Setting the Table: Your Case Mix, Volume, and Triggers

• How many vascular access and peripheral or coronary intervention procedures does your team perform per month? Options: 0-50, 51-150, 151-300, 301-600, 600+
• In the past 12 months, which events most often trigger a device review or purchase cycle at your hospital? Options: New clinical indication expanding volume, A physician hire or champion request, Contract or value analysis renewal, Repeat supply shortage, Adverse patient event, Reimbursement change, Other
• Tell me about the last time your group adopted a new device line, what started the process and how long did it take?
• Which clinical indications are driving the biggest growth in procedural volume for your team right now? Options: Peripheral arterial disease, Critical limb ischemia, Dialysis access interventions, Coronary chronic total occlusion, Neurovascular cases, Other
• Who on your team usually raises the first concern about a device or supply issue? Options: Interventional cardiologist, Vascular surgeon, Interventional radiologist, Cath lab director/manager, Materials management / purchasing, Other
• When a new device is proposed, which types of evidence or demonstrations do your physicians require first? Options: Peer-reviewed clinical data, Hands-on simulation or benchtop testing, Cadaver lab demonstration, Limited-use clinical trial/pilot, On-site proctoring, Physician peer reference
• Tell me the operational trigger that would make you start a formal evaluation within 30 days. Options: Immediate supply outage affecting schedule, Physician demand from a new hire, Regulatory or reimbursement change, Impending contract renewal, Significant adverse event

Where Care and Supply Collide

• If one supply issue could make you stop scheduling certain procedures, what would it be?
• How often do you encounter intra-procedural device performance problems such as poor deliverability, device kinking, or failed deployment? Options: Multiple times per week, Weekly, Monthly, Rarely, Never
• Describe a recent procedure where device choice or a supply issue changed the clinical outcome or significantly prolonged case time.
• Which hospital systems tend to strain most when you adopt a new device line, for example sterilization, inventory, or billing? Options: Sterilization / reprocessing, Inventory stocking and par levels, OR / cath lab scheduling, EMR order entry and billing, Materials management workflows, Clinical education
• Who is most affected when a backup device must be used mid-procedure, and what downstream costs or risks result?
• How long can your team tolerate a recurring supply disruption before it triggers emergency sourcing, case cancellations, or an escalation to leadership? Options: Less than 1 week, 1-4 weeks, 1-3 months, Longer than 3 months, Intolerable immediately

Who Signs Off, and What Makes Them Push Back

• Name the stakeholder whose veto would block a new device from being added to your formulary. Options: Interventional department chief (physician), Cath lab director/manager, Value analysis committee, Infection control / sterilization, Materials management / purchasing, Hospital administration / finance
• Walk me through the committee or approval path from clinician trial to full formulary addition in your institution.
• How do your physicians quantify acceptable tradeoffs between device performance and per-case cost? Options: Performance is primary regardless of cost, Willing to accept moderate premium for clinical gains, Cost-sensitive up to reimbursement limits, Strict per-case cost cap
• Identify who owns training for new devices and how ongoing competence is tracked after initial sessions. Options: Clinical education team / nurse educators, Vendor clinical specialists, Department leads / physicians, Materials management, No formal owner currently
• Tell me about a time the value analysis committee rejected a device, why they did, and what would have changed that outcome.
• If a sponsoring physician left the organization during evaluation, how likely is the trial to continue to completion? Options: Very likely, Somewhat likely, Unlikely, Stops immediately

Alternatives You're Actively Considering

• What alternatives would have to perform or cost differently for you to keep your current devices instead of switching?
• List the types of alternatives you are weighing right now, including incumbent suppliers, other vendors, or internal options. Options: Incumbent device line, Other external vendor(s), Internal adaptation or reprocessing, Generic or lower-cost options, Maintain current approach, no change, Other
• Name the incumbent features or contract terms you most value and would require matching to change vendors. Options: Price guarantees or caps, Guaranteed supply commitments, On-site physician training, Compatibility with reprocessing trays, Clinical outcomes data, Service and warranty terms
• Has anyone inside your organization proposed solving this without an external vendor, and if so what did that proposal look like?
• What or who would be the strongest force pushing you to switch despite incumbent advantages? Options: Physician champion demand, Repeated supply failures, Reimbursement pressure, Regulatory or safety concerns, Cost savings opportunity, Other

If This Works, How Will Care Be Different?

