Quick Introductions — What Brings You Here?

• Which best describes your role today? Options: Cath lab director/manager, Interventional cardiologist, Vascular surgeon, Interventional radiologist, OR/Interventional suite manager, Supply chain/procurement, Value analysis committee member, Other
• Tell us briefly about your site—type of hospital, annual cath/intervention volume, and the top three procedures you run most often.
• What initially prompted you to explore new vascular access/intervention devices right now? Options: New clinical indication/technique, Physician champion request, Contract renewal/value analysis, Device failures with current vendor, Supply disruptions, Cost pressure, Other
• How urgent is a change in device options for you on a scale from operational tweak to immediate patient-safety priority? Options: Immediate (patient safety), High (within 1–3 months), Medium (3–6 months), Low (6+ months), Exploratory/not yet committed
• Who on your team would be the primary contact for coordinating a clinical evaluation or trial?

What If One Device Failure Cost a Patient's Trust?

• How often do you experience device-related failures or intra-procedural product issues that meaningfully change patient care? Options: Multiple times per month, Monthly, Quarterly, A few times a year, Rarely/never
• Can you describe the most recent device failure event—what happened, who noticed it first, and how was it resolved?
• When a failure occurs, what downstream impacts do you see most often (select all that apply)? Options: Procedure delays, Use of unfamiliar backup device, Increased procedure time, Patient harm/adverse event, Escalation to admin/QA, Costly case re-booking, Other
• How long have you tolerated the current device failure rate before deciding to change vendors or devices? Options: Immediate action, After several incidents in one month, After a pattern over 6–12 months, Only at contract renewal, We haven't set a tolerance
• Who feels the emotional weight of those failures most—clinicians, nursing, patients, or administration—and how does that show up day-to-day?

Where Supply Breaks Down — Not What You Hope, What Actually Happens

• When supply issues arise, do they typically appear as short-term stockouts, delayed shipments, sudden product discontinuation, or inconsistent lot quality? Options: Short-term stockouts, Delayed shipments, Product discontinuation, Inconsistent lot quality, All of the above, Other
• How often have supply disruptions forced you to switch to backup devices mid-procedure, and what are the clinical or operational consequences? Options: Often (weekly/monthly), Occasionally (quarterly), Rarely (yearly), Never
• Who owns inventory visibility and reorder decisions at your hospital, and how confident are you in real-time accuracy? Options: Supply chain team, Cath lab manager, Vendor-managed inventory, Distributor-managed, Mixed ownership
• What lead times do you typically require for critical vascular devices to avoid interruption? Options: <1 week, 1–2 weeks, 2–4 weeks, 1–2 months, Variable/unpredictable
• If you could fix one supply problem tomorrow, which would it be and why?

Who Actually Decides — And What's Hidden in That Decision?

• Who are the decision-makers and influencers for adding a new vascular device to formulary at your institution? (select all that apply) Options: Interventional physicians (all), Physician champion, Cath lab director/manager, Value analysis committee, Supply chain/procurement, Infection control, Sterile processing/central sterile, Finance/COO, Nursing leadership, Other
• Which stakeholder typically has the final veto and why? Options: Value analysis committee, Physician group consensus, Procurement, Hospital leadership/finance, Sterile processing, Other
• What internal criteria carry the most weight in your evaluations (select top three)? Options: Clinical outcomes/data, Physician preference, Per-case cost, Reprocessing compatibility, Training burden, Supply reliability, Regulatory/quality documentation, Other
• Tell us about a past adoption decision that stalled—what hidden issues or personalities caused the delay?
• How do you prefer vendor engagement during that decision process (evidence-first, hands-on demos, co-presenting at VAMC, other)? Options: Clinical evidence and peer-reviewed data, Hands-on simulation/cadaver, Physician-led demos, Cost/financial modeling, Joint presentations to VAMC/committee, Other

If Adoption Had a Measurable Signal, What Would It Look Like?

