Getting to Know Your Practice and Priorities

• Tell me about the mix of joint procedures your team performs in a typical week, and which three surgeons drive the most volume
• On average, how many primary and revision arthroplasties does your facility perform per month? Options: 0-10, 11-25, 26-50, 51-100, 100+
• How do your surgeons currently choose an implant for a given case, walk me through the decision steps from preop templating to implant selection
• Which implant families and instrument sets are in routine use across your ORs, and how standardized are they between surgeons? Options: Fully standardized across surgeons, Mostly standardized with exceptions, Little standardization, No standardization
• Who on your team owns surgeon preference discussions, and who owns contract or value analysis decisions? Options: Lead surgeon(s), Service line director, Value analysis committee, Supply chain/procurement, Shared responsibility
• Describe a recent case where your current implant or instrumentation approach produced a clear win or a frustrating problem
• Which measurable outcome would convince your team that a new implant system is worth adopting—operative time, revision rate, length of stay, cost per case, or something else? Options: Reduced operative time, Lower revision/readmission, Shorter length of stay, Lower cost per case, Improved patient-reported outcomes, Other

Where Outcomes and Workflow Clash

• If a single intraoperative problem forced you to stop considering a new system, what would that be and why?
• How often do instrument handling or tray layout issues extend your average OR time for arthroplasty cases? Options: Never, Rarely, Sometimes, Often, Almost every case
• Which specific instrument ergonomics or tray failures have caused a surgeon to pause mid-case in the last 12 months?
• When an unfamiliar instrument or implant is introduced, what support do your surgeons expect in the first three cases? Options: Full intraop rep coverage, Surgeon-to-surgeon mentoring, On-site clinical specialist, Virtual support, No support needed
• What downstream cost or operational consequences happen when a case runs longer than planned because of instrument trouble? Options: Overtime pay, Canceled cases later in day, Room turnover delays, Increased infection risk, Supply shortages
• Which single intraoperative metric, if improved by 20%, would most accelerate your willingness to adopt a new offering? Options: Case length, Blood loss, Implant positioning accuracy, OR turnover time, Reoperation rate

Where the Current System Breaks Trust in the OR

• What's the recurring OR failure that frustrates surgeons most, and how long has the team been tolerating it?
• Which types of implant or instrument problems have led to surgeon complaints to procurement or service line leadership in the past year? Options: Broken instruments, Missing SKUs, Poor implant fit options, Tray sterilization issues, Inadequate intraop support
• Who typically raises these complaints first, and how quickly do they escalate to a decision maker? Options: Circulating nurse, Scrub tech, Surgeon, OR manager, Service line director
• How do these recurring issues affect surgeon willingness to try alternatives—from a sentiment and scheduling standpoint? Options: Surgeons refuse alternatives, Surgeons will try alternatives selectively, Surgeons open to alternatives with guaranteed support, Surgeons lead change initiatives
• Which operating room or sterilization practice would have to change immediately for a new implant to be usable on day one?

Inventory, Cost Pressure, and Purchasing Realities

• If implant cost pressure increases this year, which purchasing rule would you change first to protect margins? Options: Narrow preferred vendor list, Increase standardization, Switch to lower-cost SKU options, Negotiate bundle pricing, Other
• How many unique implant SKUs do you stock today for hips and knees combined, approximately? Options: 0-25, 26-50, 51-100, 101-200, 200+
• Which stakeholders must sign off on a pricing change that affects implant reimbursement or case cost? Options: Value analysis committee, Supply chain/procurement, CFO/finance, Service line director, Lead surgeons
• What happens to implant selection when a surgeon's preferred component is not on contract or in inventory? Options: Surgeon delays case, Surgeon uses alternate implant, Case converted to different approach, Surgeon arranges outside implant, Decision escalates to leadership
• Which commercial term would move the needle fastest—volume discounts, consignment inventory, guaranteed SKU fill, or training credits? Options: Volume discounts, Consignment inventory, Guaranteed SKU fill, Training credits, Other
• Is there a hard cost threshold per case that would make your CFO reject a change outright? Options: Yes, specify amount, No fixed threshold, Depends on demonstrated outcomes

