Fit & Reimbursement: Clinical Volume and Case Mix

• Roughly how many neuromodulation trial starts does your team perform per month? Options: 0-2, 3-5, 6-10, 11-20, 21+ (high volume)
• What is your typical trial-to-permanent conversion rate (best estimate)? Options: Less than 25%, 25% to 50%, 51% to 75%, 76% to 100%, Unsure

Payer and Reimbursement Landscape

• Which payer types make up the majority of cases at your center? Options: Commercial/private insurance, Medicare, Medicaid, Workers' compensation, Self-pay, Other
• How often do prior authorization issues or coverage denials materially delay or block cases? Options: Rarely, Occasionally, Frequently, Systemic barrier (significant delays)

Decision Authority and Key Stakeholders

• Who is the primary decision maker for selecting a neuromodulation therapy at your site? Options: Attending physician (pain/neurosurgery/neurology), Medical director or department chair, Hospital procurement/contracting, Group practice consensus, Other
• Which additional stakeholders typically need input before a trial or purchase? Options: Field clinical team/engineers, Anesthesia, OR operations/scheduling, Payer case managers/denials team, Patient or caregiver, Other

Timeline and Compliance Readiness

• If a fit is confirmed, what timeline are you targeting to begin trial procedures? Options: Within 30 days, 30 to 90 days, 3 to 6 months, 6+ months, Unsure
• Are there any compliance or data requirements we should know about (for example a BAA, PHI restrictions, or hospital security controls)? Please describe briefly.

A quick start: your clinic and caseload

• Tell me about your clinic setting and the typical patient population you see for implantable neuromodulation.
• How many neuromodulation trials and permanent implants does your team perform per month on average? Options: 0-2, 3-5, 6-10, 11-20, 20+
• Describe the roles on your team who influence device selection, prior authorization, and scheduling. Options: Attending physician, Fellow or trainee, Advanced practice provider, OR coordinator, Prior authorization specialist, Field clinical engineer, Other
• Which indications drive most of your cases, for example chronic low back pain, complex regional pain syndrome, movement disorders, or epilepsy? Options: Chronic low back or radicular pain, Complex regional pain syndrome, Failed back surgery syndrome, Parkinsons or essential tremor, Drug resistant epilepsy, Peripheral neuropathic pain, Other
• Who typically signs the final treatment decision, and who handles prior authorization and insurance appeals? Options: Primary implanting physician, Department chair, Multidisciplinary panel, Clinic manager, Other
• Walk me through your typical patient pathway from referral to trial decision, noting any recurring bottlenecks.

Where outcomes are falling short

• If a single outcome measure would make you stop offering a device at your center, which one would it be and why? Options: Pain reduction of 50 percent or more, Objective functional improvement on validated scale, Sustained opioid dose reduction, Quality of life improvement, Other
• When post implant follow up shows declining benefit, how long on average before you consider reprogramming, revision, or explant? Options: Within 2 weeks, 2-6 weeks, 6-12 weeks, 3-6 months, More than 6 months
• Describe the types of patients who lose benefit during trial or early follow up, and what distinguishes them from those who maintain benefit.
• How often do you track objective functional scores versus patient reported pain scales after implant? Options: Mainly objective measures, Mainly patient reported outcomes, Both equally, Rarely track
• Estimate your center's current explant rate for loss of efficacy over the last year. Options: Less than 1 percent, 1 to 5 percent, 6 to 10 percent, 11 to 20 percent, More than 20 percent

Is the trial revealing the right patients?

• Could your current trial selection process be inflating conversion rates, and if so how would you prove or disprove that? Options: Yes, likely, Possibly, Unlikely, Not sure
• On average, trials run for how many days and what conversion criteria do you use to move to permanent implantation? Options: 1 to 3 days, 4 to 7 days, 8 to 14 days, More than 14 days
• Who reviews trial programming data and decides whether a patient is a candidate for permanent implantation? Options: Implanting physician, Multidisciplinary team, Field clinical engineer, Nurse practitioner or APP, Other
• When a trial fails to meet target, what are the common technical or patient related reasons you identify?
• What would need to change about trial provisioning or support to increase your conversion rate by at least 15 percent?

