IQ/OQ/PQ
- Labeling per MI-000279 requirements
- Manufacturing + Quality sign-off
References
- QWI-321 — Device Master Record
- 21 CFR 820.181
- QSP-098 — Design Transfer
Phase E
Master Data Governance Readiness
Confirms master data governance readiness for production including Arena PLM status, SAP configuration, and part number provisioning. Prerequisite for Phase F part number release.
Components
Arena PLM Item StatusSAP Material Master SetupPart Number ProvisioningBOM Structure ValidationRouting ConfigurationQuality Plan SetupLabel Template LinkageData Integrity Verification
Acceptance criteria & references
Acceptance criteria
- All part numbers in Arena PLM at correct status
- SAP material masters created
- BOM and routing verified
- Quality plans configured
- Quality Operations sign-off
References
- QSP-182 — Product Launch
- SDLC Blueprint: Phase E/F Quality Ops Activities
Phase E◆ Gate
Stage Exit Presentation — Phase E (Transfer & Launch)
Formal presentation to PDT summarizing Phase E design transfer completion, manufacturing readiness, regulatory clearance/approval status, and requesting authorization to enter Phase F (Post-Launch). The final major gate before commercial launch.
Components
Program Status & Contract VarianceExecutive Summary (1-slide)Design Transfer Completion StatusDMR Completeness (QWI-321)Process Validation Results (IQ/OQ/PQ)Pilot Production Results & YieldRegulatory Approval/Clearance StatusLabeling & Packaging FinalizationSupply Chain Readiness & InventoryCommercial Launch ReadinessTraining Completion StatusPost-Market Surveillance PlanDHF Completeness Assessment (QSP-081)Master Data Governance ReadinessPhase E Exit Criteria Compliance MatrixDRI Sign-Off StatusLaunch Go/No-Go Recommendation
Acceptance criteria & references
Acceptance criteria
- Design transfer package complete and approved
- Process validation (IQ/OQ/PQ) all passing
- Regulatory clearance/approval obtained or imminent
- DMR released to production status
- Pilot production yield meets target
- Commercial and supply chain launch-ready
- DHF complete per QSP-081 checklist
- All 15 DRI sign-offs obtained
- Presentation ≤35 slides plus appendix
References
- SOP-003 — Design Control
- QSP-098 — Design Transfer
- QSP-182 — Product Launch
- QWI-321 — DMR
- 21 CFR 820.30(h) — Design Transfer
- Phase E Exit Criteria Matrix
Phase F Sustaining · 16 deliverables
Phase F◆ Gate
FDA Clearance/Approval Record
Documentation of regulatory clearance/approval — 510(k) clearance letter, PMA approval order, CE Certificate, or equivalent.
Components
Clearance/Approval LetterConditions of Approval (if any)Indications for Use (Cleared)Post-Market RequirementsRegistration & ListingGUDID SubmissionInternational Filing Status
Acceptance criteria & references
Acceptance criteria
- Clearance/approval letter received
- Conditions of approval addressed
- Device registered and listed
- GUDID submitted
- International filing timeline confirmed
References
- 21 CFR 807.100
- 21 CFR 814
- EU MDR Article 56
Phase F◆ Gate
Commercial Launch Package
Complete set of commercial launch materials — positioning, messaging, collateral, digital assets, and launch event plan.
Components
Positioning & Messaging (Final)Sales Collateral PackageDigital Marketing AssetsLaunch Event PlanPR & Media StrategyHCP Education MaterialsPatient Education MaterialsPromotional Compliance Review
Acceptance criteria & references
Acceptance criteria
- All materials reviewed by Medical/Legal/Regulatory
- Messaging aligned with cleared indications
- Digital assets deployed
- Launch event planned
- Sales team briefed
References
- Insulet Launch Playbook
- Promotional Review SOP
Phase F
Sales Training & Certification
Sales team training program with certification requirements ensuring the team can effectively position and sell the new product.
Components
Training CurriculumProduct Knowledge ModulesCompetitive Positioning TrainingObjection Handling GuideDemonstration ProtocolCertification AssessmentOngoing Education PlanField Coaching Guide
Acceptance criteria & references
Acceptance criteria
- All sales reps completed training
- Certification assessment pass rate ≥90%
- Demo protocol validated
- Field coaching plan in place
References
- Insulet Sales Training SOP
Phase F
Distribution Activation
Confirmation that distribution channels are activated with inventory positioned for launch.
Components
Distribution Channel Activation ChecklistInventory Positioning PlanOrder Management SetupShipping & Logistics ValidationReturns ProcessChannel Partner AgreementsLaunch Inventory Quantities
Acceptance criteria & references
Acceptance criteria
- Distribution channels activated
- Launch inventory positioned
- Order management system configured
- Logistics validated end-to-end
- Channel partners confirmed
References
- Insulet Distribution SOP
Phase F
Lifecycle Management Framework
Framework for ongoing product sustaining — change control, continuous improvement, obsolescence management, and next-generation planning.
Components
Sustaining Engineering ProcessChange Control ProceduresObsolescence Management PlanContinuous Improvement RoadmapCustomer Feedback IntegrationNext-Generation Planning InputProduct Retirement Criteria
Acceptance criteria & references
Acceptance criteria
- Sustaining team identified and transitioned
- Change control process active
- Obsolescence watch list established
- CI roadmap created
- Retirement criteria defined
References
- Insulet Lifecycle Management SOP
- ISO 13485 §7.3.9
Phase F◆ Gate
Program Retrospective
Structured post-program review capturing lessons learned, process improvements, team feedback, and recommendations for future programs. Ensures organizational learning and continuous improvement of the product delivery process.
Components
Program Summary & Key MetricsTimeline — Plan vs. ActualBudget — Plan vs. ActualWhat Went WellWhat Could Be ImprovedProcess & Tool RecommendationsCross-Functional Collaboration AssessmentRisk Management Effectiveness ReviewLessons Learned Database EntryRecommendations for Future Programs
Acceptance criteria & references
Acceptance criteria
- All 15 DRI functions contributed feedback
- Lessons learned documented and categorized
- Process improvement recommendations prioritized
- Findings shared with product delivery leadership
- Lessons learned entered into organizational knowledge base
References
- Insulet Retrospective Template
- Continuous Improvement Framework
Phase F◆ Gate
MDR / Vigilance Reporting
Medical Device Reporting procedures for adverse events, malfunctions, and field safety corrective actions.
Components
Reportable Event Criteria5-Day Report Triggers30-Day Report ProcessAnnual ReportMedWatch Form CompletionEU Vigilance (EUDAMED)Trending & Signal Detection
Acceptance criteria & references
Acceptance criteria
- Reporting criteria defined
- Timelines documented
- Staff trained
- System tested end-to-end
References
- 21 CFR 803
- MDR Article 87
- MEDDEV 2.12/1
Phase F
Post-Market Clinical Follow-Up
PMCF plan and results for ongoing clinical evidence gathering after market release.
Components
PMCF PlanStudy Design (Registry/Survey/RWE)Data Collection MethodsAnalysis PlanPMCF Evaluation ReportCER Update Schedule
Acceptance criteria & references
Acceptance criteria
- PMCF plan proportionate to risk
- Data collection methods validated
- Analysis plan pre-specified
- Timeline for CER updates defined
References
- MDR Annex XIV Part B
- MDCG 2020-7
Phase F
Yield & Cycle Time Metrics
Ongoing manufacturing performance metrics tracking yield, cycle time, OEE, and defect rates against targets.
Components
Yield TrendingCycle Time TrendingOEE DashboardDefect Rate ParetoSPC Control ChartsImprovement ActionsTarget vs. Actual Summary
Acceptance criteria & references
Acceptance criteria
- Metrics baselined from PQ/pilot data
- Targets established
- Dashboards operational
- Improvement actions tracked
References
- Insulet Manufacturing KPI SOP
Phase F
Portfolio ROI Reporting
Post-launch ROI analysis comparing actual financial performance to business case projections.
Components
Revenue vs. ForecastCOGS vs. EstimateGross Margin AnalysisR&D Investment RecoveryMarket Share AchievementROI CalculationLessons LearnedPortfolio Impact Assessment
Acceptance criteria & references
Acceptance criteria
- 12-month post-launch data available
- Actuals compared to business case
- Variance root causes identified
- Lessons documented for future programs
References
- Insulet Portfolio Review Process
Phase F
Launch Package & Collateral
Complete launch materials set — sales collateral, digital assets, HCP materials, and patient education.
Components
Sales Aids & BrochuresDigital Marketing AssetsHCP Education MaterialsPatient Education MaterialsLaunch Event PlanPR & Media KitPromotional Compliance Review
Acceptance criteria & references
Acceptance criteria
- All materials MLR reviewed
- Digital assets deployed
- Launch event planned
- Compliance sign-off obtained
References
- Insulet Launch Playbook
- Promotional Review SOP
Phase F
Sales Enablement & Training
Sales team training and enablement program ensuring effective product positioning and competitive selling.
Components
Training CurriculumProduct Knowledge ModulesCompetitive Battle CardsObjection HandlingDemo ProtocolCertification AssessmentOngoing Education Plan
Acceptance criteria & references
Acceptance criteria
- All reps certified
- Assessment pass rate ≥90%
- Demo protocol validated
- Ongoing education scheduled
References
- Insulet Sales Training SOP
Phase F
Year 1 Revenue Forecast
Detailed Year 1 revenue forecast by geography, channel, and product SKU with monthly tracking.
