Embracing the Internet of Things (IoT) is appealing as more medical devices support connected features – but there are new challenges and problems that must be addressed in this era of increased connectivity in the medical field.
There has been an explosion in the amount of software going into devices, but cybercriminals have found new vulnerabilities to exploit in devices. Software has become the key differentiator for manufacturers of medical devices – and utilizing application lifecycle management (ALM) helps bridge the gap between development, assurance, and proof of compliance.
Medical devices are just as vulnerable as other devices to cybersecurity threats, and trying to prevent security issues is problematic. Due to security problems, devices were taken offline, changes were made to operating parameters or alarms, patient data has been stolen, and backdoors have been manipulated to gain access to hospital networks.
To address these challenges, Polarion and Siemens recently hosted a cybersecurity webinar, “Cybersecurity Risks to Avoid When Developing a Medical Device.”
The webinar features the following speakers:
Laurence Sampson, Expert FDA Risk Management, Polarion Software
Steve Mounts, Medical Device Expert in FDA Compliance
James B. Thompson, Ph.D., Director, Industries Medical Device & Pharmaceutical, Siemens Product Lifecycle Management Software Inc.
Frank Fleischer, Business Development Consultant, Product Lifecycle Management, Strategic Pursuit Team, Siemens Industry Software GmbH
Cybersecurity has turned into a significant problem for manufacturers and service providers, but medical device manufacturers are adamant about why connectivity is critical moving forward. Connected medical devices are helpful because they increase better patient diagnosis, monitoring and prevention of medical problems, and an overall reduction of reported medical errors.
Newer cybersecurity concerns include off-the-shelf software use in medical devices, as the FDA urges proper documentation for all premarket devices that use traditional software. Looking ahead, security must be considered – and designed – from the very beginning.
Polarion Software has a successful track record of assisting companies advance the development, governance and maintenance of software using a unified platform for Requirements-, Quality- and Application Lifecycle Management (ALM). If given the opportunity, we’d like to explain how we can help your organization take your product to market faster, while also passing FDA audits.