Hardware Bible: Build a Medical Device from Scratch The brutally honest guide to medical device development that the industry doesn't want you to read. After watching brilliant technologies die quiet deaths while mediocre devices with stellar strategies flourished, medical device engineer Lisa Voronkova realized the industry needed a reality check. This is the unvarnished truth about bringing medical devices to market, written by someone who's been doing this for over a decade. What you'll discover: Why 80% of medical device startups fail before getting approved (and how to avoid their mistakes) - The real regulatory game behind FDA clearance—it's not what you think - How to identify clinical needs that are actually worth solving (most aren't) - Design principles that keep devices safe when lives are on the line - Manufacturing realities that kill promising prototypes during scale-up - Go-to-market strategies that work in healthcare's complex ecosystem Perfect for: Entrepreneurs building their first medical device company - Engineers transitioning from consumer tech to healthcare - Clinicians with brilliant ideas but no development experience - Anyone who wants to understand why healthcare innovation is so damn hard This book could save your medical device startup. No exaggeration. "This is the book I wish existed when I started in medical devices—it would have saved me years of painful mistakes and millions in wasted resources." - Lisa Voronkova From clinical need identification to post-market surveillance, this comprehensive guide covers every phase of medical device development with the practical wisdom that only comes from real-world experience. If you're ready for the unvarnished truth about medical device development—not the sanitized version from consultants—this is your roadmap to success. The patients waiting for better solutions are counting on you. This book shows you how to deliver.