Start: The OR reality we need to see

• To begin, how many spine procedures does your service line schedule in an average month? Options: 0-5, 6-15, 16-30, 31-60, 60+
• How many of those are fusion cases versus decompression or revision, roughly? Options: Mostly fusion, Mostly decompression, Mixed but more fusion, Mixed but more decompression, Evenly split
• Tell me about the implant systems and instrument families your surgeons currently prefer and why those choices matter in the OR.
• Describe a recent case where a tray, instrument, or implant issue changed the plan, what happened and who made the call?
• Who owns schedule decisions on the day of surgery, and who is the primary contact when something goes wrong? Options: Surgeon, OR director/manager, Charge nurse/scrub tech, Service line administrator, Other

Where the schedule breaks and what that costs

• If instrumentation or rep coverage failed tomorrow, what single immediate problem would most likely cancel your next scheduled spine case?
• When missing implants cause a case delay, how do delays typically ripple through your block that day? Options: Case cancelled, Cases pushed later same day, Overflow to next day, Surgeon converts plan, Other
• Which outcome from those delays hits you hardest, revenue loss, patient dissatisfaction, OR staff overtime, or surgeon backlog? Options: Revenue loss, Patient dissatisfaction, Staff overtime, Surgeon backlog, Other
• Give an example of the last time a missing or incomplete tray changed your day and who decided how to proceed
• How often in the past 12 months have scheduled spine cases been canceled or postponed due to instrumentation, implants, or rep coverage issues? Options: Never, Rarely (1-3), Occasionally (4-8), Regularly (9-20), Frequently (20+)

Roles and rituals in the room, who actually moves the pieces

• Who in your OR setup has the final authority to stop a case if a critical implant or instrument is unavailable? Options: Surgeon, OR director/manager, Charge nurse, Scrub tech with surgeon consult, Other
• List the roles that routinely touch instrument trays for spine cases, including circulating techs, scrub techs, and distributor reps. Options: Surgeon, Scrub tech, Circulating tech, Distributor rep, Sterile processing staff, Other
• In practice, how often does the distributor rep lead the tray check versus your own staff? Options: Distributor always, Distributor usually, Shared responsibility, Hospital staff usually, Hospital staff always
• What training cadence do OR staff and techs have for new implant systems, and who tracks competency? Options: No formal cadence, Annual refresh, At hire and then annual, At hire and proctor-led cases, Other
• Tell me about turnover in your OR and how new or temporary staff handle unfamiliar instrumentation.

Clinical goals and the surgeon signals you watch

• What single clinical outcome would need to improve for your lead surgeons to endorse switching implant systems?
• Which surgeon-level metrics matter most to you, operative time, blood loss, construct stability, fusion rate, or patient reported outcomes? Options: Operative time, Blood loss, Construct stability, Fusion rate, Patient reported outcomes, Other
• Estimate how quickly your surgeons would expect to regain baseline operative time after adopting a new system. Options: 1-2 cases, 3-5 cases, 6-10 cases, More than 10 cases, Unsure
• Describe the intraoperative cues that tell you a case is proceeding well with new instrumentation, for example smooth set-up, intuitive instruments, or rep support.
• Identify who signs off on clinical readiness after the proctored cases, surgeon, service line chair, or value analysis committee? Options: Surgeon, Service line chair, Value analysis committee, OR director, Other

Trial stakes, success gates, and the things that will stop it

• If the initial proctored cases miss your success gates, what would make you stop the trial immediately?
• On average, how many proctored cases do you require to judge a new implant system's safety and workflow fit? Options: 1 case, 2-3 cases, 4-6 cases, 7-10 cases, More than 10
• List the objective criteria your OR team will measure during the trial, for example tray completeness, case duration, implant availability, or complication rates. Options: Tray completeness, Case duration, Implant availability, Complication rates, Surgeon feedback, Other
• Name the individual or role who will own acceptance decisions at the end of the trial and what simple documentation they need.
• Point to the operational evidence that must be present to continue beyond the trial, and which missing item would stop the pilot immediately.

