Starting with Your Clinical Priorities

• Tell me about the primary clinical goals your implant program is aiming to achieve in the next 12 months.
• Which of these outcomes would you rank highest when choosing a device supplier right now? Options: Lead reliability and low revision rates, MRI conditional labeling, Longest battery life, Remote monitoring that reduces clinic burden, Field clinical engineer availability during implants, Cost and procurement alignment
• On a typical month, how many device implants does your service line perform and how does that volume influence device selection? Options: Fewer than 10, 10 to 25, 26 to 50, More than 50
• Describe a recent implant case that went exactly as you wanted. What went right and which device features made it smooth?
• If you could change one measurable thing about how devices perform for your patients, what would that be and why?

Where Device Performance Actually Breaks Trust

• If a single device performance issue in the next year would make you stop recommending a vendor, what specific failure would it be? Options: Lead fracture or insulation failure, Premature battery depletion, Loss of MRI conditional status in practice, Unreliable arrhythmia detection, Remote monitoring data gaps
• Tell me about the most recent device complication you had to manage, how it was detected, and who ended up bearing the operational burden.
• How often do lead-related revisions or generator replacements occur in your program, and which patient groups are most affected? Options: Weekly, Monthly, A few times a year, Rarely
• Which metrics or reports do you look at to decide whether a device line is performing acceptably? Options: Revision rate, Battery longevity estimates, MRI success rate, False positive arrhythmia alerts, Clinic workload from remote monitoring
• What single metric or evidence would cause your section chief to cancel a planned device adoption within 6 weeks?

How Implant Day Really Works in Your OR

• Walk me through a typical implant day workflow from patient arrival to discharge, focusing on where device features or field clinical engineering step in.
• Who on your team must be present or on-call to consider a new device safe to use in your ORs? Options: Section chief or attending electrophysiologist, Device clinic director, OR nursing lead, Biomedical engineering, Procurement representative
• How many cases per day do your ORs schedule that require dedicated field clinical engineer support for device programming or troubleshooting? Options: None, 1, 2 to 3, More than 3
• Describe a time when lack of field clinical engineering coverage impacted an implant. What was the operational consequence?
• What would have to change about implant staffing or onsite technical support for you to adopt a new device line within a quarter?

How Remote Monitoring Must Fit into Your Clinic Rhythm

• If remote monitoring is creating unsustainable work in your clinic, where does it hurt most, and why would that alone make you pause a vendor decision? Options: Excess false alerts, Poor integration with EMR, Complex enrollment process, Unclear escalation paths, Vendor platform logins per clinician
• Which parts of remote monitoring are you willing to have the seller handle versus which must remain under your clinic's control? Options: Patient enrollment and education handled by seller, Data triage handled by seller, All clinical decision making remains with clinic, Platform access managed by clinic IT, Other
• Walk me through the last time remote monitoring produced a clinically useful alert, how it was routed, and how much staff time it took to resolve.
• How integrated is your current remote monitoring data with the electronic medical record, and who owns that integration? Options: Fully integrated, owned by IT, Partially integrated, clinical owner, Not integrated, manual workflow, Integration in planning
• What change in alert volume or false positive rate would trigger a requirement to renegotiate monitoring terms with a vendor? Options: Increase by 10%, Increase by 25%, Increase by 50%, Any increase that raises staffing needs

Stakeholders, Politics, and Procurement Realities

• Describe the decision pathway from clinical preference to contract signature in your system, including committees and timing.
• Who are the nonclinical decision makers that can stop a device adoption, and what is their primary concern? Options: Procurement, cost and contract terms, Supply chain, stocking and logistics, Legal, indemnity and warranty, IT, integration and security, Finance, total cost of ownership
• When procurement pushes to standardize on fewer manufacturers, what conditions would allow your clinical team to keep a non-standard device in the portfolio? Options: Clear clinical benefit supported by data, Short term trial or pilot, Vendor covers additional service costs, Formal exception signed by leadership
• If your clinical case volume shifted by 30% next year, who would need to be convinced to revisit device selection and how quickly could that happen? Options: Clinical leadership within 4 weeks, Clinical and procurement within 8 weeks, System decision makers within a quarter, Unsure
• Which stakeholder objection has stopped a device adoption in the past, and what would have changed that outcome?