Operational Readiness and Technical Gateways

• What operational or regulatory constraint would stop a rollout before it started, even if surgeons were supportive?
• Which sterilization or tray processing capacity details must be confirmed before first shipment arrives, pick all that apply Options: Tray washer capacity, Sterilizer cycle types, Tray dimension limits, Number of sterilization cycles per day, Dedicated instrument storage
• Who owns the site-level approvals we need, and how long does each approver typically take to sign off?
• How clean and accessible is the data we would need for implant tracking and registry submission, and who can grant access? Options: Fully accessible with owner, Partially accessible, Not accessible without IT work, No registry/data capability
• Which internal technical resources are available to support integrations or device tracking, select all that apply Options: IT systems analyst, Biomedical engineering, Inventory manager, Clinical data team, None
• If any one of the following was missing—sterilization capacity, named site owner, or registry access—which single gap would kill your pilot? Options: Sterilization capacity, Named site owner, Registry/data access, None would kill it

The Competitive Landscape and Internal Alternatives

• Who or what is the default option most clinicians will revert to if nothing in this proposal changes? Options: Incumbent implant system, Standardized in-house SKU list, Another vendor being evaluated, Surgeon brings outside implant, Internal engineering workaround
• Which competitor features or commercial terms have already impressed your value analysis committee? Options: Lower unit price, Consignment stock, Strong clinical data, Hands-on training programs, Better instrument reliability
• Has anyone proposed solving the issue internally rather than contracting with a vendor, and if so what was the proposed fix? Options: Yes, internal standardization, Yes, in-house instrument repair, No internal proposal, Other
• What would have to be true about your current incumbent solution for you to stay with it instead of switching? Options: Lower cost, Improved intraop support, Better clinical outcomes, Fewer SKUs, All of the above
• Which decision criteria carry the most weight in the final vendor selection, rank by importance Options: Clinical evidence, Surgeon preference and ergonomics, Total cost per case, Inventory and logistics burden, Training and intraop support
• If we matched your top three commercial asks, would anyone still block a change based on clinical or workflow concerns? Options: Yes, surgeons would block, Yes, procurement would block, No blockers remain, Unsure

Clear Acceptance Criteria and Decision Triggers

• If a short pilot met the clinical and operational goals you name, what would stop you from executing a systemwide rollout that week?
• Which three measurable criteria must a pilot achieve for you to recommend adoption, choose up to three Options: Case time reduction, Lower per-case implant cost, Improved alignment/positioning metrics, Zero critical instrument failures, Positive surgeon satisfaction score
• How long after a successful pilot do you expect contracting, and who must approve final contract terms? Options: Immediate (within 2 weeks), 4-8 weeks, 2-3 months, Longer than 3 months
• Who would be the named owners for training, inventory, and OR support during rollout?
• Which clinical outcome threshold, if missed during pilot, would make you stop the project immediately? Options: Increase in complication rate, No improvement in case time, Surgeon dissatisfaction score below target, Other

Practical Next Steps and Commitment Signals

• Which single commitment from us would make you comfortable scheduling a three-case pilot at your facility? Options: Guaranteed instrument availability, Intraop rep coverage, Training for surgeons and staff, Price protection for pilot SKUs, Data collection and registry support
• How soon could you allocate OR dates and named staff for a pilot once contracts are acceptable? Options: Immediately, Within 2 weeks, 2-6 weeks, Longer than 6 weeks
• Who must sign off on the pilot budget and who signs the final go/no-go after the pilot?
• What would you consider a reasonable timeline for initial rollout after a successful pilot, in months? Options: 0-1 month, 1-3 months, 3-6 months, 6+ months
• Is there any unresolved operational, legal, or procurement issue that would prevent you from authorizing a pilot today? Options: Yes, operational, Yes, legal/compliance, Yes, procurement/contracting, No unresolved issues, Unsure

• Clinical & OR Workflow Walkthrough

• Collect and confirm current OR workflows
• You confirm the documented current-state problems and the quantified consequences reflect reality.
• Deliver a tailored instrument tray mock-up and ergonomics assessment for two representative cases within 10 business days.
• Provide an anonymized list of typical case mix with volumes and the top five surgeon preferences for implants and instruments.
• Confirm the consequences to time, cost, and clinical flow
• You confirm the proposed instrument layout and ergonomics remove the handling issues you experience in target cases.
• Map the offering to 2–3 representative cases
• You confirm the intraoperative support model and escalation path meet your scheduling and coverage needs for high-volume surgeons.
• Schedule an in-OR or simulated surgical session to validate instrument handling and rep coverage within three weeks.
• Instrument ergonomics and tray layout review
• Intraoperative support and escalation walkthrough
• Validation checkpoint

• Clinical & OR Workflow Walkthrough
• Solution Experience Deck
• Solution Brief — Clinical & OR Workflow Walkthrough