The other options on the table

• Name the vendors, incumbent systems, or internal options you are actively comparing against for the next 6 months. Options: Incumbent vendor, Other vendor(s), Internal rollout, Hybrid approach, Unsure
• Under which conditions would you choose to remain with the incumbent, listing inventory, training, or commercial factors?
• Has anyone inside the hospital proposed solving this with an internal rollout rather than partnering with an outside vendor? Options: Yes, actively proposed, Discussed but not proposed, No one has proposed it, Unsure
• Rate how important each alternative is as a true contender, incumbent system, another vendor, or an internal solution. Options: Not important, Somewhat important, Important, Critical
• Identify which stakeholders are advocating for each option, surgeon, OR leadership, procurement, or service line leadership. Options: Surgeon, OR leadership, Procurement, Service line leadership, Other

Operational readiness and hard constraints we must clear

• Point out the logistical, technical, or compliance constraint on your side that would block a proctored case from happening.
• Do you have an instrument tracking or sterilization system the distributor must interface with, and who manages access to it? Options: Yes, instrument tracking system, Yes, sterile processing only, No formal system, Unsure
• Provide the role and contact owner for instrument ownership, tray checks, and on-day escalation.
• Give the number of full tray sets you have per suite and per surgeon that could be dedicated to a trial. Options: 0, 1, 2-3, 4-6, More than 6
• Are there regulatory reviews, value analysis steps, or contracting milestones that must complete before proctoring begins, and how long do they usually take? Options: No gating steps, 1-2 weeks, 3-6 weeks, 7-12 weeks, Longer

Pricing, procurement, and the commercial gates

• Explain the commercial commitment or inventory guarantee from the seller that would make your procurement team sign this quarter.
• Where does budget for implants and distributor coverage currently sit, capital, operational, department, or a combination? Options: Capital, Operational, Departmental budget, Combination, Unsure
• Provide the title that holds final budgetary approval and indicate whether a GPO or contract window dictates timing.
• Assuming the pilot shows promised savings or outcomes, how quickly could purchase orders be issued? Options: Within 1 week, 1-2 weeks, 2-4 weeks, One billing cycle, Longer
• State the commercial terms that are nonnegotiable for you, for example inventory ownership during the trial, returnability, or rep coverage guarantees.

Communication, governance, and day-of escalation

• Explain which people must be in the governance loop when a proctored case goes off the rails, and what outcome would satisfy each.
• Select your preferred channel for urgent day-of escalation, phone, secure messaging, or an OR runner to a manager. Options: Phone call, Secure messaging platform, Text message, Email, OR runner to manager
• Choose the regular check-in cadence your team would want during the trial, weekly, after each case, or milestone reviews. Options: After each case, Weekly, Biweekly, Only at milestones, Other
• Assign the role that will own day-to-day logistics between the seller, distributor, and your staff once the pilot starts. Options: OR manager, Service line coordinator, Surgeon designee, Procurement rep, Other
• Select the immediate mitigation that would be acceptable if a proctored case is delayed mid-case, backup implants, converting to alternative fixation, or rescheduling. Options: Backup implants on site, Convert to alternative fixation, Call another OR to borrow, Reschedule the case, Other

Timing, decision triggers, and the earliest possible path

• Assuming the pilot reaches each success metric, what is the earliest date your value analysis committee could vote to adopt?
• Choose your typical evaluation window for new implants, 3 months, 6 months, or 12 months. Options: 3 months, 6 months, 9 months, 12 months, Custom/Other
• State the internal deadlines, surgeon start dates, or contract expirations that create nonnegotiable milestones for this project.
• Rank which of these would accelerate your committee decision to the next meeting, signed pilot results, surgeon endorsement, or supplier guarantees. Options: Signed pilot results, Surgeon endorsement, Supplier inventory guarantee, Commercial concessions, Other
• Specify the single piece of evidence from the trial that would make you sign within two weeks.