Programming, explant decisions, and durability in practice

• If programming stops delivering sustained relief beyond six months, what failure modes do you see most often? Options: Lead migration or break, Physiologic progression of disease, Scar tissue or neural adaptation, Programming strategy exhausted, Other
• Tell me about the programming approaches you rely on for complex pain cases, including waveform categories and electrode configurations you prefer.
• Which clinical or device signals prompt you to recommend explant rather than reprogramming or revision? Options: Persistent loss of benefit, Device infection, Hardware failure, Intolerable side effects, Patient preference, Other
• Provide the distribution of your patients on rechargeable systems versus non rechargeable devices and the factors that influence that choice. Options: Mostly rechargeable (>75%), Mostly non rechargeable (>75%), Mixed (25 to 75 percent rechargeable), Even split about 50/50, Unknown
• List any recurring adverse event patterns and how they change your counseling or follow up protocols.

Operational snags that stop cases cold

• Point to the single operational bottleneck that costs you the most canceled or delayed cases in a typical quarter. Options: Prior authorization delays, Inventory shortages, OR availability, Field engineer scheduling conflicts, Patient transportation or logistics, Other
• Do prior authorizations or inventory constraints drive more scheduling delays at your site? Options: Prior authorizations, Inventory constraints, Both equally, Neither
• Name the person on your team who owns liaison with the field clinical engineer during trials and implants.
• Where do remote programming or connectivity issues most commonly appear, for example clinic network, patient home, or rehab setting? Options: Clinic network, Patient home wifi or mobile, Mobile app connectivity, Rehab or SNF setting, Not applicable
• On average, what is the turnaround time to resolve a programming escalation that requires the field engineer to be present? Options: Same day, 1 to 3 days, 4 to 7 days, More than 7 days

The other options your team is weighing

• Consider the alternatives, which incumbent product or internal pathway are you most tempted to stick with, and why?
• Are there internal proposals to keep therapy management in house, for example expanding nursing support or building a programming team? Options: Yes, a formal proposal exists, Yes, informal discussions only, No internal proposals, Not sure
• What would have to be demonstrably true about your current approach for you to stay with it rather than adopt an external system?
• Has anyone on your team recently proposed solving this without an outside vendor or by switching to a different vendor, and what was their main reason? Options: Yes, recommended an internal solution, Yes, recommended a different vendor, No proposals, Not sure
• Rate the importance of these evaluation criteria when you compare vendor options. Options: Trial conversion rate, Battery longevity and recharge burden, Programming flexibility and waveform options, Field clinical support responsiveness, MRI conditional labeling, Per case cost, Other

Do you have the capacity to run the program?

• Assuming a pilot required EHR integration within eight weeks, can your team provide a technical owner and API access to make that possible? Options: Yes, owner and API access available, Yes, owner available but API access limited, No, we would need vendor support, Not sure
• Name the person who will own prior authorization, appeals, and benefits investigation if we support trials at your center.
• Do you have a documented imaging protocol and DICOM export process compatible with device planning needs? Options: Yes, standard protocol exists, Partial protocol, needs work, No protocol, Not sure
• Identify any regulatory or IRB approvals, local payer policies, or contract reviews that could delay a pilot beyond two months.
• Estimate your internal staffing bandwidth for post implant follow up and iterative programming in the first 12 weeks. Options: >4 staff available, 2 to 3 staff, 1 staff member, No dedicated staff, Contracted or vendor supported only
• Are there hospital contracting or credentialing steps that must be completed before field engineers can attend cases? Options: Yes, credentialing required, Yes, contracting agreement required, Both required, No additional steps, Not sure

If the pilot proves the numbers, how do we get to yes?