• What single metric would make you confident a new device is delivering value—reduced complications, time savings, fewer device failures, or cost per case? Options: Reduced complications, Shorter procedure time, Lower device failure rate, Reduced re-interventions/readmissions, Lower cost per case, Improved clinician satisfaction, Other
• For the metrics you care about, what are realistic thresholds you’d accept during a limited trial (give specific numbers where possible)?
• Who will own measurement and reporting during a trial—clinical research, QA, the cath lab, or vendor-supported monitoring? Options: Clinical research/IRB, Quality assurance/patient safety, Cath lab staff, Vendor with hospital oversight, Hybrid/other
• How long of an evaluation period do you need before you’d consider moving from trial to standard use? Options: 1–2 weeks, 1 month, 3 months, 6 months, Variable by device
• What data sources do you trust most for acceptance (EHR/procedure logs, clinician logs, recorded procedure time, patient outcomes)? Options: EHR/procedure logs, Clinician-reported outcomes, QA/adverse event reports, Video/recorded procedures, Third-party studies, Other

Trial Design — Are You Measuring the Right Things or Just Running a Demo?

• If a trial ends up feeling like a friendly demo and not a true evaluation, what will you lose or waste?
• Which trial elements are essential for you: clinician-led scenario walk-throughs, simulation/cadaver labs, supervised live cases, or staged comparative cases? Options: Clinician-led scenarios, Cadaver/simulation sessions, Supervised live cases, Staged comparative trial cases, Other
• What acceptance criteria would the trial need to meet (select all that apply)? Options: Specific complication rate vs baseline, Procedure time reduction, Technical success rate, User satisfaction score, Compatibility with reprocessing, Inventory/usage thresholds, Other
• What training and proctoring support will your clinical team require during the trial phase? Options: On-site proctoring, Train-the-trainer program, Simulation/cadaver sessions, Online modules and assessments, Periodic refresher sessions, No training needed
• Are there sterilization or reprocessing constraints we must verify before trialing products on your floor? Options: Compatibility with existing reprocessing, Single-use disposal only, Vendor-supplied sterile trays, Requires new sterilization validation, Unknown—need assessment
• How many live cases and which case-mix would feel statistically and operationally sufficient to evaluate the device?

Hidden Roadblocks — What Often Comes Up After Sign-Off?

• When a device is approved, what unexpected operational issues have most commonly delayed deployment? Options: Inventory integration issues, Reprocessing/sterilization conflicts, Nursing workflow changes, EMR order types missing, Billing/reimbursement coding gaps, Staff resistance to change, Other
• How do you handle reprocessing validation and cleaning protocols for new device materials or sizes? Options: Central sterile validates, Vendor provides protocols and training, External lab validation, We do not reprocess similar devices, Other
• Who must be trained or credentialed before a new device is used independently, and how long does that typically take?
• What commercial or contracting terms have historically blocked final sign-off (minimum order quantities, consignment vs buy, pricing floors)?
• If we could remove one deployment barrier for you—what would that be?

How This Feels — Risk, Confidence, and What Keeps You Up at Night

• What about switching devices or vendors causes you the most anxiety—clinical risk, logistics, political fallout, or budgetary surprise? Options: Clinical risk, Logistics/supply risk, Political/internal resistance, Budget/cost surprise, Regulatory/quality concerns, Other
• When you imagine a successful adoption, what emotions do clinicians and staff express (relief, pride, skepticism turned to trust, other)?
• Have you ever ended a trial early due to poor clinician sentiment or loss of confidence? Tell us what led to that decision. Options: Yes—clinical concerns, Yes—operational friction, Yes—supply/contract problems, No
• What would a vendor need to do to earn your trust quickly during evaluation? Options: Transparent quality data, Rapid supply guarantees, Hands-on training and proctoring, Clear commercial terms, On-call clinical support, Other
• What keeps you awake the most when thinking about patient safety and device choice in your lab?

Next Steps Together — What Would Make Moving Forward Feel Safe and Easy?

• What would make the path from trial to standard use feel inevitable rather than optional?
• Which of these would accelerate your decision: a short pilot with guaranteed supply, shared risk commercial terms, peer site testimony, or pre-approved training and sterile validation? Options: Short pilot with guaranteed supply, Shared risk commercial terms, Peer site testimonial/visit, Pre-approved training and sterile validation, All of the above, Other
• Who would need to sign an internal 'go/no-go' on completion of the trial, and what documentation do they require?
• Realistically, what timeline would you be comfortable with for pilot start to formulary decision? Options: Immediately/within 2 weeks, 1 month, 2–3 months, 3–6 months, 6+ months
• What would you like our team to deliver next to make it easier to evaluate—data package, in-person demo, simulation session, trial proposal, or something else? Options: Clinical data package, On-site demo/proctoring, Cadaver/simulation session, Formal trial proposal with acceptance criteria, Supply/inventory plan, Other
• Is there anything else about your clinical workflow, staffing, or priorities we haven't asked that would change how we'd design a safe, useful evaluation for you?

