Quick Intro: Who Are You in This Story?

• Which role are you representing in this conversation today? Options: Spine surgeon (attending), Neurosurgeon, OR Director/Manager, Value Analysis Committee (VAC) chair, Perioperative nurse/tech, Distributor rep, Hospital procurement/supply chain, Other
• Which facility or account are you speaking for? (hospital name / ASC / system)
• Roughly how many spine fusion or decompression cases does this facility perform per year? Options: <50, 50–150, 151–300, 301–600, 601+
• Which spine procedures are most critical to your team's volume and decision-making? Options: Lumbar fusion (open), Lumbar fusion (MIS), Cervical fusion, Decompression (laminectomy/discectomy), Motion preservation/arthroplasty, Other
• When a new implant system is being evaluated here, what single outcome matters most to you? Options: Surgeon clinical outcomes, OR efficiency & operative time, Tray/instrument reliability, Cost per case, Inventory complexity, Staff ease-of-use
• Tell us about a recent switch or trial your team ran—what went surprisingly well?

Is the OR Quietly Resisting Change?

• How often do instrument or implant availability issues cause delays, cancellations, or unexpected workflow changes in booked spine cases? Options: Almost every week, Monthly, A few times a year, Rarely, Never
• Give a specific example of a day a spine case was disrupted by missing or incompatible instrumentation—what chain of events followed?
• Who typically raises the alarm when an instrument or implant problem appears (surgeon, scrub tech, rep, scheduler, supply)? Options: Surgeon, Scrub tech/OR nurse, Distributor rep, Scheduling/central sterile, Supply chain/CS manager, Other
• When a disruption happens, what are the most visible consequences here—patient delay, increased OR time, staff stress, billing problems, other? Options: Patient delay/cancellation, Longer operative time, Surgeon frustration, Scrub team confusion, Charge/revenue issues, Other
• How long has your team been tolerating the frequency and impact of these disruptions? Options: Months, 1–2 years, 3–5 years, 5+ years, Not an ongoing issue

What Happens When a Surgeon Asks for Something New?

• When a surgeon requests a different implant or system, what single obstacle most often prevents timely adoption? Options: VAC/GPO approval, Inventory & ordering process, Lack of distributor coverage, Surgeon training concerns, Cost/contract terms, OR staff resistance
• Walk us through the formal steps your facility takes from a surgeon request to an approved trial—where do you typically see bottlenecks?
• Which internal stakeholders are required to sign off before a trial can proceed? Options: VAC chair, OR Director, Supply Chain/Materials, Finance/Revenue, Chief of Surgery, Infection Control, Other
• How do you currently estimate the operational or financial risk of switching systems (e.g., canceled cases, extra OR time, inventory write-offs)? Options: Qualitative review, Historical cost analysis, Per-case cost model, We don't estimate it, Other
• Have previous trial or onboarding plans met the surgeon’s expectations? If not, describe one unmet expectation.

If Day One Could Be Perfect, What Would It Look Like?

• Imagine the first proctored case went flawlessly—what three things stood out that made it feel successful?
• Which measurable signals would you need to see during the trial to feel confident moving to full adoption? Options: Operative time within X% of baseline, No tray or implant shortages for 3 consecutive cases, Surgeon satisfaction rating, No increase in complications, OR staff comfortable with set-up, Cost per case target met
• From your perspective, what is a realistic timeline from initial workshop to independent surgeon use? Options: <3 months, 3–6 months, 6–9 months, 9–12 months, >12 months
• What minimum training format and rep coverage would make your team comfortable scheduling proctored cases? Options: Cadaver lab + OR simulation, Peer case observation, On-site proctor for first 3 cases, Checklist + digital resources, Hands-on in-service for OR staff
• Describe the explicit go/no-go criteria your VAC or surgical leadership would require after initial cases?

Who's Going to Carry the Torch—and Who Might Drop It?

