Health, Education & Government Life Sciences & Pharma Implantable Devices

Orthopedic Implants

Regulated development and commercialization journeys where clinical, quality, and market access align.

Stryker Zimmer Biomet DePuy Synthes (J&J) Smith & Nephew
Inside this journey
  1. Pre-Discovery

    Align stakeholders on decision roles, timelines, and acceptable tradeoffs before deeper discovery.

    1. Stakeholder Alignment

      Confirm surgeon preferences, VAF priorities, decision roles, timing, and what ‘good’ looks like for each stakeholder.

      Alignment Questions

      Start Here: Who's in the Room?

      • Who will be directly involved in evaluating implants, instruments, and OR workflow for this program? Options: Surgeon(s), Orthopedic Service Line Director, OR Manager/Nurse Lead, Value Analysis Committee (VAF) Member, Hospital Procurement/Materials Management, GPO Representative, IDN Contract Manager, Biomedical/ Sterile Processing, Other
      • Tell us about the primary surgeon(s) who might adopt a new system—what do they value most in an implant platform and OR support?
      • How long does your typical implant evaluation and approval process take from introduction to decision? Options: Less than 1 month, 1–3 months, 3–6 months, 6–12 months, 12+ months, Variable/Unsure
      • Historically, which party has driven final decisions on implants and why? Options: Surgeons, VAF, Hospital Procurement, GPO/IDN, Shared decision, Other
      • What top three measurable outcomes does your institution use to judge a successful implant program? Options: Revision rate, OR time per case, Per-case implant spend, Length of stay, Readmission rate, PROMs/Functional outcomes, Surgeon adoption rate, Other
      • Which vendors have you evaluated or used recently, and what ultimately drove any change (or prevented change)?

      Are You Settling for Compromise?

      • Which long-standing compromise between surgeon preference and hospital cost pressure do you accept that still frustrates you?
      • How often do these surgeon vs. hospital conflicts surface during procurement or VAF reviews? Options: Almost every case, Often, Occasionally, Rarely, Never
      • Give a real example where that compromise led to a clinical, financial, or operational problem—what happened and who felt the impact?
      • When those disputes occur, who typically gets the final say and why does that party usually prevail? Options: Surgeon - clinical autonomy, VAF - cost governance, Procurement - contract terms, GPO constraints, Shared decision, Other
      • If a structured process could resolve these trade-offs without eroding surgeon trust, how willing would your team be to try it? Options: Very willing, Somewhat willing, Skeptical but curious, Not willing
      • What emotional or cultural barriers (e.g., fear of losing autonomy, reputational risk) tend to block productive compromise here?

      What's Really Costing You?

      • If you could eliminate one hidden or tolerated cost in your arthroplasty program tomorrow, what would it be and why?
      • Which of the following are the biggest cost drivers for you today? Options: Implant list price, Disposable instruments/consumables, OR time and turnover, Inventory carrying and stockouts, Reprocessing and sterilization labor, Warranty and revision costs, Clinical complications/readmissions, Other
      • What is your current target or acceptable range for per-case implant spend for primary arthroplasty? Options: <$2,000, $2,000–$4,000, $4,000–$6,000, $6,000–$8,000, >$8,000, No target/Undisclosed
      • How has per-case implant spend trended over the last 12–24 months at your facility? Options: Rising, Stable, Decreasing, Volatile/Uneven, Unknown
      • Describe any active standardization efforts (e.g., formulary rules, preferred vendor lists) and the main barriers you've run into.
      • What systems or reports do you have today to track cost drivers (choose all that apply)? Options: ERP/Materials Management dashboards, Clinical registry integration, Manual spreadsheets, Periodic finance reports, Real-time OR analytics, Limited or no tracking

      When the OR Isn't Moving: Pinpointing Friction

      • Which specific OR moment—instrument missing, tray setup, implant fit, rep unavailable—most often turns a routine case into a crisis?
      • How frequently do instrument or instrumentation workflow problems cause delays or case cancellations? Options: Daily, Weekly, Monthly, Occasionally, Rarely, Never
      • Which intraoperative support model do you rely on today and which pain points does it create? Options: Rep scrubbed in and handling instruments, Rep in room but non-scrubbed, Remote/phone-based support, Dedicated hospital-employed tech, No vendor support, Other
      • Have you experienced instrument failures or set incompleteness that changed clinical decisions mid-case? Tell the story and the downstream impact.
      • What level of vendor rep involvement in the OR would surgeons and OR staff consider acceptable or ideal? Options: Scrubbed assistance, Non-scrubbed in-room support, On-call remote support, Scheduled proctorship only, No vendor presence
      • How does instrument reprocessing or tray complexity affect your sterile processing workflow and turnaround times?

      What Would 'Good' Look Like for Each Person?

      • Pick a stakeholder—surgeon, VAF rep, OR manager, or procurement—what would a perfect adoption outcome look like to them and why would they care?
      • Which of the following best describes stakeholder priorities across your organization right now? Options: Clinical outcomes first, Cost reduction first, Balanced clinical+cost, Operational efficiency prioritized, Surgeon autonomy emphasized, Other
      • For surgeons specifically, which of these are absolute non-negotiables when evaluating a new implant system? Options: Implant geometry/kinematics, Proven clinical outcomes, Instrument ergonomics and reliability, Minimal learning curve, Strong intraop support, Specific bearing options, Other
      • For hospital/VAF reviewers, what evidence or assurances move the needle fastest? Options: Economic modeling/ROI, High-quality registry data, Peer-reviewed studies, Warranty/registry programs, Standardization potential, Contract/GPO pricing
      • What operational deliverables (e.g., tray counts, staff training hours, guaranteed rep coverage) would make your OR manager feel confident?
      • Where do you see the greatest misalignment between 'surgeon good' and 'hospital good' that we should address first?

      Are You Confident in the Evidence?

      • Which missing piece of evidence would cause your team to stop debating and move straight to adoption?
      • What types of evidence do you currently rely on when vetting implants? Options: Randomized controlled trials, Registry data, Single-center clinical series, Surgeon peer testimonials, Biomechanical/bench testing, None/Varies by case
      • Which clinical outcomes are tracked and reported routinely at your facility for arthroplasty? Options: Revision rate, Infection rate, PROMs/Patient satisfaction, Procedure time/OR efficiency, Readmission/complication rate, Dislocation rate, Other
      • How open is your team to sharing outcome data or participating in a vendor-supported registry as part of a pilot? Options: Open to full data sharing, Open to de-identified sharing only, Prefer limited sharing, Not open
      • Would peer proctorship, a local pilot, or a multi-center study be most persuasive to your decision-makers? Options: Peer proctorship (surgeon-led), Local pilot (defined cases), Multi-center registry/published study, Randomized trial, Existing evidence sufficient
      • What concerns cause you to distrust vendor-provided outcome claims or economic models?

      What Would Switching Actually Feel Like?