Components
Revenue by GeographyRevenue by ChannelRevenue by SKUMonthly Ramp PlanVolume AssumptionsASP AssumptionsSensitivity AnalysisTracking Dashboard
Acceptance criteria & references
Acceptance criteria
- Forecast aligned with business case
- Monthly targets set
- Tracking mechanism operational
- Variance triggers defined
References
- Insulet Revenue Forecasting SOP
Phase F◆ Gate
Sales Team Certification
Sales team certification program ensuring product knowledge, competitive positioning, and demonstration proficiency.
Components
Certification RequirementsKnowledge AssessmentDemo Competency AssessmentCompetitive Positioning TestField Coaching ChecklistRecertification Schedule
Acceptance criteria & references
Acceptance criteria
- Pass rate ≥90%
- Demo competency verified
- All reps certified before launch
- Recertification schedule set
References
- Insulet Sales Certification SOP
Phase F
Training Effectiveness Metrics
Metrics and KPIs measuring training program effectiveness — knowledge retention, behavior change, and business impact.
Components
Kirkpatrick Level 1 (Reaction)Level 2 (Learning)Level 3 (Behavior)Level 4 (Results)Assessment Score TrendsTime-to-CompetencyCustomer Satisfaction Correlation
Acceptance criteria & references
Acceptance criteria
- Metrics baselined
- Targets established
- Dashboard operational
- Quarterly review scheduled
References
- Kirkpatrick Model
- Insulet Training Metrics SOP
Phase F
Product Obsolescence Plan
Plan for obsoleting a finished good product from manufacturing without adversely impacting active product types. Required when replacing an existing product.
Components
Product IdentificationReplacement Product ReferenceManufacturing Cessation PlanComponent DispositionDocumentation Removal PlanCustomer Communication PlanService & Support TransitionRegulatory Notification (if required)Timeline & Milestones
Acceptance criteria & references
Acceptance criteria
- Active products not adversely impacted
- Documentation references removed
- Product no longer manufacturable
- Customer communication completed
- Quality + Program Mgmt sign-off
References
- QSP-184 — Product Obsolescence
- SOP-069 — Change Management
Full RACI matrix
R = Responsible · A = Accountable · C = Consulted · I = Informed. Scroll horizontally for all 25 functions.
| Deliverable | PMO | EPM | RTE | SM | PdM | PO | SysE | HW | SW | Cloud | CldOps | DevOps | SWAT | UX | DCX | Cyber | Qual | Reg | Clin | Mfg | SC | Comm | Fin | Train | Legal |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product & Program Planning | |||||||||||||||||||||||||
| Product Vision & Roadmap | C | C | I | I | A | R | C | I | I | C | I | I | I | C | C | I | I | C | C | I | I | R | C | I | I |
| Integrated Program Plan (IPP) | R | A | C | C | C | C | R | C | C | C | C | C | I | C | C | C | C | C | C | C | C | C | C | I | I |
| Release Train / PI Plan | C | C | A | R | C | R | R | C | R | R | C | R | C | R | R | C | C | I | I | I | I | I | I | I | I |
| Product Backlog & Sprint Goals | I | I | C | R | C | A | C | C | R | C | I | C | I | C | C | C | C | I | I | I | I | I | I | I | I |
| Program Budget | R | R | I | I | C | I | C | I | I | I | I | I | I | I | I | I | I | I | I | I | I | C | A | I | I |
| Design Control (SOP-003) | |||||||||||||||||||||||||
| User Needs Document | I | C | I | I | R | C | C | C | C | C | I | I | I | C | A | I | C | C | C | I | I | C | I | I | I |
| Design Input Spec | I | C | I | I | C | C | R | R | R | R | I | C | I | C | C | C | A | C | C | I | I | I | I | I | I |
| Risk Management File (FMEA) | I | C | I | I | C | C | R | R | R | R | C | C | C | C | C | R | A | R | C | C | I | I | I | I | I |
| V&V Protocol / Report | I | C | I | I | I | C | R | R | R | R | C | R | C | C | C | C | A | R | C | C | I | I | I | I | I |
| DHF / Design History File | I | C | I | I | I | I | C | C | C | C | I | I | I | C | C | C | A | R | I | I | I | I | I | I | I |
| Digital, Cloud & Cyber | |||||||||||||||||||||||||
| Cloud Architecture & Data Flows | I | C | I | I | C | C | C | I | C | A | R | R | I | I | C | R | C | C | I | I | I | I | I | I | I |
| CI/CD Pipeline & Release Automation | I | C | R | R | I | C | C | C | R | C | C | A | C | I | I | C | C | I | I | I | I | I | I | I | I |
| Production Runbooks & SLOs | I | C | I | I | I | C | C | I | C | R | A | R | R | I | C | C | C | I | I | I | I | I | I | C | I |
| Cybersecurity Threat Model & SBOM | I | C | I | I | C | C | C | C | R | R | C | C | C | I | C | A | C | R | I | I | I | I | I | I | I |
| Incident / Hotfix Response Report | I | C | C | C | C | C | C | C | R | R | R | R | A | I | C | R | C | C | I | I | I | C | I | I | I |
| Customer Experience (DCX) | |||||||||||||||||||||||||
| Digital Customer Experience Design (App/Portal/Onboarding) | I | C | I | I | C | C | C | I | C | C | I | I | I | R | A | C | C | C | C | I | I | C | I | C | I |
| Patient Training & Education Content | I | C | I | I | C | C | I | I | I | I | I | I | I | C | R | I | C | C | C | I | I | C | I | A | I |
| Labeling / IFU | I | C | I | I | R | C | C | I | I | I | I | I | I | C | R | I | C | R | C | C | I | C | I | C | A |
| Regulatory, Clinical & Commercial | |||||||||||||||||||||||||
| Regulatory Submission | I | C | I | I | C | I | C | C | C | C | I | I | I | I | C | C | C | A | R | I | I | I | I | I | R |
| Clinical Protocol | I | C | I | I | C | I | C | I | I | C | I | I | I | I | C | I | C | C | A | I | I | I | I | C | C |
| Manufacturing Transfer | I | C | I | I | C | C | C | R | R | C | I | C | I | I | I | C | C | C | I | A | R | I | C | R | I |
Command Center · Operations
Ops Board
PMO operations, one section, many lenses. Switch between board variations over the same operating picture.
--:--
Center of Excellence · People
The Team.
Product Delivery & Operations Management — the leadership team and the extended Scrum Master community behind the Center of Excellence.
Leadership & initiative leads
Who leads, and the CoE initiative each owns.
Efdal Elferri
Sr. Director, Product Delivery & Operational Excellence
Building & leading high-performing Agile teams.
Scope: Leads the Product Delivery & Operational Excellence organization — the Scrum Master managers across Pod & iOS, Android Classic & Modern, and Cloud & DCX, plus the PMO Center of Excellence.
Charter: Scale operational excellence across product delivery — strengthening systems, governance, and processes with AI as the enabler.
Focus areas: high-performing Agile teams, standardized ways of working, strategic alignment, and a people-first culture.
Paula Davis
Sr. Manager, Scrum Masters · Pod & iOS
PI Planning Optimization
Senior Scrum Master Manager. 15+ yrs project management, 10+ yrs team leadership. At Insulet since Jan 2022.
Experience: Fidelity Investments (17 yrs), MFS (4 yrs), John Hancock (7 yrs).
Education & certs: BS Business Management, UMass · PMP · SAFe Advanced Scrum Master · CSPO/CSM · SAFe Agilist
Tenure: Year 4 at Insulet (Jan 2022)
Depth: 15+ yrs project management · 10+ yrs team leadership
Based: Lowell / Chelmsford / Westborough, MA
Family: husband Kevin; children Andrew & Caroline
Fun facts: One of 12 children; loves international travel (Rome, St. Petersburg) and Maine summers; lifelong Boston sports fan.
Carlos Lopez
Sr. Manager, Scrum Masters · Android Classic & Modern
Performance Optimization
19 yrs IT software development, 10 yrs Agile leadership. At Insulet since Jan 2021.
Experience: Insulet (SM → SM Manager), Technical PM, Tech Lead, BI Engineer, Software Engineer, University Teacher (12 yrs).
Education & certs: Master’s in Systems Engineering · CSP-SM · SASM · RTE
Tenure: 5.4 yrs at Insulet (Jan 2021)
Depth: 19 yrs IT software development · 10 yrs Agile leadership
Based: Ciudad Obregón · Mexico City · Guadalajara · Ensenada
Fun facts: Lived across Mexico (Ciudad Obregón, Mexico City, Guadalajara, Ensenada); gamer (Hollow Knight), manga & anime fan.
Scott Desatnick
Sr. Manager, Scrum Masters · Cloud & DCX
Enterprise Agile & Scrum Training
26 yrs IT software development, 14 yrs Agile leadership. At Insulet since Sept 2021.
Experience: Insulet (4+ yrs), MathWorks (3 yrs), McGraw-Hill Education (4 yrs), EF Education First (6 yrs), Ascend Consulting (2 yrs).
Education & certs: BS Finance, Syracuse University · CSP-SM, A-CSM, CSM · PSM I · SAFe 6.0 SA, SSM, RTE
Tenure: 4.9 yrs at Insulet (joined Sept 2021)
Depth: 26 yrs IT software development · 14 yrs Agile leadership
Based: Massachusetts · New York
Fun facts: Lived in MA & NY; avid runner (3 marathons, ran up Mt. Washington Auto Road twice); golfer; former Boston food blogger & radio guest.
Anitha Athipathy
PMO · Center of Excellence
Tool Optimization
Role: CoE initiative lead — delivery toolchain consolidation & AI-assisted workflows.
