Platform / Medical Device / Stage 01 · Concept & Strategy
Stage 01 · Medical Device Track

Concept & Strategy

Validate the clinical problem, survey the competitive landscape, and select a regulatory pathway.

Before a single dollar of capital should be raised or a single line of design controls written, two questions must be answered: What does the FDA, the published literature, and the patent landscape already say about devices like yours? And what regulatory pathway is realistic? This stage answers both in order — a Product Review first, the regulatory pathway recommendation second. Every artifact in Stages 02–08 traces back to outputs created here.

Cards below are arranged in chronological use order. Step numbers reflect the recommended sequence; an experienced practitioner may interleave or revisit cards as needed, but a first pass through this stage should follow the order shown.
Stage 00 · Project Workspace Stage 02 · Design & Development
Step 1
Active
Product Review
One search across the FDA (510(k) clearances, classifications, MAUDE adverse events, recalls), the published literature (PubMed, ClinicalTrials.gov), and patent records. Surfaces both product intelligence (regulatory pathway, predicate devices, safety profile) and business strategy (market maturity, competitive shape, evidence base). Generates a Product Intelligence PDF, a Literature & Clinical Evidence Brief PDF, and a multi-device comparison XLSX.
Launch Tool
Step 2
Active
Regulatory Pathway Strategy
Larger than just FDA class. Predicate search with substantial-equivalence pre-assessment, recommended pathway (510(k) / De Novo / PMA / IDE), Q-Sub strategy, timeline and cost estimate. The most expensive consulting engagement, restructured.
Launch Tool