      • Imagine a smooth vendor switch—what specific friction points would still be most likely to derail it before you even start?
      • Have you attempted a product or vendor change in the past 3 years? If so, what worked and what stopped full adoption?
      • Which instrument or inventory constraints are most likely to block adoption (choose all that apply)? Options: Instrument compatibility with hospital trays, Incomplete or missing instrument sets, Excessive tray counts/sterilization burden, High reprocessing time, Capital cost for new trays/storage, Other
      • Which contractual or GPO-related concerns are most likely to prevent a switch? Options: GPO pricing lockouts, IDN master contract limitations, Buy-out or inventory write-off costs, Lengthy procurement approvals, Clinical preference clauses, Other
      • How many proctored cases, and of what type, would surgeons expect before feeling comfortable adopting a new system? Options: 1–3 cases, 4–10 cases, 10–25 cases, 25+ cases, Depends on complexity/implant type
      • What would your ideal timeline look like from pilot agreement to full roll-out (weeks/months)? Options: Immediate (weeks), 1–3 months, 3–6 months, 6–12 months, 12+ months

      Next Steps, Signals, and Mutual Acceptance

      • What specific, measurable acceptance criteria would your team require to consider a pilot successful? Options: OR time reduction per case, Per-case implant cost target, No increase in complication/revision rate, Surgeon satisfaction score threshold, Staff competency metrics, Inventory turnover/improvement
      • What trial length and case volume would you consider sufficient to judge success? Options: 1 month or 10 cases, 3 months or 25 cases, 6 months or 50 cases, By outcomes rather than time/case count, Unsure
      • Who absolutely must sign off on a pilot or adoption (names or roles)? Options: Lead Surgeon(s), Orthopedic Service Line Director, VAF Chair, OR Manager, Materials Management/Procurement, GPO/IDN Rep, Other
      • What cadence and format of updates would you prefer during a pilot (e.g., weekly case review, dashboard, monthly executive summary)? Options: Weekly operational huddle, Biweekly clinical review, Monthly executive summary, Real-time dashboard access, Ad-hoc as-needed updates
      • Are there regulatory, credentialing, or credentialing documentation hurdles we should address upfront? Options: Surgeon proctoring credentialing, OR staff training certifications, Implant tracking/UDI setup, Insurance/coverage considerations, None/Handled internally
      • List any outstanding risks, political dynamics, or hidden constraints we must mitigate before drafting a mutual commitment.
      • Realistically, when could we schedule a follow-up to review a pilot proposal and acceptance criteria? Options: Within 1 week, 1–3 weeks, 1–2 months, 3+ months, Undecided
    2. Current State Mapping

      Document implant portfolio, standardization efforts, surgical workflows, OR instrumentation gaps, and cost drivers.

      Current State

      Tell Me About Your Implant Lineup

      • Which implant families are you using for most of your cases today (select all that apply)? Options: Primary knee arthroplasty, Primary hip arthroplasty, Revision hip/knee, Shoulder arthroplasty, Trauma fixation (plates/nails), Sports medicine anchors/soft tissue
      • Roughly what percentage of your total arthroplasty/trauma volume does each of those families represent? (e.g., 50% knees, 30% hips)
      • Which manufacturers supply your primary implants and instrument sets today? (select all that apply) Options: Stryker, Zimmer Biomet, DePuy Synthes (J&J), Smith & Nephew, Exactech, NuVasive/Other specialty vendors, Independent reps/other
      • Do you maintain a documented, surgeon-level map of who prefers which systems? Options: Yes — up to date, Yes — but outdated, No formal map, informal knowledge only, No
      • Tell me about one recent case where implant choice felt clearly right—or clearly wrong—and why.

      Are You Settling for Patchwork Standardization?

      • When leadership says 'we've standardized implants,' whose definition of 'standard' usually wins here—clinical preference or cost pressure? Options: Surgeons/clinical preference, Service line admin/hospital leadership, VAC/GPO influence, A hybrid compromise, Other
      • What percentage of arthroplasty/trauma cases currently use a single preferred system versus exceptions? Options: >90% standardized, 70–90% standardized, 40–70% standardized, <40% standardized
      • How are exceptions handled today when a surgeon requests a non-standard implant? Walk me through the approval and logistics.
      • Which factors typically override standardization at your site? (select up to three) Options: Surgeon preference/technique, Complex/revision cases, Lack of clinical data for standard option, Instrument set limitations, Contract/GPO constraints, Other
      • If you could change one policy or process to make standardization actually stick, what would it be?

      Where Does the OR Slow Down?

      • If you had to name the single most frequent cause of intraoperative delay or fragility, what would it be? Options: Missing/incorrect instruments, Implant availability/templating issues, Lengthy trialing/fit adjustments, Communication with rep/tech support, Room turnover/sterile processing delays, Other
      • How often do cases exceed your target OR time because of implant or instrument issues? Options: Almost every case, Weekly, Monthly, Rarely, Never tracked
      • Describe a recent OR incident tied to instrumentation or implants and the downstream impact (time, staff stress, case cancellation, patient outcome).
      • Who in the OR typically escalates when an implant/instrument problem appears (surgeon, RN, tech, rep)? Options: Surgeon, Circulator RN, Scrub tech/sterile processing, Sales rep/vendor tech, Service line admin
      • What workarounds have become 'normal' to avoid delays, and how comfortable are teams with those workarounds? Options: Standard workaround used and accepted, Used but creates concern, Used rarely, risky, No consistent workaround

      What's Missing From Your Instrument Room?

      • How often does the OR discover a required tray, instrument, or implant component only after the patient is prepped? Options: Weekly, Monthly, Quarterly, Rarely, Never tracked
      • What percentage of your instrument trays are vendor-owned versus hospital-owned? Options: Mostly vendor-owned (>75%), Mixed (25–75%), Mostly hospital-owned (<25%), Unknown
      • How reliable are your sets in terms of completeness and function—do you track missing instruments, broken instruments, or repeated repairs? Options: We track in detail, We track informally, We notice but don't track, We don't track
      • What reprocessing turnaround time do you need to keep OR schedules reliable, and do you hit that target now? Options: <6 hours, 6–12 hours, 12–24 hours, >24 hours
      • Tell me about one instrument or tray design you wish existed to reduce complexity or setup time.

      Who Is Paying — Really?

      • When the finance team looks at total cost per case, which line item causes the most surprise or debate? Options: Implant per-case cost, OR time and staffing, Instrument repair and replacement, Inventory carrying costs, Revision/readmission costs, GPO/fee structures
      • What's your estimated average implant spend per primary hip/knee case today? If ranges vary by surgeon or case type, please specify.
      • How much variability do you see in implant cost between surgeons for the same case type? Options: Minimal (<10%), Moderate (10–25%), High (25–50%), Very high (>50%), Not sure
      • Which purchasing mechanics are in place today? (select all that apply) Options: GPO contracts, IDN master agreements, Facility-level purchasing, Surgeon buy-in with exception process, Value-analysis committee oversight, Direct negotiation with vendors
      • Are there hidden or recurring costs tied to your implants (e.g., instrument repair, special sterilization, warranty fees)? Please list and estimate impact if possible.

      When Teams Tried to Change, What Broke?

      • Think of the last time you introduced a new implant or tried to standardize—what failed first and why do you think it failed?
      • Which stakeholder most commonly resists adoption of new implants or instruments? Options: Surgeons, OR staff, Sterile processing, Procurement/VAC, GPO partners, Other
      • How long did it take for the team to either adopt or abandon the change in that example? Options: <1 month, 1–3 months, 3–6 months, 6–12 months, >12 months
      • What support or intervention would have changed the outcome in that attempt (training, dedicated reps, guaranteed outcomes, financial incentives)? Options: Focused surgeon training/proctorship, Dedicated intraop rep/tech, Clear outcome guarantees/warranty, Financial incentives or shared savings, Better data tracking/metrics, Other
      • Describe any emotional or cultural barriers you noticed—what made people reluctant beyond the practical issues?

      If We Could Build the Perfect Case Together

      • Imagine an ideal day in your OR—what single outcome change would make surgeons feel clinically confident and administrators feel the spend is justified?
      • Which measurable success signals matter most to you for any new implant solution? (select up to three) Options: Reduced OR time, Lower per-case implant spend, Reduced revision/readmission rates, Fewer instrument-related delays, Improved patient-reported outcomes, Registry participation/warranty
      • Would you be open to a structured pilot (defined case mix, proctorship, tracked metrics) to validate a new system? If yes, who would need to sign off? Options: Yes — clinical and admin signoff required, Yes — clinical signoff only, Maybe — need more info, No
      • What guarantees or supports would switch the balance for you (inventory assurance, instrument ownership models, intraop rep coverage hours, financial guarantees)? Options: Guaranteed instrument availability, Vendor-owned instrument sets, Dedicated intraop rep coverage, Outcome/warranty commitments, Training/proctorship included, Other
      • Realistically, what timeline would your team need to pilot and decide on a new implant solution? Options: 1–3 months, 3–6 months, 6–12 months, 12+ months, Unsure
  2. Outcome Discovery

    Define clinical and financial success signals (e.g., revision rates, OR time, per-case implant spend) and non-negotiables.