Consolidate and standardize the delivery toolchain; embed AI-assisted capabilities into daily workflows; integrate systems end-to-end for data integrity.
Evelyn Betances Topete
PMO · Center of Excellence
Metrics Standardization
Role: CoE initiative lead — standard metrics, formulas & the automated Power BI dashboard.
Define standard metrics & formulas mapped to Jira statuses; build an automated Power BI dashboard pulling live from Jira; audience-specific views.
Travis Picou
PMO Operations
Operations Excellence
Role: PMO Operations — governance, core systems & processes, with AI as the enabler.
Strengthen governance across product delivery; optimize core systems & processes; position AI as the enabler to accelerate delivery.
Extended team · Scrum Masters
By manager and product domain. [C] denotes contractor.
Carlos Lopez · Android Classic & Modern
Ade AdeyemiAngel RodriguezWaldo CazarezBrian EstradaAndrea MarquezAlejandra VargasPatricia Macias
Scott Desatnick · Cloud & DCX
Juan TijerinaLizeth HernandezKanav GuptaSergio ArcePratap PattanayakJuhi Sing [C]
Paula Davis · Pod & iOS
Sandra LopezKaren GomezAlex MirandaGerman GutierrezGustavo GallegosElliot SanchezMalgorzata Mickiewicz [C]Sandra Borcic [C]Daria Matyszewska [C]
Scrum Teams
Delivery teams by platform / value stream. Members are the currently-active contributors (issues updated in the last 6 months) from Jira; roles are derived from each person’s primary work type. Avatars are initials placeholders — swap in headshots anytime.
Pod Software · Omnipod 5 Pod · OP5POD · 10 active
PK
Pawel Kaczmarek
Developer
IM
Ievgen Maliarenko
Engineer
TK
Tomasz Karpiesiuk
Engineer
JS
John Sanford
SW Engineer
JC
Jeet Chauhan
Engineer
TP
Tomasz Podgorski
Engineer
JR
Junaid Rathore
Engineer
DK
Dacjan Kijowski
Developer
GJ
Grzegorz Janicki
QA Engineer
EC
Ernesto Carvallo
Contributor
Mobile · iOS · Horizon iOS PDM · PDMI · 10 active
EJ
Emmanuel Salcedo Jackez
SW Engineer
IQ
Ivan Quintana
Contributor
JD
Joel Dawn
Test Engineer
LR
Leon Lopez Rojas
SW Engineer
SH
Sandra Herrera
Contributor
HM
Hooman Maleknejad
Contributor
JF
Juan Carlos Torres Fuerte
Delivery
HR
Haydee Rodriguez
Contributor
PA
Peter Alt
Contributor
JR
Juan Pablo Rodriguez
Contributor
Mobile · Modern · Modern Backlog · MODB · 10 active
GM
Greg Milette
Delivery
SW
Shawn Witte
Engineer
AB
Alice Bobovich
Engineer
LA
Laith Alnagem
Delivery
SU
Sean Unger
Delivery
VT
Vu Tran
Engineer
ZA
Zaq Avila
Contributor
AB
Alec Boyle
SW Engineer
KI
Kelly Inzunza
Engineer
BC
Brian Chu
Contributor
Cloud Platform · Cloud · MBCLD · 10 active
RV
Rostislav Vatolin
SW Engineer
HB
Hugo Alejandro Bulnes
SW Engineer
SR
Sangeetha Raman
SW Engineer
RC
Ramses Carbajal
SW Engineer
SG
Sebastian Medina Garcia
SW Engineer
BH
Bruno Herrera
SW Engineer
MB
Miguel Bolanos
SW Engineer
OP
Oscar Eduardo Morales Portuondo
SW Engineer
SG
Sivaiah Gurijala
SW Engineer
DW
Derek Washington
SW Engineer
Discover / Data · Data Insights · INSIGHT · 10 active
AT
Andrew Tucker
Product / PO
TJ
Teresa Janz
Product / PO
JD
Johnathan Do
Product / PO
NV
Nika Varpahovsky
Product / PO
JW
Jonathan Wandke
Product / PO
SP
Suresh Pittala
Product / PO
MT
Mruthyunjaya Talamanchi
Product / PO
AW
Aline Thomé Williams
Product / PO
JC
Joan Carter
Product / PO
MM
Matt Madison
Product / PO
Algorithm / SmartAdjust · ALGO · 10 active
GZ
Gary Zhang
Contributor
AZ
Ashutosh Zade
Contributor
GG
Gary Girzon
Engineer
JW
JC Weber
Developer
AK
Ayse Kalkan-Savoy
Developer
JT
Joshua Tranfaglia
Engineer
RB
Rahul Raj Babburu
Engineer
PD
Priyanka Dasari
QA Engineer
PG
Prasanth Kumar Reddy Gorla
QA Engineer
MM
Martin Morales Montelongo
QA Engineer
DSCX · NextGen CRM · NGCRMI · 10 active
AS
Ajay Doddangadi Satish
Engineer
SK
Sourabh Khambalkar
Delivery
SS
Snigdha Suravita Sahoo
Engineer
NK
Neeraj Kumar
Engineer
ST
Saketh Tanjavur
Engineer
PK
Pradip Kokate
Engineer
PM
Praveen Murugesan
Engineer
DT
Daniel Tran
Delivery
RK
Ramesh Kumar
Engineer
DS
Durga Prasad Sanapala
Engineer
System Test · SYS · 10 active
AM
Anand Kumar Mishra
Test Engineer
SS
Summer Smith
Test Engineer
AS
Abhinay Sriram
Test Engineer
HE
Heather Edgerly
Contributor
TG
Taylor Gomez
Contributor
MS
Matthew Sheehan
Contributor
PK
Pavan Kumar Katakam
Test Engineer
LS
Lakshmi Aparna Saride
Test Engineer
VG
Venkata Nagasai Gande
Test Engineer
MM
Monisa Sulthana Mohammed
Test Engineer
Initiative · Paula Davis
PI Planning Optimization
Owned by Paula Davis. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Initiative · Anitha Athipathy
Tool Optimization
Owned by Anitha Athipathy. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Initiative · Carlos Lopez
Performance Optimization
Owned by Carlos Lopez. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Initiative · Scott Desatnick
Enterprise Agile & Scrum Training
Owned by Scott Desatnick. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Initiative · Evelyn Betances Topete
Metrics Standardization
Owned by Evelyn Betances Topete. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Initiative · Travis Picou
Operations Excellence
Owned by Travis Picou. This is a blank canvas — ready to build out with objectives, milestones, and metrics.
＋
Blank canvas. Add content for this initiative when ready.
Center of Excellence
Initiatives
The CoE initiatives led by the leadership team — each its own workspace.
✦
PI Planning Optimization
Led by Paula Davis
Blank canvasOpen →
✦
Tool Optimization
Led by Anitha Athipathy
Blank canvasOpen →
✦
Performance Optimization
Led by Carlos Lopez
Blank canvasOpen →
✦
Enterprise Agile & Scrum Training
Led by Scott Desatnick
Blank canvasOpen →
✦
Metrics Standardization
Led by Evelyn Betances Topete
Blank canvasOpen →
✦
Operations Excellence
Led by Travis Picou
Blank canvasOpen →
System
Settings & About
Connections and information for this workspace.
Connect Claude (Anthropic API)
Store your Anthropic API key locally (this browser only) to power AI Studio prompts directly from InsuletOS. Your key is sent only to api.anthropic.com.
About this build
Each surface is the strongest design you've built in that area, embedded intact in the Insulet design system. Command Center answers performance & observability; Center of Excellence answers practice & standards. Use ⌘K-style sidebar navigation or the cards above. Built 2026-06-16.
Tool
Smartsheet
Status reporting & milestone rollups.
Key processes
The core process flows we run in Smartsheet.
Status rollup
Collect program updates→Normalize RAG→Roll up to portfolio→Publish monthly
Milestone tracking
Set milestones→Track met / missed→Trend by quarter→Feed the scorecard
Tool
Jira
Agile delivery — epics, sprints, velocity & defect flow.
Key processes
The core process flows we run in Jira.
Backlog refinement
Capture stories→Refine & estimate→Acceptance criteria→Ready for sprint
Sprint planning
Pull from backlog→Capacity check→Commit sprint goal→Daily flow
Defect triage
Intake defect→Severity / priority→Assign owner→Fix & verify
Release cut
Scope version→Code complete→Regression→Release
Tool
Jira Product Discovery
Idea & opportunity backlog; product discovery and prioritization.
Key processes
The core process flows we run in Jira Product Discovery.
Idea intake
Capture idea→Add context→Link evidence
Prioritization
Score impact / effort→Rank→Roadmap slot→Hand off to delivery
Tool
Confluence
Documentation, runbooks & decision logs.
Key processes
The core process flows we run in Confluence.
Doc creation
Pick template→Draft→Review→Publish
Decision log
Capture decision→Owner & date→Link to PDT→Archive
Runbook publishing
Document steps→Validate→Publish→Maintain
Tool
Microsoft Teams
Collaboration, meetings & channels.
Key processes
The core process flows we run in Microsoft Teams.
Channel governance
Define channels (T1/T2/cross)→Membership→Naming standard→Lifecycle
Meeting cadence
Schedule→Pre-read→Run→Minutes
Async decisions
Post proposal→Discuss→Decide→Log to Confluence
Tool
Arena PLM
PLM — BOM, change & document control.
Key processes
The core process flows we run in Arena PLM.
