Minimally Invasive Surgery
Regulated development and commercialization journeys where clinical, quality, and market access align.
Inside this journey
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Clinical & Value Discovery
Align on clinical goals, per-procedure cost constraints, decision makers (surgeons, OR leadership, value committees), and success signals for instrument evaluation and standardization.
Discovery Questions
Who You Are in the OR — Quick Intro
- Tell us your primary role and typical caseload (specialty, avg cases/week).
- Which procedure types make up the majority of your minimally invasive volume?
- Roughly what percent of cases are performed with laparoscopy/thoracoscopy vs open?
- What's one thing about your current instrument set or vendor relationship that you appreciate?
Are You Settling for 'Good Enough' When It Should Be Great?
- If you’re honest, where does current instrument performance most fall short at critical moments?
- How often do those shortcomings change your intraoperative decisions or slow a case?
- Tell me about a specific case where an instrument’s handling or tissue effect altered the outcome—what happened and how did it feel?
- What trade-offs are you tolerating today (e.g., ergonomics vs cost, single-use convenience vs waste/reuse reliability)?
- How worried are you about variability between instruments or vendors affecting patient safety metrics?
What Keeps Your Team Up at Night?
- What operational problems related to instruments drive the most OR delays or set-up errors?
- Which of these issues has the biggest financial impact on your service line?
- How do nurses and OR techs describe the most frequent frustrations with current instrument sets?
- How long has your team been tolerating these issues?
- If someone asked your OR director what they would change first about instruments, what would they say?
What Would Perfect Actually Feel Like in the OR?
- Imagine peak operative flow: what instrument performance or set-up changes would make you confident to standardize across cases?
- Which clinical outcomes would you prioritize improving with a new instrument solution?
- Beyond clinical metrics, what would a meaningful improvement look like for your OR team day-to-day?
- What level of surgeon buy-in would you need to make a hospital-wide change feel safe and sustainable?
- Which one change would produce the largest morale boost for your clinical staff?
How Will You Know This Solution Actually Worked?
- What are the top 3 measurable success signals you would need from an evaluation to recommend adoption?
- What magnitude of change (percent or absolute) in those metrics would be sufficient to move forward?
- Who needs to sign off on those metrics—surgeons only, OR leadership, value committee, finance, or all of the above?
- Have you used formal acceptance criteria in past trials? If so, what were they and did you meet them?
- Would you prefer predefined pass/fail thresholds or a more qualitative surgeon-led assessment for trial success?
Who's Really Steering This Ship?
- List all stakeholders who influence instrument selection and purchasing at your facility.
- How does your value analysis committee weigh surgeon preference against per-case cost targets?
- Are there explicit budget or per-procedure cost caps that would block adoption even if clinical performance is better?
- Who within your team will be the day-to-day owner of a trial (logistics, data capture, training)?
- What decision timelines does leadership usually expect for device evaluations (weeks, months)?
Talk to Me About Cost — The Real Tradeoffs
- Are you more concerned about immediate per-case disposable cost or the total cost of care across episodes (repairs, reprocessing, OR time)?
- What is your current average allocated instrument cost per case (ballpark)?
- How open are you to hybrid models (mix of reusable and single-use) to balance cost and performance?
- Which cost levers are available to you during procurement (volume discounts, standardization incentives, bundled contracts)?
- If a high-performance device raised per-case cost by X but reduced OR time or complications, how would you evaluate that trade-off?
What Would a Real-World Trial Need to Look Like Here?
- If we ran an in-OR trial, what success criteria and case mix would you require to feel the data are credible?
- Which cases should we include or exclude for initial trials (complexity, patient BMI, specific procedures)?
- Who would you want scrubbed vs observing during the first 10 trial cases?
- What logistical barriers do you foresee for instrument trials (sterile processing, inventory, sterilization cycles, tray space)?
- How would you prefer data be collected during the trial (automated case metrics, brief surgeon surveys after each case, observational audit)?
Training, Support, and the Human Side of Adoption
- What training formats have worked best for your surgeons and OR teams (simulation lab, in-OR proctoring, video modules)?
- How much proctoring do your surgeons typically want before they feel comfortable with a new device?