What's Getting in the Way, Practically and Politically

• When you look at past attempts to change device suppliers, what single logistical or political obstacle caused the effort to stall? Options: Insufficient clinical evidence, Procurement contract terms, Inventory and consignment concerns, Training and FCE scheduling, Regulatory or registration delays
• Describe any current regulatory, credentialing, or institutional approvals that must be secured before a new device can be implanted at your sites.
• How prepared is your IT and biomedical engineering to accept a new remote monitoring endpoint or device telemetry feed? Options: Ready with API access, Need planning and resources, No capacity this quarter, Unsure who owns it
• How many additional full time equivalents would you need to absorb increased remote monitoring workload without changing patient safety? Options: 0, 0.5 to 1, 1 to 2, More than 2
• What single operational constraint would kill the project if it cannot be resolved before pilot start?

Competitive Landscape, Choices on the Table

• Which alternatives are you actively evaluating besides external vendors, including incumbent suppliers and internal solutions? Options: Incumbent vendor, Competing external vendors, Internal device standardization, In-house remote monitoring tools, No active alternatives
• What would have to be true about your incumbent supplier for you to stay with them rather than move to a new partner? Options: Clear improvement in reliability data, Better commercial terms, Improved field clinical engineer coverage, Integrated remote monitoring improvements, Other
• Has anyone on your team proposed building or expanding an internal monitoring or device management solution instead of contracting with a vendor, and what was the rationale? Options: Yes, for cost reasons, Yes, for data control, No, not proposed, Discussed but not pursued
• If a competitor offers a lower upfront price but our data shows fewer years of battery life and higher revision rate, what weights do you place on price versus long term reliability? Options: Price dominates, Balanced trade off, Clinical reliability dominates, Depends on specialty or patient population
• What single competitive feature or proof point would make you switch vendors next quarter?

Operational Readiness and Integration Constraints

• Describe the EMR and device data landscape, including which systems must receive telemetry and who currently owns those integrations.
• Which of these integration prerequisites are already in place at your sites? Options: API access and integration owner identified, Partial integration, more work needed, No integration, will require project, Integration blocked by security policies
• Who in your organization will be the day to day contact for data-sharing consents, patient enrollment, and device registration? Options: Device clinic director, Biomedical engineering, IT integration manager, Clinical operations manager, Other
• How many weeks of lead time do you require for any device training and field clinical engineer scheduling before the first implant? Options: Less than 2 weeks, 2 to 4 weeks, 4 to 8 weeks, More than 8 weeks
• What single technical blocker would prevent you from running a pilot within the next 90 days?

Clinical Acceptance Criteria and Decision Triggers

• Which measurable acceptance criteria would you require to consider a pilot successful? Options: Revision rate below X per 100 implants, Battery life median exceeds target, MRI scans performed without device-related issues, Alert false positive rate below Y, Staff time for monitoring reduced by Z%
• Tell me about the specific data or evidence your value analysis committee expects to see before they will green light a full adoption.
• If the pilot meets your clinical acceptance thresholds, what internal approvals would be needed to move to system wide adoption and how quickly could those be secured? Options: Clinical leadership sign off within 2 weeks, Procurement and contract within 4 weeks, System level approval within a quarter, Multiple committee approvals needed
• Which warranty, recall, or field support responsibility would be a deal breaker if not contractually addressed? Options: Vendor covers device failure revisions, Clear recall notification and tracking process, Defined field clinical engineer SLA for implants, Vendor liability limited to device replacement only
• What single outcome from a pilot would let you sign for broader deployment that same week?