• Who is the single person here whose support is make-or-break for adoption, and what will happen if they are not on board?
• How consistent is distributor or rep coverage across your hospital locations and satellite ASCs? Options: Consistent (same rep/team), Mostly consistent, Inconsistent by site, No formal distributor coverage, Other
• Which responsibilities do you expect a distributor to own during a trial and after adoption? Options: Case-day instrument logistics, Proctoring support, Inventory management & reorder, Surgeon scheduling coordination, Staff training modules, Regulatory/GPO paperwork help
• How does your OR staff prefer to receive training for a new system? Options: Hands-on in-OR training, Simulation/cadaver lab, Peer observation, Standard operating checklists, Short digital micro-learning modules
• Do you have local surgeon champions who would actively support the change? If yes, who are they and what influence do they hold?

Logistics That Break Trust (And How We Can Prevent It)

• What single logistic failure in past switches damaged trust most (missing tray, wrong implant sizes, rep no-show, billing surprises)?
• How are tray lists, sterilization turn-around, and instrument set completeness currently tracked and validated? Options: Electronic tray tracking, Paper/whiteboard lists, Central sterile logs, Distributor-managed tracking, No formal process
• Who owns implant inventory ordering, allocation, and reconciliation across your sites? Options: Supply chain/materials, Per-site charge nurse, Distributor-managed consignment, Surgeon/privately stocked, Other
• What contingency plans do you want in place when an instrument or implant shortage threatens a booked surgery? Options: Backup implant inventory on-site, Alternative instrument set readiness, Same-day transfer policy, Surgeon backup list, Escalation path to distributor/rep
• How would you prefer responsibilities and day-of-case roles to be documented and shared (checklists, shared channel, EHR notes, printed run sheet)? Options: Shared messaging channel (Slack/MS Teams), Printed run sheet in chart, EHR case notes, Checklist stored in central sterile, Other

Decisions, Timelines, and the Metrics That Matter

• If we committed to a trial that truly minimized OR disruption, what assurances or documentation would you need before approving? Options: Written case-day responsibility matrix, Training schedule and attendees, Inventory ownership plan, Liability/insurance confirmation, Cost-neutral trial terms
• What upcoming internal or external deadlines drive urgency for making a decision (GPO renewals, contract expirations, new surgeon start date)?
• Which one or two KPIs will determine whether commercial leadership signs off after a trial? Options: Operative time change, Number of completed proctored cases, Tray completeness rate, Surgeon adoption rate, Per-case implant cost
• Who is the ultimate decision-maker for proceeding from trial to full adoption, and what information do they require? Options: VAC chair, Chief of Surgery, Hospital CEO/COO, Supply chain director, Surgeon group consensus
• What evidence from the trial (data, surgeon feedback, OR metrics) would be sufficient to close the deal for you?

Small Commitments That Build Trust — Practical Next Steps

• If we asked you to commit to one small, low-risk action this week to keep momentum, what would you be willing to do? Options: Schedule a 30-min planning call, Share current tray lists, Provide a date window for a cadaver lab, Identify the VAC packet owner, Nominate an OR champion
• Which weeks or date ranges are realistic for an outcome-focused workshop or cadaver lab in the next quarter?
• Which stakeholders must be present at the initial Solution Experience for it to be productive? Options: Lead surgeon(s), OR Director/Manager, VAC representative, Distributor rep, Central sterile lead, Finance/supply chain
• Before that meeting, what documentation or data would you like from us to prepare (cost model, case studies, tray specs, training plan)? Options: Cost per case model, Peer case outcomes, Complete tray/instrument list, sample protocols & checklists, Training syllabus
• Is there anything important we haven’t asked that would change how you evaluate a new spine system?

• Pre-Workshop Alignment
• Cadaver Lab Workshop (Hands-on Validation)
• Peer Case Observation (Plan & On-Case Debrief)
• Proctored Case Planning & Readiness
• Post-Experience Validation & Go/No-Go Decision

