In her role at MedCrypt, Schwartz will lead analyses of cybersecurity designs for medical devices and help medical device manufacturers 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.
Prior to joining MedCrypt, Schwartz was a premarket reviewer and consumer safety officer for the U.S. FDA in the Office of In Vitro Diagnostics and Radiological Health (OIR).
During her time with the FDA, Schwartz 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. 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, Schwartz 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. She has also received multiple industry achievement awards throughout her career.
“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,” says Shwartz. “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.”
“Amid the rise in cybersecurity needs within the medical industry, we’re thrilled to welcome Naomi to our expanding team,” says 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.”
Schwartz 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.
Featured image: Naomi will be joining the leading provider of medical device cybersecurity following a 6.5-year career at the U.S. Food and Drug Administration. Photo: MedCrypt