Immediate next steps and a low-risk way to start

• Would scheduling a hands-on lab and a proctored case within your next available surgeon start window make you proceed? Options: Yes, proceed, Maybe, need details, No, not ready
• Share any dates in the next 8 weeks we should avoid because of surgeon or OR conflicts.
• Confirm the role on your side that will coordinate day-of logistics, OR access, and the distributor rep assignment.
• Pick the acceptable first pilot length, one proctored case, three cases, or a full week of cases. Options: 1 proctored case, 3 proctored cases, Full week of cases, Other
• Indicate which of these next steps you would like to commit to today, scheduling a lab, confirming trial dates, or initiating contracting. Options: Schedule a hands-on lab, Confirm trial dates, Start contracting, Assign internal owners, Not ready yet

• Solution Experience: Implant Systems & OR Support

• Confirm the current state and its cost
• You confirm the demonstrated end-to-end case workflow prevents the instrument- and rep-related delays you described.
• Deliver a tailored proctoring plan and instrument tray checklist for the relevant OR types within five business days.
• Walk a representative scheduled-case end-to-end
• You agree on measurable acceptance criteria and proctoring cadence that define trial success.
• Provide three recent scheduled-case examples where instrument or rep issues occurred, including time lost and case outcome.
• Show the instrument tray checklist and logistics plan
• Map typical OR start times and case mix to the proposed tray and rep coverage to confirm staffing needs and on-call windows.
• You identify any remaining operational gaps and the evidence required to close them before proctored cases begin.
• Run a sample inventory coverage plan and recommend on-hand stock levels and restocking cadence for each hospital account.
• Validate proctoring cadence and acceptance criteria
• Forced validation, confirm this maps to your problem
• Agree next evidence and decision steps

• Solution Experience: Implant Systems & OR Support
• Solution Experience Deck
• Solution Brief

• meeting
• slides
• document

• Deliver implant and instrument starter kits
• Assemble case-specific implant kits
• Provide intraoperative technical representation
• Provide proctored initial surgical cases
• Deliver cadaver lab training sessions
• Supply sterile-ready instrument trays
• Reconfigure instrument trays for OR workflow
• Replace missing or damaged instrument components
• Provide consignment inventory and replenishment
• Deliver navigation-compatible instrument sets
• Supply expandable interbody cage systems
• Provide instrument sterilization validation packs

Deliver implant and instrument starter kits

• Which implant families should be included in your starter kit (for example: cervical plates, lumbar pedicle screw sets, interbody cages)? Options: Cervical plates, Thoracolumbar pedicle screw sets, Interbody fusion cages, Motion preservation devices, Other (describe)
• How many each of primary SKUs (screw diameters and lengths, cage footprints) do you need in the starter kit for initial surgeon evaluation? Options: Minimal trial assortment (1-2 per SKU), Standard starter (3-5 per SKU), Surgeon-preferred counts (specify below)
• For which procedure types should starter kits be configured (e.g., ACDF, TLIF, PLIF, lateral interbody)? Options: Anterior cervical discectomy and fusion (ACDF), Transforaminal lumbar interbody fusion (TLIF), Posterior lumbar interbody fusion (PLIF), Lateral interbody (LLIF/XLIF), Other
• Who in your team will receive and inventory the starter kit on delivery (e.g., OR charge nurse, sterile processing department contact)?
• What physical delivery constraints must we meet (OR dock hours, receiving door dimensions, need for liftgate)? Options: Standard hospital receiving hours, OR dock only (specified time windows), Ambulatory surgery center receiving, Requires liftgate or pallet jack
• Describe any documentation you require with the starter kit (SKU manifest, implant lot numbers, IFU, clinician quick-reference cards).