ECO / change control
Raise change→Impact assessment→TRB review→Approve & implement
BOM release
Draft BOM→Validate→Release→SAP handoff
Item master setup
Create item→Set attributes→Lifecycle state→Govern
AI · Agent Management Platform
The agentic fleet, in one view.
Specialists — each a job, not a prompt: a named role, an input constraint, a signature technique, an expected output. One orchestration layer above them holds the cross-view. Every agent is built on the same seven-layer OS.
—
Agents
—
Enabled
7
OS layers
—
Runs logged
An OS in seven layers
Every agent inherits the same stack — identity up through automations.
L07
Automations
Chief of Staff · Daily Brief · Research
L06
Verification
10 gates · 28 failure modes · 15 invariants
L05
Connections
Outlook · Teams · Clarity · Jira · MCP
L04
Memory
decision logs · meeting notes · QMS
L03
Skills
agents · sitrep · red-team · design
L02
Context
stakeholders · strategy · FY26 priorities
L01
Identity
values · communication · 7 non-negotiables
The executive fleet
Four specialists, orchestrated by the Chief of Staff. The agents we want for sure.
Analyst
◉ The Research Analyst
On-demand deep research for a single executive decision — never a search engine.
Input constraint
Defined constraints — time horizons, named reliable sources, marketing fluff excluded.
Signature technique
Wisdom of the Crowd — one brief across many models; aggregate agreement, investigate divergence, fact-check.
Output
Interactive dashboards & verified facts.
Grounded, or pattern-matched?What context is missing?Would I sign it?
Strategist
◆ The Strategic Thought Partner
A 24/7, ego-free sounding board for the decisions that are still unformed.
Input constraint
Personal & market context — role, priorities, decision history, fed continuously.
Signature technique
Board of Advisors — named personas argue the decision, then converge.
Output
Biases surfaced & stress-tested scenarios.
DebateCalibrateStress-test
Communicator
✎ The Communication Expert
A writer that internalizes your actual voice and rhythm — not a generic ghostwriter.
Input constraint
Ten years of your historical writing & tone, with the patterns named.
Signature technique
Scored persona review — read as the target reader, rate concrete dimensions.
Output
Distinctive, action-driving prose.
Clarity 9Wit 5Concise 7Action 8
Operator
■ The Operational Powerhouse
Customized daily operational visibility, carried by the OS — not your working memory.
Input constraint
Unspoken context — the visibility you'd demand with unlimited headcount.
Signature technique
Stealth Mode — run it by hand first, calibrate against real use, then automate.
Output
Frictionless daily ops visibility.
StealthCalibrateDeploy
PD&OM domain agents
Run, configure, or disable each agent. Configure shows its seven layers.
Recent activity
Last runs across the fleet (this browser).
PDT · Governance
PDT Charter
Insulet's monthly portfolio governance forum — 120 minutes, separate meetings by segment (Type 1, Type 2); the decision body for stage-gate exits, Phase-B locks, and re-baselines.
Operating mechanics
The adopted decisions that codify how the PDT runs.
Cadence
Monthly · 120 min · separate meetings by segment (T1, T2).
Member expectations
Attendance is a leadership duty; named delegates allowed, no silent seats.
Gate-exit outcomes
Four outcomes only: Go · Go-with-Conditions · Hold · No-Go.
Phase model
Programs run Phases A → F through the phase-gate process.
Phase B contract lock
Phase B locks scope · schedule · cost · resources; re-opening requires a PDT vote.
Steve's bar
Every meeting is measured on four numbers.
Invitees
Who is expected
Attendees
Who showed (leadership duty)
Decisions
What was decided & logged
Actions
What was committed, owned, dated
PDT · People
PDT Leadership & Membership
Chaired by the VP of the PMO. 32 invitees across segments; attendance is a leadership duty — named delegates allowed, no silent seats.
32
Invitees · 19 T1 / 19 T2 / 6 shared
28
Attended May 15
18/19
T1 attendance
16/19
T2 attendance
Chair & quorum
The PDT is chaired by the VP of the PMO; segment meetings run independently for T1 and T2.
Chair
VP of the PMO — owns the bar and the decision log.
Segments
Type 1 and Type 2 meet separately; 6 shared cross-segment seats.
Delegation
Named delegates permitted; no silent seats.
May 15 no-shows
Tracked against the leadership-duty expectation.
4 no-shows
Neil Lazo · Drake Hepp · Sue Gunnet · Dan Carlow
Full 32-seat roster lives in Command Center → Stakeholders.
PDT · Cadence
Standard Agenda
120 minutes, run by segment. The same shape every month so the meeting stays a decision forum, not a status readout.
01
Pre-read distributed T-48h (Jun 12)
02
Roll call & attendance — leadership duty
03
Portfolio status & program updates
04
Gate-exit reviews → Go · Go-with-Conditions · Hold · No-Go
05
Phase-B locks & re-baselines (per D-05)
06
Decisions logged to the record
07
Action review — owners & due dates
08
Next-meeting bar: invitees · attendees · decisions · actions
PDT · Pre-reads
Presentations
Pre-reads are due T-48h (Jun 12). Program and platform updates are the substance of the pack — reviewed before the room, so the meeting can decide.
◉
Pod Platform Sync
26Q2-5 program update — objectives, defects, burn-up
Pre-readOpen →
◫
Data Cloud Sync
26Q2-5 program update — objectives & test progress
Pre-readOpen →
◐
iOS Platform Sync
26Q2-5 program update
Pre-readOpen →
◑
Android Classic Sync
26Q2-5 program update — 135 bugs fixed
Pre-readOpen →
PDT · Commitments
Action Items
18 commitments from May 15 — every one must clear before Jun 14. A-11 is the only past-due item.
| ID | Action | Owner | Pri | Due | Status |
|---|---|---|---|---|---|
| A-11 | Libre LinkUp data-gap | Ed Souza | P0 | May 17 | past due |
| A-02 | Membership / HEMA split correction | PMO Ops | P0 | May 22 | open |
| A-03 | Release-governance forum use case | Brian Baumann | P0 | May 22 | open |
| A-06 | Resource-impact prediction tool — scope | Travis | P1 | May 22 | open |
| A-17 | Teams channels (T1/T2/cross-segment) | PMO Ops | P1 | May 22 | open |
| A-04 | Membership slide-15 correction | PMO Ops | P1 | May 29 | open |
| A-05 | Heavy-lifting roles slide-16 | PMO Ops | P1 | May 29 | open |
| A-09 | Resource-Impact Prediction Tool — MVP | Travis | P1 | Jun 14 | open |
| A-10 | Moonshot — recovery plan or rebaseline | Program / PMO | P0 | Jun 14 | open |
| A-13 | Matterhorn UK LMR date commit | Discover Intl PM | P0 | Jun 14 | open |
Showing the live P0/P1 set; 18 total · 6 P0 · 11 P1 · 1 P2.
PDT · The bar
PDT KPIs
Steve's bar: invitees · attendees · decisions · actions — the four numbers every PDT is measured on.
32
Invitees
28
Attendees (88%)
13
Decisions logged
18
Actions · 6 P0 / 11 P1 / 1 P2
Attendance by segment · May 15
| Segment | Invited | Attended | Rate |
|---|---|---|---|
| Type 1 | 19 | 18 | 95% |
| Type 2 | 19 | 16 | 84% |
Next PDT: Sun Jun 14, 2026 · 120 min · by segment. Pre-read due T-48h (Jun 12).
PDT · Record
Decisions Log
13 logged — adopted operating mechanics are codified; parked items are real decisions, collapsing at Jun 14.
| ID | Status | Topic | Detail |
|---|---|---|---|
| D-01 | Adopted | Cadence | Monthly · 120 min · separate meetings by segment (T1, T2). |
| D-02 | Adopted | Member expectations | Attendance is a leadership duty; named delegates allowed, no silent seats. |
| D-03 | Adopted | Gate-exit outcomes | Four outcomes only: Go · Go-with-Conditions · Hold · No-Go. |
| D-04 | Adopted | Phase model | Programs run Phases A → F through the phase-gate process. |
| D-05 | Adopted | Phase B contract lock | Phase B locks scope · schedule · cost · resources; re-opening requires a PDT vote. |
| D-06 | Committed | FSL3+ launch dates | LMR May 28 / commercial Jun 3, phased through Jun 9 (closed; past due since May 17). |
| D-07 | Approach | Matterhorn UK LMR | Staggered behind US; translations + IPC dependencies to resolve. A-13 due Jun 14. |
| D-P1 | Parked → Jun 14 | Terminology | Parked to Jun 14. |
| D-P6 | Parked → Jun 14 | Moonshot decision | Parked to Jun 14 · A-10 follow-up (recovery plan or rebaseline). |
Source of record: PDT_Meeting_Record (v9) → pdt_decisions_log. Parked set (D-P1…D-P6) decides at Jun 14.
Governance
Portfolio Decision Team
Insulet's monthly portfolio governance forum — charter, leadership, agenda, pre-reads, actions, KPIs, and the decision log.
◫
Charter
Purpose, cadence, and decision rights
Open →
☺
Leadership
Chair, membership, attendance
Open →
▤
Agenda
The standard 120-minute shape
Open →
◳
Presentations
Pre-read pack — program & platform updates
Open →
✓
Action Items
18 commitments, owned and dated
Open →
▰
KPIs
Invitees · attendees · decisions · actions
Open →
◆
Decisions
The 13-item decision log
Open →
AOP · Plan
FY26 Annual Plan
The FY26 operating plan — roughly 84 dated actions, owned through year-end, reconciled to Clarity PPM and FP&A.
FY26
Plan year
~84
Dated actions
A–F
Phase-gated
Clarity
System of record
What the plan holds
Committed scope
Programs, milestones, and launch commitments for the fiscal year.
