ARTICLE SUMMARY:
More congressional scrutiny is falling on device cybersecurity and FDA has moved from issuing guidance documents to publicly stating that it is finding submissions not approvable based solely on cybersecurity concerns. MedCrypt stands ready to serve, with four specialized cybersecurity solutions offering the ability to understand, track, and mitigate risk factors in devices’ programming.
Any piece of software has vulnerabilities in its programming that motivated hackers can exploit to change its functionality. In healthcare, an intrusion of this kind can threaten patient safety and incur unexpected costs. Devices for drug delivery and cardiac rhythm management, as well as those that are remotely accessible or affect multiple patients simultaneously, are of particular concern to the FDA. (See “FDA Proposes Tougher Cybersecurity Rules as Threat Risk Multiplies,” Market Pathways, April 21, 2022.) Though these technologies are no less inherently secure than others, their sensitive nature can constitute a fruitful target for malicious agents. Working for a major medical device manufacturer in 2014, MedCrypt co-founders Mike Kijewski and Eric Pancoast began thinking seriously about cybersecurity, creating the dedicated software start-up in San Diego two years later with Kijewski as CEO and Pancoast as chief technology officer.