• Assuming the pilot hits its target outcomes, what final approvals or contracts would still block a quick signature?
• Document the measurable success criteria you would require to consider a full commercial rollout after a pilot, including exact thresholds and time windows.
• Identify the roles that need to sign off on commercial terms, clinical governance, and inventory commitments to make a deployment happen. Options: Chief of service or division head, Procurement or contracts, Finance or CFO office, Legal and compliance, Clinical lead or physician champion, OR manager or surgical scheduling, Supply chain
• Point to the single unanswered risk that would cause you to pause the engagement even if clinical data looked positive.
• Provide the earliest realistic start date for a six to twelve patient pilot once contracts and approvals are complete. Options: Within 2 weeks, 2 to 6 weeks, 6 to 12 weeks, 3 to 6 months, Later than 6 months
• Would you be willing to name a trial champion who can commit to the pilot timeline and internal coordination? Options: Yes, already identified, Yes, can identify quickly, Not yet identified, No

• Therapy Experience Session

• Confirm the current state and cost to your team
• You confirm the demonstrated programming workflow directly eliminates the variability that has been reducing trial-to-permanent conversion.
• Deliver a tailored case scenario workbook that maps programming steps, expected parameter adjustments, and field-support touchpoints for your implanting centers.
• You agree that the shown field support activities would shorten time-to-optimal programming and reduce clinician escalation calls.
• Walk through a lumbar pain trial case scenario
• Provide recent center-level baseline metrics including trial conversion rate, average time-to-optimal programming, and explant rate for the last 12 months.
• You identify the measurable pilot metrics needed to prove outcomes at one of your centers.
• Review comparative outcomes and operational proof
• Define pilot site and agree target metrics and timeline for a 3-month pilot to validate conversion and optimization improvements.
• Validate this maps to your needs

• Therapy Experience Session
• Therapy Experience Deck
• Therapy Experience Brief

• meeting
• slides
• document

• Provision External Trial Neurostimulator and Leads
• Field Clinical Support During Trial Programming
• Intraoperative Programming and Implant Support
• Supply Permanent Implantable Neurostimulator System
• Post‑Implant Optimization Programming Sessions
• Remote Teleprogramming and Titration Sessions
• Clinician Hands‑On Device Programming Training
• Patient Education and Recharge Management Training
• Provide MRI‑Conditional Scan Protocols and Modes
• Deliver Advanced Waveform Configuration Package
• Supply Replacement IPG and Revision Device Kits
• On‑call Field Clinical Engineering Support

Provision External Trial Neurostimulator and Leads

• Is the planned trial using percutaneous spinal leads, wearable external leads, dorsal root ganglion leads, or a mix? Options: Percutaneous spinal leads, Wearable external leads, Dorsal root ganglion leads, Mixed
• Specify the trial neurostimulator battery and output capacity you need for typical 3–7 day trials (mA, hours of continuous stimulation)
• Estimate how many external trial kits you will require per month at this site Options: 1-5, 6-20, 21-50, 50+
• List the lead lengths and fixation (anchor) types your surgeons expect during trial placement
• Provide your sterilization or single-use policy for trial components (single-use sterile, reprocessable allowed, other) Options: Single-use sterile, Reprocessable components allowed, No preference / site policy
• Indicate the acceptance evidence you will require to confirm a successful trial conversion at this site (conversion threshold, documented patient response, device report)