Dated actions
~84 actions owned and dated through year-end, tracked to closure.
Reconciliation
Three-way tie-out: Clarity PPM · FP&A plan · baseline.
Operating plan administration lives in Tools → Clarity. Open the Simulator to rehearse FY27.
AOP · Capacity
Resource Forecast
Demand versus capacity across the portfolio — where the plan is over-subscribed and where the capacity wall bites.
Demand
From the plan
Capacity
From the org
Δ
The gap to close
Demand
Program demand derived from the FY plan and committed milestones.
Capacity
Team-level capacity by segment and platform.
Capacity wall
Where forecast demand exceeds capacity — the trade-offs for the PDT.
Live demand-vs-capacity detail is in Command Center → Resource & Capacity.
AOP · Tracking
Progress Tracker
How we are tracking against the plan — committed actions versus delivered, and where the plan is slipping.
On plan
Tracking to date
At risk
Watch items
Slipped
Re-baseline candidates
| Plan area | Target | Status | Note |
|---|---|---|---|
| Milestone commitments | Met by quarter | On track | See Metrics → Portfolio |
| Dated actions (~84) | Closed through YE | In progress | Owned in Clarity |
| FY27 plan build | Rehearsed pre-commit | Planned | Use the Simulator |
Blank canvas for live plan-vs-actual — wire to Clarity exports when ready.
Planning
Annual Operating Plan
The FY plan, the resources behind it, the simulator that rehearses it, and how we track against it.
◷
FY26 Annual Plan
~84 dated actions, owned through year-end
Open →
◑
Resource Forecast
Demand vs capacity across the portfolio
Open →
◳
Simulator
FY27 scenario, Monte Carlo & reconciliation
Open →
▰
Progress Tracker
How we're tracking against the plan
Open →
Metrics · Delivery
Agile Delivery
PI-objective health, defect flow, and throughput across the four platforms — the agile heartbeat of delivery.
283
Objectives complete (26Q2-5)
137
On track
42
At risk
65
Delayed
135
Android bugs fixed (26Q2)
4
Platforms
PI
Planning cadence
Full platform scorecards are in Command Center → Agile Metrics.
Metrics · Portfolio
Portfolio
Portfolio health, risk posture, and milestone commitment — how the whole book of work is performing.
29
Programs observed
93
Risks tracked
8+2
PMBOK-7 + Agile/Contract
Quarterly
Milestone scorecard
Health matrix
Program RAG across the portfolio.
Risk command
The 92-item master RAID register, deduped and owned.
Milestones
Investor-Day commitment — met vs missed by quarter.
Open Command Center → Portfolio for the live matrix.
Metrics · Quality
Quality
Quality-system signals — CAPA, design-control traceability, and defect containment.
CAPA
Open / closed
DHF
Traceability
Defects
Containment
Blank canvas — wire to MasterControl / Greenlight Guru. See Governance → Quality Management System.
Metrics · Financial
Financial
Plan financials — Capex/Opex classification, R&D credit, and AOP variance.
Capex/Opex
Classification
R&D
Credit
Variance
Plan vs actual
Blank canvas — wire to FP&A / Clarity. See AOP → FY26 Annual Plan.
Performance
Metrics
One source per metric, trended. The full scorecard plus the breakouts that matter most.
▤
Scorecard
33 metrics across PMBOK-7 + Agile + Contract
Open →
▦
Agile Delivery
PI-objective health, defects, throughput
Open →
◉
Portfolio
Health, risk, and milestone commitment
Open →
✚
Quality
CAPA, DHF traceability, defect containment
Open →
⛁
Financial
Capex/Opex, R&D credit, AOP variance
Open →
Tool
Clarity
Portfolio, demand & resource management — the FY26 operating plan, reconciled to FP&A.
Key processes
The core process flows we run in Clarity.
Monthly closeout (MC-1)
Pull time-card compliance→Generate Power BI report→VP escalation email→Confirm approvals before close
Resource forecast
Demand from plan→Capacity by team→Identify capacity wall→PDT trade-offs
Operating-plan tracking
Log dated action→Owner & due date→Status review→Close through year-end
Center of Excellence
Training
Learn the operating mechanisms — how to run PDT, build the AOP, and define metrics. The live, operational instances live under Command Center.
◫
PDT — How to run it
Prep, run, and follow through on the Portfolio Decision Team
Open →
◳
AOP — How it's built
Plan, simulate, reconcile, and track the annual operating plan
Open →
▤
Metrics — Define & read
Standard metrics, Jira mapping, and honest scorecards
Open →
Center of Excellence · Training
PDT — How to run it
How to prepare for, run, and follow through on the Portfolio Decision Team. The operational instance lives in Command Center → PDT.
The fundamentals
Steve's bar
Every meeting is judged on four numbers: invitees · attendees · decisions · actions.
Gate-exit outcomes
Only four: Go · Go-with-Conditions · Hold · No-Go. Decide, don't discuss.
Member duty
Attendance is a leadership duty; named delegates allowed, no silent seats.
Phase B lock
Phase B locks scope/schedule/cost/resources; re-opening needs a PDT vote.
How to prep a pre-read
Pre-read flow
Collect program updates→Build the deck (T-48h)→VP review→Distribute to members
In the room
Roll call→Gate-exit reviews→Log decisions→Assign actions + dates
See the live instance: Command Center → PDT.
Center of Excellence · Training
AOP — How it's built
How the Annual Operating Plan is built, simulated, and tracked. The operational instance lives in Command Center → AOP.
The build
Plan build
FY26 annual plan→Resource forecast→Simulate FY27→Track progress
Key concepts
Capacity wall
Where forecast demand exceeds capacity — the trade-off the PDT must make.
Three-way reconciliation
Clarity PPM · FP&A plan · baseline must tie to one number.
Dated actions
~84 actions, owned and dated through year-end.
See the live instance: Command Center → AOP.
Center of Excellence · Training
Metrics — Define & read
How to define standard metrics and read the scorecard honestly. The operational instance lives in Command Center → Metrics.
The discipline
Metric standardization
Define metric & formula→Map to Jira states→One source→Audience-filtered views
Reading the board
Agile Delivery
PI-objective health, defect flow, throughput across platforms.
Portfolio
Health matrix, risk posture, milestone commitment.
Spot the watermelon
Green on the outside, red underneath — read the drivers, not just the RAG.
See the live instance: Command Center → Metrics.
Center of Excellence · People
Roles & Responsibilities.
Every role at the product-delivery edge — 23 roles across charter, team-composition, and QMS gate/specialist functions. Expand a role for its mission and accountabilities.
23
Roles cataloged
3
Role families
SAFe
Agile framework
QMS
Gate & specialist
Agile Ways of Working · Charter Roles
Scrum MasterAgile · Dedicated
Mission: Servant leader and coach for one or more Agile teams. Educates the team on Agile/SAFe, enforces process, removes impediments, and fosters high-performing team dynamics, continuous flow, and relentless improvement.
Playbook §1.1 · See "R&R-Scrum Master.docx"
Individual Accountabilities
- Build a high-performing team — help individuals develop, resolve conflicts
- Coach Agile team on Agile/SAFe through regular check-ins, 1:1s, team rules
- Drive team progress toward goals and relentless improvement
- Plan, lead, and time-box all Agile team ceremonies
- Prepare for and assist in ART events (PI Planning, I&A, System Demos)
- Collaborate with PO to plan/estimate work and resolve ambiguities
- Capture story changes; enforce Definition of Ready and Definition of Done
- Remove impediments; track blockers to closure or escalation
- Coordinate with other Agile teams to manage interdependencies
- Provide transparency through sprint and PI-level metrics
- Leverage metrics to maintain continuous flow and drive improvements
- Maintain on-time completion of required regulatory & QMS training
Decision Rights — Owns
- Agile Team ceremony calendar
- Agile Team ceremony mechanics
- Agile Team tooling (Jira, etc.), aligned with standards
- Individual team goal setting and measures of success
- Team resource levels and staffing
- Agile ways of working & ceremony agendas
- Sprint Planning & Backlog Refinement — quality of user stories, DoR/DoD
- Sprint Review (ensure stakeholder presence)
- Sprint Retro (use feedback to plan future sprints)
- N/A — Scrum Master is a collaborative role and does not veto decisions made by RTE or Dev Team
Influences Veto
Key Collaborators
Agile Coach Align on best practice and team challenges, especially ceremony mechanics Product Align on resourcing/transparency for company-wide decisions RTE / Scrum Masters Align on delivery issues, opportunities, and PI prioritization
Key Success Criteria
- Velocity and predictability of Agile teams
- Adherence to project Burnup plan
- Agile maturity and adoption of best practices
- Team feedback on effectiveness
- On-time completion of sprint and PI deliverables
Release Train Engineer (RTE)Agile · Dedicated
Mission: Servant leader and Agile/SAFe coach for the 5–10 Agile teams that comprise the Agile Release Train (ART). Aligns strategic business goals to PI Objectives, drives PI execution, manages dependencies, and reports ART progress.