• Pre-Experience Alignment: Current State, Consequence & Future State
• Clinician-Led Simulation / Cadaver Session (Outcome Validation)
• Trial Case Definition Workshop (Protocol & Metrics)
• Operational & Sterilization Logistics Review
• Post-Simulation Validation & Decision Review

• Establish and schedule all necessary training and identify owners for inventory and ordering workflows.
• Customer to deliver one-sentence current state, failure log (last 12 months), and baseline metrics before the simulation.
• Vendor to map each scenario to acceptance criteria and produce a simulation script and measurement plan.
• Schedule simulation/cadaver session date, location, and confirm clinician availability.
• Recap of Current State, Consequence & Future State
• Produce objective, measured evidence showing whether the product achieves the defined future state in representative scenarios.
• Obtain explicit clinician validation (yes/no + qualifiers) for each acceptance criterion tested.
• Generate a prioritized gap list and a set of candidate trial cases to move forward with or iterate on.
• Capture and store all measurement data, annotated video, and observer notes; deliver to stakeholders within 48 hours.
• Compile clinician validation statements and a prioritized list of unresolved issues with proposed mitigations.
• Vendor to prepare a proposed set of trial-case candidates and updated acceptance criteria based on simulation results.
• Review Simulation Outcomes & Key Evidence
• Produce a draft trial protocol with measurable endpoints and clear ownership for data collection and safety monitoring.
• Ensure each trial case is explicitly mapped to acceptance criteria and the methods to prove or disprove success.
• Establish decision gates and sign-off authorities for moving from trial to formulary consideration.
• Draft and circulate the trial protocol including case definitions, data forms, timeline, and sign-off checklist.
• Assign case owners, data stewards, and a safety officer for the trial execution.
• Set the trial start date and schedule interim review meetings tied to decision gates.
• Supply & Inventory Forecast for Trial
• Ensure no operational barriers exist to run the trial, including sufficient inventory and sterilization/reprocessing compatibility.
• Introductions & Meeting Objectives
• Have a documented contingency plan that prevents case cancellations or unsafe conversions during the trial.
• Provide a trial-specific inventory forecast and confirm buffer stock ownership and delivery commitments.
• Deliver sterilization compatibility documentation or validation tests for hospital reprocessing team review.
• Prepare and schedule training sessions and quick-reference materials for the clinical and reprocessing teams.
• Summary of Captured Data vs Acceptance Criteria
• Make a documented, defendable decision to proceed to trial, iterate on the product/experience, or halt based on objective evidence.
• Capture clinician sign-off statements and assign clear owners and timelines for the chosen path.
• Prepare the evidence package and communication plan for value analysis and formulary stakeholders.
• Produce a decision memo summarizing data, clinician validations, operational impact, and the chosen path for circulation.
• If proceeding, finalize and publish the trial protocol, schedule the kickoff, and notify all operational owners.
• If iterating, document required simulation changes, responsible parties, and timeline for re-test.
• Produce a single-sentence current state, single-sentence future state, and quantified list of consequences to anchor the experience.
• Agree and document clear, measurable acceptance criteria and who will measure them.
• Confirm clinician leads, observers, logistics, and required pre-work ahead of the hands-on session.
• Clinician Validation & Statement
• Scenario 1 — Routine Case (Access & Delivery)
• One-sentence Current State
• Define Trial Objectives and Primary Endpoints
• Sterilization & Reprocessing Compatibility
• Operational Impact Estimate
• Training Plan for Clinicians & Reprocessing Staff
• Explicit Consequence Review
• Scenario 2 — Challenging Anatomy / Failure Mode
• Select Trial Case Types, Inclusion/Exclusion Criteria, and Volumes
• Map Each Trial Case to Acceptance Criteria & Metrics
• Define Future State (Outcome Statement)
• Scenario 3 — Emergency Conversion / Backup Workflow
• Decision: Proceed to Limited Trial / Iterate / Decline
• Packaging, Tray Configuration & Sterile Field Handling
• Data Capture Plan & Ownership
• Review & Lock Acceptance Criteria
• Contingency Plan for Supply Disruption
• Real-time Data Capture & Metric Review
• Define Next Steps, Owners & Timelines
• Prepare Communication for Value Analysis & Formulary
• Ordering, Billing & Inventory Ownership
• Targeted Proof Points Review
• Confirm Clinician-led Scenarios & Roles
• Safety, Escalation & Stop Criteria