Next Steps and Meeting Readiness

• Who on your side should be included in a technical kickoff to ensure rapid decisions on integration and training? Options: Electrophysiology section chief, Device clinic director, Biomedical engineering lead, IT integration owner, Procurement representative
• When is your ideal window to run a pilot program for new devices, and do you have blackout dates for implants or EMR change freezes we should avoid? Options: Within 30 days, Within 60 days, Within 90 days, Not ready this quarter
• Would a short technical readout with telemetry examples and a sample implant day plan help accelerate approval from your stakeholders? Options: Yes, Maybe, No
• What would you like the seller to bring to the pilot planning meeting so your team can make a go no go decision? Options: Clinical outcome data, Device inventory plan and consignment terms, Field clinical engineer schedule, Integration plan and API specs, Training curriculum
• Finally, what immediate concern, if unresolved, would make you decline to engage further after this discovery conversation?

• Clinical Experience & Use Cases Session

• Confirm the current state and its cost
• You confirm the demonstrated implant and monitoring workflows address the OR delays and clinic workload you described.
• Provide three recent implant cases that represent your typical complications and staffing constraints.
• Scenario walkthrough — routine pacemaker implant
• You agree on the measurable acceptance criteria that will prove the future state in your environment.
• Provide remote monitoring alert volumes and average triage times for the last three months.
• Scenario walkthrough — MRI-conditional patient pathway
• Deliver a tailored implant scenario runbook showing required field clinical engineer coverage, expected OR time impact, and projected clinic-hour savings before the follow-up session.
• You identify any unresolved risks that require additional evidence before procurement or clinical approval.
• Run a sample alert-reduction projection using your supplied metrics and deliver the analysis before the decision checkpoint.
• Proof of remote monitoring triage and workload reduction
• Validate the future state with a direct confirmation
• Align on remaining evidence and acceptance criteria

• Clinical Experience & Use Cases Session
• Solution Experience Deck
• Solution Brief — Clinical Experience & Use Cases

• meeting
• slides
• document

• Supply implantable cardiac devices and lead kits
• Provide field clinical engineer in‑procedure support
• Program devices at implant and run initial diagnostics
• Perform device interrogation and routine follow‑up support
• Support generator exchange and battery replacement procedures
• Provide lead implantation technical guidance
• Provision remote monitoring platform access
• Enroll and configure patients for remote monitoring
• Provide remote monitoring alert triage support
• Register devices with regulatory tracking databases
• Deliver clinician training on device programming workflows
• Deliver patient education and home monitoring training
• Perform device firmware and software updates

Supply implantable cardiac devices and lead kits

• Do you have a preferred list of device model families and lead kit SKUs for each implant indication (single‑lead pacemaker, dual‑chamber ICD, CRT, insertable monitor)? Options: Provide list of models/UDIs, No preference / use standard offering, Need recommendation
• How many units of each device model and lead kit SKU should we provision for the initial implant inventory (by model and hospital item number)? Options: <10, 10-50, 51-200, >200
• Which hospital item numbers, sterile kit lot tracking fields, or internal SKU tags must appear on delivery paperwork for inventory reconciliation?
• When should the first shipment of devices arrive relative to the first scheduled implant (choose a target lead time)? Options: At least 14 days before, 7-13 days before, 3-6 days before, Same day
• Confirm the acceptance criteria we should apply on delivery: matching ordered model numbers and UDI, intact sterile packaging, and inventory counts reconciled on receipt. Add any additional acceptance thresholds.