Field Clinical Support During Trial Programming

• Should a field clinical engineer be physically present for first-time trial programming or is remote guidance acceptable? Options: Physical presence for first trial, Remote guidance for first trial, Physical presence only for complex cases, Remote-only
• Estimate the typical on-site programming time you expect a field clinical specialist to provide per trial case Options: 0-1 hour, 1-3 hours, 3-6 hours, 6+ hours
• Name the clinician roles you expect the field specialist to collaborate with during trials (e.g., implanting physician, OR RN, device clinic RN) Options: Implanting physician, Fellow/Resident, Device clinic RN, OR nurse/anesthesia
• List available remote connectivity options at your clinic for live programming (clinic Wi-Fi, cellular hotspot, hospital VPN, none) Options: Clinic Wi-Fi, Cellular hotspot, Hospital VPN/secure network, No reliable connectivity
• Who will be the on-site clinical contact during trial programming sessions (role/title)?
• Select your documentation preference for programming records after trial sessions Options: Auto-exported device PDF to chart, Manual PDF upload, EMR integration for values, No formal export

Intraoperative Programming and Implant Support

• Is a field clinical engineer required in the operating room for initial intraoperative programming for your standard implant cases? Options: Yes, for all implants, Yes, for complex cases only, No, remote support is sufficient
• List the intraoperative monitoring modalities used at your site that interact with device programming (intra-op neurophysiology, fluoroscopy sequence IDs, EMG mapping)
• Describe how baseline stimulation thresholds and intra-op impedance values are recorded in your surgical documentation
• Indicate OR connectivity available for live device activation (wired ethernet, hospital Wi-Fi, dedicated tablet with cellular) Options: Wired ethernet, Hospital Wi-Fi, Dedicated tablet with cellular, No connectivity
• Describe any anesthesia workflow differences that affect programming sequence (awake mapping versus general anesthesia protocols)
• Should spare leads and an IPG be staged on-site for intra-op contingencies for your cases? Options: Yes, per-case spares, No, central inventory covers it, Need recommendation

Supply Permanent Implantable Neurostimulator System

• Estimate the monthly stock level of permanent implantable pulse generators (IPGs) you want available at this center Options: 0-5, 6-20, 21-50, 50+
• Select required IPG form factors you must have on hand (rechargeable, non-rechargeable, MRI-conditional) Options: Rechargeable, Non-rechargeable, MRI-conditional required, No preference
• Provide the specific lead families and lengths that must be stocked to support your typical implant mix
• Who will be responsible for device registration and warranty activation after implant (role/title)? Options: Clinic staff handles registration, Manufacturer handles registration, Shared responsibility
• Please specify the acceptance evidence required at receipt to confirm correct IPG shipment (serial numbers, model codes, device labels matched to implant plan)
• Are explant/revision kits to be included in your regular implant supply plan and, if so, how many reserve kits do you want? Options: No revisions reserved, Reserve 1-2 kits, Reserve 3-5 kits, Custom quantity

Post‑Implant Optimization Programming Sessions

• Estimate the number of programming follow-up visits you schedule within the first 90 days post-implant Options: 1, 2-3, 4-6, 6+
• Select your preferred modality for post-implant optimization (in-person, remote teleprogramming, hybrid) Options: In-person, Remote teleprogramming, Hybrid (initial in-person, then remote)
• Identify the outcome measures you require at optimization visits (Numerical Rating Scale pain, opioid dose, functional scale, tremor rating) Options: Pain NRS, Opioid dose/medication change, Functional outcome scales, Tremor rating / UPDRS, Device usage logs
• Specify which programming endpoints should be captured in each visit note (amplitude, pulse width, frequency, impedance, patient-reported side effects) Options: Standard device report, Custom clinic form, Both
• Define the escalation criteria that would prompt surgical revision or urgent reprogramming consult at your center (for example loss of efficacy at X weeks or impedance change thresholds)
• Would you like structured patient-reported outcome entry integrated into follow-up workflows (app-based daily NRS, clinic surveys, none)? Options: App-based daily NRS, Clinic surveys, No structured PRO collection