• Deliver Procedure-Specific Trial Device Kits
• Run Hands-On Cadaver Lab Demonstrations
• Provide On-Site Proctoring for Live Cases
• Supply Pre-Configured Starter Inventory Pallets
• Deliver Custom Procedure Starter Packs
• Deploy Vendor Barcodes on Device Stock
• Provide In-OR Technical Troubleshooting Support
• Ship Sterile Single-Use Prep Packs
• Deliver Clinical Evidence Dossier and IFUs
• Supply Simulation Phantoms and Training Models
• Supply Device-Compatible Introducer Sheaths
• Deliver Pre-Stocked Procedure Case Carts

Deliver Procedure-Specific Trial Device Kits

• Which procedure categories should the trial kits cover? Options: Peripheral vascular (PVD), Coronary, Neurovascular, Dialysis access, Embolization, Other
• What is the expected number of trial cases per month using these kits? Options: 1-5, 6-15, 16-30, 30+
• Which exact SKUs, sizes and device configurations must be included in each kit? (list SKUs / sizes)
• What is the intended trial duration for these kits? Options: 2 weeks, 1 month, 3 months, 6 months, Custom
• Do trial kits need sterile single-use packaging and hospital-ready labeling (including lot/expiry)? Options: Yes, No
• Are there any storage, refrigeration, or special handling requirements for the kits? Options: Ambient storage only, Temperature-controlled, Controlled humidity, Other

Run Hands-On Cadaver Lab Demonstrations

• Which demonstration format do you prefer? Options: On-site cadaver lab, Regional simulation center, Virtual demo + shipped samples, Hybrid (onsite + virtual)
• How many participants and which roles should be included (e.g., attending physicians, fellows, cath lab techs)?
• Which clinical scenarios and case types should the lab focus on?
• What equipment or imaging compatibility is required for the lab (e.g., fluoro, angio tower, ultrasound)? Options: Fluoroscopy/angio, Ultrasound, CT/CBCT compatibility, None required, Other
• Do you require vendor-provided proctors, instructors, or CE accreditation for attendees? Options: Vendor proctors/instructors, CE accreditation required, No proctors needed, Other
• Are there preferred dates, scheduling windows, or OR downtime constraints we should accommodate?

Provide On-Site Proctoring for Live Cases

• How many live cases do you want proctored initially? Options: 1-2, 3-5, 6-10, 10+
• Which physicians or teams require proctoring (names, roles, or departments)?
• Which proctor duties are expected (pre-op briefing, device setup, in-room coaching, troubleshooting, post-case debrief)? Options: Pre-op briefing, In-room coaching, Device setup, Troubleshooting, Post-case debrief
• Are there credentialing, background check, or badge access requirements for vendor proctors? Options: Yes, No
• What scheduling windows and OR booking constraints should proctor visits respect?
• Should travel, lodging and per-diem for proctors be arranged by the vendor? Options: Vendor arranges travel, Hospital arranges travel, Not applicable

Supply Pre-Configured Starter Inventory Pallets

• What duration should starter inventory cover on arrival (e.g., 2 weeks, 1 month, 3 months)? Options: 2 weeks, 1 month, 3 months, Custom
• Please list SKUs and target quantities per pallet (or upload SKU list).
• Do pallets require cold chain, special crates, or handling instructions? Options: No special handling, Cold chain required, Fragile/crate required, Other
• Where should pallets be delivered (central supply, cath lab, OR storage) and who signs for delivery? Options: Central supply, Cath lab, OR storage, Other
• Do you want vendor-managed consignment or vendor-triggered replenishment for pallet stock? Options: Vendor-managed consignment, Vendor-triggered reorder, Hospital-managed inventory
• Do starter pallets need barcode labeling, bin assignments, or integration with your inventory system? Options: Barcode labeling, Bin assignment, Inventory system integration, None