• meeting
• slides
• document

• Supply Hip and Knee Implant Systems
• Supply Shoulder Replacement Implants
• Supply Fracture Fixation Plates and Nails
• Supply Soft Tissue Anchors and Suture Systems
• Provide Complete Surgical Instrument Sets
• Deliver Patient-Specific Instrumentation and Guides
• Provide Preoperative Templating Tools
• Provide Intraoperative Technical Support (OR Rep)
• Deliver Surgeon Training and Onsite Proctoring
• Activate Implant Tracking and Registry Submissions
• Provide Implant Warranty and Recall Support
• Perform Instrument Repair and Spare Part Supply

Supply Hip and Knee Implant Systems

• Do you intend to include primary and revision hip and knee implant SKUs (catalog numbers or UDI ranges) in the initial scope? Options: Primary only, Primary + Revision, Revision only, Custom selection
• What femoral, tibial and acetabular size ranges or catalog SKUs should be stocked for the initial deployment (list sizes or SKU prefixes)?
• How many bearing surface options per head (polyethylene, ceramic, metal) must be available on day one and what percentage of your hip/knee case mix will use each?
• Who are the surgeon(s) with specialized implant preferences we must support and what templating constraints or preferred neck/head lengths must be honored (surgeon name and notes)?
• Which inventory buffer model do you require at site level for hip and knee SKUs (minimum trays per size, or days of supply)? Options: Minimum trays per SKU (specify), Days of supply (specify), Just-in-time reorder
• When should implant lot number and expiration be recorded in your implant log relative to case time (on receipt, at implant use, both)? Options: On receipt into inventory, At implant use in OR, Both, Not required

Supply Shoulder Replacement Implants

• Describe required humeral and glenoid implant types and SKU ranges for primary and reverse shoulder procedures.
• Provide the expected shoulder case mix by subtype (percentage anatomic primary vs reverse vs revision) to size initial stock levels.
• List the stem fixation preferences (cemented, press-fit, short stem) and indicate which surgeons or sites require each. Options: Cemented, Press-fit, Short stem, Mixed
• Confirm whether patient-specific glenoid guides or augmented baseplates must be included as deliverables for shoulder cases. Options: Yes, No, Case-by-case
• Specify required trial head/neck sizes and trial instrument counts to be included per shoulder tray.
• Estimate acceptable spare-part lead time for shoulder-specific instruments (number of days) and the instrument repair SLA you expect. Options: 3-5 days, 6-10 days, More than 10 days, Custom SLA

Supply Fracture Fixation Plates and Nails

• Indicate the priority fracture indications (proximal femur, distal radius, tibial plateau, etc.) you require covered by stocked plate and nail SKU sets.
• State the minimum assortment of plate lengths and nail diameters (list SKU ranges or specific catalog codes) required at each site.
• Select the locking screw diameters and driver types that must be available in the initial trauma instrument set. Options: 2.0 mm, 3.5 mm, 4.5 mm, Multiple sizes
• Identify any targeting jigs or fluoroscopy templates that must be supplied with nails and the compatible C-arm models on site.
• Outline the intraoperative screw and rod inventory buffer you expect per trauma tray (quantity per tray or days of coverage).
• Assign the owner responsible for implant lot traceability during trauma cases and confirm required documentation format (paper log, EMR field, CSV export). Options: OR manager, Circulating nurse, Supply chain, Other

Supply Soft Tissue Anchors and Suture Systems

• Choose the anchor types (bioabsorbable, PEEK, metallic) and suture configurations (limb count, suture size) that must be stocked for shoulder and sports cases. Options: Bioabsorbable, PEEK, Metallic, Mixed
• Upload or list the preferred anchor sizes and driver SKUs for rotator cuff and labral repair procedures.
• Explain the suture material and needle preferences that must be available (e.g., #2 nonabsorbable, tapered needle) and note surgeon-specific requirements.
• Share required packaging aliquots per case (single-unit, packs of 2, packs of 3) and any OR waste-reduction preferences. Options: Single-use, Multi-pack, Surgeon-preferred packaging
• Calculate your expected monthly consumption rate for anchors and suture systems per OR based on historic case volume (units/month).
• Agree the implant warranty window you require for soft tissue anchors and the documentation needed to validate a claim. Options: 90 days, 1 year, Lifetime, Other