Playbook §1.2
Individual Accountabilities
- Coach the ART on Agile/SAFe principles; model the Lean-Agile mindset
- Train and coach Scrum Masters; ensure adequate SM capacity
- Work with cross-fxn leaders & PMs to translate strategic goals to PI Objectives
- Plan and lead quarterly PI Planning, Inspect & Adapt, System Demos
- Drive readiness, prioritization, and PI Objectives/Features for PI Planning
- Drive PI execution and effective delivery of PI Objectives
- Track and manage PI deliverables, integrations, and dependencies
- Lead weekly Scrum of Scrums to clarify dependencies and resolve impediments
- Resolve risks; manage cross-team and cross-ART dependencies
- Track and report ART progress with data-driven insights (PI Outcomes, Feature Ready, Feature Definition, ART Velocity & Predictability, Team Health)
- Manage program burn-up chart across interdependent teams through DV completion
- Coordinate solution-level dependencies with other ART RTEs
- Maintain on-time completion of required regulatory & QMS training
Decision Rights — Establishes
- Plan and drive PI planning (schedule, agenda, attendees); align with other RTEs
- ART ceremonies and calendar (mid-PI, pre-PI, post-PI events)
- ART performance measurement, metrics, reporting, progress communication
- ART tooling (Jira Align) for PI Planning
Owns
Key Collaborators
Agile Coach Foster Lean-Agile mindset; leverage SAFe to accelerate value delivery Product Coach Agile team on backlog management best practices DevOps Leadership Monitor investment in continuous delivery pipelines & resourcing Solution Architects Architect for flexibility; mitigate continuous-delivery barriers Other RTEs Pre-PI planning dependency conversations across ARTs Solution RTEs Align feature release dates to product launch timelines
Key Success Criteria
- ART commitments and dependencies meet program/launch timelines
- Delivery of Completed & Accepted ART Epic Backlog at PI end (incl. System Demo)
- Team & Technical Agility Assessments
- ART flow measures: lead time, cycle time, feature delivery rate, defect rate
5–10 teams 50–150 people 1 RTE per ART
Enterprise Solution Delivery Manager (ESDM)Agile · Dedicated
Mission: Develops the end-to-end release plan in Phase B and tracks progress to launch in Phase E. Supports the Primary Product Manager in a phase-driven target operating model — synthesizing resources, dependencies, and design-control deliverables across the full lifecycle.
Playbook §1.3
Phase-Driven Accountabilities
- Phase A (Scoping & Business Case): support Primary Product Manager in initial scoping
- Phase B (Plans & Inputs): develop end-to-end release plan covering development, commercial, manufacturing, regulatory, clinical, HF, external partners, packaging
- Phase C (Development & Testing): schedule phase gates and cross-functional team interactions; track predicted ART allocations per quarter
- Phase D/E (DV/Validation, Conditional Approval): synthesis of resource commitments and impact analysis; development burn-up charts; critical path analysis to launch
- Phase F (Launch & Maintenance): track completion of Design Control deliverables and DHF
- Maintain RAIDE Register and risk-adjusted plans
- Drive product development plan per SOP-003 and SOP-069
Decision Rights
- Owns E2E program plan integration across functions
- Influences cross-functional schedule and resource sequencing
- Primary Product Manager triggers Phase Gate closure; Franchise Head is Accountable for Business Gate Review
- Scheduling for phase-gate and cross-functional interactions
- Predicted ART allocations per quarter
- Development target burn-up charts
- Critical path analysis to launch
- Product development plan per SOP-003 & SOP-069
Example Deliverables
Product OwnerAgile · Dedicated
Mission: Owns the team's "what next" — drafts and prioritizes stories, maintains conceptual and technical integrity of features, and is the bridge between the Product Manager's vision and the Agile team's execution.
Playbook §1.4
Individual Accountabilities
- Draft and prioritize Stories in Jira backlog
- Provide input to Software Requirement Specifications (SRS) and other documents
- Prioritize team backlog to streamline program priorities
- Maintain conceptual and technical integrity of Features for the team
- Work with team to agree on accepted story completion — validate acceptance criteria, persistent acceptance tests, compliance with DoD
- Lead the Sprint Review/Demo — solicit feedback and incorporate learnings
- Refine features through delivery in Phase C; support test through Phase D
Decision Rights — Owns
- Product vision and strategy for the team; what features/enhancements ship per iteration/release
- PO sync events to coordinate dependencies with other POs
- Sprint Review / Demo
- Drafts of User Stories
- Story acceptance & DoD verification
- Holds the ability to prioritize one user story over others (not a traditional veto)
Influences Veto
Key Collaborators
Agile Coach Enhance understanding of Agile product-management principles Scrum Master Communicate progress; identify risks & mitigations; represent dev group cross-functionally Product Manager Facilitate feature roadmap creation — implementation plan, dependencies, risks Engineering & Developers Strategize team output; engage in design discussions; provide direction and feedback
Key Success Criteria
- User stories that are Definition-of-Ready for development
- A clearly prioritized backlog
- Feature adoption rate demonstrates value of releases
- Consistent sprint velocity
1 PO : 1–2 teams 50–100% allocated
Product ManagerAgile · Dedicated
Mission: Cultivates deep understanding of customer needs, competitive dynamics, and market opportunities. Owns the integrated product vision and roadmap, leading cross-functional execution from concept through launch and on-market performance.
Playbook §1.5
Individual Accountabilities
- Cultivate deep understanding of customer needs, competitive dynamics, market opportunities
- Lead data-driven processes to test feasibility & viability; translate into business cases
- Develop and articulate clear product vision; lead integrated roadmap to deliver franchise goals globally
- Own full product lifecycle — trade-offs, release plans, in-market sustaining, technical debt retirement
- Define integrated release targets & scope, value proposition, delivery cadence
- Accountable for on-market performance: market share, retention, complaints, NPS, cost-to-sustain, product cost
- Lead execution and release across technology, medical, regulatory, manufacturing teams
- Collaborate with Product Marketing Managers on integrated launch strategy
- Set targets, objectives, reviews with all PMs within the Franchise
- Manage and develop a team of world-class Product Managers
- Coordinate on architecture and scalability requirements; guide investment timing
- Create bottom-up planning for annual & strategic plans
- Coordinate medical & scientific input & review
Decision Rights — Owns
- Product strategy, including product roadmap and feature sets
- Priority of product features and improvements
- Release dates based on available development capacity
- Acceptance of Production or Solution quality
- Go/no-go for commercial or enterprise rollout
- Development decisions impacting product scope or release timelines
- Architecture and design decisions
- Development priorities based on business value
- Development or Product decisions that affect scope or release timelines with higher business priorities
Influences Veto
Key Collaborators
Product Owner Provide product direction; resolve scope & dependency questions RTE / Lead Build 24-month release roadmap and 9-month release plan of features RTE Assign Features to ARTs; align feature dates with launch timelines Franchise Lead Develop product vision and commercial path
Key Success Criteria
- Well-defined Solutions and Features for development
- Clear product roadmap, aligned to internal development capabilities/capacity
- Successful launch of commercially viable products and solutions
Software Development Engineer / LeadAgile · Dedicated
Mission: Designs, develops, tests, delivers, maintains, and improves Insulet's software — across the full SDLC. Leads provide feature guidance, technical architecture, and mentorship while holding the team to quality-first, FDA-aligned engineering practice.
Playbook §1.6
Individual Accountabilities
- Adhere to and hold team accountable to Insulet's Agile ways of working
- Design, develop, test, deliver, maintain, improve applications across the SDLC
- Estimate and deliver end-to-end features per Definition of Done incl. documentation
- Develop rigorous testing suites in collaboration with SDV
- (Leads) Provide feature guidance, lead technical architecture, mentor junior engineers
- Ensure software & documentation adhere to FDA and other regulatory guidelines
- Ensure software has been verified and validated; design meets specified requirements per DoD
- Participate in ideation and brainstorming for creative digital solutions
- Complete and enforce documentation standards (deployment, maintenance, support)
- Ensure code scalability and efficiency at implementation
Decision Rights — Owns
- "How" solutions are built and delivered
- Coding standards and code quality process
- (Leads) Technical architecture and direction
- Work estimates at Story and (Leads) solution level
- Releases/deployment decisions
- Solution design and refinement
- Commitment to milestones
- Ways of working & innovation via continuous improvement, training
- Incompatible scope for targeted timeline and available resources
Influences Veto
Key Collaborators
DevOps Coordinate builds and releases; set production code standards/tooling Information Security Collaborate on preventing security risks from design Systems Engineering Design/maintain monitoring tools; enhance stability & scalability SDV Engineering Investigate, debug, resolve quality issues; thorough testing Operations Engineering Coordinate code deployment into production
Key Success Criteria
- High-performing, highly collaborative teams
- Solution performance & scalability
- Continuous improvement & milestone adherence
- Quality-first software development
C/C++ · Java · Python · Swift Android · iOS · Cloud 3–5 yrs exp
Software Design Verification (SDV) / LeadAgile · Dedicated
Mission: Plans, designs, and implements thorough test cases that ensure production code is bug-free and FDA-compliant. Owns the test infrastructure, V&V plans, and quality engineering best practices that keep Insulet's software audit-ready.
Playbook §1.7
Individual Accountabilities
- Plan, design, implement thorough test cases for FDA-compliant production code
- Ensure valid verification environments for testing
- Develop and enhance test infrastructure and CI framework across teams
- Coordinate failure investigations; implement corrective actions
- Ensure defect resolution in further iterations
- Serve as SME in quality engineering — manage test plans & methodology
- (Leads) Lead V&V plan, protocol, and validation; mentor junior SDV
- Perform studies and analysis to validate conceptual designs (CAPAs)
- Document testing, analysis processes, data, results, recorded defects
- Ensure smooth transition from R&D development into production
- Drive initiatives like defining coding standards/processes for quality code
- Architect, develop, maintain innovative test automation system
Decision Rights — Owns
- Testing process, reporting, infrastructure
- Testing best practices & standards
- Recorded defects documentation
- (Leads) V&V plan, protocol, execution
- Corrective action implementation
- Bug / defect resolution
- Coding standards
- Defective / non-compliant software release into production
Influences Veto
Key Collaborators
System Design Verification Lead Shared testing best practices; system-specific knowledge; unified E2E strategy SW Devs & Systems Engineers Functional/technical expertise in bug fixes; SME on test plans & methodology DV Automation Engineers Test planning, automation of manual tests; embed automation across testers DevOps Engineers Identify automation opportunities; coordinate tooling
Key Success Criteria
- Number of defects/quality issues & reporting
- FDA regulation compliance
- Testing coverage
- Code quality
Systems EngineerAgile · Dedicated
Mission: Leads system-level realization of the product vision. Translates business and user needs into system components, interfaces, and requirements, and owns the System Architecture Description, System Hazard Analysis, and safety risk assessment.
