At Medcrypt, the work we do every day would not be possible without an amazing team of experts — one that is passionate and committed to transforming healthcare cybersecurity. For years, Medcrypt’s services team has been helping organizations across the medical device industry navigate FDA regulations. In our new series Meet The Experts, we’ll be introducing the wonderful, committed, and hardworking people people behind Medcrypt’s industry-leading services division. Each week we’ll spotlight a new team member, sharing their stories and showcasing their expertise.
Our first expert to be introduced is none other than our VP of Services, Naomi Schwartz! Read on to learn more about her and her work at Medcrypt.
Q: What is your area of expertise? What are some of your previous work experiences?
A: I am an expert in the regulation of medical devices, particularly in the diabetes diagnostic and therapeutic space, with more than six years of experience at the FDA's Center for Devices and Radiological Health. In my time at CDRH, I expanded on previous work in the space of dependable system design by evaluating the software, cybersecurity, and interoperability of medical devices and helping develop new class II pathways to improve the regulatory science for interoperable diabetes devices.
Q: How did you get into a career in Medical Device Cybersecurity?
A: I joined the FDA as a medical device regulator and was dunked head-first into a review of cybersecurity in 2016. There was not a great deal of maturity in the space at the time, and the FDA was maturing in parallel with the industry, so it was a great opportunity to learn together.
Q: Why did you join Medcrypt?
A: I really enjoyed my time at the FDA, but there is a critical (and necessary) limitation placed on reviewers that I found to be somewhat frustrating: FDA premarket reviewers can identify shortcomings in system design and documentation, but are not allowed to propose potential solutions as this could be unfair across different medical device manufacturers (MDMs). It is a reasonable limitation placed on the reviewers, but for an engineer who excels in identifying and solving problems relating to system robustness, it always left me feeling like I had a hand tied behind my back. At Medcrypt, I can do the same work, supporting a wide variety of MDMs, and I can offer solutions at the same time. This is so exciting for me!
Q: What problem(s) are you trying to solve in your role?
A: If we do our jobs right, we help the MDMs to get their quality systems into good shape, to incorporate security thinking at all phases of the device development lifecycle, to feed back data from postmarket into premarket decision making and designs, and to ensure business reputation and stakeholder trust.
Bonus Question: If you could have dinner with anyone, from both past and present, who would it be and why?
A: Ohhh, I would love to have dinner with someone like Billie Holiday, Nina Simone or Janis Joplin. Some of the female singers from the 20th century were amazing women who defied a lot of social norms to excel in their careers, and just having a meal with and getting to know one of those women would be absolutely amazing.
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