Remote Teleprogramming and Titration Sessions

• Identify the remote endpoints available for teleprogramming at your clinic and for patients at home (clinic tablet, patient smartphone, hospital VPN, none) Options: Clinic tablet with cellular, Patient-owned smartphone/tablet, Hospital VPN/secure connection, No reliable endpoint
• Indicate whether remote sessions require a clinician physically present at the clinic or can be performed with the patient at home Options: Clinician-supervised in clinic, Patient connects from home with remote clinician, Unsupervised remote adjustments allowed
• Describe how you verify patient identity and device location before a remote programming session (two-factor authentication, photo of surgical site, patient ID)
• State any network bandwidth or firewall constraints at your site that could limit live telemetry during teleprogramming
• Select your compliance documentation preference for remote sessions Options: Session recording retained, Saved device report only, Both recording and device report, No recording
• Who is authorized at your center to approve remote parameter changes (role/title)?

Clinician Hands‑On Device Programming Training

• How many clinicians at your center require hands-on device programming training prior to independent use? Options: 1-2, 3-5, 6-10, 10+
• List the clinician roles to be trained (attending physician, fellow, advanced practice provider, device clinic nurse) Options: Attending physician, Fellow/Resident, Advanced practice provider, Device clinic nurse
• Select the preferred training format for competency attainment (simulation lab, supervised live cases, hybrid) Options: Simulation lab, Supervised live cases, Hybrid
• Please specify the acceptance evidence you will require to confirm clinician competency after hands-on training (signed competency checklist, observed case log, proficiency sign-off)
• When would you like initial clinician training scheduled relative to your first implant date? Options: 2+ weeks before first implant, 1 week before, Day of first implant, Within 2 weeks after first implant
• Would recurring refresher training or a certification renewal cadence be required (annual, biennial, none)? Options: Annual, Biennial, No recurring training

Patient Education and Recharge Management Training

• Select the patient education artifacts you require at discharge for device and recharge management Options: Printed recharge guide, Instructional video link, App-based tutorial, All of the above
• How will you assess a patient's ability to manage recharge sessions prior to discharge (observed in clinic, checklist, phone assessment)? Options: Observed in clinic, Checklist completion, Phone assessment, No formal assessment
• Provide your standard recharge schedule recommendation for rechargeable IPGs (weekly, biweekly, monthly, device-dependent) Options: Weekly, Biweekly, Monthly, Device-dependent
• Would you like spare chargers provided or a loaner program during the first 90 days post-implant? Options: Provide spare charger, Loaner program, No spare needed
• Describe common patient mobility or dexterity limitations in your population that affect recharge training (for example severe tremor, limited shoulder ROM)
• Select your preference for automated reminders for recharge and device checks (app push, SMS, email, none) Options: App push notifications, SMS, Email, No reminders

Provide MRI‑Conditional Scan Protocols and Modes

• Which MRI field strengths and scanners are most commonly used at your imaging centers (1.5T, 3T, both)? Options: 1.5T, 3T, Both, Other
• Do you require site-specific MRI safety protocols for each implanted IPG and lead configuration, or a single clinic-wide protocol? Options: Site-specific per configuration, Clinic-wide generic protocol, Not required
• Select the scan regions most likely for your patients post-implant (spine, brain, whole-body, other) Options: Spine, Brain, Whole-body, Other
• Who in your radiology team will be the named MRI safety point of contact (role/title)?
• Which artifacts do you need supplied to perform MRI-safe scans at your facility (pre-scan checklist, device label matrix, programming mode instructions)? Options: Pre-scan checklist, Device label matrix, Programming mode instructions, All of the above

Deliver Advanced Waveform Configuration Package

• Select the advanced waveform families you anticipate using for your target indications (burst, high-frequency, closed-loop/sensing, custom sequencing) Options: Burst, High-frequency, Closed-loop/sensing, Custom sequence
• Would you like pre-configured waveform templates mapped to specific diagnoses (failed back surgery syndrome, complex regional pain syndrome, Parkinsonian tremor)? Options: Yes, per diagnosis, No, clinician-defined, Partial set
• Specify how many clinician-editable waveform presets should be provisioned per device at implant Options: 1-3, 4-8, 9+
• Describe any outcome thresholds that should trigger a waveform change in your clinical protocol (for example pain reduction <30% after X days)
• Do you require waveform configuration export into the EMR and device logs for each programming event? Options: Auto-export to EMR, PDF on demand, No export needed
• Explain any integration required between the waveform package and external sensing devices you use (for example wearable tremor accelerometer, pain diary app)