Assemble case-specific implant kits

• Which case types do you expect to use case-specific kits for in the trial (e.g., single-level TLIF, two-level lumbar fusion, ACDF)? Options: Single-level TLIF, Two-level lumbar fusion, ACDF, Revision fusion, Other
• How many case-specific kits per operating day should we prepare and stage at the OR (to match your OR schedule and backups)? Options: Primary case only, Primary + 1 backup, Primary + 2 backups, Specify exact number
• What surgeon-specific preferences must be reflected in each kit (preferred screw diameters, cage footprint, implant lordosis angles)?
• Do you require kits labeled with case identifiers and OR case numbers tied to your OR schedule? Options: Yes, label with OR case number and patient initial, No, general case labels are acceptable, We need an alternative labeling protocol (describe)
• Specify any sterility or packaging requirements for case kits beyond standard sterile packs (e.g., double-wrapped, single-use sterile drape inclusion). Options: Standard sterile packaging, Double-wrapped trays, Include single-use sterile drapes, Other (describe)
• How will you verify kit completeness in the OR (instrument checklist, barcode scan, visual sign-off)? Options: Instrument checklist signed by RN/tech, Barcode scan at case open, Visual confirmation only, Other

Provide intraoperative technical representation

• Which model of intraoperative coverage do you prefer for cases (in-person distributor rep, dedicated clinical specialist, remote tech support via video)? Options: In-person distributor rep, Dedicated clinical specialist (scheduled), On-call remote technical support, Hybrid (in-person + remote)
• What hours of OR coverage are required (start time before incision, end time after wound closure) for routine cases? Options: Start 30 minutes prior to incision, Start 60 minutes prior to incision, Start 15 minutes prior, Custom window (specify)
• Who on your staff will be the daily point of contact for the intraoperative representative (OR charge nurse, surgical coordinator, lead tech)? Options: OR charge nurse, Surgical coordinator, Lead surgical tech, Other (name/role)
• What documentation or credentialing does your hospital require for intraoperative representatives to scrub or be present in the sterile field? Options: Standard ID and HIPAA training, Hospital vendor credentialing packet, Scrub privileges required, Other (describe)
• Describe any case escalation paths you expect the representative to follow if an instrumentation problem arises (who to call in SPD, engineering contact, alternate instrument set location).
• Are there OR access or infection control policies (e.g., time-out participation, LAF/laminar airflow restrictions) the representative must follow? Options: Standard OR policies apply, Additional vendor restrictions required, Specific PPE required (specify)

Provide proctored initial surgical cases

• How many proctored cases do you want included in the trial before independent use is approved? Options: 1-2 proctored cases, 3-5 proctored cases, 6-10 proctored cases, Other (specify)
• Which case types will be used for proctoring (e.g., primary one-level TLIF, multi-level fusion, deformity cases)? Options: Primary one-level TLIF, Two-level fusion, Deformity cases, ACDF, Other
• What cadence of proctoring visits do you prefer (consecutive cases, weekly scheduled blocks, ad-hoc on-call proctor)? Options: Consecutive cases (same week), Weekly scheduled blocks, Ad-hoc on-call proctor, Hybrid scheduling
• Who will be your clinical sign-off authority for proctored cases (named surgeon proctor, OR director, value analysis committee designee)?
• What defines successful completion of the proctored phase for your team (provide measurable thresholds such as instrument checklist completeness, operative time within X% of baseline, and surgeon-reported proficiency)?
• Describe required documentation after each proctored case (case log entry, instrument incident report, surgeon proficiency attestation). Options: Case log entry, Instrument incident report if applicable, Surgeon proficiency attestation, All of the above
• If a proctored case requires conversion to an alternate implant or set, what escalation or approval steps do you require (who authorizes conversion, who documents change)?

Deliver cadaver lab training sessions

• What format of cadaver lab do you prefer (hands-on surgeon lab, scaled demo with scrub techs, wet lab with navigation integration)? Options: Hands-on surgeon lab, Hands-on with scrub techs, Wet lab with navigation integration, Observation-only demo
• How many surgeon seats and scrub-tech seats should be reserved per session? Options: 1-4 surgeons, 5-8 surgeons, 9-12 surgeons, Custom number
• Which training objectives should the lab cover (instrument workflow, implant sizing strategy, navigation workflows, complication avoidance)? Options: Instrument workflow, Implant sizing strategy, Navigation workflows, Complication avoidance, Other
• What onsite equipment must be provided from your side (fluoroscopy, navigation console model, instrument table), and what should we supply?
• Do you require proctor or faculty CVs and competency documentation prior to the lab? Options: Yes, provide CVs and credentials, No, not required, Only for external faculty
• What outcomes from the cadaver lab will indicate readiness to schedule proctored clinical cases (surgeon comfort score, completion of specified tasks checklist)?