• If a new device reduced your average procedure time by 15 to 30 minutes, what operational or clinical changes would you expect to see the following quarter?
• List the clinical outcomes that matter most to your team when evaluating new vascular devices. Options: Reduced access-site complications, Lower contrast or radiation exposure, Shorter fluoroscopy time, Improved first-pass success, Lower reintervention rate, Fewer conversion to open procedures
• How would you measure clinician acceptance after a trial, and what numeric threshold would count as success (for example percent adoption or physician preference)? Options: % of eligible cases using the device, % of physicians who prefer the device, Reduction in procedure time, Reduction in complication rate, Cost per case improvement
• Describe the operational metrics that would make procurement or value analysis sign off, such as inventory turns, stockout rates, or per-case cost targets.
• If a pilot proves the clinical numbers you need, which remaining internal approvals are required and who signs them? Options: Value analysis committee vote, Chief medical officer approval, CFO or finance signoff, Materials management / purchasing contract, Infection control clearance

Readiness Rules: Practical Musts Before a Pilot

• Identify the single missing operational capability that would stop a pilot from going ahead.
• Tell me how your decontamination team handles sterilization or reprocessing for new single-use or reusable devices, and list any absolute incompatibilities.
• Does your EMR or inventory system support new SKU integration, automated par-level alerts, and who would own that integration? Options: Yes, materials management owns it, Yes, IT owns it, Possible but needs IT resource, No, system limitations, Unsure
• How many dedicated staff hours per month can your team realistically allocate to vendor training, trial setup, and data collection during a pilot? Options: 0-10 hours, 10-40 hours, 40-80 hours, 80+ hours
• Outline any regulatory or committee reviews that must occur before a device can be used clinically in your facility, including typical timeline for each review.
• Are there supplier contract clauses that historically prevent pilot-scale supply agreements, such as exclusivity or minimum purchase commitments? Options: Exclusivity clauses present, Minimum purchase requirements, Long-term pricing locks, No blocking clauses, Unsure

Decision Triggers and Practical Next Steps

• If the pilot meets every success metric you define, what is the fastest realistic time frame for full formulary adoption in your organization? Options: Immediate within 2 weeks, 1 month, 2-3 months, 3-6 months, Longer than 6 months
• Please identify the people who need to be present at the handover meeting to allow procurement to execute without further delay. Options: Sponsoring physician(s), Cath lab director/manager, Value analysis representative, Materials management / purchasing, Finance or CFO representative, Infection control / compliance
• How will you document trial outcomes so the value analysis committee has what it needs to approve adoption? Options: Case logs with outcomes, Procedural videos and imaging, Complication tracking and root cause, Cost per case analysis, Physician surveys and preference data
• Select the purchasing authority range that typically allows procurement to sign without executive escalation. Options: Under $10,000, $10,000–$25,000, $25,000–$100,000, Over $100,000, Varies by item
• Walk me through the one concrete deliverable or concession that would make you sign this quarter rather than later.
• Realistically, when should we schedule a follow-up meeting to review pilot design, required resources, and an initial timeline? Options: Within 1 week, Within 2 weeks, In 1 month, In 6 weeks, Other

• Solution Experience Session

• Confirm the current state and its cost to your team
• Customer confirms the demonstrated device behaviors eliminate the intra-procedure swaps and reduce procedure time for the prioritized clinical scenarios.
• Provide a tailored trial protocol with metrics mapped to the agreed clinical scenarios and simulation outcomes.
• Customer agrees on a measurable trial protocol and acceptance thresholds for clinical performance, workflow impact, and per-case cost.
• Review prioritized clinical scenarios and simulation outcomes
• Deliver a pre-trial checklist including sterilization compatibility, SKU list, and proposed training plan within one week of agreement.
• Customer identifies remaining evidence required before trial, such as sterilization compatibility and inventory handling checks.
• Demonstrate device performance against the failure modes
• Supply simulation logs and anonymized case extracts that illustrate the failure modes discussed.
• Validate that this maps to your acceptance criteria
• Confirm physician participants, trial lead, and proposed dates for the cadaver lab and limited-use trial window.
• Agree next evidence and trial handover items