Supply Replacement IPG and Revision Device Kits

• Estimate your expected annual revision or explant rate to size replacement kit inventory Options: <1%, 1-3%, 4-7%, 8%+

• Purchase Agreement
• Master Services Agreement (MSA)
• Statement of Work (SOW) — Clinical & Field Services
• Trial Device & Consignment Agreement
• Procedure Scheduling & Responsibility Addendum
• Prior Authorization Support Plan
• Service Level Agreement (SLA) — Field Clinical Support
• HIPAA Business Associate Addendum (BAA)

• Go-live Health Check (Weeks 1-4)
• First Outcomes Measurement (Weeks 4-10)
• Acceptance Gate Review (Day ~90)
• Ongoing Clinical Outcomes Review (Quarterly)

• Close or escalate any aging support tickets that are preventing outcome improvements and record the escalation path.
• Open a tracked remediation plan that maps each corrective action to the acceptance gate date.
• Restate acceptance criteria and numeric targets from Clinical Program Scope
• Produce a documented acceptance decision referencing the targets recorded in Clinical Program Scope, with pass/fail status for each named criterion.
• If any criterion is unmet, agree a timebound remediation plan with clear owners and resolution dates.
• Publish the formal acceptance record that lists pass/fail status per criterion and the buying owner's documented decision.
• For any unmet criteria, open remediation tickets with owners, target resolution dates, and verification steps.
• Circulate the data package used for the acceptance decision to clinical governance and the program sponsor.
• Rolling outcomes review versus Clinical Program Scope targets
• Confirm whether the 6-month explant rate and mean programming adjustments per patient per month are within the acceptable range recorded in Clinical Program Scope.
• Ensure open support and enhancement requests that materially impact outcomes are assigned owners and have committed resolution dates.
• Publish the quarterly outcomes dashboard showing the named metrics from Clinical Program Scope and the status of remediation items.
• Create protocol update proposals for any programming patterns that should be adopted broadly and schedule training where required.
• Re-confirm committed success criteria and owners
• Confirm the program is materially deployed per the Clinical Program Scope checklist and named owners are confirmed.
• Document top 3 deployment or safety blockers with owners and completion dates.
• Publish the deployment validation summary and owner list for the items in Clinical Program Scope.
• Open remediation tickets for each blocker with target completion dates and required resources.
• Circulate any early adverse event reports and interim containment actions to clinical governance for awareness.
• Present initial outcome data versus targets
• Determine whether the two named metrics, percent of patients with >=50% pain reduction at 30 days and trial-to-permanent conversion rate, are on track to meet targets recorded in Clinical Program Scope.
• Agree a prioritized list of corrective actions with owners and target completion dates to close any gaps before the acceptance gate.
• Deliver a case-level findings packet for any failed cases showing programming history, device config, and timeline for clinician review.
• Schedule targeted field engineering or clinician training sessions for identified programming gaps.
• Open support and enhancement request burn-down
• Deployment and provisioning validation
• Root-cause diagnosis for any gaps
• Present consolidated outcome data against each criterion
• Protocol and programming pattern review
• Document pass or conditional pass per criterion and capture decision
• Early patient and usage signals
• Review adverse events, explant signals, and safety trends
• Agree corrective actions and timeline
• Safety and adverse event triage
• Agree remediation items and resolution timeline if any criteria are unmet
• Agree next quarter actions and monitoring cadence
• Blockers, owners, and immediate remediation plan