• Introductions & Objectives
• Assign a single point of contact for day-of coordination for each event.
• Recap Current State, Consequences & Goals
• Demonstrate measurable improvement against at least one agreed KPI in the lab setting.
• Identify and document required tray/instrument changes and procedural adjustments.
• Obtain explicit surgeon validation that the proposed workflow addresses the stated problem.
• Agree concrete next steps for peer observation and proctored case planning.
• Produce a lab report with timed measurements, tray change list, and surgeon sign-offs.
• Update tray manifests and request any missing instruments or implants from distribution.
• Schedule peer observation dates and confirm observers and data capture templates.
• If critical failures observed, define remediation tasks before any live case.
• Observation Objectives & Metrics
• Capture objective, on-case evidence showing whether lab gains translate to live OR.
• Document operational impacts to OR staff, instrument flow, and scheduling.
• Decide whether to proceed to proctored cases as planned or iterate on instrument/workflow changes.
• Deliver a concise observation report including KPI comparisons, photos, and immediate surgeon feedback.
• If gaps found, list required changes and owner assignments before proctored cases.
• Confirm proctoring dates or additional observations based on the debrief outcome.
• Reconfirm Future-State & Acceptance Criteria
• Achieve a fully-signed pre-proctored-case readiness checklist with owners assigned for every risk area.
• Confirm that all implants, trays, and rep coverage are committed to the case-day.
• Ensure everyone understands the acceptance criteria and contingency responses.
• Distribute the signed validation checklist and assign owners for any open items.
• Stage implants and instrument sets at the facility and confirm inventory with central distribution.
• Confirm travel/logistics for proctor/rep and create a day-of communication plan.
• Publish the case-day timeline and contingency contacts to all stakeholders.
• Synthesis of Measured Results
• Reach a documented go/no-go decision based on objective evidence and surgeon readiness.
• Create a prioritized corrective action list with owners and deadlines for any remaining gaps.
• Establish the trial start date and first validation checkpoint if approved.
• Prepare and distribute the post-experience report summarizing metrics, decisions, and assigned actions.
• If 'go', schedule first proctored case(s) and publish the deployment timeline and owners.
• If 'iterate', define required follow-up (additional lab, instrument mods, training) and timelines.
• Set the date for the first post-deployment validation checkpoint and invite stakeholders.
• Produce a single-sentence current-state statement that all stakeholders accept.
• Agree on quantified consequences that create urgency to change.
• Define the operational future-state and 3–5 KPIs to validate it.
• Confirm calendar dates, participants, and pre-work assignments for the cadaver lab and peer observation.
• Distribute pre-work template and collect OR case lists, imaging, and existing tray lists.
• Reserve cadaver lab facility and confirm required implants/instruments on the lab manifest.
• Confirm proctor and peer surgeon availability and tentative observation dates.
• Select Peer Case(s) & Logistics
• Re-evaluate Consequence Positioning
• Technique & Workflow Demonstration
• Final Case Selection & Schedule
• One-Sentence Current State
• Surgeon & OR Team Readiness Assessment
• Surgeon Hands-on Stations
• Tray, Implant & Inventory Checklist
• Explicit Consequences
• Data Capture Protocol
• Rep & Distributor Coverage Plan
• Pre-op Planning Review
• Define Future-State Outcomes
• Objective Measurements & Time Trials
• Operational Readiness Review
• Instrument Tray & Workflow Validation
• Close Gaps & Assign Corrective Actions
• Success Signals & KPIs
• Case Workflow Run-through & Contingency Plans

• Deliver complete implant case kits
• Supply sterile instrument trays
• Provide intraoperative technical rep support
• Provide proctored initial surgical cases
• Run cadaver surgical workshops
• Deploy navigation-compatible instrument sets
• Supply minimally invasive access kits
• Deliver expandable interbody cage systems
• Perform instrument reprocessing and restock
• Consign implant inventory to hospital
• Transfer instrument trays between facilities
• Provide on-site OR staff instrument orientation
• Supply emergency backup implant sets
• Install patient-specific surgical guides

Deliver complete implant case kits

• Do you require single-case, pre-packaged complete kits or modular pick-lists assembled per case? Options: Single-case complete kits, Modular pick-lists, Both, Not sure
• What is your expected average number of cases per month that will use these kits? Options: 1-5, 6-20, 21-50, 50+, Specify
• Which specific implant types, levels, or sizes must be guaranteed in each kit (e.g., pedicle screw diameters, cage footprints)?
• Do you require vendor labeling that matches hospital charge / procedure codes or OR-specific labeling? Options: Standard vendor labels, Hospital-specific labels, Both, Other
• Who will be responsible for kit inventory tracking and restocking between cases? Options: Distributor/vendor, Hospital supply chain, Consignment with vendor reconciliation, Shared responsibility
• What acceptance criteria must be met at time-zero (before skin incision) for a kit to be considered complete? Options: All implants & instruments present, Critical items present; non-critical can be substituted, Surgeon sign-off required, Other