• Solution Experience Session
• Solution Experience Deck
• Solution Brief

• meeting
• slides
• document

• desired_state
• current_state
• stakeholders
• gaps
• success_criteria
• decision_readiness
• desired_state
• decision_readiness
• current_state
• success_criteria
• gaps
• stakeholders
• desired_state
• success_criteria
• stakeholders
• gaps
• current_state
• decision_readiness
• decision_readiness
• decision_readiness
• decision_readiness
• decision_readiness

• Supply catheters, guidewires, stents, and grafts
• Provide cadaver lab and simulation product demonstrations
• Deliver limited-use procedure trial kits
• Onsite proctorship for initial clinical cases
• Deliver clinical evidence dossier and peer-reviewed publications
• Configure sterile procedure trays and packaging
• Inventory consignment and just-in-time replenishment
• Provide backup device kits for case contingencies
• 24/7 field technical and troubleshooting support
• Provide instructions for use and sterilization compatibility data
• Custom device kitting by procedure type
• Deliver bench performance and deliverability reports

Supply catheters, guidewires, stents, and grafts

• List the procedure types at your facility that must be covered by the device assortment (for example peripheral angioplasty, dialysis access, carotid stenting)
• Estimate the initial number of unique SKUs across catheters, guidewires, stents, and grafts you plan to stock Options: Less than 25, 25-50, 51-100, More than 100
• Name the role that will own SKU master data and ordering approvals in your organization (for example cath lab director, supply chain manager, procurement lead)
• When do you expect peak monthly case volume for the covered procedures (provide range of average cases per month) Options: Less than 25 cases/month, 25-75 cases/month, 76-150 cases/month, More than 150 cases/month
• Provide device size or profile constraints that are mandatory for your workflows (for example sheath size 6F, specific catheter outer diameter, preferred guidewire length and stiffness)

Provide cadaver lab and simulation product demonstrations

• Who should attend the cadaver lab and simulation sessions (list clinician types such as interventional cardiologists, vascular surgeons, interventional radiologists, cath lab nurses)
• Estimate how many parallel simulation stations or cadaver setups you need to run the planned sessions Options: 1, 2, 3-4, 5+
• When would you prefer the demonstrations to occur relative to trial start (for example 4+ weeks, 2-4 weeks, within 2 weeks) Options: 4+ weeks before trial, 2-4 weeks before trial, Within 2 weeks of trial, TBD
• Describe the specific clinical scenarios you want covered during hands-on simulation (for example chronic total occlusion crossing, complex bifurcation stenting, dialysis outflow stenosis)
• Provide the acceptance criteria physicians will use from the cadaver lab to greenlight trial participation (for example successful crossing rate, time-to-deploy threshold, subjective handling score)

Deliver limited-use procedure trial kits

• Estimate the number of limited-use procedures per operator you want included in the initial trial Options: 1-3, 4-6, 7-10, More than 10
• List which procedure types will be eligible for limited-use trial kits (match to your procedure mix)
• Name the individual or role authorized to release a limited-use kit in the procedure area Options: Operator/physician, Charge nurse/case coordinator, Supply chain representative, Other
• When should trial kit inventory be delivered relative to a scheduled case (for example 24-48 hours prior, morning of case) Options: 24-48 hours before case, Morning of case, Case-day on-call delivery, Other
• Describe required labeling and traceability elements for each trial kit (for example case ID, operator name, lot number, attached Instructions for Use)
• What acceptance criteria will confirm a successful limited-use trial for formulary consideration (for example procedure success rate threshold, device handling score, absence of device-related complications)

Onsite proctorship for initial clinical cases

• Provide the primary clinical proctor credentialing you expect onsite (title, board certification, or privileges required)
• Specify the number of proctors required per case and the total number of proctored cases anticipated Options: 1 proctor per case, 2 proctors per case, 1 proctor for first 3 cases then remote, Other
• Indicate the preferred timeline for transitioning from onsite proctorship to remote support Options: After 1 case, After 3 cases, After 5+ cases, By clinical performance sign-off
• List the proctoring documentation you require after each case (for example proctor report, complication log, device handling checklist) Options: Proctor report, Complication log, Device handling checklist, Other
• Have you confirmed facility requirements for vendor proctors to be credentialed or listed in vendor privilege forms? Options: Yes, No, Need assistance to confirm
• Outline the escalation contacts and expected response times during proctored cases (for example field engineer onsite within X hours, remote technical within Y minutes)