Playbook §1.8
Individual Accountabilities
- Lead definition of system requirements and solution architecture realizing the product vision
- Translate & decompose business and user needs into system components, interfaces, requirements
- Provide efficient solution architecture for new features on deployed architecture
- Own the System Architecture Description (SyAD) and associated model
- Own the System Hazard Analysis (SHA); conduct safety risk assessment
- Provide system impact & safety risk assessment of component failure modes as DFMEA input
- Ensure Feature Define / Refine outputs are complete and consistent system-level descriptions
- Review SRS, HRS, SW Arch Description, DFMEA for consistency with system inputs
- Serve as technical lead for system integration to deliver high-value features early
- Ensure system features meet input with quality
- Perform system triage and safety evaluation of defects
Decision Rights — Owns
- Product Requirement Specifications (PRS)
- System Hazard Analysis (SHA)
- System Architecture Description (SyAD)
- Technical lead for system integration
- Decomposition of Solutions/Epics into Features
- HRS, SRS, user stories & acceptance criteria
- Regulatory submission documentation
- DFMEA for feature development
- Candidate solution evaluation
- Ensures acceptable safety and quality profile of delivered product
Influences Veto
Key Collaborators
Product Manager Drive system-level realization; decompose Solutions/Epics into Features & Enablers Product Owner Provide system requirements, safety assessment, solution architecture for stories SW Development Eng Lead Technical feasibility/cost; clear input requirements; lead Phase C integration Architect Evaluate solution architecture; assess feasibility, architectural impact, cost
Key Success Criteria
- Refined features efficiently realize product vision on system architecture
- Minimal rework — clean hand-off, linear execution
- Complete, clear, compliant system documentation
- Rapid system triage, isolation, defect resolution
- Clean verification; high-quality product release
System Design Verification / LeadAgile · Dedicated
Mission: Develops test strategies for system-level features; creates and executes quality test cases for high product quality and regulatory submissions. Ensures the system test strategy vertically aligns with component-level test strategies and ensures clean design transfer.
Playbook §1.9
Individual Accountabilities
- Develop test strategies for new features; create and execute quality test cases
- Ensure system configurations are valid and scoped optimally for DV
- Execute test cases during integration and verification phases
- Document test results, recording objective evidence and defects
- Coordinate with dev teams for defect investigation, resolution, verification
- Ensure system test strategy vertically aligns with component test strategies
- (Leads) Develop V&V strategy and plan with stakeholders and functional owners
- Ensure smooth design transfer to production from R&D
- Architect, develop, maintain innovative test automation system
Decision Rights — Owns
- Testing process, V&V plans, execution & reporting
- Testing methodologies, best practices & standards
- Recorded high-quality defects and support investigation
- Configuration management to determine device-under-test
- Development of good, testable feature requirements
- Defect resolution and verification
- Determination of product quality
- Ensures acceptable quality level prior to design transfer to production
Influences Veto
Key Collaborators
Systems Design Verification Lead Coordinate E2E V&V strategy for regulatory submissions compliance Systems DV Engineer Expertise for feature test strategies during concept development; investigate issues Systems Design Verification Automation Common automation strategy & tooling; reliability auto testing; train automation
Key Success Criteria
- Right level of test coverage
- System quality builds through integration testing yielding clean verification
- Compliance with regulatory submission needs
Agile Ways of Working · Team Composition Roles
UX LeadTeam · Dedicated
Mission: Lead the user-experience function within the Agile team. Researches, designs, and advocates for intuitive, safe, and innovative product and service experiences across the Omnipod ecosystem.
Playbook §2.2 · CPXO team design
Key Activities
- Research, design, advocate for intuitive, safe, innovative product/service experiences
- Provide GRS (Graphical Requirements Spec), HF deliverables, instructional design plan
- Validate UX flows traced against PRS
- Approve UX flows, designs, mockups for Story Definition of Ready
- Update GUI/Flows and delta document at Feature Complete Technical Review
Sits With
Product Owner Story-level UX trade-offs Systems Engineer UX flow traced to PRS Human Factors Usability validation, IEC 62366-1 evidence Instructional Designer Training assets & user guides
UX Researcher / Human Factors (UxR/HF)Team · Dedicated
Mission: Lead human-factors engineering per IEC 62366-1. Drive use-specification, UFMEA, formative and summative studies, and the User Error Risk Analysis (UERA) that gates regulatory submission.
Playbook §2.2 · CPXO design
Key Activities
- Use Specification → UFMEA → formative → summative → validation studies
- Human Factor Risk Assessment for every Feature Defined (regulated products)
- Maintain UERA per QSP-257; assess updates per development changes
- Validate use cases & UX flows mapped to user journey
Tech Lead / Dev LeadTeam · Dedicated
Mission: Lead the engineering practice inside the Agile team. Empowered with the SDV Lead to set technical direction and champion the team's autonomy in delivering against the PI Objectives.
Playbook §2.2 · Agile Team design
Key Activities
- Provide technical leadership; lead architecture, mentor engineers
- Co-empower self-organizing team with Scrum Master & SDV Lead
- Estimate effort at Story/Feature; own engineering DoD compliance
- Drive code review, static analysis, coding standards
DevOps EngineerTeam · Extended
Mission: Builds and operates Insulet's continuous-delivery pipeline. Coordinates builds and releases into production environments and sets requirements/tooling for code shipped to production.
Playbook §2.2 · Extended team
Key Activities
- Coordinate builds and releases into production
- Set requirements for production-bound code and strategy/tooling
- Participate in security and regulatory compliance processes
- Identify opportunities for test automation; coordinate tooling for consistent strategy
Tester / DV Engineer (Team-embedded)Team · Dedicated
Mission: The DV Engineer is a 100% team member: 1 per Agile Team allocation. Executes test cases, drafts protocols, documents defects, and ensures the team's stories meet DoD and required regulatory test coverage.
Playbook §2.2 · Agile Team design
Key Activities
- Draft, dry-run, and execute test protocols organized in ALM
- Develop high-quality test cases identifying product issues during dev & integration
- Verify Test Tasks linked to each Story
- Vertical-slice testing for feature integration
- Trace links from CRS through Test Case
System & Software ArchitectSolution · Dedicated
Mission: Authors & maintains the System Architecture Description; reviews Software Architecture Description. Evaluates solution architecture during Feature Define / Refine and assesses feasibility, architectural impact, cost of candidate solutions.
Playbook §2.2 · CPXO design
Key Activities
- Architectural Impact Assessment for every Feature Defined
- Authors & maintains System Architecture Description (SyAD)
- Reviews SW Arch Description (SAD)
- Evaluate solution architecture of feature during Feature Define / Refine
- Assess technical feasibility, architectural impact, cost of candidate solutions
- Provide technical leadership for system integration through Phase C
Solution RTESolution · Dedicated
Mission: RTE for a Solution Train — a group of ARTs united by a common solution purpose. Coordinates feature release dates across ARTs to align with product launch, sequencing solution-level dependencies, and aligning multiple ART RTEs to one delivery cadence.
Playbook §2.4 · Solution Train design
Key Activities
- Align feature release dates from ART RTEs to product launch
- Drive 24-month program roadmap and supporting integrated project plan
- Coordinate solution-level dependencies across ARTs
- Lead Solution PI Planning
Solutions Lead (E2E, non-medical teams)Solution · Dedicated
Mission: For non-medical/E2E teams, the Solutions Lead is the Solution Delivery Manager — coordinating overall product & commercial release and defining Release & PI Objectives and tracking. Parallels the Solution Train's leadership pattern for non-regulated product surfaces.
Playbook §2.4
Key Activities
- Coordinate overall product & commercial release across non-medical/E2E teams
- Define Release & PI Objectives & tracking
- Support solution architecture aligned with strategic flexibility choices
Franchise LeadLeadership
Mission: Owns the business gate review and the franchise commercial path. The Franchise Head is Accountable for the Business Gate Review at every phase transition; the Primary Product Manager triggers each Phase Gate closure.
Playbook §1.5 · Product Manager collaboration
Key Activities
- Accountable for Business Gate Review at every phase transition
- Develop product vision and commercial path with Product Manager
- Set franchise-level targets, objectives, and reviews for all PMs in the franchise
- Collaborate on franchise roadmap and priorities aligned to enterprise strategy
Instructional DesignerTeam · Extended
Mission: Provides instructional design plans, training materials, and patient-facing learning experiences. Member of the extended Agile team consulted at key milestones; partners with UX Lead and HF on user-guide and onboarding experiences.
Playbook §2.2 · Extended team
Key Activities
- Develop instructional design plan accompanying every feature requiring training
- Build user guides, patient-onboarding materials, training videos
- Partner with UX, HF, Translations Management for global launch
QMS · Gate & Specialist Roles
Gate ReviewerQMS · Gate
Mission: Independent assessor of gate-readiness at every Phase A→B→C→D→E→F transition. Validates exit criteria, confirms tier-rigor alignment, and confirms the funding tranche conditions are met before capital flows.