- Describe the best vendor clinical support experience you’ve had—what made it work?
- What are your top concerns about vendor presence in the OR during adoption (distraction, liability, workflow)?
- Would your team prefer bundled support (training + data analysis + supply logistics) or modular options?
Evidence and Risk — What Will Move the Needle?
- What types of clinical evidence persuade your value committee most (RCTs, registry data, surgeon testimonials, cost modeling)?
- How much weight does local surgeon preference carry versus published evidence?
- What residual risks do you worry about after a positive trial (scalability, supply continuity, long-term costs)?
- If we committed to an evidence package and a warranty/guarantee, what would you need to see contractually to feel comfortable?
Practical Next Steps — What Would Make This Easy to Start?
- What is the simplest pilot we could run here that would meaningfully de-risk a larger decision?
- Who should be in the kickoff meeting to ensure quick momentum?
- What timeline would feel realistic for a pilot to produce defensible results?
- What would make you say “yes” to starting a pilot this quarter—what assurances or resources do you need?
- Any initial logistical constraints or blackout dates we should avoid when scheduling training or trials?
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Solution Experience
Run outcome-led scenarios (in-OR trial planning, tissue handling assessments, and cost-per-case comparisons) to confirm surgeon confidence and clinical fit.
Experience Meetings
- Solution Experience Alignment
- In-OR Trial Planning Workshop
- Tissue Handling & Clinical Simulation
- Cost-Per-Case Modeling & Value Workshop
- Results Validation & Surgeon Confidence Decision
- Align procurement and value committee expectations for decision criteria post-trial.
- Produce the final trial protocol document and checklist and circulate for stakeholder sign-off within 48 hours.
- Create and distribute data capture templates (electronic or paper) and test the capture workflow in a dry run.
- Schedule the first N cases and confirm instrument inventory, sterile sets, and proctor availability.
- Arrange brief pre-trial simulation or OR dry-run for the surgical team and clinical support staff.
- Objective Recap & Forced Validation Rule
- Collect objective tissue-effect data and ergonomics measurements mapped to success signals.
- Obtain explicit surgeon validation (or rejection) of clinical fit using forced validation questions.
- Identify any immediate technique or configuration changes required prior to live-trial cases.
- Deliver recorded video, measurement logs, and surgeon scoring to the project folder within 24 hours.
- If adjustments are required, create a short retraining checklist and schedule a focused simulation session.
- Surgeon champion to sign an interim clinical-fit statement (pass/conditional/fail) against each success signal.
- Present Baseline Cost-Per-Case
- Produce a shared and adjustable cost-per-case model with transparent assumptions.
- Set explicit financial acceptance thresholds that map to the trial's success signals.
- Introductions & Objectives
- Deliver the working cost model spreadsheet with editable assumptions and scenario tabs.
- Procurement to provide current pricing and contract constraints; vendor to supply pricing scenarios for the agreed volumes.
- Value committee rep to define required documentation and approvals needed for adoption if trial meets thresholds.
- Recap Success Signals & Acceptance Criteria
- Verify whether trial results meet each success signal and financial thresholds.
- Capture explicit surgeon confidence levels and a documented decision (adopt/extend/iterate) with rationale.
- If adopting, agree a concrete implementation timeline and immediate next steps to operationalize change.
- Publish a results packet (data, video clips, surgeon statements, cost model) and an objective recommendation memo.
- If adopt: procurement to prepare PO/contract options and training to schedule proctoring and simulation sessions.
- If extend/iterate: create an adjusted protocol addressing observed gaps and schedule the extension with owners and timelines.
- Capture a post-implementation monitoring plan outlining KPIs, review cadence, and issue escalation paths.
- Achieve collective agreement on a precise current-state sentence that will guide the entire Solution Experience.
- Document quantifiable consequences (financial, time, clinical) that create urgency for change.
- Define a single future-state outcome and 3–5 measurable success signals the trial must prove.
- Align owners, timelines, and required data sources to execute the trial.
- Publish the agreed one-sentence current state, consequence statement, future-state sentence, and success signals to the shared project channel.
