1. Is this probably a medical device?
Use these first to understand whether your concept resembles an FDA-regulated device and what product codes may apply.
FDA: how FDA may classify a device FDA Product Classification DatabaseMedical Device Concept Research Toolkit
Before you build, search what FDA and CMS already know.
A medical device idea becomes clearer when you can name the likely device category, comparable products, regulatory pathway, payment logic, evidence burden, and major risks. This page gives clinician founders a starting set of official links and a prompt that turns those findings into a plain-language company roadmap.
This is educational strategy, not regulatory, legal, coding, reimbursement, or investment advice. Use it to prepare better questions for regulatory counsel, reimbursement experts, engineers, customers, and potential collaborators.
Research links
Start with the question you are trying to answer.
These links help you find device classifications, predicates, approval pathways, adverse events, recalls, and payment clues before you spend time or money building.
Generated device roadmap prompt updates as you type.
2. What similar devices already exist?
Search cleared, approved, and De Novo devices to understand predicates, summaries, intended use, indications, and evidence patterns.
FDA 510(k) Clearances FDA Medical Device Databases FDA PMA Approvals FDA De Novo Classification Request3. Is this novel and patentable?
Search for similar patents, publications, inventors, companies, and phrases before assuming the invention is new. These tools help you prepare better questions for patent counsel; they do not determine patentability or freedom to operate.
Lens.org Patent Search Google Patents USPTO Patent Public Search USPTO Patent Search Strategy WIPO PATENTSCOPE EPO Espacenet4. What risks show up after launch?
Look for adverse event reports, recalls, failure modes, user confusion, hardware problems, software issues, and safety signals.
FDA MAUDE Adverse Event Database openFDA Device Recall API5. How might this be paid for?
Search CPT/HCPCS payment clues, then decide whether reimbursement, hospital budget, value-based care, or customer ROI is the real payment path.
CMS Physician Fee Schedule Lookup CMS PFS Lookup OverviewHow to read the roadmap
The goal is to see the whole arc before committing to the build.
Regulatory gates are the points where classification, predicate strategy, testing, quality systems, or FDA interaction may change the plan.
Value inflection points are moments where the company becomes meaningfully less risky: prototype proof, bench testing, usability, pilot data, clearance, first revenue, or distribution.
Roadmap risk is the gap between a promising clinical idea and a fundable, buildable, reimbursable, adoptable company.