Supply sterile instrument trays

• Do you require vendor-supplied sterile trays (single-use or sterilized by vendor) or hospital-sterilized trays? Options: Vendor-supplied sterile trays, Hospital-sterilized reusable trays, Mixed approach
• How many instrument sets should be available per OR per scheduled block (including backups)? Options: 1 set, 2 sets, 3+ sets, Varies by case
• Do you have tray set lists or do you need the vendor/distributor to propose tray contents? Options: Hospital will provide set lists, Vendor to propose and iterate, Shared review
• What is your required turnaround time for reprocessing and returning a tray to sterile stock? Options: Same-day turnaround, 24 hours, 48 hours, Other
• Who is responsible for instrument repair and replacement when damage is identified? Options: Vendor/distributor, Hospital biomed/sterile processing, Third-party repair, Shared
• Are there specific sterilization constraints (low-temp sterilization for trackers, peel-packs, validated cycles) the vendor must meet? Options: Standard steam acceptable, Low-temp or special cycles required, We will confirm per instrument, Other

Provide intraoperative technical rep support

• Should a technical representative be present for all trial and proctored cases or only for a subset? Options: Present for all trial/proctored cases, Only initial cases, On-call/remote support, As scheduled
• What portion of the case must the rep attend (setup only, critical steps, entire case)? Options: Setup & implant insertion, Critical procedural steps only, Entire operative case, Surgeon discretion
• Are there hospital credentialing, badge, or vaccination requirements that the rep must satisfy before OR access? Options: Yes - list will be provided, No, Pending hospital approval
• What clinical background or competency level do you require for the rep (RN, CST, clinical specialist)? Options: RN/clinical specialist, Experienced surgical tech/CST, Basic product training acceptable, Surgeon preference
• Who is the escalation contact and expected response time for intraoperative device or instrument issues?
• What acceptance metrics will determine satisfactory rep support (surgeon satisfaction, zero instrument-related delays, on-time case completion)? Options: Surgeon satisfaction, No instrument-related delays, Case meets scheduled OR time targets, Other

Provide proctored initial surgical cases

• How many proctored cases does the surgeon request before independent use is authorized? Options: 1-2, 3-5, 6-10, 10+, Specify
• What type of proctor is required (peer surgeon proctor, company clinical specialist, or hybrid)? Options: Peer surgeon proctor, Company clinical specialist, Both, Other
• What scheduling windows, blackout dates, or OR block constraints must we accommodate for proctored cases?
• Who will handle proctor travel, credentialing, and hospital privileges if an external surgeon proctor is used? Options: Vendor covers travel & credentialing, Hospital handles credentialing, Costs split, Other
• What documentation or sign-off is required after each proctored case (proctor report, surgeon attestation, operative note addendum)? Options: Proctor report, Surgeon sign-off, Both, No additional documentation
• What are the success criteria for concluding the proctoring phase (surgeon independence, operative time target, complication threshold)? Options: Surgeon independent on subsequent case, Operative time within agreed target, Surgeon satisfaction survey, Other

Run cadaver surgical workshops

• How many workshop seats or surgeon attendees should be planned for each session? Options: 4-8 seats, 9-16 seats, 16+ seats, Specify
• Which procedures and techniques should be included (e.g., TLIF, ALIF, PLIF, cervical approaches)? Options: TLIF, ALIF, PLIF, Cervical, Other
• Do you require CME accreditation and formal certificates for attendees? Options: Yes, No
• Do you prefer vendor-hosted off-site labs, on-site hospital labs, or hybrid formats? Options: Off-site cadaver lab, On-site hospital lab, Hybrid
• What equipment and instrument sets must the vendor supply for the workshop versus what the hospital will provide? Options: Vendor supplies all instruments, Hospital supplies OR equipment, Shared responsibility
• Which measurable outcomes from the workshop are important (surgeon confidence, procedural competency, decision-making for implants)? Options: Surgeon confidence, Technical competency, Willingness to trial cases, Other