Deliver Custom Procedure Starter Packs

• Which specific procedure types and kit configurations are required for starter packs?
• How many starter packs are needed initially? Options: 5, 10, 25, 50, Custom
• Should each pack include procedure checklists, IFUs, quick-reference cards or patient billing codes? Options: Checklists, IFUs, Quick-reference cards, Billing/charge codes, None
• Are there hospital-specific labeling or component preferences to include (e.g., color coding, SKU labels)? Options: Yes, No
• Do starter packs need to be compatible with existing introducer sheaths or other hospital-supplied items? Options: Fully compatible, Partially compatible - list exceptions, Not compatible
• Do you want sample disposables or spare parts included with starter packs? Options: Include disposables, Include spare parts, No extras

Deploy Vendor Barcodes on Device Stock

• Do you require vendor-applied barcodes/UDI (GTIN + lot/expiry) on device packaging? Options: Yes, No
• What barcode format(s) must we support or integrate with (e.g., GS1/GTIN, UDI, hospital custom)? Options: GS1/GTIN, UDI, Hospital custom barcode, Other
• Which hospital inventory or ERP system must the barcode data integrate with?
• Do you require on-site barcode validation and scanner compatibility testing? Options: Yes, No
• Should barcodes include serialized device identifiers for traceability? Options: Yes - serialized, No - lot level only
• Who will perform barcode scanning and inventory updates (vendor staff, hospital staff, both)? Options: Vendor, Hospital, Both

Provide In-OR Technical Troubleshooting Support

• Which level of in-OR technical support do you expect for live procedures? Options: Phone support, Remote video support, On-site technician, Vendor proctor with troubleshooting
• What is the expected weekly case volume that may require technical support? Options: 1-2, 3-5, 6-10, 10+
• What are the top device failure modes or scenarios for which you require troubleshooting expertise?
• What response time SLA do you require for technical issues during cases? Options: Immediate (≤15 min), Within 1 hour, Same day, Next business day
• Do vendor personnel need OR credentialing, device handling training, or infection control clearance before entry? Options: Yes, No
• Do you require incident reporting, root-cause documentation and corrective action records for technical events? Options: Yes, No

Ship Sterile Single-Use Prep Packs

• Which sterile components must be included in each prep pack (e.g., drapes, sterile fields, disposables)?
• How many prep packs are used per case and what is your expected monthly usage? Options: 1 per case, 2 per case, Variable - specify
• What sterilization method and shelf-life expectations are required for the packs? Options: Ethylene oxide, Gamma, Sterile single-use supplied, Other
• Do prep packs need custom hospital labeling, lot traceability, or regulatory declarations? Options: Custom labeling, Lot traceability, Regulatory statement, None
• Are there special packaging, disposal, or transport requirements (e.g., sharps containment)? Options: Yes, No
• Do you require validation documentation for sterility and bioburden for the prep packs? Options: Yes, No

Deliver Clinical Evidence Dossier and IFUs

• Which evidence types are required for your review (select all that apply)? Options: Randomized controlled trials, Registry/real-world data, Bench and bench-to-bedside testing, Cost-effectiveness / economic analysis, Meta-analysis / systematic review, Other
• Who is the primary audience for the dossier (e.g., VA committee, clinicians, procurement)? Options: Value Analysis committee, Clinicians/physicians, Supply chain/procurement, Administration, Other
• Do you require hospital-formatted IFUs, quick-reference cards, and procedure checklists? Options: IFUs (hospital-formatted), Quick-reference cards, Procedure checklists, Digital access only, Printed binder
• What delivery formats do you need for the dossier (PDF, printed copies, online portal)? Options: PDF, Printed binder, Online portal, All of the above
• Are translations, localized regulatory statements, or specific credentialed author signatures required? Options: Translations required, Localized regulatory statements, Signed by clinical author, None
• Are there specific clinical or operational outcome metrics the committee will evaluate (e.g., complication rate, procedure time, cost per case)?

Supply Simulation Phantoms and Training Models

• Which anatomical regions or models are required (e.g., peripheral leg, carotid, coronary, dialysis access)? Options: Peripheral (leg), Carotid, Coronary, Dialysis access, Neurovascular, Other
• Do you require high-fidelity (fluoro/angio-compatible) models or low-fidelity skill trainers? Options: High-fidelity (fluoro compatible), Low-fidelity trainers, Both
• How many models do you need and for what loan/purchase duration? Options: 1-3 weeks, 1 month, 3 months, Permanent purchase
• Do models need to support specific device types (stents, grafts, catheters) and imaging modalities? Options: Yes - specify devices/modalities, No - general training models
• Do you require vendor-led training sessions or train-the-trainer support with the models? Options: Vendor-led training, Train-the-trainer, No vendor training
• Are there return logistics, disposal, or cleaning/maintenance requirements we should plan for? Options: Yes, No