    Discovery Questions

    Setting the Table: Who Matters and Why

    • Who are the core decision-makers and influencers we should include on this project? Options: High-volume arthroplasty surgeon(s), Orthopedic service line administrator, VAF/Value Analysis Committee members, OR manager/charge nurse, Procurement/Purchasing, GPO/IDN contracting lead, Sterile processing lead, Other
    • For each stakeholder you just selected, tell us their single top measurable priority and how they would describe 'success' in one sentence.
    • Which stakeholders have absolute veto power or non-negotiable requirements we must satisfy? Options: Surgeon - clinical outcomes, VAF - price/standardization, OR leadership - instrument reliability, Procurement - contract terms, GPO/IDN - compliance, Other
    • How do your surgeons usually balance clinical evidence against cost and standardization pressure when selecting implants? Options: Clinical evidence almost always wins, Clinical usually wins but cost matters, Equal weight, Cost/standardization usually wins, It varies by surgeon
    • Who would you recommend we meet with first to make the fastest, most constructive progress and why?

    If 'Good' Is a Line Item — Where Will We Measure It?

    • If you had to pick one headline metric that would make you say 'this change is working', what would it be? Options: Reduced revision rate, Reduced OR (skin-to-skin) time, Lower per-case implant spend, Fewer instrument-related delays/cancellations, Improved patient-reported outcomes (PROMs), Shorter length of stay, Other
    • What is your current baseline for that metric (please provide the latest numeric value and the time window it covers)?
    • Over what timeframe would you expect to see a meaningful shift in that metric after implementation? Options: 0–3 months, 3–6 months, 6–12 months, 12–24 months, >24 months
    • How many cases (per month or year) must be observed before you would consider the signal statistically or operationally reliable? Options: <50/year, 50–200/year, 200–500/year, >500/year
    • Who on your team will own tracking this metric day-to-day, and who needs executive visibility? Options: Surgeon lead, Service line admin, OR manager, Quality/Analytics, VAF lead, Procurement, Other
    • If we hit the numerical target but surgeon sentiment remains negative, what behaviors or outcomes should that trigger us to investigate?

    What Keeps You Awake at Night?

    • Which potential failure scares you most: a preventable revision, creeping hidden costs, or a pattern of OR cancellations — and why? Options: Preventable revision, Hidden ongoing costs, Case cancellations/OR delays, Reputational harm, Other
    • Tell us about a recent case, pilot, or vendor change that produced unexpected negative consequences—what happened, and what were the root causes?
    • How frequently do instrument or implant issues cause intraop delays, cancellations, or extended anesthesia time? Options: Weekly, Monthly, Quarterly, Rarely, Never
    • When those problems occur, how does it affect your team's confidence, stress levels, and willingness to try new systems?
    • From past vendor relationships, which remedial actions restored your trust fastest (pick all that apply)? Options: Immediate in-OR technical support, On-demand replacement implants/instruments, Formal root-cause analysis + corrective plan, Financial remediation/credits, Clinical outcome monitoring and transparency, Other
    • What level of clinical or safety signal during early use would force you to pause or stop a rollout? Options: Any increase in revisions, Any major intraop safety event, Instrument failure rate above X%, Surgeon adoption below threshold, Other

    Money Talks: Where Outcomes Meet the Budget

    • If VAF had to choose between a 10% implant cost reduction and a 10% improvement in OR time, which would they prioritize? Options: Cost reduction, OR time improvement, Clinical outcomes improvement, Depends on the committee member, Undecided
    • What is your current average per-case implant spend for the procedure set we're discussing (select the range)? Options: <$5,000, $5,000–$10,000, $10,000–$20,000, >$20,000, Unsure / varies by case
    • Do you have a formal target per-case implant spend or cost-savings goal for this fiscal year? If yes, please state it.
    • How much of your budget can be allocated to one-time adoption costs (training, instrumentation, proctorship) versus recurring implant spend reduction? Options: Significant, Some, Limited, None
    • Are there contractual or GPO/IDN pricing floors, pass-throughs, or clawbacks we must be aware of? Options: Yes — there are specific floors/caps, No, Unsure — need to check
    • Which financial KPIs would you expect reported monthly versus quarterly (choose all that apply)? Options: Per-case implant spend, Cost avoidance vs baseline, Warranty/return costs, Case volume and adoption rate, Cost per OR minute saved, Other

    The OR Story: What Success Looks Like in Real Time

    • Imagine the ideal OR day with our implants and support — what two things happen differently that make the whole day noticeably better?
    • Which intraoperative metrics do you currently capture and trust for each case? Options: Skin-to-skin OR time, Turnover time, Instrument tray completeness, Instrument malfunction incidents, Estimated blood loss, Case cancellations, Other
    • How would your surgeons describe a 'frictionless' instrument system—what tactile, timing, or setup details matter most to them?
    • Which forms of intraop support have the greatest influence on surgeon confidence and adoption (select all that apply)? Options: Trained in-OR technical rep, Proctor-led first cases, Simulation/practice sessions, Detailed templating and planning, Quick instrument swap/backup policy, Other
    • How often do instruments or trays arrive incomplete or require reprocessing issues that delay cases? Options: Often (weekly), Sometimes (monthly), Rarely (quarterly), Never
    • If an intraop problem occurs with the device or instruments, what is your current escalation path and acceptable maximum resolution time?

    Non-Negotiables and Dealbreakers

    • Tell us the single absolute dealbreaker that would cause you to walk away from an otherwise promising partnership.
    • Which contractual protections are essential (select all that you require)? Options: Implant warranty terms, Registry participation and data sharing, Instrument replacement SLA, Price protection/guardrails, Clinical indemnity clauses, Performance-based clauses (outcome guarantees), Other
    • What minimum level of clinical evidence do you require before broad adoption (choose any that apply)? Options: 2-year outcome data, 5-year outcome data, Comparative/controlled studies, Real-world registry outcomes, Surgeon peer-reviewed case series, No fixed minimum — pragmatic pilot ok
    • What implementation SLAs would be unacceptable if not met (e.g., timing for training, OR coverage hours, instrument availability)? Options: Training not within agreed window, No OR rep for first X cases, Instrument availability gaps, No registry setup, Other
    • How much procurement flexibility exists for one-off surgeon-preference exceptions during a trial period? Options: Very flexible, Somewhat flexible, Rarely flexible, Not flexible
    • If we propose a pilot, what non-negotiable acceptance criteria must be in place before you would consider it fair and valid?

    If This Works, How Will You Know?

    • What would an internal headline read six months after rollout to show this was a success?
    • Select the 3–5 measurable success signals you want included in the acceptance criteria. Options: Reduction in revision rate, Decrease in OR time (minutes per case), Lower per-case implant spend, Improvement in PROMs, Reduced instrument-related delays/cancellations, Surgeon adoption rate (%), Increased case volume or retention, Registry submission and outcomes tracking, Other
    • How often would you like to receive outcome reporting: real-time dashboard, weekly digest, monthly report, or quarterly review? Options: Real-time dashboard, Weekly digest, Monthly report, Quarterly review, Other
    • Who signs off on final acceptance, and what governance cadence (meetings/reviews) do they require during the pilot and first-year rollout? Options: Surgeon committee, Service line admin + VAF, Procurement + GPO, Quality/analytics team, Executive sponsor, Other
    • If early safety or performance signals emerge, how would you like those communicated and what immediate actions do you expect? Options: Immediate phone call + corrective plan, Daily updates until resolved, Weekly summary + mitigation plan, Formal incident report only, Other
    • What would surgeon-level success feel like to them emotionally (confidence, speed, patient outcomes, less cognitive load)? Describe in their words if possible.
  3. Solution Experience

    Use realistic clinical cases to show how our implants, instruments, and OR support produce the targeted clinical and workflow outcomes.