Provide field clinical engineer in‑procedure support

• How many operating rooms and which procedure types should we schedule FCE coverage for (list OR room numbers and implant types)?
• Which hours of coverage do you expect per case for the field clinical engineer (start-to-finish, first two hours, on-call as needed)? Options: Full procedure, First 2 hours, On-call only
• When the FCE attends, what administrative artifacts must they complete in your implant log (implant report entry, device serials, UDI, programming template saved)?
• Identify the hospital credentialing or vendor access requirements we must meet for FCEs to work in your ORs (badge, EMR access, vendor privilege form).
• Specify the target response time for emergent technical issues during implant (for example programming failure or lead connector issue) and any SLA formats you require. Options: Immediate/on-site, Within 30 minutes, Within 60 minutes, Next business day

Program devices at implant and run initial diagnostics

• Provide the programming template name or the explicit target settings you want applied at implant (pacing mode, AV delays, detection zones, sensitivity).
• How should we record initial lead sensing, capture threshold, and impedance values in the implant note or EMR form (fields required and any discrete data mapping)?
• Are there center-specific arrhythmia detection thresholds you require at implant (example: VF detection > 200 bpm, VT zone 150-199 bpm)? Options: Use our standard vendor template, Use your center thresholds, We will supply exact bpm thresholds
• Who must sign off on the final device programming at implant (implanting physician, section chief, other), and how should that sign-off be recorded? Options: Implanting physician, Section chief, Device clinic director, Other
• Confirm whether you require a downloadable implant report (PDF) with serial numbers, UDI, and programmed settings uploaded to the EMR immediately after implant. Options: Yes - PDF and EMR upload, Yes - PDF only, No

Perform device interrogation and routine follow‑up support

• Estimate the number of routine in-clinic interrogations you expect per implanted device annually. Options: 1 per year, 2 per year, As clinically indicated, Other
• List the clinic staff roles who will perform device interrogations and indicate which roles require training (device clinic RN, cardiology technician, EP fellow). Options: Device clinic RN, Cardiology technician, EP fellow, Other
• Indicate whether interrogation reports should be pushed into your EMR via HL7, FHIR, or uploaded manually. Options: HL7 interface, FHIR interface, Manual upload to EMR
• Specify the discrete data elements you need in routine interrogation reports (examples: battery percentage, lead impedance, percent ventricular pacing, arrhythmia episode log).
• Are there target SLAs for turnaround on routine follow-up support requests (for example report review or technical response within X business days)? Options: 24 hours, 48 hours, 5 business days, Custom

Support generator exchange and battery replacement procedures

• Estimate the expected generator exchange volume at your center in the first 24 months post-implementation. Options: None, 1-5, 6-20, More than 20
• Select the level of vendor support desired for generator exchange procedures: dedicated on-site FCE, on-call remote support, or no vendor support. Options: Dedicated on-site FCE, On-call remote support, No vendor support
• List required post-exchange documentation we must deliver (replacement device UDI, explanted serial, updated implant log entry).
• Indicate any hospital policies for explanted device handling, returns, or disposal we must follow and provide the policy document reference if available. Options: Policy provided, No special policy
• Will you require vendor‑supplied sterile replacement kits stocked onsite for exchanges and what par levels should we maintain by SKU?

Provide lead implantation technical guidance

• Select the lead fixation types planned for these implants (active fixation screw, passive tined, or both). Options: Active fixation, Passive fixation, Both
• Provide preferred lead models or connector types to match your implant technique, including any legacy connector size constraints.
• Does your center require fluoroscopy time targets or a lead positioning checklist to be followed during implantation? Options: Yes - we will supply checklist, No
• Who will perform final acceptance of lead placement in the OR and how should that acceptance be recorded in the implant note? Options: Implanting physician, Proctor, OR nurse, Other
• Describe preferred guidance for difficult venous access scenarios to include in the procedure plan (wire-assisted techniques, cutdown, leadless options).