Provide Complete Surgical Instrument Sets

• Name the instrument trays required by procedure (hip primary tray, knee revision tray) and list core contents or catalog SKUs for each tray.
• Detail maximum tray weight and dimension constraints imposed by your sterile processing department and autoclave chamber sizes.
• Report the number of duplicate instrument sets required per OR per day to support your scheduled case load and turnover needs. Options: 1 set, 2 sets, 3+ sets
• Quantify the acceptable instrument sterilization turnaround time between cases (hours) and indicate preferred sterilization method (steam, ETO). Options: <1 hour, 1-3 hours, 3-6 hours, ETO required
• Prioritize which tray instruments require spare coverage (e.g., cutting blocks, reamers) and provide part numbers where available.
• Include any certification or maintenance documentation you require for instruments (calibration certificates, maintenance logs, biological indicator records). Options: Calibration certificate, Maintenance log, Biological indicator records, Other

Deliver Patient-Specific Instrumentation and Guides

• Flag which procedures require patient-specific guides (CT-based hip jigs, MRI-based shoulder guides) and specify the imaging modality and DICOM export requirements.
• Measure the acceptable lead time from DICOM upload to guide delivery for scheduled cases (days). Options: 7 days, 10 days, 14 days, Custom timeline
• Note required data fields for patient-specific orders (laterality, implant SKU, CT slice thickness, patient position) and any EMR export constraints.
• Tell who will approve patient-specific guide designs (surgeon, coordinator) and state the approval SLA (hours/days). Options: Surgeon, Surgical coordinator, Both, Other
• Suggest sterilization instructions and maximum autoclave cycles allowed for patient-specific guides.
• Determine whether a trial fit on a sterilized phantom or intraoperative trial fit is required and what evidence (photo, surgeon note) will confirm fit. Options: Trial fit photo, In-procedure note, Instrument gauge confirmation, Other

Provide Preoperative Templating Tools

• Do you require digital templating software with DICOM import and integrated implant SKU libraries for preoperative planning? Options: Yes, No
• What templating measurement standards do your surgeons require (femoral offset in mm, neck cut height in mm, stem version) to be available in the tool?
• How many simultaneous user licenses for templating will you need for preoperative planning across clinics and ORs? Options: 1-3, 4-10, 10+
• Who owns templating approval prior to scheduling (surgeon, clinic coordinator) and which export format must be attached to the OR record (PDF, image, DICOM SR)? Options: Surgeon, Clinic coordinator, Both
• Which implant libraries (list SKU families or code prefixes) must be present in the templating tool on day one?
• When must templating annotations be attached to the case record in your scheduling system relative to the case date (24 hours, 48 hours, 1 week)? Options: 24 hours prior, 48 hours prior, 1 week prior, On day of surgery

Provide Intraoperative Technical Support (OR Rep)

• Describe the expected intraoperative rep scope per case (number of reps, tasks such as instrument management, implant trialing) for arthroplasty and trauma procedures.
• Provide the standard hours of OR coverage required for typical arthroplasty and trauma cases at your facility (start and end times).
• List credentialing criteria you require for OR reps (scrub training, device competency checklist) and how those credentials are presented onsite.
• Confirm the acceptance criteria that will validate intraoperative rep performance (signed intraoperative checklist, surgeon satisfaction note, OR nurse confirmation). Options: Signed intraop checklist, Surgeon satisfaction note, OR nurse confirmation
• Specify the escalation path and preferred contact method (pager, phone, on-call) if rep coverage is interrupted during a case. Options: Pager, Phone, On-call rep within X minutes
• Estimate the maximum acceptable rep response time for emergency add-on cases (minutes) at your site. Options: 30 minutes, 60 minutes, 2 hours

Deliver Surgeon Training and Onsite Proctoring

• Indicate the training formats you require (cadaver lab, dry lab, proctored cases) and the minimum attendee counts per session. Options: Cadaver lab, Dry lab, Proctored cases, Virtual
• State the number of proctored cases included in scope per surgeon and whether proctoring must cover revision procedures.
• Select the key learning objectives that must be demonstrated during proctoring (correct implant sizing, instrument workflow, complication handling) and how you want them recorded.
• Identify the acceptance criteria that will confirm successful training completion (signed competence checklist by surgeon, observed independent case without proctor) and required evidence. Options: Signed competence checklist, Observed independent case
• Outline scheduling constraints for onsite proctoring (lead time required, preferred OR block dates) and who will authorize proctor assignment.
• Assign the post-training follow-up cadence you prefer for performance review and outcome reporting (30 days, 90 days). Options: 30 days, 90 days, Both, Custom

