#341: What NOT to say to FDA

In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industr ...  Show more

In this deep-dive episode, host Etienne Nichols shifts away from the "inspiring" fluff of entrepreneurship to deliver a gritty, practical masterclass for medical device founders. Drawing from his experience judging at MedTech Innovator and speaking with hundreds of founders, Etie ...  Show more

<span style= "font-size: 12pt;"><span lang="EN" style= "mso-ansi-language: EN;" xml:lang="EN">Sarah Gallo</span> <span lang="EN" style="mso-ansi-language: EN;" xml:lang="EN">is ...

It’s worse than you think. Dr. Jane Ruby, a scientist with over 20 years of experience in regulatory processes for drug approval with the FDA, explains several important ways that the FDA and the drug companies violated the most basic safety protocols at every stage of the develo ...  Show more

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology ...

This week, I am joined by Dr. Lloyd Minor, the Carl and Elizabeth Naumann Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford University. Dean Minor talks about the transformative potential of AI in healthcare delivery, research, ...  Show more