A structured workspace for medical device teams navigating the Stanford Biodesign process — from clinical need identification through regulatory strategy, IP protection, and standards compliance.
Built around the Stanford Biodesign process — the gold standard for systematic medical device innovation.
Discover and filter high-value clinical needs through structured observation, stakeholder mapping, and evidence-based prioritization.
Generate diverse solution concepts and systematically screen them across technical, regulatory, and commercial dimensions.
Build the regulatory strategy, IP portfolio, clinical evidence plan, and business model required for commercialization.
Navigate global standards and compliance frameworks with auto-selected requirements based on your device profile.
Eight purpose-built modules covering the complete medical device development lifecycle.
Structure clinical observations into actionable need statements using the Stanford format: a way to [solve problem] for [population] in [setting].
Score concepts across 5 dimensions — technical feasibility, IP freedom, regulatory risk, reimbursement viability, clinical adoption.
510(k), PMA, De Novo, Exempt — define your FDA pathway with predicate analysis, product code, and timeline estimation.
Track provisional patents, utility patents, PCT applications, trademarks, copyrights, and trade secrets with deadline management.
Auto-select applicable ISO and IEC standards from your device profile. Track status, assignees, and completion across 8 global markets.
Design study endpoints, enrollment criteria, sample sizes, and site requirements for IDE and pivotal trial planning.
Map TAM/SAM, revenue model, ASP, COGS, reimbursement codes, payer mix, and go-to-market strategy in one workspace.
Generate structured patent claims, trademark applications, PCT summaries, and copyright registrations with guided templates.
Give your project a name and clinical indication. All data saves automatically to your browser — no account, no server, no sync required.
Navigate the four phases at your own pace. Each module guides you with structured forms, scoring rubrics, and built-in biodesign methodology.
Draft IP filings, download structured documents, and export your compliance checklist. Take your work wherever it needs to go.
Free to use. All data stays in your browser. No login, no setup. Autosaved as you work.
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