Deploy navigation-compatible instrument sets

• Does the site currently have navigation hardware/software, or will it be procured concurrently? Options: Existing navigation system, No navigation yet, Planned installation
• Which navigation platforms must our instruments be compatible with? Options: Brainlab, Medtronic Stealth, Stryker NAV3, Other (specify)
• Are instrument adapters, trackers, or sterile drape interfaces required for compatibility? Options: Yes - adapters/trackers required, No - native compatibility, Depends on platform
• Who will perform integration testing and clinical validation of navigation workflows (vendor, hospital IT/biomed, distributor)? Options: Vendor, Hospital IT/Biomed, Distributor, Shared
• What acceptance criteria define acceptable navigation performance (target accuracy, registration time, OR workflow fit)?
• Are there sterilization or tracker handling constraints (low-temp sterilization, single-use trackers)? Options: Standard sterilization, Low-temp required, Single-use trackers, Other

Supply minimally invasive access kits

• Which MIS approaches should the kits support (tubular retractors, percutaneous screws, endoscopic, lateral approaches)? Options: Tubular retractors, Percutaneous screw kits, Endoscopic, Lateral/XLIF, Other
• How many MIS kits should be staged per room or per block? Options: 1 per room, 2 per room, Depends on schedule
• Do you prefer single-use disposable consumables or reusable MIS instruments? Options: Single-use consumables, Reusable instruments, Mixed approach
• Are there imaging system compatibility constraints (fluoroscopy-only, O-arm, navigation) that affect kit contents? Options: Fluoroscopy, O-arm, Navigation, Other
• Will additional MIS-specific proctoring or staff training be required before independent use? Options: Yes - proctoring required, No, As-needed
• What acceptance criteria determine MIS kit readiness on case day (complete instruments, backup kits, surgeon sign-off)? Options: Complete instruments present, Backup kit available, Surgeon sign-off, Other

Deliver expandable interbody cage systems

• Which cage footprints, heights, lordosis angles, and expansion ranges must be stocked?
• Do you require trial/demo implants and sizing trials for surgeon evaluation prior to using implants in patients? Options: Yes - trial implants needed, No - proceed with implants, Partial/demo inventory
• What inventory model do you prefer for cages: consignment, hospital purchase, vendor-stocked with case billing? Options: Consignment, Hospital purchase, Vendor-stocked billing by use, Custom
• Are the expandable cages required to be compatible with MIS insertion instruments or specific MIS workflows? Options: Yes - MIS-compatible, No - open approach only, Both
• Are there sterilization or single-use instrument constraints associated with cage deployment instruments? Options: Single-use implant, reusable instruments, Single-use instruments, Reusable instruments
• What clinical or radiographic acceptance criteria will you use to evaluate cage performance post-implantation? Options: Surgeon satisfaction, Radiographic placement criteria, Fusion progress metrics, Other

Perform instrument reprocessing and restock

• Who will be responsible for reprocessing instrument trays between cases? Options: Vendor/distributor reprocessing, Hospital SPD, Third-party reprocessor, Shared
• What is the required SLA for tray turnaround and restock to support scheduled cases? Options: Same day, 24 hours, 48 hours, Custom agreement
• Do you require electronic inventory tracking (barcode/RFID) and automated restock notifications? Options: Yes - barcode/RFID, No, Planned implementation
• Who bears cost for lost, damaged, or non-repairable instruments identified during reprocessing? Options: Vendor, Hospital, Consignment terms apply, Shared
• Do you require sterilization cycle documentation and tray count logs be provided after each reprocessing cycle? Options: Yes, No
• How often should preventive maintenance and calibration of reusable instruments be scheduled and documented? Options: Monthly, Quarterly, Annually, Per vendor recommendation

Consign implant inventory to hospital

• Which hospital locations or ORs should hold consigned stock and what is the maximum consignment value per location?
• What billing trigger should be used for consignment (case use, monthly inventory reconciliation, periodic consumption report)? Options: Billed on case use, Monthly inventory invoice, Periodic reconciliation, Other
• Who will perform inventory audits and at what frequency (weekly, monthly, quarterly)? Options: Vendor weekly, Hospital monthly, Third-party audits, Custom schedule
• What insurance, liability, and indemnification terms does the hospital require for consigned stock? Options: Vendor carries insurance, Hospital carries insurance, Shared liability
• What is the policy for returning expired, unused, or near-expiry implants from consignment? Options: Returnable, Non-returnable, Credit on rotation, Other
• Do you require EMR/ERP integration (material management) for real-time consignment tracking and charging? Options: Yes, No

