Thinking about launching a health tech startup, digital health app, or wearable device? Moving fast and breaking things might work in software, but in healthcare, breaking things means breaking people. In this episode of the KLF Deep Dive, host Darshan Kulkarni connects with Emily Hu Shapiro—a Silicon Valley native, chemical/biomedical engineer, former Google clinical research lead, powerlifter, and startup investor—to bust the myth of the solo "garage startup" in medical devices.
Emily breaks down why building a compliant medical device requires deep domain experts from day one in quality, regulatory, clinical, and manufacturing. From navigating strict FDA claims and avoiding the traps of "vibe coding" with AI to leveraging top accelerators like Y Combinator and knowing when to hire regulatory consultants over costly legal teams, this conversation is an essential guide for early-stage founders and health tech innovators.
What You'll Learn in This Episode:
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