Design Pattern · Sep 10, 2026
Reimbursement-first device discovery
Find the reimbursed problem before designing anything. Coverage, coding, payment, and utilization are public, so whether anyone will pay is a research question with a documented answer, not a bet taken after two years of engineering.
Under the pillar Consumer tech for medical grade devices
The pattern
Read the coverage rule first, then the code, then the utilization, then the incumbent, then decide whether to build. Most device companies run that sequence backwards and discover the coverage rule after the design is frozen.
The coverage determination is the specification nobody reads. It states which patients qualify, what documentation the supplier must hold, and what continued coverage requires. Those requirements are product requirements. A device that makes the required documentation fall out of normal use is a different product from one that leaves the clinic to assemble it.
The opportunity record
Each candidate gets a structured record so that opportunities can be compared rather than admired one at a time. Anything unknown stays visibly unknown; a blank field is information.
| Field | Source |
|---|---|
| Clinical problem | Guidelines, clinical literature, practitioner interviews |
| Existing device category | FDA classification, supplier catalogues |
| Reimbursement code | HCPCS, CPT, quarterly updates |
| Reimbursement mechanism | DMEPOS fee schedule, physician fee schedule, coverage determinations |
| Qualifying population | NCD and LCD criteria |
| Utilization evidence | CMS public use files |
| Existing suppliers | Supplier directories, competitive bidding records |
| Device cost and price | Public pricing, filings, procurement records |
| Replacement cadence and supplies | Coverage articles, supply codes |
| Reimbursement dependencies | Documentation and prior authorization requirements |
| Clinical workflow | Site observation and practitioner interviews |
| Regulatory classification and pathway | FDA classification database, cleared predicates |
| Evidence requirements | Special controls, predicate submissions, standards |
| Competitive intensity | Clearance counts by product code, supplier concentration |
| Technical and regulatory complexity | Our estimate, written down with reasoning |
| AI-native development opportunity | Our estimate, written down with reasoning |
- CMS, Medicare Coverage Database (NCDs, LCDs, and billing and coding articles)
- CMS, DMEPOS Fee Schedule
- CMS, Physician Fee Schedule Look-Up Tool
- CMS, HCPCS Quarterly Update
- CMS, Medicare Provider Utilization and Payment public use files (data.cms.gov)
- openFDA, device APIs: 510(k), classification, recall, and adverse event endpoints
What disqualifies a candidate early
Coverage exists but the qualifying population is defined so narrowly that volume cannot support a product. Payment is bundled into a service, so a better device changes nobody's economics. The category is in competitive bidding and the price already reflects the floor. The documentation burden, not the device, is what suppliers are paid for. Any of those, and the record is closed with the reason recorded, because a rejected candidate is a research output too.