• Statement of Work (SOW)
• Commercial Terms & Purchase Order
• Trial / Evaluation Agreement
• GPO / Contract Addendum
• Distributor Service & OR Coverage Agreement
• Surgeon Proctoring & Training Commitment
• Inventory Allocation & Consignment Agreement
• Acceptance Criteria & Go/No-Go Checklist
• Compliance, Credentialing & Regulatory Exhibit
• Instrumentation Delivery & Validation Schedule
• Insurance, Indemnification & Liability Terms
• Data & Outcomes Sharing Agreement
• Implementation Project Plan & Owners
• Change Order & Amendment Process

• Final Outcomes Review — Clinical & Operational
• Lessons Learned & Continuous Improvement Workshop
• Operational Readiness Handover — OR, Supply Chain & Distributor
• Surgeon & OR Staff Feedback Session
• Shared Issues & Enhancements Channel Setup + Governance

• Agree on additional training, reference materials, or proctoring if required.
• One‑sentence Future State
• Establish single owners for inventory, rep coverage, and OR training for steady‑state operations.
• Agree on concrete inventory and tray standards that will prevent case delays.
• Set monitoring cadence and SLAs to sustain adoption and quickly resolve issues.
• Publish definitive tray lists and inventory thresholds to supply chain and distribution partners.
• Formalize rep coverage schedule and backup roster with distributor signatures.
• Create an operational runbook (day‑of checklist, escalation path) and distribute to OR managers.
• Validated Current State from Users
• Obtain explicit surgeon confirmation on acceptance criteria or documented objections.
• Capture frontline OR staff issues that could cause future case delays and identify quick mitigations.
• One‑sentence Current State
• Compile a surgeon acceptance log with signed confirmations or documented objections.
• Prepare quick reference guides and schedule targeted OR staff refreshers based on requests.
• If objections remain, schedule targeted proctored cases or peer observations to close gaps.
• Purpose & Channel Choice
• Create a single source of truth for issues and enhancement requests with clear triage rules.
• Define owners, SLAs, and escalation paths so issues are resolved predictably.
• Establish a governance cadence to review trends and prioritize systemic fixes.
• Create the shared channel and onboard all stakeholders with credentials and guidelines.
• Publish triage matrix and SLA document to the channel and operational teams.
• Schedule recurring governance meetings (monthly) and a rolling review of the enhancement backlog.
• Confirm alignment on whether the trial met the predefined clinical and operational success signals.
• Quantify the operational and financial consequences of the results.
• Assign owners and timelines for either formal adoption or targeted remediation.
• Produce and distribute a formal outcomes report mapping each success signal to measured data and decision recommendation.
• Assign remediation owners and create a 30/60/90 day plan for any unmet signals.
• Schedule governance cadence for monitoring agreed KPIs if moving to adoption.
• Brief Recap of Outcomes
• Document concrete lessons learned and root causes for top operational and clinical variances.
• Agree on a prioritized list of improvements with owners and pilot plans.
• Define measurable success criteria for each pilot change to validate impact.
• Create a prioritized improvement backlog with owners, estimated effort, and target metrics.
• Initiate pilots for top 1–3 improvements and schedule checkpoints.
• Update training materials or SOPs based on agreed changes and distribute to OR staff and reps.
• Issue Triage & SLAs
• Surgeon Satisfaction & Case Review
• Clinical Outcomes Summary
• Incident & Near‑miss Review
• Tray & Inventory Standards
• Operational Metrics Summary
• Enhancement Backlog Process
• Rep & Distributor Coverage Plan
• OR Staff Workflow & Setup Feedback
• Root Cause Analysis (Fishbone/5 Whys)
• Consequence & Financial Impact
• Improvement Brainstorm & Prioritization
• Roles, Escalation & Governance Cadence
• Force Validation of Acceptance Criteria
• OR Staffing & Training Handover
• Onboarding & Channel Norms
• Validation & Decision
• Monitoring, Reporting & SLAs
• Pilot Selection & Success Definition
• Quick Wins & Training Requests
• Next Steps & Owner Assignments