- Owner to draft initial trial hypothesis and circulate trial metric list and data capture requirements within 48 hours.
- Assign trial lead, surgeon champion, OR coordinator, and value committee rep with contact and preliminary timeline.
- Review Hypothesis & Acceptance Criteria
- Finalize a written trial protocol with clear inclusion criteria, metrics, and acceptance thresholds.
- Assign roles and schedule the first set of trial cases with owners for each logistic element.
- Agree and distribute data capture templates and select tools for measurement and storage.
- Confirm safety and escalation processes so clinical teams feel supported during trials.
- Model Scenario: Reusable vs Single-Use Mix
- Baseline Technique Demonstration
- Case Selection & Scheduling
- Data Presentation: Clinical & Operational Metrics
- One-Sentence Current State (Diagnosis)
- Explicit Consequence Statement
- Include Clinical Outcome Sensitivity
- Trial Protocol & Roles
- Financial Results: Cost-Per-Case Outcomes
- Hands-On Surgeon Simulation
- Data Capture Plan & Tools
- Pricing, Discount & Contract Scenarios
- Surgeon Review & Forced Validation
- Objective Tissue Effect Measurements
- Define Future State & Success Signals
- Break-Even & ROI Analysis
- Logistics: Sets, Stock, Sterility & Training
- Decision & Rationale
- Structured Qualitative Feedback & Validation
- Metrics, Data Sources & Validation Methods
- Hypothesis & Next Steps
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Solution Scope
Define product mix (reusable vs single-use), trial logistics, training, clinical support, acceptance criteria, and measurable cost/performance targets.
Scope Configuration
- Deliver prepackaged procedure-specific disposable instrument kits
- Supply sterilized reusable laparoscopic hand instruments
- Deploy trocar and access device sets to the OR
- Provide single-use energy sealer per case
- Provide reusable energy sealer with sterilization turnover
- Deliver endoscopic stapler and reload cartridges to the OR
- Install and commission insufflation console and tubing
- Install smoke evacuation unit and disposable filters
- Provide in-OR clinical specialist support during live cases
- Run hands-on simulation training on instruments and stapling
- Assemble and deliver surgeon-configured instrument sets
- Perform point-of-care sterilization and maintenance for reusables
Scope Questions
Deliver prepackaged procedure-specific disposable instrument kits
- Which procedure types should the prepackaged kits cover?
- What is the average number of cases per week for each procedure type?
- Do you require surgeon-specific kit variations (surgeon-configured preferences)?
- List mandatory and optional items that must appear in each kit (e.g., graspers, scissors, trocars).
- What is your preferred delivery cadence and stocking location for kits (e.g., per-case cart, central sterile, satellite storage)?
- Are there labeling, barcoding, or tray-sterility documentation requirements for your kits?
Supply sterilized reusable laparoscopic hand instruments
- Which reusable instrument types are required (e.g., atraumatic graspers, needle drivers, scissors)?
- How many instruments of each type are needed per OR/procedure set?
- What sterilization method(s) does your facility use or prefer (e.g., steam autoclave, low-temp H2O2, EtO)?
- What is the typical case turnover time and the maximum acceptable instrument sterilization turnaround?
- Do you require tracking and asset-tagging for reusable instruments (serial numbers, maintenance logs)?
- What are your acceptance criteria for reusables (e.g., functional lifespan in cases, failure rate thresholds)?
Deploy trocar and access device sets to the OR
- Which trocar types and sizes are required in the sets (e.g., 5 mm, 8 mm, 10 mm, 12 mm; optical vs bladeless)?
- How many ports are typically used per procedure and which port positions do you standardize?
- Do you require pre-assembled trocar/access trays delivered to each OR or loose inventory for central processing?
- Are specialized access devices needed (e.g., balloon trocars, dilation systems, single-incision ports)?
- Are there specific fixation or sealing accessories required (e.g., valve assemblies, insufflation seals)?
- Do any ORs require pre-staged sets for emergency cases or trauma packs?
Provide single-use energy sealer per case
- Which procedures and case volumes will use single-use energy sealers?
- What per-case cost target or allowable range do you have for single-use energy devices?