• Formulary Acceptance Letter
• Commercial Terms & Pricing Schedule
• Value Analysis Committee Approval
• Statement of Work (SOW)
• Trial Acceptance & Conversion Conditions
• Purchase Order / Contract Signature
• Inventory & Consignment Agreement
• Training & Clinical Education Commitment
• Reprocessing & Sterilization Compatibility Certification
• Service, Warranty & Recall Policy
• Regulatory & Clinical Compliance Attestation
• Site Readiness & Deployment Plan
• Supply Risk Mitigation & Contingency Plan
• KPI Monitoring & Escalation Path
• Change Order & Amendment Process

• Clinical Outcomes Confirmation
• Operational Outcomes & Inventory Integration
• Lessons Learned & Continuous Improvement Workshop
• Shared Support Channel & Escalation Cadence Setup

• Opening & Objectives
• Surface and assign remediation for any adverse events or unresolved clinical failure modes.
• Define the operationally measurable future state that adoption must deliver.
• Publish an outcomes report consolidating trial metrics, representative cases, and clinician sign-offs.
• Assign owners to investigate and remediate any adverse events/failure modes with target completion dates.
• If validated, prepare clinical sign-off document for the value analysis/commercial handoff.
• Opening & Objectives
• Agree initial inventory par levels and replenish cadence to support standard use.
• Validate that reprocessing and sterilization processes are compatible or define necessary changes.
• Assign operational owners and an escalation path for supply interruptions.
• Document the ordering and receiving workflow with required system updates.
• Finalize and publish inventory par levels and submit purchase orders for initial stocking.
• Update sterile processing SOPs or submit validation tests if changes are required.
• Implement ordering workflow changes in the inventory system and confirm user access.
• Intro, Goal Setting & Prework Review
• Produce a documented lessons learned report covering clinical and operational findings.
• Create a prioritized improvement backlog with owners and timelines.
• Agree on pilot plans or experiments to validate high‑impact changes.
• Establish how learnings will be circulated and tracked (owner, cadence, metric).
• Publish the lessons learned document with root cause analyses and recommended actions.
• Create backlog items in the agreed tracking tool and assign owners and target dates.
• Schedule pilots or follow-up experiments for top-priority mitigations and define success criteria.
• Agree triage rules, severity definitions, SLAs, and the escalation matrix.
• Opening & Desired Outcomes
• Select and configure a shared support channel and confirm how issues will be submitted.
• Validate the support flow via simulation and schedule recurring support review meetings.
• Define reporting metrics and cadence for ongoing oversight.
• Create and provision the shared channel (ticket queue or secure chat) and invite stakeholders.
• Document the triage process, SLAs, and escalation contacts and distribute to all participants.
• Schedule the recurring support review cadence (e.g., weekly for 30 days, then monthly) and set up dashboard reporting.
• Confirm whether trial clinical metrics meet the pre-agreed acceptance criteria and document results.
• Obtain explicit clinician validation (sign-off) or a clear list of remaining clinical objections.
• One‑Sentence Current State & Consequence Recap
• One‑Sentence Future State for Support
• One‑Sentence Current State (Prework)
• One‑Sentence Current Operational State
• Consequence of Inadequate Support (Examples)
• Consequence Summary
• Root Cause Analysis (Breakout)
• Operational Consequences
• Choose & Configure Shared Channel (Proof)
• Outcomes vs Acceptance Criteria (Data Walk)
• Brainstorm Mitigations & Enhancements
• Inventory Reconciliation & Forecast
• Reprocessing/Sterilization Compatibility Confirmation
• Case Walk‑throughs (Proof)
• Prioritize Improvements (Impact vs Effort)
• Define Triage, Priority Levels & SLAs
• Supply Chain Handoff & Ordering Workflow (Proof)
• Roadmap & Owner Assignment
• Adverse Events & Failure Mode Review
• Escalation Matrix & Contacts
• Validation & Commitment
• Contingency & Mitigation Plan
• Reporting Cadence & Dashboard
• Future State Confirmation (One‑Sentence)
• Validation & Physician Sign‑off
• Validation Simulation & Close
• Validation & Owner Assignment
• Close & Communication Plan