MedCrypt, Inc. has announced the appointment Naomi Schwartz as their new Senior Director of Cybersecurity Quality and Safety. Prior to MedCrypt, Naomi was a premarket reviewer and consumer safety officer for the U.S. Food and Drug Administration (FDA) in the Office of In Vitro Diagnostics and Radiological Health (OIR). With over 20 years of systems engineering experience, Naomi’s primary focus at MedCrypt will be to lead analysis of cybersecurity designs for medical devices and help medical device manufacturers (MDMs) optimize their cybersecurity framework to meet guidelines set by the FDA.
During her time with the FDA, Naomi approved the software and cybersecurity for the world’s first regulated Automated Insulin Dosing (AID) System and created Class II pathways for the three major components of AID systems, a game-changer for supporting patients with insulin-dependent diabetes. She was also the FDA’s liaison on standards for cybersecurity of diabetes devices and for EMC of In Vitro Diagnostic (IVD) devices. Prior to that, Naomi spent 15 years supporting the Department of Defense as a contractor, specializing in radar system requirements and performance analyses, system design, and independent verification and validation. Additionally, throughout her career, she has received multiple industry achievement awards, including:
- The Center for Devices and Radiological Health (CDRH) Plain Language Award
- The CDHR Group Recognition Award for the Urgent 11 Response Team
- The Outstanding Customer Service Award from the CDRH for her time with the FDA
- The Samuel J. Heyman Service to America Medal: “Management Excellence: Courtney Lias, Stayce Beck and the FDA Artificial Pancreas Team (2017)”
“Interoperability is the future of medical devices, and of healthcare overall, and I’m very excited to join MedCrypt to develop tools and services for manufacturers that will improve their cybersecurity processes,” said Naomi Shwartz, MedCrypt’s new Senior Director of Cybersecurity Quality and Safety. “MedCrypt is doing such important work and I’m looking forward to advancing the public health mission by providing security solutions that ensure patients and healthcare providers have access to world-class devices.”
In her role at MedCrypt, Naomi will lead analyses of cybersecurity designs for medical devices and help MDMs optimize their cybersecurity implementations. She will also evaluate manufacturer and cybersecurity processes to develop tools that will improve the integration of cybersecurity into quality management systems and reduce the burden and uncertainty of postmarket management.
“Amid the rise in cybersecurity needs within the medical industry, we’re thrilled to welcome Naomi to our expanding team,” said Shannon Lantzy, Vice President of Consulting at MedCrypt. “Her previous experience at the FDA, as well as multiple roles in systems engineering, will help our clients accelerate their innovation pipeline while reducing cybersecurity risk and uncertainty.”
“In the years that I’ve known Naomi,I’ve seen the impact she’s had on the way we approach cybersecurity through her work with two of the largest government security teams in the country,” said Seth Carmody, MedCrypt’s Vice President of Regulatory Strategy. “Her experience with the FDA will help orient MedCrypt’s methodology to provide device manufacturers with a balanced approach to cybersecurity to achieve timely, security designs without compromising safety.”
Naomi is joining MedCrypt alongside Jamell Pentecost, who was recently announced as MedCrypt’s Senior Director of Product Security Services along with Ken Hoyme, who joined MedCrypt’s Advisory Board. MedCrypt currently provides enhanced security features and services for seven of the top 10 medical device manufacturers as well as startups and mid-sized companies.