At APRACITI we provide ongoing product security engineering support for medical device manufacturers and healthcare companies, including design discussions and reviews, analysis of security testing results, answering questions from regulatory agencies, completing questionnaires from healthcare delivery organizations and more.
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Regulators and healthcare delivery organizations have incorporated cybersecurity into their processes and are now expecting medical device manufacturers to integrate cybersecurity in the total-product lifecycle of a device. These changes are driving medical device manufacturers to build out Product Security capabilities to ensure these growing requirements are being met; however, there are several challenges arising.
A medical device manufacturers product development process can span several months to years and cybersecurity activities may occur at various points in the development timelines. This can present a challenge in justifying the hiring of a full-time employee (FTE), due to the varying levels of engagement required during the process. For post market support, the challenge is similar. A single security incident on a commercialized product may only occur once a year, but when it does occur it may consume the entire schedule of a FTE, impacting other activities being actively worked on. Additionally, there is a known workforce shortage of Cybersecurity professionals in healthcare, with organizations having difficulty finding qualified resources when they attempt to hire.
To help overcome these challenges, Apraciti offers a Product Security Team offering. The goal of this offering is to provide experienced Cybersecurity support to medical device manufacturers, to help ensure Cybersecurity is built into every product. Choosing Apraciti’s Product Security Team enables a medical device manufacturer to take a more cost-effective approach to managing Product Security, by planning for support when needed, rather than hiring a full-time employee.