01
Intended use & claims
Who, where, what benefit—and what you will not claim. Everything else hangs from this sentence.
Strategy practice
Medical device development strategy
One operating layer across regulatory, engineering, quality, clinical evidence, and market entry. The goal is a product that clears, ships, and stays honest under scrutiny.
The stack that decides outcomes
Every serious med device program fails or succeeds at the interfaces. We treat those interfaces as the product.
02
FDA / regulatory path
Class, predicate or De Novo logic, pre-sub plan, labeling, cybersecurity, and clinical evidence needs.
03
Architecture & engineering
Sensor/RF, electronics, firmware, cloud, ML, and UX co-designed against verification reality.
04
Risk & design controls
ISO 14971 risk management, DHF discipline, change control, and requirements traceability.
05
V&V and usability
Verification protocols, validation against user needs, human factors, and field-environment tests.
06
Quality system
Stage-appropriate QMS: CAPA, suppliers, production transfer, and post-market vigilance posture.
07
Clinical & evidence
What evidence the path actually requires—pilots, bench, clinical—without inventing a study for a deck.
08
Commercialization
Channel, reimbursement context, manufacturing scale, IP boundaries, and entity clarity for partners.
How strategy work runs
- Diagnostic. Current architecture, regulatory posture, gaps in design controls, and the real critical path to a shippable artifact.
- Decision memo. Path options with tradeoffs—time, capital, residual risk—not a 40-page wish list.
- Operating plan. Gates, owners, and exit criteria for the next 90–180 days.
- Build or advise. Stay as retained technical lead, or hand a clean plan to your internal team.
What we will not do
Invent clearance status, inflate pilot results, or write grant-speak that collapses under diligence. If the product is not ready for a claim, we say so and fix the path.
Talk through your device