MedTech Startup Guide: From Idea to FDA and Beyond
75% of medtech startups fail. This comprehensive guide reveals how founders and boards navigate regulatory, funding, and advisory challenges to beat the odds. Updated for 2026.
Guidance for MedTech and HealthTech founders and executives from practitioners who've been there.
75% of medtech startups fail. This comprehensive guide reveals how founders and boards navigate regulatory, funding, and advisory challenges to beat the odds. Updated for 2026.
The 14 FDA cybersecurity artifacts explained: threat models, SBOMs, penetration testing, and the top reasons for hold letters. Start on day one.
Ranked tables of the most active U.S. MedTech VCs by capital deployed, exits, and seed-stage deals. Covers 30+ firms across $14.2B in digital health funding.
Your employees disclosed proprietary information to AI last week. Balance Acceleration, Assurance, and IP—or risk regulatory failure, IP loss, and competitive collapse.
A systematic framework to identify what's holding your MedTech startup back. Diagnostic checklists for vision-setting, regulatory coordination, constraints, team evaluation, risk analysis, and root cause investigation.
How Owlet lost $23M and 2 years by skipping regulatory homework. Learn why claims come first, the myth of wellness exemptions, and a risk-scoring framework for regulatory due diligence before you invest or build.
$12.1B in MedTech venture funding through Q2 2025, but early-stage rounds are scarce. Where the money is going and what's driving the shift to SaaS and smaller M&A.
From plumbing-part prototypes to a Fast Company award. Customer journey mapping, hypothesis testing, and how to build "11-star experiences" in MedTech.
Why you need to talk to 100 investors, how to create FOMO, and the truth about lead investors. Fundraising tactics from three economic downturns.
A compensation framework for MD advisors, three types of physician partnerships, and why junior trialists outperform big-name KOLs.
Curative pivoted three times—from sepsis diagnostics to COVID tests to a health plan. When data says pivot and how to bring your team along.
Tackle "death blow uncertainties" first. A framework for categorizing technical, market, and business risks in early-stage medtech R&D.
A founder shares hard-won lessons on hiring, selling before building, and navigating healthcare's long sales cycles. Real advice from inside Tori Health.
70% of healthcare digital transformations miss their objectives. Executive buy-in gets you in the door; middle management and frontline users keep you there. Three overlooked factors that determine whether your innovation scales or stalls.