Deliver clinical evidence dossier and peer-reviewed publications

• Identify the clinical endpoints your value analysis committee prioritizes for dossier review (for example target lesion revascularization, procedural time, complication rate)
• Estimate how many peer-reviewed publications, abstracts, or registry entries you expect to support a formulary submission Options: 0-2, 3-5, 6-10, More than 10
• State whether you require anonymized local case series or early-adopter outcome data for your internal review Options: Yes, No, Maybe — request details
• Provide the payer or reimbursement codes (for example CPT or HCPCS) that dossier evidence should map to
• When do you need the clinical dossier delivered relative to trial completion or VAC meeting dates Options: Before trial completion, At trial completion, Two weeks after trial completion, TBD
• Specify whether you require comparative bench or head-to-head clinical data included in the dossier Options: Yes — comparative data required, No — acceptable without comparison, Optional

Configure sterile procedure trays and packaging

• List the procedure names that should have pre-configured sterile trays (for example peripheral angioplasty, dialysis access revision)
• Estimate par levels required for each tray type in the OR/cath lab stockroom Options: 1-2 trays, 3-5 trays, 6-10 trays, More than 10 trays
• Provide the sterilization method(s) used at your central sterile services (for example steam autoclave, low-temperature hydrogen peroxide, ethylene oxide) Options: Steam autoclave, Low-temperature hydrogen peroxide, Ethylene oxide (ETO), Other
• Describe any tray dimension, shelf, or rack constraints the trays must conform to in your sterile storage
• Confirm whether your central sterile services require tray layout maps and reprocessing instructions to be provided with each tray Options: Yes — maps and reprocessing instructions required, No — not required, Partial — some documentation required
• Specify the approval workflow and SLA for tray configuration change requests (for example 48 hours, 1 week) Options: 48 hours, 1 week, 2 weeks, Custom

Inventory consignment and just-in-time replenishment

• Select the inventory model you prefer for initial deployment Options: Consignment (vendor-owned), Vendor just-in-time (JIT) with billing on use, Purchase-on-delivery, Hybrid model
• List the physical storage locations where consigned inventory would be staged (for example cath lab stockroom, central supply, sterile core)
• Name the roles authorized to sign release paperwork or electronic confirmations when consigned items are used Options: Operator/physician, Charge nurse, Supply chain manager, Other
• Estimate the target on-hand coverage JIT replenishment should maintain given average case volume (for example days of coverage) Options: Same-day replenishment (0-1 days), 2-3 days, 4-7 days, More than 7 days
• What acceptance criteria will confirm successful inventory handover at go-live (for example stock accuracy rate >= 98%, replenishment lead time <= specified hours)?
• Specify the inventory reporting cadence and format you require (for example weekly CSV par report, daily portal feed, real-time API) Options: Weekly CSV par report, Daily summary report, Real-time portal access, API feed

Provide backup device kits for case contingencies

• List critical backup device types that must be included in contingency kits (for example stiff guidewire, bailout stent, thrombectomy catheter)
• Estimate how many backup kits should be staged per procedural bay Options: 1 kit, 2 kits, 3-5 kits, More than 5 kits
• Name the role responsible for replenishing used backup kits after a contingency event Options: Charge nurse, Supply coordinator, Vendor representative, Other
• When should backup kits be validated or checked relative to scheduled cases (for example before each case, daily, weekly) Options: Before each case, Daily, Weekly, Other
• Describe any special labeling, rapid-access storage, or transport requirements for contingency kits in your lab
• Do you require a documented contingency drill or simulation to validate rapid deployment of backup kits? Options: Yes, No, Optional

24/7 field technical and troubleshooting support

• Select the after-hours support channels you require Options: On-call engineer onsite, Phone hotline, Remote video support, Secure portal ticketing
• State your target initial response time for critical device-support incidents Options: 30 minutes, 1 hour, 2 hours, 4 hours
• Provide the designated escalation contact role and contact method at your facility for device failures
• Are spare parts kits or replacement device pools required to be staged locally for rapid swap? Options: Yes — local spares required, No — not required, Conditional — limited spares
• List the documentation that must accompany any field intervention (for example service report, lot traceability, corrective action plan) Options: Service report, Lot traceability, Corrective action plan, Other
• Specify any regulatory, credentialing, or screening checks required before a field engineer may enter procedural areas