Activate Implant Tracking and Registry Submissions

• Choose the identifiers you require recorded at implant use (UDI, lot number, expiration date, implant catalog SKU) and specify the exact field format for each.
• Upload or specify the registry submission template fields you need and note any local registry or study IDs that must be included with each submission.
• Explain the integration method you prefer for your EMR or implant log (API endpoint, SFTP CSV batch, manual entry) and any HL7 constraints. Options: API endpoint, SFTP CSV, Manual entry
• Share your data retention and privacy constraints for registry submissions (HIPAA fields, de-identification requirements).
• Confirm the acceptance criteria for registry activation (target percent of cases with complete UDI/lot data within a set timeframe). Options: >=95% within 7 days, >=90% within 14 days, Custom
• Specify who at your facility will sign off on registry go-live (implant coordinator, quality officer) and what sign-off documentation they will provide. Options: Implant coordinator, Quality officer, Other

• Purchase Agreement
• Order Confirmation
• Master Supply Agreement (MSA)
• Statement of Work (SOW)
• Pricing Schedule & Exhibit
• Inventory & Consignment Agreement
• OR Support & Training Addendum
• Warranty & Returns Policy
• HIPAA Business Associate Addendum (BAA) — conditional
• Contract Execution & Order Authorization

• Go-live Health Check (Week 1-4)
• First Outcomes Measurement (Week 4-10)
• 90-Day Acceptance Gate Review (Day ~90)
• Quarterly Post-Launch Outcomes Review

• Circulate the quarter's clinical outcomes summary to clinical governance and archive supporting evidence for registry and warranty purposes.
• If complication rate exceeds target, initiate chart review for affected cases and propose immediate clinical mitigations.
• Restate acceptance criteria and numeric targets
• Produce a documented acceptance decision with per-criterion pass/fail status tied to the numeric targets recorded in the Implant & Service Scope stage.
• For any failed or conditional criteria, agree a remediation plan with named owners and completion dates.
• Confirm the post-acceptance monitoring cadence and required evidence to close remediations.
• Publish the acceptance decision and the per-criterion pass/fail outcomes to the shared workspace.
• Create remediation tickets for each unmet criterion with owner, success evidence, and target close date.
• Schedule the first quarterly outcomes review and circulate the metrics pack required for that meeting.
• Quarterly metrics review
• Ensure the key outcome metrics remain within acceptable ranges relative to targets recorded in the Implant & Service Scope stage.
• Prioritize and assign owners to the top open issues and enhancement requests from the shared channel.
• Confirm operational readiness items for the next quarter including inventory, sterilization capacity, and rep coverage plans.
• Publish the prioritized enhancement and issue backlog with owners and target resolution dates.
• Implement instrument maintenance or replacement actions where instrument failure incident rate exceeds threshold.
• Update sterilization and inventory process agreements to address any repeat tray completeness shortfalls.
• Reconfirm committed acceptance criteria and owners
• Confirm physical deployment matched the locked configuration and identify any delivery gaps.
• Establish an incident log with owners and target resolution dates for all open go-live issues.
• Validate initial adoption signals and training completion status for surgeons and OR staff.
• Publish the post-go-live incident log with owners, severity, and resolution dates.
• Schedule shipment or local pick-up for any missing trays or instruments and confirm expected delivery date.
• Send summary of who attended training and which surgeons have completed observed proctoring sessions.
• Present first measurement data
• Determine whether instrument tray completeness rate and surgeon satisfaction score and 30-day postoperative complication rate are tracking to the targets recorded in the Implant & Service Scope stage.
• Assign root-cause owners and specific corrective actions with due dates to close metric gaps before day 90.
• Confirm the timeline for the acceptance gate and any interim verification steps.
• Investigate missing or incomplete instrument trays and publish a corrective shipment or process change plan.
• Deploy a standardized surgeon feedback form for every case and publish the procedure for collection and review.
• Present outcome data against each criterion
• Longitudinal clinical outcomes and safety review
• Deployment and delivery validation
• Root cause diagnosis for gaps
• Document pass/fail per criterion and acceptance decision
• Early adoption signals
• Shared channel backlog and enhancement requests
• Impact review
• Operational health items
• Agree remediation plan for failed or conditional items
• Incident log and immediate issues
• Agree corrective actions and timeline
• Confirm readiness timeline to acceptance gate
• Confirm post-acceptance monitoring cadence
• Agree quarterly action plan
• Agree immediate remediation actions