Supply sterile-ready instrument trays

• Which instrument sets need to be delivered sterilized and ready-to-use (name tray sets or SKU IDs used in your OR)?
• How many sterile-ready trays per set should be staged per OR day to meet your case throughput and backup needs? Options: 1 tray per set, 2 trays per set, 3+ trays per set (specify)
• What sterilization method does your facility use for vendor-supplied trays (steam autoclave, ethylene oxide gas, low-temperature hydrogen peroxide)? Options: Steam autoclave, Ethylene oxide (EO) gas, Low-temperature H2O2 plasma, Facility varies
• What acceptance checks must occur on arrival in SPD or OR (sterility indicator intact, instrument function check, tray weight verification)? Options: Sterility indicator intact, Instrument function check, Tray content checklist, Barcode scan inventory
• What defines an acceptable sterile tray at go-live (list required evidence such as biological indicator records, tray checklist sign-off)?
• Are there labeling or traceability requirements for trays (UDI, lot/expiry labels, barcodes tied to patient case)? Options: UDI and lot labels required, Barcode inventory acceptable, No additional labeling required

Reconfigure instrument trays for OR workflow

• Which existing tray layouts or vendor tray names should be matched or replaced when configuring for your OR workflow?
• What OR workflow constraints drive tray reconfiguration (limited table space, scrub tech handedness, preference for instrument sequence)? Options: Table space constraint, Scrub tech handedness, Preferred instrument sequence, Other (describe)
• Who will approve the tray layout changes in your facility (OR director, sterile processing manager, lead surgeon)?
• Do you require instrument placement diagrams, reagent maps, or sterilization load sheets to accompany reconfigured trays? Options: Instrument placement diagrams, Sterilization load sheets, Reagent maps, No additional documentation
• Provide the maximum acceptable tray weight or dimensions for transfer between SPD and OR at your site. Options: Up to 20 kg, 20-30 kg, Over 30 kg (special handling)
• How many trial iterations of tray reconfiguration do you anticipate before final sign-off (one, two, three)? Options: One iteration, Two iterations, Three or more

Replace missing or damaged instrument components

• What is your target turnaround time for replacing a missing or damaged instrument component needed for a scheduled case? Options: Within 2 hours, Within 4 hours, Same day delivery, Next business day
• Where should replacement instruments be staged or delivered (central SPD, OR storage room, vendor consignment bin)? Options: Central sterile processing department (SPD), OR storage room, Vendor consignment bin, Other (specify)
• Who authorizes replacement instrument use during a case if documentation (lot, sterilization) is incomplete?
• Describe the replacement component documentation you require on delivery (lot numbers, sterilization cycle record, replacement manifest).
• Do you prefer replacements pulled from consignment inventory or from a centralized loaner pool? Options: Consignment inventory, Centralized loaner pool, Hybrid
• Are there any components you consider non-repairable and must be replaced with factory-new items (e.g., torque-limited drivers, implant-specific instruments)? Options: Yes, list below, No, repairs acceptable, Depends on component

Provide consignment inventory and replenishment

• Which SKUs should be held on consignment at each account and in what par levels (per OR or per hospital account)?
• How often do you want consignment inventory counts performed and reconciled (daily, weekly, per case)? Options: Per case, Daily, Weekly, Monthly
• What replenishment trigger should be used (par-level threshold, scheduled weekly ship, barcode scan reorder)? Options: Par-level threshold, Scheduled weekly shipment, Barcode scan reorder, Manual reorder
• Who will be responsible for signing consignment inventory receipts and authorizing use (OR charge nurse, materials manager)?
• What reporting format do you require for consignment usage (monthly SKU-level consumption, case-linked usage report, live dashboard)? Options: Monthly SKU consumption report, Case-linked usage report, Live dashboard access, Other
• Are there billing or ownership rules we should enforce on consignment (bill on implant use only, periodic reconciliation write-off)? Options: Bill on implant use only, Periodic reconciliation with adjustments, Other (specify)