- Do surgeons require specific jaw styles or staple/seal lengths from the sealer?
- How many single-use sealers are typically used per case on average?
- Are there waste-disposal or sharps protocols we should observe for single-use devices?
- Do you require clinical evidence or comparative cost-per-case analysis for single-use options?
Provide reusable energy sealer with sterilization turnover
- Do you have on-site capacity to process and turn over reusable energy devices between cases?
- How many reusable sealing units and handpieces would you require to support peak daily case volume?
- What maintenance and preventive service contract expectations do you have for reusable energy sealers?
- What is the acceptable downtime threshold for a reusable sealer before a loaner is required?
- Do you require sterilization validation documentation for each turnover of the reusable sealer accessories?
- List measurable performance targets for the reusable sealer (e.g., seal burst pressure, staple line integrity, failure rate).
Deliver endoscopic stapler and reload cartridges to the OR
- Which stapler platforms and reload sizes must be supported (e.g., 45 mm, 60 mm; curved vs linear)?
- What is the average number of reloads used per procedure by specialty?
- Do you require compatibility checks with existing stapling platforms or only supply our proprietary systems?
- How do you prefer cartridges be staged for cases (pre-charged tray, on-call reorder, OR cabinet)?
- Are there expiration tracking or inventory rotation processes we must follow for reload cartridges?
- Do you require backup/standby staplers available in the OR for device failures?
Install and commission insufflation console and tubing
- How many ORs will require a new insufflation console installation?
- Do you need integration with existing surgical platforms or hospital gas/monitoring systems?
- Are there space, mounting, or power constraints in the ORs we should plan for?
- What tubing lengths and connector types are required for your OR layouts?
- What commissioning timeline do you need (dates) and do you require zero-downtime installations between cases?
- Do you require training and competency sign-off for staff operating the insufflation console?
Install smoke evacuation unit and disposable filters
- How many ORs need smoke evacuation units and what are peak simultaneous uses?
- Do you prefer portable bedside units, ceiling-mounted systems, or centralized smoke evacuation?
- What filter type/filtration rating is required (e.g., ULPA, HEPA, charcoal + ULPA)?
- What is your expected disposable filter replacement cadence (per case, daily, weekly)?
- Are there noise-level or surgeon-acceptance constraints for units placed in ORs?
- Do you require connection/compatibility between smoke evacuation and insufflation consoles?
Provide in-OR clinical specialist support during live cases
- How many proctored/live-support cases do you anticipate during initial rollout?
- Do you require in-person clinical specialist presence, remote support, or a hybrid model?
- Which roles should the clinical specialist perform (e.g., device setup, troubleshooting, surgeon coaching, data capture)?
- What scheduling windows are acceptable for clinical specialist coverage (weekdays, nights, weekends)?
- What key metrics or observations should the specialist record during each supported case?
- Who will be the internal point-of-contact and escalation pathway for clinical support requests?
Run hands-on simulation training on instruments and stapling
- How many surgeons and OR staff do you expect to train per session?
- Which training formats do you prefer (wet lab, dry-lab box trainers, virtual simulation, proctoring in OR)?
- What learning objectives or competencies must be demonstrated to consider the training successful?
- Do you require formal assessment and certificates of competency after training?
- Are there preferred dates or windows for scheduling training (e.g., quarter start, weekends)?
- Do you require training materials or takeaways (checklists, quick reference guides)?
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Mutual Commit
Finalize commercial terms, trial agreements, evidence commitments, and the roadmap for standardization and adoption.
Agreement Modules
- Commercial Terms & Order Form
- Statement of Work (SOW)
- Clinical Trial Agreement / Evaluation Protocol
- Evidence & Publication Commitment
- Training, Proctoring & Implementation Plan
- Logistics & Supply Agreement
- Acceptance Criteria & Performance Sign-off
- Warranty, Service & Clinical Support Agreement
- Standardization & Adoption Roadmap
- Master Terms & Indemnification
- Change Order & Scope Amendment Process
- Data Use & Privacy Agreement (DUA/DPA)
- Purchase Order / Financing & Payment Schedule
- Rebate, Discount & Volume Incentive Schedule
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Deployment & OR Enablement
Coordinate deliveries, instrument set configuration, simulation and proctoring schedules, and OR team enablement with clear owners and timelines.