Provision remote monitoring platform access

• List user roles and the number of accounts required for the remote monitoring portal (example: device clinic RN x3, EP physician x2, admin x1).
• By which authentication method should users access the portal: SAML single sign-on, OIDC, or separate vendor credentials? Options: SAML SSO, OIDC, Vendor credentials
• Confirm the acceptance test for portal provisioning: ability for a set of test patients to transmit telemetry, alerts delivered to the clinic account, and successful EMR documentation of an event. Options: Test pass required before pilot, Pilot without full test
• For user provisioning do you prefer bulk CSV upload of accounts, manual creation, or automated sync with your identity provider? Options: Bulk CSV upload, Manual creation, Automated sync with IDP
• Are there audit log, access retention, or data access review requirements for portal accounts we must support? Options: Yes - specify retention period, No

Enroll and configure patients for remote monitoring

• For the first 6 months, approximately how many patients do you plan to enroll in remote monitoring? Options: <50, 50-200, 200-500, >500
• Through which enrollment workflow do you prefer patients be configured: in-OR pairing, clinic-based enrollment, mailed home monitor activation, or a mixed approach? Options: In-OR pairing, Clinic enrollment, Mail-home activation, Mixed
• In which formats do you want patient materials for pairing and home monitoring: printed quick-start card, mailed activation packet, or video tutorial linked in the patient portal? Options: Printed card, Mailed packet, Video tutorial, All
• Where will patient consent for remote monitoring be documented and stored (EMR consent form, paper chart, or patient portal acknowledgement)? Options: EMR, Paper chart, Patient portal
• At what cadence should we verify remote monitor connectivity post‑implant for new patients (for example check at 24 hours, 7 days, 30 days)? Options: 24 hours, 7 days, 30 days, Custom

Provide remote monitoring alert triage support

• Identify which alert categories you want the vendor to triage before forwarding to your clinic (examples: device malfunction, arrhythmia detections, low battery). Options: Device malfunction, Arrhythmia detections, Low battery, Other
• Outline acceptable vendor triage SLAs for critical alerts (time from alert to clinic notification). Options: Immediate <15 minutes, <1 hour, <4 hours, Next business day
• Name the escalation path for ambiguous or high‑risk alerts (on‑call EP, device clinic director, emergency department) and required contact details.
• State whether triage actions must be documented in a shared triage log, in the EMR, or both. Options: Shared triage log, EMR note, Both
• Choose the credentials level required for vendor triage staff (clinician-level such as RN/NP/MD versus trained technical staff) for initial review. Options: Clinician-level, Trained technical staff, Both

Register devices with regulatory tracking databases

• Using which device identifiers should we perform regulatory registration at implant (UDI, local device tracking ID, hospital inventory ID)? Options: UDI, Local inventory ID, Both
• Within what timeframe do you require completed registry entries and confirmation numbers to be delivered after implant? Options: Within 7 days, Within 14 days, Within 30 days
• Who will be the hospital contact responsible for device registration tasks (name, role, contact e-mail/phone)?
• Do you require exported reports of registered devices for inventory reconciliation and UDI audit (CSV, PDF)? Options: CSV export, PDF report, Both, No
• Are there local or national regulatory reporting steps for explanted or returned devices we must follow and document (for example local registry return workflows)? Options: Yes - provide policy, No

Deliver clinician training on device programming workflows

• Who are the clinician groups requiring training (implanting physicians, device clinic nurses, electrophysiology fellows)? Options: Implanting physicians, Device clinic nurses, EP fellows, Other
• Choose the preferred training formats: in‑OR hands‑on, simulation lab, virtual webinar, or a blended approach. Options: In-OR hands-on, Simulation lab, Virtual webinar, Blended
• How will you assess competency after training (observed procedure checklist, post-training quiz, or documented proficiency sign-off)? Options: Observed checklist, Post-training quiz, Proficiency sign-off
• Do you require a train‑the‑trainer program so we certify internal educators, and if so how many trainers should be certified? Options: Yes - number: specify, No
• Specify maximum acceptable class sizes for hands-on sessions to maintain training quality. Options: 1-2, 3-5, 6-10, 10+

