The need for the medical device industry to consider cybersecurity risks grows exponentially every year. In short, every company of any size risks ransomware attacks. However, it’s the products of medtech companies specifically that require more attention.
The Need for Cybersecurity in MedTech
Hospitals need medical devices to connect to hospital networks and the Internet to enable healthcare professionals to track and treat patients. Therefore, those same medical devices, like any computer system, become at risk for cybersecurity attacks. Certainly that’s no small risk, as the FDA states, “to the safety and effectiveness of the device.” In fact, the FDA denies premarket approval of some medical devices based solely on cybersecurity concerns.
FDA Recommendations
As such, the FDA recommends building in threat models. Threat models ensure your device design, throughout the medical device life cycle, is ready for the challenge. Beginning in design and risk analysis, consider a variety of external cyberattack methods as inputs to your threat model. Those variable risks not only challenge device function but include data security. In short, sensitive patient data often stored with the device, even temporarily, becomes threatened.
FDA Guidance
To counteract the growing threat, the FDA issued updated guidance in 2018 detailing the design and development factors medical device companies should consider to ensure security. First and foremost, companies need to include threat modeling as a critical issue in preparing premarket submissions. In 2021, the FDA funded the development of a cybersecurity playbook to improve further device makers’ approaches to cybersecurity threats. In fact, it’s now available here.
Medical Devices Companies and Cybersecurity
Certainly facing cybersecurity risks challenges medical device companies. Like all risk, it can’t be completely eliminated. Yet a sound threat model in place throughout the lifecycle of the medical device ensures your potentially life-saving device remains safe and effective.
Final Words on Cybersecurity
To sum up, cybersecurity attacks threaten the privacy and security of confidential patient information, disrupt essential operations and procedures, and require significant financial investment to rectify. In other words, the market effects of having your product and company name associated with poor cybersecurity can be severe.
However, you don’t have to face that challenge alone. MAE Group offers assistance and support to develop and manage biomedical device security programs, identify and report vulnerabilities, and work with your engineering team to remediate the risks.
Contact MAE Group today to learn more about how we can assist your company.