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Success & Standardization Reviews
Validate outcomes against success signals, capture surgeon and OR feedback, and maintain a shared channel for issues and enhancements.
Success Reviews
- Outcome Validation Review
- Surgeon & OR Feedback Roundtable
- Issue Triage & Rapid Resolution
- Standardization & Value Governance
- Continuous Improvement & Shared Channel Handoff
Issues & Enhancements
- Document financial and clinical rationale so procurement and VAB can finalize commercial terms.
- Add prioritized product change requests or set reconfiguration items to the shared enhancements channel.
- Roll-call of Open Issues
- Resolve high-consequence issues within agreed SLAs to avoid derailing adoption.
- Ensure each issue has a clear owner, mitigation plan, and communication path.
- Document decisions in the shared channel so progress is visible to all stakeholders.
- Open prioritized incident tickets in the shared channel with owners and SLA timestamps.
- Deploy immediate mitigations (e.g., temporary instrument swaps, checklists) and confirm efficacy after X cases.
- Escalate any safety/regulatory issues to appropriate internal teams within 24 hours.
- One-line Executive Summary
- Obtain formal approval for the recommended standardization package or define required modifications.
- Agree on an adoption roadmap with measurable KPIs and governance owners to track outcomes.
- Opening & Objective Statement
- Finalize the Standardization Proposal with SKU lists, set configurations, and expected cost impact for procurement sign-off.
- Create a Rollout Plan with owners, milestones, and KPI dashboards for monthly tracking.
- Update contracts or purchasing agreements to reflect approved product mix and pricing commitments.
- Handoff Statement (Current State -> Ongoing State)
- Ensure a functioning shared channel with clear rules, owners, and SLAs so issues and enhancements are managed transparently.
- Prioritize the initial backlog and schedule the first recurring backlog-review meeting.
- Confirm access and provide training so all clinical and operational stakeholders can contribute reliably.
- Create the shared channel (or workspace) and migrate all open issues, feedback, and decision documents into it.
- Assign channel moderators and define SLA timers for response and resolution.
- Schedule recurring review cadence (e.g., weekly triage, monthly governance) and invite all owners.
- Determine whether trial outcomes meet the pre-defined success signals and formally document the acceptance decision.
- Ensure every variance is tied to a measurable consequence and assigned an owner for remediation or follow-up.
- Agree on next steps, timelines, and a communication plan for stakeholders (surgeons, OR leadership, VAB).
- Produce a one-page Outcome Summary showing baseline vs trial metrics, decision rationale, and sign-offs.
- Assign owners for each identified gap with clear mitigation steps and deadlines.
- Schedule a follow-up acceptance checkpoint (date & attendees) if remediation is required.
- One-sentence Current State from Surgeons' Perspective
- Capture actionable surgeon and OR feedback tied to specific case moments and metrics.
- Prioritize training, workflow, and product adjustments that will most effectively close gaps.
- Establish owners and a feedback-to-resolution pathway so clinicians see progress.
- Create a consolidated Feedback Log that links each comment to trial cases and metrics.
- Assign training sessions or proctoring dates for identified technique gaps.
- Shared Channel Structure & Rules
- Per-Case Cost & Clinical Benefit Trade-off
- Structured Surgeon Feedback (Handling & Tissue Effect)
- Recap of Success Signals & Acceptance Criteria
- Prioritization by Consequence
- Proposed Standardization Package
- Quantitative Metrics Review
- Root Cause & Proposed Immediate Fixes
- OR Team Workflow & Set Management
- Backlog Triage & Prioritization Process
- Consequence & Variance Assessment
- Decision & Owner Assignment
- Adoption Roadmap & KPIs
- SLAs, Escalation Paths & Reporting Cadence
- Validation: Tie Feedback to Metrics
- Escalation & Communication Plan
- Deviations & Root Observations
- Co-create Fixes and Training Needs
- Approval & Governance Assignments
- Training & Access
- Confirm Ownership & Communication
- Decision & Next Steps