Interview: Paul Gadiock, Overcoming FDA Challenges with 3D Printed Medical Products

Paul Gadiock

Paul Gadiock is counsel in the San Francisco office of Wilson Sonsini Goodrich & Rosati, where his practice primarily focuses on representing medical device companies, small and large alike, inefficiently navigating local and national regulatory requirements. He brings unique first-hand experience with the development and application of regulatory programs to counsel clients at all stages of the medical product life cycle. Paul provides premarket and postmarket regulatory solutions for medical product clients. Previously, he served on the senior leadership team at the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA). In this role, he advised key agency officials on issues related to the application of policies, programs, regulations, and legislation and was instrumental in appropriately encompassing or excluding devices from the scope of medical product regulation. Paul also minimized legal risk in Government Accountability Office (GAO) and Office of Inspector General (OIG) investigations, major national programs such as unique device identification (UDI), and medical device cybersecurity, as well as specific matters involving petitions and appeals to the FDA. In addition, he conducted numerous presentations and trained staff on how to streamline complex processes to reduce costs. Before his directorship role at the FDA, Paul served as a business development executive at a national diagnostic biotechnology company, advising international directors on how the company could comply efficiently, leading to cost-effective development of products that could be marketed in multiple countries with different regulatory requirements. Paul united scientists and sales teams to develop an extensive strategy that enhanced the company’s image and visibility by launching aggressive marketing campaigns. Paul will be speaking on “Legal and Regulatory Landscape for Healthcare 3D Printing” panel, discussing “Overcoming FDA Challenges with 3D Printed Medical Products” on June 6th, 2020.

Jenny: When was it like when you first encountered the concept of 3D printing?

Paul: So much intrigue.  When I was a kid, I loved taking things apart and putting them back together.  I liked seeing where each of the individual components was made and the material.  3D printing turned all that on its head.  But I wasn’t disappointed that my childhood experience was phasing out, it just meant a whole new area opened up to be fascinated with.

Jenny: What inspired you to start your legal practice focusing on 3D printed medical devices?

Paul: I have a friend from school who knew I was doing a lot of cutting edge FDA work.  My friend works at a medium-size 3D printing company with some health applications and tapped me for a project.  It had to do with marketing for health applications and gave me an opportunity to get more familiarized with the technology and sensitive issues.

Jenny: Who inspired you the most along this journey?

Paul: My clients.  Their ideas keep me on my toes and prompt me to think creatively and be resourceful.

Jenny: What are most passionate about right now?

Paul: Helping create an advocacy trade association to help shape FDA’s 3D Printing policy.

Jenny: What do you think what has not been done enough in the regulatory space?

Paul: There isn’t enough clear policy on FDA’s regulatory policies.  Yes, that might mean I get more client work, but it also builds uncertainty.

Jenny: What are you biggest accomplishments in 2019? And any big plans for 2020?

Paul: Last year I moved to a new firm and found a great home at WSGR.  I was lucky enough to have my clients come with me.  This year, my plan is to do even more healthcare work.

Jenny: What are some of the most notable progress made in the regulatory field of 3D printing medical devices in 2019? Anything we should hope for in 2020?

Paul: More bio-printing pioneers.

Jenny: If you can go back 5 or 10 years, what would you have done differently?

Paul: I might have left FDA sooner, but the agency was in a tough spot and I didn’t want to abandon my colleagues.  

Jenny: Software, materials, or 3D printers. It has been a debate in the industry forever as to which is the most important player. What do you think is the most important player in healthcare 3D printing?

Paul: I think it’s a 3-legged stool.  But if I could lean the stool against the wall, I would probably lean off the printer leg.

Jenny: What motivates you the most for your work?

Paul: Being the best version of me I can be and making my clients happy.  I’m a people pleaser.

Jenny: What do you think are the biggest challenges in bio-printing? What do you think the potential solutions are?

Paul: From a technical standpoint, I understand tissue vascularization is a huge challenge.  From a regulatory point of view, there is no established pathway to market.  But FDA tends to be reactionary in these circumstances to gain experience so I don’t see a lot of movement on the regulatory side until the technical challenges are ironed out.

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice do you think they should ignore?

Paul: It’s difficult to say but if I go into that encounter thinking I will be the one to impart wisdom, I’m losing out on an opportunity to learn from the college student.

Jenny: If you could have a giant billboard to promote a message to millions and even billions of people in the 3DHEALS community, what message would that be?

Paul: I haven’t worked out a good catch-phrase but in developing industries, it’s important to realize the public judges the industry as a whole.  One bad actor can reflect on the whole segment.  So it’s important to self-police so that others don’t step in and police you.

Jenny: What was the biggest risk you took in your career?

Paul: Leaving FDA and going to private practice was a huge leap for me but I couldn’t be happier with the move.

Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?

Paul: I moved from DC to SF about 2 years ago.  The climate and scenery here are incredible.  I worked a good amount so every opportunity I get, I’m exploring CA.

Jenny: What is your favorite quote? Why?

Paul: “Above all, be flexible.”  It’s a quote I heard while traveling and when I face challenges, it helps me become poised and take pride in the change I may have originally resisted. 

Jenny: What does the word “3DHEALS” mean to you?  =)

Paul: It’s an intersection of two areas I’m passionate about – health and technology.  So to me, it only means good things (that aren’t easy to conquer).

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