Shadow AI in Medical Device Companies: Find It Before Your Next Audit
An engineer pastes a design file into free ChatGPT. In a device company, shadow AI lands in your DHF and quality records — how to find it before an audit.
Guidance for MedTech and HealthTech founders and executives from practitioners who've been there.
An engineer pastes a design file into free ChatGPT. In a device company, shadow AI lands in your DHF and quality records — how to find it before an audit.
Y Combinator wins MedTech Connect's inaugural Investor of the Year. BillionToOne's $2.7B IPO delivered an extraordinary return on a $120K seed check.
75% of medtech startups fail. How founders and boards navigate regulatory, funding, and advisory challenges to beat the odds. Updated 2026.
The 14 FDA cybersecurity artifacts explained: threat models, SBOMs, penetration testing, and the top reasons for hold letters. Start on day one.
Which venture capital firms should MedTech founders pitch? U.S. medtech and health tech investors ranked by capital, exits, focus, and seed deals.
Your employees disclosed proprietary information to AI last week. Balance Acceleration, Assurance, and IP—or risk regulatory failure and IP loss.
A diagnostic framework for MedTech founders: checklists for team, regulatory, vision, and risk to identify what's holding your startup back.
How Owlet lost $23M skipping regulatory homework—why claims come first, the wellness-exemption myth, and a risk-scoring framework for due diligence.
$12.1B in MedTech venture funding through Q2 2025, but early-stage rounds are scarce. Where the money is going and 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. Nathan Friedman's framework for sorting technical, market, and business risks when resources are scarce.
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 goals. Why executive buy-in isn't enough—and the three overlooked factors that make adoption stick.