Provide instructions for use and sterilization compatibility data

• Select the IFU delivery method you require with each kit Options: Paper IFU in kit, Digital IFU access, Both paper and digital
• Select the sterilization compatibility documents required by your sterile processing team Options: Cycletime data, Validated sterilization parameters, Materials compatibility matrix, Other
• Describe how your sterile processing team validates compatibility with low-temperature hydrogen peroxide or ethylene oxide cycles
• When do you require final IFU translations or hospital-branded labeling to be available Options: Before trial start, Before deployment go-live, TBD
• Specify required shelf-life and storage condition statements to appear on device labeling
• Is lot-level traceability linking IFU to device lot required in your inventory system Options: Yes, No, Prefer but not required

Custom device kitting by procedure type

• List the procedure types that require custom kitting rather than standard trays
• Estimate the number of unique kit configurations you anticipate across your procedure mix Options: 1-3 kit types, 4-6 kit types, 7-10 kit types, More than 10

• Purchase Agreement
• Order Confirmation
• Master Supply Agreement (MSA)
• Limited-Use Trial Agreement
• Trial Handover & Formulary Adoption Protocol
• Service Level Agreement (SLA) — Supply & Support
• Pricing & Payment Schedule
• Warranty, Returns & Recall Procedure
• Regulatory & Compliance Addendum (Healthcare)

• Go-live Health Check (Week 1-4)
• First Measurement Review (Weeks 4-10)
• Acceptance Gate — Outcome Decision (Around Day 90)
• Quarterly Success Review (Ongoing cadence)

• Publish the prioritized enhancement request list with expected delivery quarters and acceptance criteria.
• Update the clinician training schedule to include focused hands-on sessions if adoption is below target.
• Restate acceptance criteria and numeric targets
• Produce a documented acceptance decision that lists pass/fail status for each numeric target recorded in Solution Scope and captures the buyer signatory.
• Agree remediation items with concrete timelines for any failed criteria and define the evidence required to close each remediation.
• Confirm the incumbent device wind-down status and that no critical fallback workflows remain active that would undermine adoption metrics.
• Publish the acceptance decision record including pass/fail per criterion and the buyer's named signatory.
• Deliver the remediation plan for any failed criteria with milestone dates and required evidence for closure.
• Provide documentation proving incumbent device decommissioning or the agreed retention conditions and archive/migration status.
• Metrics and trend review
• Confirm the core metrics remain within agreed tolerances or document corrective actions if any metric is trending off-target.
• Reduce the count of open critical issues and agree a prioritized list of enhancement requests with timelines.
• Ensure supply reliability issues identified in the quarter have concrete resolution plans and updated par levels where needed.
• Update inventory par levels and ordering cadence based on quarterly usage data.
• Close critical supply reliability tickets within the agreed SLA and report closure evidence at the next review.
• Reconfirm success criteria and owners
• Confirm the deployment checklist is complete and each measurable success criterion has a named owner in Solution Scope.
• Identify and document the top 5 open issues or safety items with remediation timelines.
• Agree immediate remediation actions to clear any supply or training blockers before measurement window.
• Publish the go-live health checklist with outstanding items and resolution dates.
• Provide a list of clinicians who completed training and a plan for targeted coaching for those who did not.
• Confirm inventory ETAs for any missing SKUs and update par levels in the ordering system.
• Present first measurement data
• Determine whether physician adoption rate and on-time supply fulfillment rate are trending toward the targets recorded in Solution Scope, and identify any metrics at risk.
• Produce a root-cause summary for each gap and a set of corrective actions with resolution dates.
• Confirm the timeline and deliverables required to reach the acceptance gate around day 90.
• Deliver a written root-cause analysis for any procedure failures or complications within 7 days.
• Provide a supply remediation plan to achieve the target on-time fulfillment rate by the acceptance gate.
• Present outcome data against each criterion
• Supply reliability and inventory posture
• Deployment and inventory validation
• Root-cause diagnosis for metric gaps
• Document pass/fail and formal acceptance
• Early adoption signals and training status
• Clinical outcomes, complaints, and near-misses
• Clinical incidents and device complaints
• Blockers and safety issues
• Agree corrective actions and timeline to acceptance gate
• Open issue burn-down and enhancement requests
• Remediation items and resolution timeline
• Immediate remediation actions
• Incumbent device wind-down confirmation
• Quarter actions and checkpoints