Operating Manual · SOP-003 §5 (Business Stage-Gate)
Accountabilities
- Validate exit criteria against the appropriate gate (A: investment to feasibility · B: authorize design · C: design freeze → V&V · D: design transfer · E: commercial release · F: sustain/sunset)
- Confirm tier rigor (1–5) is right-sized to program risk and investment
- Halt funding when a gate fails — the financial enforcement mechanism behind the QMS
- Document the gate decision in DHF; route to executive sponsor
Decision Rights
- Owns the gate decision recommendation; the Franchise Head is Accountable for the Business Gate Review
- Approves tailoring of deliverables for Tier 3–5 programs
Risk AnalystQMS · Specialist
Mission: Owns the Risk Management File. Drives hazard analysis, risk controls, and benefit/risk evaluation across the Phase A–F lifecycle per ISO 14971 and IEC 62366-1.
Operating Manual · SOP-048 · ISO 14971 · QSP-140 · QSP-146 · QSP-150
Accountabilities
- Maintain the Risk Management File (risk plan, hazard analysis, controls, benefit/risk)
- Drive System Hazard Analysis (SHA) per QSP-140
- Author Residual Risk Reports per QSP-146
- Maintain Risk Management Plan per QSP-150
- Coordinate User Error Risk Analysis (UERA) with HF per QSP-257
- Provide risk input to DFMEA (QSP-246) and Biocompatibility (QSP-179)
Decision Rights
- Owns RMF closure for every gate review
- Owns benefit/risk evaluation gating regulatory submission
V&V PlannerQMS · Specialist
Mission: Builds and stewards the V&V Master Plan that takes a design from Gate C through Gate D. Translates design inputs into verification protocols and user needs into validation activities.
Operating Manual · SOP-020 · QSP-126 · QSP-127
Accountabilities
- Author V&V Master Plan (Phase D entry deliverable)
- Plan Design Verification per QSP-126 (Phase D — V&V Start → FDA Submit)
- Plan Design Validation per QSP-127 (Phase E)
- Coordinate Software Integration Testing per QWI-456
- Test Strategy Development per QWI-327
- Coordinate Verification Reports and Validation Reports for DHF
Decision Rights
- Owns V&V Plan completeness; required to enter Phase D
- Cross-checks Test Coverage against Design Inputs at Gate C
Regulatory DrafterQMS · Specialist
Mission: Drafts FDA/global regulatory submissions. Owns predicate strategy, claims management, and translates clinical/V&V evidence into the right submission language for 510(k), PMA, MDR, or post-market modules.
Operating Manual · SOP-026 · QSP-067 · QSP-221
Accountabilities
- Draft 510(k), PMA, MDR submission modules
- Own predicate strategy and claims communication per QSP-067
- Coordinate translations of submission materials per QSP-221
- Manage advertising, promotion, and labeling claims per SOP-026
- Maintain Regulatory Feature Assessment for every Feature Defined
Decision Rights
- Owns regulatory pathway recommendation at Gate B
- Owns submission readiness assessment at Gate D
Center of Excellence · Reference
Data Dictionary.
The agentic data-management foundation behind InsuletOS — the model the agents read and write, now live in the PMO Command Center Supabase.
The foundation
Agentic data foundation
The data layer architected for an agentic future — structured, governed, and queryable by both people and agents.
Multi-Agent System (MAS) architecture
How specialized agents share a common data substrate, with clear ownership and read/write boundaries.
Event-driven communication & protocols
Agents and systems communicate through events and contracts, not brittle point-to-point integrations.
Enterprise knowledge graphs
The cognitive substrate for agentic memory — entities, relationships, and provenance that let agents reason over context.
Multi-hop reasoning
Graph structure enables agents to chain facts across entities to answer questions no single record holds.
Specialized agent personas
Each agent persona maps to the data domains it owns — deliverables, programs, risks, decisions, KPIs, and PDT records.
Live data domains (Supabase)
Core tables backing the platform.
deliverables (149)deliverable_raci (21)agents (29)programs (32)clarity_projects (222)risks (22)kpis (54)pdt_decisions_log (13)pdt_action_items (23)pdt_stakeholders (32)procedures (76)milestones / SREjira_issues (27.6k)
Comms · Inbox
Inbox & Triage
Group email routed into the site — classified by urgency tier (1–4), sender importance, and content type for tiered handling.
T1
Needs you now
T2
Review & send
T3
FYI / watch
T4
Auto / resolved
✉
Connect a group email address to populate the triage queue. Messages will be classified and routed here.
Comms · Drafts
Drafts
AI-drafted replies in your voice for review — never auto-sent above your autonomy threshold. Approve, edit, or regenerate.
✉
No drafts yet. Drafts will appear here once the group inbox is connected and a message needs a reply.
Comms · Rules
Routing Rules
Natural-language rules that decide who owns a message, which tier it lands in, and whether a draft is prepared.
By sender
VP / chair messages → Tier 1; route to the relevant program lead.
By topic
PDT, AOP, gate-exit → route to PMO Ops; draft a reply.
By autonomy
Tier 4 (status FYI) → auto-acknowledge; everything else waits for review.
Rules are applied by the Communication Expert agent. Configure the Claude key in Settings.
Communications
Comms
A group inbox routed through InsuletOS — triage, draft, and route PMO communication from one surface.
✉
Inbox & Triage
Tiered triage of the group inbox
Open →
✎
Drafts
AI-drafted replies in your voice
Open →
⇄
Routing Rules
Who owns it, which tier, draft or not
Open →
Agile Metrics · Pod
◉ Pod platform
26Q2-5 program sync — 58 slides. PI-objective health, releases, defects, and test progress.
69
Complete
19
On Track
7
At risk
5
Delayed
Objective status mix
On Track 19Complete 69At Risk 7Delayed 5Planning 4
Releases in flight
4.0.24.1.1MH-REG2Pinnacle Algo 1.0Summit Algo 2.5
Source: 26Q2-5 Pod Platform Sync. Roll-up across platforms: Command Center → Agile Metrics.
Agile Metrics · Data Cloud
◫ Data Cloud platform
26Q2-5 program sync — 33 slides. PI-objective health, releases, defects, and test progress.
82
Complete
86
On Track
27
At risk
44
Delayed
Objective status mix
On Track 86Complete 82At Risk 27Delayed 44Planning 14
Test progress
45% Complete24% In Progress65% Complete6% In Progress
Releases in flight
4.10.04.11.04.12.04.8.14.9.0Cloud 4.10.0Cloud 4.9.0MH REG2MH-REG2OP5 4.9.0
Teams
AcadiaArchesBryceFHIRGrand CanyonMembersNA Cloud Data ToolsOlympicPerformanceYellowstoneYellowstone PresentsYosemiteZion
Source: 26Q2-5 Data Cloud Platform Sync. Roll-up across platforms: Command Center → Agile Metrics.
Agile Metrics · iOS
◐ iOS platform
26Q2-5 program sync — 42 slides. PI-objective health, releases, defects, and test progress.
99
Complete
18
On Track
4
At risk
12
Delayed
Objective status mix
On Track 18Complete 99At Risk 4Delayed 12Planning 4
Releases in flight
MH REG2MH-REG2MHREG2OP5 v2.2.1OP5 v2.4OP5 v3.0OP5 v3.1OP6 1.0OP6 1.1
Source: 26Q2-5 iOS Platform Sync. Roll-up across platforms: Command Center → Agile Metrics.
Agile Metrics · Android Classic
◑ Android Classic platform
26Q2-5 program sync — 28 slides. PI-objective health, releases, defects, and test progress.
33
Complete
14
On Track
4
At risk
4
Delayed
Objective status mix
On Track 14Complete 33At Risk 4Delayed 4Planning 2
Defects
135
Bugs fixed (26Q2)
Releases in flight
MH-REG2OP5 v.4.1OP5 v3.1.6OP5 v3.1.7OP5 v3.1.8OP5 v4.0.0OP5 v4.0.2OP5 v4.0.3OP5 v4.1OP5 v4.2OP5 v4.3
Source: 26Q2-5 Android Classic Platform Sync. Roll-up across platforms: Command Center → Agile Metrics.
Command Center · Observability
R&D Portfolio.
Programs & projects across segments — RAG-rated, owned, and milestone-tracked. Click any program for the full picture.
Command Center · Observability
Risk Register
The master RAID register — risks, issues & opportunities, RAG-rated and owned, live from Supabase.
◌ SupabaseLoading live data from Supabase…
Command Center · Observability
Milestones
Investor-Day milestone commitment — met-rate trend by reporting month, live from Supabase.
◌ SupabaseLoading live data from Supabase…
Command Center · Observability
Resource & Capacity
Demand vs capacity vs actuals (FTE) by month — the capacity wall, live from Supabase.
◌ SupabaseLoading live data from Supabase…
Command Center · Observability
Program Gantt.
Portfolio roadmap — every program's phase window by segment. Click a bar to open its detail & full Gantt.
Loading roadmap…
Governance · Lineage
Traceability
Every surface traces to a source of record, a spec, and a set of acceptance criteria. Click any row to open it.
| Surface | Source build | Spec | Status | As of | Outcomes | Acceptance criteria |
|---|
Lineage sourced from Site_Inventory_2026-06-09 + AgentOS/specs/. "—" = not yet mapped. Acceptance-criteria status is tracked locally and persists in this browser.