    Experience Meetings

    • Solution Experience Alignment (Pre-Showcase)
    • Clinical Case Selection & Prework
    • Tabletop Surgical Walkthrough (Stakeholder Validation)
    • Live/Recorded Case Proof & Outcome Mapping
    • Adoption Criteria & Go/No-Go Decision
    • Schedule the first pilot-case review meeting date (owner: clinical sponsor).
    • Document all validation responses and unresolved objections; classify them by impact and owner for mitigation before live case (owner: program lead).
    • If requested, schedule a hands-on cadaver or sim session to prove ergonomics and instrument flow (owner: clinical education).
    • Baseline Metrics Snapshot
    • Demonstrate measurable improvement (or identify precise reasons for failure) against the pre-agreed success signals.
    • Convert observations into concrete fixes or confirmations so the pilot can proceed with confidence.
    • Agree on the sample size and cadence required to statistically validate the outcome claims across the service line.
    • Produce a case-level outcome report showing deltas vs baseline, with timestamped evidence and surgeon/OR notes (owner: data lead).
    • If any success signal missed threshold, create a corrective action plan with owners and deadlines before the next case (owner: clinical sponsor).
    • Schedule the sequence of additional pilot cases and data review checkpoints to reach the agreed statistical confidence (owner: program coordinator).
    • Review Agreed Future State & Evidence
    • Set a clear pilot plan with dates, case counts, owners, and resource commitments required to test adoption at scale.
    • Lock mutually agreed numeric acceptance criteria that define pilot success and go/no-go decisions.
    • Identify and assign owners for any outstanding contractual or operational dependencies required to proceed.
    • Obtain formal sign-off from clinical, operational, and value-analysis stakeholders to proceed to pilot.
    • Draft and circulate a one-page pilot plan and acceptance criteria for signatures (owner: program lead).
    • Confirm instrument kit inventory and rep coverage schedule for pilot cases and create contingency plans (owner: supply chain lead).
    • Resolve any GPO/IDN contracting or warranty/registry commitments necessary to enable pilot (owner: commercial/legal).
    • Introductions & Objectives
    • Produce an agreed, concise current-state sentence that frames the experience.
    • Quantify the financial, time, and clinical consequences tied to the current state.
    • Agree a one-sentence future-state outcome and 3 measurable success signals.
    • Confirm owners and timeline for case selection and required prework.
    • Document and circulate the agreed current-state sentence and consequence numbers (owner: host clinical lead).
    • Customer to provide OR logs, recent implant spend per case, revision rate and sample operative notes for selected service line (owner: hospital analyst).
    • Define and agree success-signal metrics and thresholds to be used during case validation (owner: joint clinical/finance sponsor).
    • Schedule the Case Selection & Prework meeting with required surgeon, OR manager, and rep attendees within 5 business days.
    • Review Case Candidate List
    • Confirm the set of cases to be used and ensure they reflect real customer workloads.
    • Agree on the exact prework artifacts and deadlines so the experience is realistic and reproducible.
    • Define case-level measurable outcomes that directly map back to the future-state success signals.
    • Assign clear owners for logistics and data collection for each case.
    • Customer to upload anonymized DICOMs, implant preference cards, and OR case logs for chosen cases (owner: hospital data lead).
    • Host to prepare templating plans and instrument set list for each case and confirm kit completeness (owner: product manager).
    • Assign a single data capture lead who will collect intraop timestamps and event notes during the experience (owner: clinical sponsor).
    • Confirm date/time and backup plan for live case or sim lab, and notify OR schedule stakeholders (owner: program coordinator).
    • Reframe Current-State & Target Metrics
    • Demonstrate, with step-by-step tiebacks, how the solution eliminates the customer’s top workflow failures.
    • Validate instrument ergonomics and intraop rep role with the surgeon and OR team in real-time.
    • Capture any outstanding gaps or objections and convert them into specific action items for mitigation.
    • Update instrument set and sequence to reflect surgeon feedback and re-issue a revised kit bill-of-materials (owner: product operations).
    • Play & Annotate Case (Live or Recorded)
    • Current-State One-Sentence
    • Pilot Scope & Timeline
    • Select Primary & Backup Cases
    • Stepwise Surgical Walkthrough
    • Proof Points & Tiebacks
    • Consequence Quantification
    • Outcome Mapping
    • Acceptance Criteria & Go/No-Go Thresholds
    • Confirm Prework Deliverables
    • Operational & Contractual Dependencies
    • Rapid Root-Cause & Gap Identification
    • Forced Validation Checkpoints
    • Future-State One-Sentence & Success Signals
    • Define Case-Level Success Metrics
    • Signoffs & Next Steps
    • Agree Next Steps & Case Criteria
    • Logistics & Roles
  4. Solution Scope

    Specify product lines, instrument sets, training, intraop support, registry/warranty services, and measurable deliverables.

    Scope Configuration

    • Provision sterile implant trays and complete instrument sets
    • Supply trial implants and sizing instruments
    • Deliver patient-specific cutting guides and custom implants
    • Provide intraoperative technical representative support
    • Perform in-OR instrument setup and implant assembly
    • Provide navigation and robotic integration instruments
    • Ship single-use disposable instrument kits
    • Deliver sterile cement mixing systems and accessories
    • Provide on-site surgeon proctoring for initial cases
    • Expedite instrument repair and replacement service
    • Supply barcode implant labeling and tracking registration
    • Deliver hands-on cadaveric training workshops

    Scope Questions

    Provision sterile implant trays and complete instrument sets

    • How many ORs and primary arthroplasty/trauma cases per week should the tray inventory support? Options: 1-2 ORs / Low volume (0-10 cases/week), 3-4 ORs / Medium volume (11-25 cases/week), 5+ ORs / High volume (25+ cases/week)
    • Which tray ownership/stocking model do you require? Options: Hospital-owned sterile trays, Vendor consignment trays, Vendor-owned sterile trays, Hybrid (mix of above)
    • How many complete instrument sets must be available per day for peak scheduling? Options: 1 set, 2-3 sets, 4-6 sets, 7+ sets
    • Do surgeons require customizable tray configurations per procedure or per surgeon preference? Options: Yes - per surgeon, Yes - per procedure type, No - standardized sets only
    • What restocking/turnaround SLA do you require between cases? Options: Same day (within hours), 24 hours, 48 hours, 72+ hours / no strict SLA
    • Are there site-specific sterilization or handling protocols we must follow (e.g., ETO-only, steam only)?

    Supply trial implants and sizing instruments

    • Do you require a full complement of trial implants for every size and option, or a targeted starter set? Options: Full set for all sizes/options, Targeted sizes based on surgeon preference, Minimal starter set to be expanded as needed
    • How many initial cases do you expect will use trial implants during the evaluation period? Options: 1-5 cases, 6-15 cases, 16-50 cases, 50+ cases
    • What packaging/sterility requirements do you have for trial instruments (sterile single-use, reusable sterilized trays, mixed)? Options: Sterile single-use, Reusable sterilized trays, Mixed
    • Do you require visible labeling and size markers on trial components for fast intraoperative selection? Options: Yes, No
    • Would you like a formal trial loaner program with tracking and return logistics? Options: Yes - long-term loaner program, Yes - short-term/demo only, No loaner program
    • Who will be responsible for tracking and inventory of trial implants between hospital and vendor (hospital staff, vendor rep, shared)? Options: Hospital staff, Vendor rep, Shared responsibilities

