One of the most unique parts of my work as a physician/surgeon is my interaction with medical devices companies focused on the treatment of obstructive sleep apnea and snoring.  My research on the selection of procedures for snoring and sleep apnea is directly relevant to these companies because there are many reasons why obstructive sleep apnea occurs in different people, making no single treatment perfect for all patients.  My role in working with these companies has ranged from basic advice on the use of devices to development of clinical trial protocols that will study the benefit of a particular device or procedure.  In addition, I also have developed some ideas of my own, forming a company and filing patent applications for projects that now are in the earliest stages.

Overall, my work on new treatments and medical devices has involved submissions to the United States Food and Drug Administration (FDA).  It seems like the FDA has been a target of criticism since its founding in 1906, but more recently some groups have questioned some of its practices related to medical device evaluations.  The FDA is in the unenviable position of protecting the public health while advancing the public health, a challenging balancing act, to say the least.

Recently, I was interviewed by a good friend, John Heerdink, for the Groundwork Forum Podcast.  John and I met through mutual friends over 10 years ago when I was living in San Francisco.  John is just an incredible person who always has something fascinating going on, so when he reached out to ask if I could join him for a podcast segment, I laughed because I do not consider myself anywhere near as interesting as he is.  He persisted, and it is just impossible to turn down wonderful people like John.  We had the opportunity to speak about obstructive sleep apnea, my work with medical devices, and my perspective on the challenges facing the FDA.

 

FDA medical devices

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