Deliver navigation-compatible instrument sets

• Which navigation platforms or console models at your site must the instrument sets be compatible with (specify model and vendor)?
• Do you require registered instrument arrays, tracker attachments, or dedicated navigation adapters included in the set? Options: Registered instrument arrays, Tracker attachments, Dedicated navigation adapters, No navigation accessories required
• What verification steps do you require in the OR for navigation functionality (registration accuracy threshold in mm, phantom checks)? Options: Registration within 1 mm, Registration within 2 mm, Phantom accuracy check required, Other
• How should navigation instruments be labeled or packaged to differentiate them from non-navigation counterparts? Options: Color-coded labels, Separate navigation tray, Barcode tags, Other (specify)
• If sterile navigation drapes or disposables are required, should they be included with navigation trays or billed separately? Options: Included with trays, Billed separately, Facility will supply drapes

• Purchase Agreement
• Order Confirmation
• Pricing & Payment Schedule
• Distributor Coverage Commitment
• Inventory & Consignment Agreement
• Trial Use Agreement
• Master Services Agreement (MSA)
• Statement of Work (SOW) — Proctoring & Training
• Governance & Escalation Agreement
• Warranty & Returns Policy
• Acceptance Certificate
• HIPAA Business Associate Addendum (BAA) — conditional

• Go-Live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• 90-Day Realization Review
• Quarterly Operational Review

• Produce the next quarter KPI snapshot and circulate it at least five business days before the next meeting.
• Recap acceptance criteria from Solution Scope
• Confirm which named metrics meet the targets recorded in Solution Scope and which require remediation.
• Verify the incumbent system wind-down status and close any open fallback workflows.
• Agree a timebound remediation and verification plan for remaining gaps.
• Archive or label incumbent inventory records as decommissioned or read-only and publish the archive report.
• Schedule targeted retraining sessions for OR staff and surgeons if surgeon proficiency rate is below target.
• Resolve the top three persistent instrumentation logistics issues with documented remediation steps and dates.
• KPI trend review and variance analysis
• Confirm whether KPI trends remain within acceptable variance from Solution Scope targets and identify required corrective work.
• Ensure all open issues have named owners and realistic resolution dates entered in the shared tracker.
• Prioritize the top enhancement requests and agree the evaluation or implementation timeline.
• Update the shared issue tracker with current statuses, owners, and target resolution dates for all open items.
• Deliver the prioritized enhancement request list with proposed timelines for consideration at the next quarter review.
• Re-confirm success criteria and owners
• Confirm the deployment checklist items are complete and owners are named for any gaps.
• Produce a prioritized list of immediate blockers with remediation actions and dates.
• Ensure the escalation path and on-call coverage are confirmed for the next 30 days.
• Publish a one-page go-live health summary documenting open issues and owners for distribution to the operational team.
• Capture and assign remediation tasks for each blocker with a target completion date.
• Update and circulate the escalation contact list and on-call schedule for the next 30 days.
• Present first measurement data vs Solution Scope targets
• Decide whether primary KPIs are on track toward the Solution Scope targets or require remediation.
• Agree a corrective action plan with measurable acceptance criteria and target dates.
• Set the date and owner for the next data refresh and follow-up review.
• Run a tray completeness audit for the next 10 scheduled spine cases and report the instrument set completeness rate.
• Perform an inventory reconciliation at each site and submit a variance report with corrective steps.
• Establish a temporary coverage plan for any shifts with rep or distributor gaps and document the plan.
• Deployment and logistics validation
• Open issue burn-down
• Root cause diagnosis for gaps
• Present 90-day outcome data against targets
• Agree corrective actions and timelines
• Incumbent system wind-down checkpoint
• Enhancement request queue
• Early adoption signals
• Confirm timeline to next acceptance/checkpoint
• Blockers and open issues
• Persistent issues and escalation closure
• Short operational decisions and next steps
• Agree remediation timeline and verification steps
• Agree immediate remediation actions