    Deliver patient-specific cutting guides and custom implants

    • Will you require patient-specific cutting guides or custom implant manufacturing as part of the scope? Options: Yes - cutting guides, Yes - custom implants, Both, No
    • Which imaging modalities will you provide for design (CT, MRI, X-ray)? Options: CT, MRI, X-ray, CT + X-ray, Other
    • What lead time is acceptable from image submission to delivery of patient-specific guides/implants? Options: <2 weeks, 2-4 weeks, 4-8 weeks, 8+ weeks
    • Do you require anatomical models or digital surgical plans for surgeon review prior to manufacture? Options: Yes - physical models, Yes - digital plans only, No
    • Are there regulatory, hospital formulary, or sterilization validation requirements we must meet for custom devices? Options: Yes - specific approvals required, No special requirements, Unsure - need consultation
    • Estimate monthly case volume expected to need patient-specific guides or custom implants. Options: 1-5, 6-15, 16-30, 30+

    Provide intraoperative technical representative support

    • What level of intraoperative representative support do surgeons expect? Options: Full clinical support throughout case, Technical during critical steps only, On-call remote support, No representative required
    • What qualifications are required for the onsite representative (scrubbed clinical specialist, trained sales rep, engineer)? Options: Scrubbed clinical specialist (RN/PA), Trained sales representative, Technical engineer/biomed
    • How frequently will reps be required onsite (per week/month)? Options: Per case basis, Weekly, Monthly, Ad hoc as scheduled
    • Do reps need hospital credentialing/badging and access to sterile field (scrubbed), or will they remain non-scrubbed? Options: Scrubbed (sterile), Non-scrubbed in-room (circulating), Remote support only
    • What is the maximum acceptable response time for an onsite rep request (if required during case day)? Options: 30 minutes, 60 minutes, 90 minutes, Next scheduled case
    • Are there OR-specific policies or scripts reps must follow (documentation, infection control, time-outs)?

    Perform in-OR instrument setup and implant assembly

    • Who will perform instrument setup and implant assembly prior to incision? Options: Vendor representative, OR nursing/team, Hybrid - vendor sets critical instruments
    • Do you require the vendor to perform implant assembly (e.g., taper assembly, modular constructs) inside the sterile field? Options: Yes - vendor assembles in sterile field, No - hospital staff assembles, Depends on implant type
    • Would you like a standardized pre-case setup checklist provided and completed by the setup owner? Options: Yes, No
    • What is the typical time allocation you expect for vendor setup and verification per case (minutes)? Options: <10 minutes, 10-20 minutes, 20-30 minutes, 30+ minutes
    • Do you require documented chain-of-custody or sign-off for sterile trays and implant assemblies? Options: Yes - sign-off required, No
    • Are there any site-specific assembly protocols, checklists, or manufacturer-specific warnings we must follow?

    Provide navigation and robotic integration instruments

    • Does the site use navigation or robotic platforms that must integrate with our instruments? Options: Yes - single specific vendor, Yes - multiple vendors, No robotic/navigation systems
    • Which robotic/navigation platforms should our instruments be compatible with? (list vendors/platforms)
    • Do you require dedicated compatibility kits or interface instruments for your robot/navigation system? Options: Yes - compatibility kits required, No - standard instruments suffice, Unsure - need assessment
    • Is staff training on robotic/navigation integration required as part of scope? Options: Yes - initial training, Yes - ongoing, No
    • Approximately what percentage of cases will use navigation/robotics once implemented? Options: 0-10%, 11-30%, 31-60%, 60%+
    • Do you require electronic data transfer (case logs, alignment metrics) from the robot/navigation system to hospital records? Options: Yes - EMR/registry integration required, No, Interested but needs discussion

    Ship single-use disposable instrument kits

    • Do you prefer single-use disposable kits, reusable kits, or a hybrid approach? Options: Prefer disposable kits, Prefer reusable kits, Hybrid (disposable for some components)
    • How many disposable kits will you require per month (estimate)? Options: 1-10, 11-50, 51-200, 200+
    • Are there environmental or sustainability policies that restrict use of disposable kits? Options: Yes - restrictions apply, No - no restrictions, Unsure - need guidance
    • What sterile packaging format do you require for disposable kits (individual pouches, single sterile tray, other)? Options: Individual sterile pouches, Single sterile tray kit, Other
    • Do you require vendor-managed disposal services or will the hospital handle waste stream? Options: Vendor handles disposal (arranged), Hospital handles disposal, Depends on kit type
    • Do you have a target cost-per-kit or budget constraints we should design to?

    Deliver sterile cement mixing systems and accessories

    • Which cement mixing system do you prefer? Options: Closed-system sterile mixer, Manual bowl & mix, Syringe-based delivery, No preference / need recommendation
    • How many cemented cases per month will require supplied mixing systems/accessories? Options: 0-10, 11-30, 31-100, 100+
    • Do you require pre-loaded antibiotic cement or sterile single-use mixing disposables? Options: Pre-loaded antibiotic cement, Single-use disposables, Standard cement with reusable accessories
    • What supply frequency do you require for disposable mixing accessories (per case, weekly, monthly)? Options: Per case, Weekly, Monthly, As needed
    • Are there compatibility requirements with existing OR equipment (vacuum systems, power, footprint)? Options: Yes - compatibility constraints, No constraints, Unsure - need on-site survey
    • Are there formulary, pharmacy, or procurement approvals required for cement types we must account for? Options: Yes - approvals required, No, Unsure

    Provide on-site surgeon proctoring for initial cases

    • How many initial cases do you want a proctor present for to credential and validate technique? Options: 1-2 cases, 3-5 cases, 6-10 cases, 10+ cases
    • What proctor qualifications are required (KOL surgeon, company clinical specialist, fellowship-trained proctor)? Options: KOL/proctor surgeon, Company clinical specialist, Fellowship-trained surgeon, Other
    • What proctoring format is preferred (scrubbed/hands-on, in-room advisor, remote proctoring)? Options: Scrubbed and hands-on, In-room advisor (non-scrubbed), Remote/tele-proctoring
    • What scheduling lead time is acceptable to arrange a proctor visit? Options: <2 weeks, 2-4 weeks, 4-8 weeks, 8+ weeks
    • Are there expectations around proctor reimbursement, honoraria, or credential documentation we should plan for? Options: Yes - reimbursement required, No, Dependent on proctor type
    • Does the hospital require proctor credentialing, privileges, or malpractice coverage verification prior to on-site proctoring? Options: Yes, No, Unsure

    Expedite instrument repair and replacement service

    • What is your required repair/replacement turnaround SLA for damaged or missing instruments? Options: Same day, 24 hours, 48 hours, 72+ hours
    • Do you require on-site repair capability or is central repair with loaners acceptable? Options: On-site repair required, Central repair with loaners acceptable, Central repair only
    • Should vendor provide loaner instruments during repair and what level of loaner coverage is needed? Options: Full set loaners, Partial/critical instruments only, No loaners required
    • Do you require a preventive maintenance and inspection schedule for instrument sets? Options: Yes - scheduled PM, No - reactive only, Interested in recommendation
    • Do you need incidents and repair history reported in a dashboard or periodic report? Options: Yes - dashboard reporting, Yes - periodic summary, No
    • What budget or contract model do you prefer for repairs (per repair fee, annual service agreement, bundled)? Options: Per repair fee, Annual service agreement, Bundled with product contract, Unsure - need pricing options
  5. Mutual Commit

    Resolve pricing, contract terms, GPO/IDN mechanics, OR support SLAs, and mutual acceptance criteria for adoption.

    Agreement Modules

    • Statement of Work (SOW)
    • Master Supply / Purchase Agreement (MSA/PA)
    • Pricing Schedule & Price Matrix
    • GPO / IDN Contracting Addendum
    • Service Level Agreement (OR Support & Instrument Availability)
    • Warranty, Revision Coverage & Returns Policy
    • Training, Proctorship & Education Agreement
    • Instrument Loan / Consignment Agreement
    • Registry, Implant Tracking & Data-Sharing Agreement
    • Mutual Acceptance Criteria & Go/No-Go Checklist
    • Payment Terms & Invoice Schedule
    • Change Order & Scope Modification Process
    • Termination, Exit & Transition Plan
    • Insurance, Indemnity & Regulatory Compliance Attestation
    • Signature & Execution (e-Sign)
  6. Deployment

    Operationalize rollout with readiness checks, enablement, and outcome validation.