Deliver patient education and home monitoring training

• For patient education, which materials do you require: printed quick-start guides, video tutorials, mailed activation packets, or EMR-linked instructions? Options: Printed guide, Video tutorial, Mailed packet, EMR instructions
• When should patient home monitoring training occur: pre-discharge on implant day, at first clinic visit, or via mail/video after discharge? Options: Pre-discharge, First clinic visit, Mail/video post-discharge, Combination
• For patients with special needs (cognitive impairment, limited dexterity), what additional training or caregiver support should be provided and documented?
• Who documents patient acceptance of training and pairing (patient signature, EMR entry, or portal confirmation)? Options: Patient signature, EMR entry, Portal confirmation
• Do you require patient materials in additional languages and, if so, which languages beyond English are required?

• Purchase Agreement
• Order Confirmation
• Master Services Agreement (MSA)
• Statement of Work (SOW) — Field Support & Implementation
• Service Level Agreement (SLA) — Field Support
• Warranty & Recall Addendum
• Acceptance Criteria & Procurement Approval Conditions
• Data Processing Agreement (DPA) / HIPAA Business Associate Addendum (BAA)
• Product Registration & Regulatory Support Addendum
• Indemnity, Insurance & Liability Schedule

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Quarterly Performance and Issue Review

• Clinic to confirm any changes to OR or follow-up staffing that affect monitoring workload for the next quarter.
• Capture the formal acceptance decision and the named buyer signatory role where the engagement requires one.
• When criteria are unmet, agree a remediation plan with dates that will be verified in follow-up meetings.
• Publish the acceptance decision record referencing Solution Scope criteria and attach source data files within 24 hours.
• If any criterion failed, create a time-limited remediation plan with measurable checkpoints and publish it to the shared channel.
• Schedule a verification checkpoint to confirm remediation items are resolved before closing the acceptance loop.
• Trend review for key operational metrics
• Confirm whether remote monitoring transmission success rate and incident close time remain within acceptable bounds relative to Solution Scope targets.
• Prioritize and assign resolution timelines for the top operational issues or enhancement requests.
• Agree the reporting cadence and required dashboard views for the next quarter.
• Publish prioritized issue and enhancement backlog with owners and target resolution dates.
• Technical team to deliver a quarterly device performance export for the clinic to validate local records.
• Re-confirm scope, success criteria owners, and timeline
• Confirm deployment checks are complete or have owners and dates for remediation.
• Document top 3 early operational blockers and agree remediation actions and due dates.
• Ensure clinician training gaps are recorded with assigned follow-up actions.
• Publish deployment validation checklist results and remediation assignments within 48 hours.
• Field clinical engineering to confirm OR coverage schedule for the next 30 days and surface any shortfalls.
• Device clinic to record any enrollment failures or connection errors in the shared channel for triage.
• Present first-run outcome data
• Verify whether remote monitoring transmission success rate and average remote alert volume per clinic per week are trending toward the targets recorded in Solution Scope.
• Assign clear remediation tasks with dates for any metric gaps and confirm owners for each task.
• Confirm timeline and data readiness for the Acceptance Gate meeting.
• Deliver a remediation task list with acceptance checks and completion dates within 3 business days.
• Technical team to run and share a connectivity diagnostic report for any devices with failed transmissions.
• Clinic to produce a short report on alert triage workflow and staffing impact for the next review.
• Restate acceptance criteria from Solution Scope
• Produce a documented pass/fail result for each acceptance criterion recorded in Solution Scope.
• Deployment and enrollment validation
• Present outcome data against each criterion
• Diagnose root causes for any gaps
• Open issues triage and enhancement requests
• Agree corrective actions and owners
• Early adoption signals and clinician readiness
• Operational posture and staffing review
• Document pass/fail per criterion and acceptance decision
• Agree next quarter actions and monitoring cadence
• Agree remediation plan for any failed criteria
• Confirm readiness timeline to acceptance gate
• Blockers and immediate remediation plan