    1. Pre-Deployment Readiness

      Confirm instrument availability, rep OR coverage, education schedules, implant tracking setup, and risk mitigations.

      Readiness Questions

      Quick Introductions — Who are we solving this for?

      • Tell us which roles are joining this conversation today (pick all that apply). Options: Arthroplasty Surgeon, Trauma Surgeon, Sports Medicine Surgeon, OR Nurse/Manager, Service Line Administrator, Value Analysis Committee (VAF) Member, Supply Chain/Materials Manager, GPO Representative, Other
      • Which implant families does your team currently use most frequently (brand or platform names)?
      • How would you describe the overall appetite here for product change right now? Options: Actively seeking alternatives, Open if clinical case is strong, Conservative — only incremental changes, No interest
      • What is the typical decision timeline from evaluation to first case in your organization? Options: 6–12 months, > 12 months, < 1 month, 1–3 months, 3–6 months
      • Who ultimately signs off on implant selection and contracts in your setting? Options: Surgeon(s) alone, Surgeon committee, Service line director, VAF committee, Supply chain / materials management, Multi-stakeholder (combination)

      What Would a Bad Day in the OR Reveal About Your System?

      • When a case goes poorly because of implants or instruments, what usually breaks down first? Options: Instrument availability/quality, Implant fit/compatibility, Rep intraop support, Reprocessing delays, Tray completeness, Other
      • How often in the past 6 months have you experienced intraoperative delays tied to instrument or implant issues? Options: Weekly or more, Monthly, A few times, Rarely, Never
      • Give a specific example of a recent OR problem related to implants/instruments — what happened and who felt the consequences most?
      • When these problems occur, how do they typically affect patient flow, staff morale, or surgeon confidence (select all that apply)? Options: Extended case time, Case cancellation, Extra staff overtime, Surgeon frustration, Patient dissatisfaction, Downstream scheduling issues
      • What workarounds have you put in place that feel fragile or unsustainable?

      Where Institutional Pressure and Surgeon Preference Collide — What’s the Real Tension?

      • If you had to name the single biggest source of pressure to change implants or standardize, what would it be? Options: Cost reduction initiatives, GPO contract changes, Clinical outcome concerns, Inventory constraints, Leadership directives, Other
      • How much influence does the VAF carry compared with lead surgeons when final choices are made? Options: VAF majority, Surgeon majority, Even influence, Varies by case or surgeon
      • Has the facility recently run competitive bidding or a standardization program? If yes, what was the outcome and how did surgeons react? Options: Yes — successful (surgeon buy-in), Yes — met resistance, No — not recently, Currently underway
      • Tell us about any internal incentives or metrics driving standardization (e.g., target per-case implant spend, SKU reduction goals).
      • What would have to change in the procurement process for surgeons to feel comfortable switching systems?

      What Do You Track That Actually Tells You If Patients Are Better Off?

      • Which clinical outcomes are considered most meaningful here when evaluating an implant (pick up to three)? Options: Revision rate, Infection rate, Dislocation/instability, PROMs (patient-reported outcomes), Functional scores (e.g., WOMAC), Periop complication rates
      • What operational/financial metrics influence purchasing decisions (select all that apply)? Options: OR time per case, Length of stay, Per-case implant spend, Inventory carrying costs, Implant warranty/consumable costs, Reprocessing/retrieval costs
      • Where do you currently pull these metrics from (EHR, EMR, registry, manual logs, GPO reports)? Options: EHR/EMR, National registry, Internal analytics, GPO reports, Manual spreadsheets, Other
      • What baseline numbers would you share today for revision rate, OR time (average), and per-case implant cost?
      • How confident are you in the integrity and timeliness of the data you use to judge success? Options: Very confident, Somewhat confident, Questionable, Not confident

      If Everything Worked Perfectly for 12 Months, What Would Be Different?

      • Paint a picture: what three measurable changes would convince you the new implant program is a success?
      • Beyond metrics, what changes in day-to-day experience would indicate success to OR staff and surgeons? Options: Fewer case delays, Simpler trays, Higher surgeon satisfaction, Smoother turnover, Less instrument damage
      • How quickly would you expect to see early signs of clinical or operational improvement after launch? Options: Immediate (first 1–3 cases), Short term (1–3 months), Medium (3–6 months), Longer (>6 months)
      • What level of improvement would you need to justify broader adoption (e.g., % reduction in OR time, $ saved per case)?
      • Who else would you bring in to validate that these outcomes are real and sustained? Options: Clinical data team, VAF, Surgeon champions, External registry, Hospital leadership

      What Could Sabotage Adoption Even If the Data Looks Good?

      • What non-clinical issues have sunk past adoption efforts here (start with the most surprising or frustrating)?
      • How reliable is your instrument reprocessing and sterilization cycle when new trays are introduced? Options: Very reliable, Occasionally problematic, Frequently problematic, Unknown
      • What are your worst-case concerns about vendor support in the OR (select up to three)? Options: No rep available, Inexperienced rep, Inadequate instruments, Poor intraop troubleshooting, Late tray delivery, Other
      • Has a previous vendor's promised education or proctorship failed to materialize? Tell us what happened and the impact.
      • Which contractual or supply-chain constraints would be immediate red flags (e.g., exclusivity clauses, restocking penalties, GPO pass-through issues)?

      How Would You Like a Vendor to Prove They Can Deliver?

      • Which of the following proof points would most increase your willingness to trial a new implant system? Options: Peer-reviewed clinical data, Real-world registry data, Live proctorship cases, On-site instrument validation, Cost modeling with transparency, Warranty/registry guarantees
      • What format of training works best for your team (select all that apply)? Options: Hands-on cadaver lab, In-service in your OR, Virtual modular training, Peer-led sessions, Proctorship in first cases
      • How important is having the same rep present for the first 10 cases versus an on-call model? Options: Same rep present for all, Shared coverage acceptable, On-call is fine, Depends on case complexity
      • Would you require implant tracking and registry reporting before starting a pilot? Options: Yes — mandatory, Preferable but not mandatory, Not required
      • What operational support (instrument loaners, extra trays, dedicated sterile tech) would you insist on for initial cases?

      Commitment Signals — What Would Make This Easy to Say Yes To?

      • What single contractual or program element would most lower your risk perception (choose one)? Options: Short pilot agreement, Performance-based pricing, Comprehensive warranty, Guaranteed rep coverage SLA, Registry-backed outcomes
      • What acceptance criteria do you need to see at the case-level to call a pilot successful (select up to three)? Options: Clinical fit/templating success, No instrument failures, OR time within target, No adverse events related to implant, Surgeon-stated satisfaction
      • Who needs to sign off immediately after the pilot for a wider roll-out? Options: Lead surgeon(s), VAF, Service line director, Supply chain, Hospital executive leadership
      • What's an acceptable timeline from pilot completion to wider adoption in your setting? Options: Immediate (within 1 month), 1–3 months, 3–6 months, 6+ months
      • What communication cadence do you prefer during a pilot (select all that apply)? Options: Daily check-ins first week, Weekly summaries, Monthly executive reviews, Ad-hoc if issues arise, Real-time dashboard access

      Practical Details — Logistics That Make or Break Launch

      • What storage and inventory constraints should we know about for instrument and implant trays?
      • Which sterilization and reprocessing cycles or capacity limits are likely to influence tray design or scheduling?
      • Do you have any vendor access rules for the OR (badging, vaccination, credentialing) we should account for? Options: Strict — full credentialing required, Moderate — standard badging, Minimal — vendor passes are fine, Varies by facility
      • How do you prefer implant usage and lot-tracking to be handled (select one)? Options: Vendor-managed tracking integrated w/EHR, Hospital-run with vendor reporting, Manual logs + periodic reconciliation, Registry-only reporting
      • Are there specific risk mitigations you'd require before first case (e.g., backup implants on-site, second experienced rep, guaranteed OR time window)?

      Final Reflection — If We Could Take One Thing Off Your Plate, What Would It Be?

      • Thinking about everything discussed, what single operational burden would have the biggest positive effect if solved?
      • Which stakeholder’s daily life would improve most from that change (pick one)? Options: Surgeon, OR nurse/charger, Service line admin, Supply chain manager, VAF member
      • How would you like us to follow up—what would be the most useful next step from our side? Options: Detailed cost/clinical model, On-site instrument validation, Schedule a proctorship, Draft pilot agreement, Provide peer references/data
      • What’s the best way and timeframe to reconnect once we’ve acted on this input? Options: Email in 1 week, Call in 2 weeks, On-site visit in 1 month, Submit proposal for review
    2. Deployment Enablement

      Schedule proctorships, instrument reprocessing, staff training, and OR rep coverage with owners and timelines.

    3. Validation Checklist

      Verify case-level acceptance criteria (clinical fit, instrument reliability, rep support) and capture early outcomes data.

      Validation Questions

      Start Here: What Matters Most to You?

      • Which role best describes you in this conversation? Options: Orthopedic surgeon, Service line administrator, Value Analysis Committee member, Procurement/GPO representative, OR manager/staff, Other
      • Which two outcomes are highest priority for your team right now? Options: Revision/reoperation rates, OR time per case, Per-case implant spend, Standardization of portfolio, Surgeon satisfaction, Staff efficiency/turnover, Patient functional outcomes, Other
      • When you think about past vendor partnerships that felt successful, what one thing made the biggest difference?
      • How would you describe your team's tolerance for changing implant systems today? Options: Very high — eager to try new options, Somewhat open with conditions, Cautious — requires significant evidence, Very resistant — prefer status quo
      • How soon do you need to see measurable improvement after a change in implants or OR support? Options: Within 30 days, 30–90 days, 3–6 months, 6–12 months, Unsure
      • Is there anything specific about your team's culture or history with device partners we should know up front?

      Are You Settling for Familiar Even When It Costs More?

      • How often do you keep using an implant because of habit—even when evidence or price suggests a better option exists? Options: Almost always, Often, Sometimes, Rarely, Never
      • Can you share a recent example where surgeon preference and VAF cost goals clashed? What was the outcome?
      • How do surgeons and procurement typically resolve disagreements—fast escalation, committee review, or informal negotiation? Options: Rapid escalation to leadership, VAF committee review, Negotiation between surgeon and rep, Procurement enforces policy, Other
      • What is the emotional tone when cost containment is presented to surgeons—defensive, curious, collaborative, or something else? Options: Defensive, Curious, Collaborative, Dismissive, Mixed
      • How long has the tension between surgeon preference and standardization been an active issue for your team? Options: Months, 1–2 years, 3–5 years, 5+ years, Not applicable
      • Who typically bears the clinical risk when standardization is pushed—surgeons, administrators, or both? Tell us how that feels.

      Show Me the Current Playbook

      • If you mapped a typical arthroplasty case from scheduling through discharge, where do the most costly inefficiencies hide?
      • Which parts of the perioperative process are most prone to delays or rework in your setting? Options: Pre-op templating, Instrument availability in OR, OR scheduling/turnover, Implant restocking, Sterile processing/SSU delays, Intraop troubleshooting, Other
      • List the implant systems you currently use and approximate annual volume for each (cases/year).
      • Approximately what percentage of cases follow a standardized implant pathway versus surgeon-specific selection? Options: <25%, 25–50%, 51–75%, 76–100%, Unsure
      • Where do instrument gaps or failures appear most often—set completeness, broken instruments, missing heads, or reprocessing delays? Options: Set completeness, Broken/failed instruments, Missing pieces/head sizes, Reprocessing delays, Tray damage/loss, Other
      • Tell the story of a recent case where equipment or instrumentation issues affected flow—what happened and how did the team respond?

      What Keeps You Up at Night?

      • Which single outcome would make you regret a device change the fastest—revision rate, intraoperative complication, OR time increases, or financial overruns? Options: Revision/reoperation rate, Intraoperative complications, Increased OR time, Financial overruns/cost per case, Other
      • Which clinical metrics do you track regularly (monthly/quarterly)? Options: Revision/reoperation rate, Infection rate, Length of stay, Readmissions, Patient-reported outcomes, Other
      • Which financial KPIs get the most scrutiny from hospital leadership? Options: Implant spend per case, Total episode cost, OR utilization, Cost per surgeon, Return on investment (ROI), Other
      • Have you experienced a measurable uptick in complications tied to a product or process change? Describe what happened.
      • How does staff confidence with instrumentation and rep support affect your willingness to adopt a new system?
      • What would be an acceptable threshold for early complication signals before you'd pause or escalate a pilot? Options: Any increase triggers pause, >5% increase, >10% increase, >25% increase, Depends on case mix, Unsure

      Where Would You Tolerate Risk — and Where You Wouldn't

      • What trade-off would you accept: lower implant cost with modestly longer OR time, or higher cost to preserve OR efficiency? Options: Accept lower cost with longer OR time, Prefer higher cost to preserve OR time, Depends on magnitude of trade-off, Unsure
      • Which surgeon technical features are absolute must-haves (select all that apply)? Options: Trial fidelity/fit, Broach/tactile feel, Range of sizes/options, Instrumentation ergonomics, Ease of conversion intraop, Other
      • Which service elements are non-negotiable for adoption: in-OR rep, proctorship, training, warranty/registry, or something else? Options: In-OR rep coverage, Proctorship by vendor/peers, Comprehensive staff training, Registry participation/warranty, Instrument support/loaners, Other
      • How many proctored cases do surgeons typically require before feeling comfortable without hands-on rep support? Options: 1–2, 3–5, 6–10, 10+, Varies by surgeon
      • If the first few cases show instrument reliability issues, what is your preferred immediate action—repair, replace, pause, or escalate? Options: Repair and continue, Replace instruments immediately, Pause program for root cause, Escalate to vendor leadership, Other
      • Who on your team is most likely to advocate for tolerating short-term risk in exchange for long-term gain? Name role and why.

      Imagine a Case That Goes Exactly as Planned — What Does That Look Like?

      • If your ideal first 20 pilot cases went perfectly, what measurable differences would you see versus today?
      • Which three metrics would you point to as proof we are delivering value? Options: Revision/reoperation rate, OR time per case, Implant spend per case, Staff satisfaction/turnover, Room turnover time, Patient functional outcomes, Other
      • What phrasing from surgeons would signal success—what would you want them to say after a successful pilot case?
      • How should early outcome data be presented to make decisions straightforward for your VAF? Options: Benchmarked dashboards, Case-level reports, Aggregate monthly summaries, Peer comparisons, Raw data export, Other
      • What timeline feels realistic to evaluate a pilot and decide on broader rollout? Options: 30–90 days, 3–6 months, 6–12 months, 12+ months, Unsure
      • Who needs to sign off before we move from pilot to standardization? Options: Surgeon(s), Service line administrator, VAF chair, CFO/finance, Supply chain/procurement, GPO, Other

      If We Were to Work Together, What Would a Fair Pilot Look Like?

      • What would make a pilot feel fair—skin in the game from the vendor, limited scope, or a guarantee if outcomes miss targets? Options: Vendor skin in the game (e.g., discounts/rebates), Limited scope/time-bound pilot, Performance guarantees/warranty, Shared data ownership and transparency, Other
      • Would you prefer a head-to-head case-matched pilot, an elective-only rollout, or a block-scheduled proctor model? Options: Head-to-head case-matched, Elective-only phased rollout, Block-scheduled proctorship, Combination, Unsure
      • What minimum case volume and duration would you require to make a meaningful judgment? Options: 10–20 cases, 21–50 cases, 51–100 cases, 100+ cases, Unsure
      • What specific fields must be captured on each pilot case (implant LOT, OR time, complications, surgeon notes, etc.)? Options: Implant model/LOT, OR start/finish times, Complications/adverse events, Surgeon qualitative notes, Sterile processing issues, Patient-reported outcomes, Other
      • Who on your staff will be responsible for collecting and validating pilot data? Options: Clinical coordinator/registry lead, OR manager/supervisor, Sterile processing manager, Vendor rep support, Other
      • What would success look like for patients, surgeons, and finance at the pilot's end? Please give one line per stakeholder.

      Decisions, Timing, and Who Holds the Keys

      • If a new implant met your clinical bar but saved only 5% on cost, would that accelerate or stall your decision? Options: Accelerate decision, Stall decision, Depends on surgeon buy-in, Unsure
      • Who are the formal decision-makers and the informal influencers we should know about? List names/roles.
      • How does your GPO/IDN contract structure constrain or enable new product adoption? Options: Strict GPO-only, Allows exceptions with VAF approval, Open contracting with negotiation, Other
      • What procurement or legal timelines typically determine when a new contract can start? Options: Immediate upon agreement, 30–60 days, Quarterly renewal windows, Annual contract cycle, Depends—case-by-case
      • What internal approval hurdles have surprised you in past device rollouts?
      • What level of pricing transparency and contracting flexibility do you expect from vendors? Options: Line-item pricing, Bundled pricing options, Performance-based rebates, Warranty/registry support, Custom contract language, Other

      Early Signals That Will Tell Us We're Winning — or Not

      • If the first 10 cases show a 10% slower OR time but a 15% lower implant cost, do you call that a win? Options: Yes, No, Depends on complication rates, Need more context
      • Which early signals would make you recommend expanding immediately? Options: Improved OR flow, High surgeon satisfaction, No uptick in complications, Lower per-case implant spend, Positive patient feedback, Other
      • How should negative early signals be handled—stop the program, pause for root cause analysis, or continue with mitigations? Options: Stop the program immediately, Pause and perform root cause, Continue with mitigations in place, Escalate to steering committee, Other
      • Who will review early pilot data and at what cadence (weekly, monthly, real-time)? Options: Clinical leadership weekly, OR manager weekly, VAF monthly, Vendor weekly, Real-time alerts + monthly review, Other
      • What absolute thresholds (e.g., % increase in complications or OR time) would trigger an immediate pause?
      • How quickly do you expect a vendor rep to respond to intraop issues during the pilot? Options: Immediate (<15 minutes), Within 1 hour, Same day, Next day, Other

      Keeping the Conversation — How We Stay Aligned

      • If alignment depended on one mechanism—data dashboards, regular huddles, or a named escalation path—which would you pick and why? Options: Data dashboards, Regular cross-functional huddles, Named escalation/escalation SLA, Combination, Other
      • What format and frequency of updates would make you feel informed but not burdened? Options: Weekly emails, Monthly dashboards, Quarterly review meetings, Ad hoc incident reports, Real-time alerts, Other
      • Who should sit on a standing steering committee for this partnership (roles preferred)? Options: Lead surgeon(s), Service line admin, VAF chair, OR manager, Finance/CFO rep, Supply chain/procurement, GPO rep, Other
      • How would you prefer to capture qualitative surgeon feedback after each pilot case? Options: Brief post-case survey, Short verbal debrief with rep, Structured interview, EMR-embedded rating, Other
      • What would make you confident a vendor is a true partner versus 'just another sales rep'?
      • Are there any remaining concerns or hidden obstacles we haven't surfaced that could block progress?
  7. Success

    Review outcomes against agreed success signals, capture learnings, and maintain a shared channel for issues and improvements.

    Success Reviews

    • Outcomes Review — Success Signals vs Reality
    • Root Cause & Learnings Workshop
    • Operational Action Planning & Adoption Commitments
    • Stakeholder Satisfaction, Registry & Warranty Review
    • Continuous Improvement Cadence & Shared Channel Setup

    Issues & Enhancements

    • Agree on any contractual amendments or credits required to maintain partnership trust.
    • Create a dated action plan with named owners and measurable acceptance criteria for each corrective action.
    • Resolve necessary contractual/logistical changes to remove barriers to implementation.
    • Schedule and commit to the first round of training/proctorship with owners.
    • Draft and circulate a one-page Action Plan (SOW-style) summarizing owners, milestones, and acceptance criteria.
    • Procurement to confirm any pricing/GPO amendments and update contract exhibits as required.
    • Seller to reserve instrument inventory and confirm rep coverage for the scheduled proctorships.
    • Analytics owner to create a short dashboard spec to measure adoption against acceptance criteria.
    • Registry & Warranty Outcomes Summary
    • Document surgeon and staff satisfaction level and capture top qualitative learnings.
    • Confirm registry/warranty status and decide on any immediate remedial claims or monitoring changes.
    • Welcome & Objectives
    • Seller to open/track warranty claims and provide claim IDs and next-steps timeline.
    • Clinical lead to run a quick satisfaction pulse survey for surgeons and OR staff and share results.
    • Operations to commit to rep coaching plan for intra-op support deficiencies and share schedule.
    • If contractual remediation agreed, legal/procurement to draft amendment and circulate for sign-off within 10 business days.
    • Proposed Governance & Cadence
    • Create a sustainable governance model and recurring cadence for outcome reviews and operational checks.
    • Agree and document the KPI set, dashboard specs, and data refresh cadence.
    • Provision a shared channel with clear access and escalation rules to maintain rapid issue resolution.
    • Analytics to build and share the first dashboard prototype within 10 business days and invite stakeholder feedback.
    • Seller to provision the shared CustomerNode channel, add confirmed participants, and publish channel rules.
    • Operations to schedule recurring meetings (weekly ops check, monthly outcomes review) and send calendar invites.
    • Stakeholders to confirm the 90-day success checkpoints and sign off the governance doc.
    • Confirm which success signals were met and which were not with quantification.
    • Ensure a shared, validated interpretation of outcome data among surgeon, admin, and seller reps.
    • Identify top 2–3 outcome gaps that require immediate follow-up or escalation.
    • Agree next-step decisions for any high-risk findings.
    • Seller to publish the outcomes pack and raw exports to the shared channel and confirm data owner for any follow-up queries.
    • Clinical lead to designate 1–2 representative cases for deep-dive RCA and provide full case notes within 5 business days.
    • If immediate safety or performance concerns exist, convene rapid escalation (safety) call within 48 hours.
    • Admin to confirm financial impact estimates (per-case delta, monthly run-rate) and share with group.
    • Recap Findings to Date
    • Identify root causes tied directly to the documented consequences for unmet signals.
    • Produce a prioritized list of corrective actions validated by clinical stakeholders.
    • Capture explicit learnings to update training, instrument lists, or contract terms as needed.
    • Create formal RCA documents for the top 2 root causes and assign owners.
    • Schedule hands-on simulation or proctorship to validate proposed corrective steps within 14 days.
    • Seller to propose instrument kit adjustments (shortlist SKUs) and estimated lead times.
    • OR manager to run a shortest-path workflow change pilot and report back with measured effect on OR time.
    • Review Prioritized Corrective Actions
    • Define Deliverables, Owners, and Timelines
    • Restate Agreed Success Signals and Baseline
    • Structured Case Reviews (Diagnosis)
    • Surgeon & OR Staff Satisfaction Feedback
    • Define KPIs and Dashboard Requirements
    • Contractual & Logistics Alignment
    • Shared Channel & Escalation Protocol
    • Presentation of Actual Outcomes
    • Sales Rep / OR Support Performance Review
    • Instrumentation & Workflow Failure Mapping
    • Training & Proctorship Scheduling
    • Gap Analysis: Where reality diverged
    • First 90-Day Plan & Success Checkpoints
    • Quantify Consequence per Root Cause
    • Contractual Remedies & Warranty Actions
    • Confirm Next Recurring Review
    • Open Items & Follow-up Commitments
    • Brainstorm & Validate Corrective Options
    • Stakeholder Validation
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