Increasingly, medical device suppliers must show their commitment to cybersecurity safeguards for medical devices themselves and to the production supply chain. If you’re a medical device components supplier for a medical device manufacturer, don’t let cybersecurity risks impact your competitiveness.
Medical device cybersecurity is growing more complex, and ensuring medical devices are resistant to cyberthreats to maintain patient safety is the responsibility of suppliers, medical device manufacturers, and healthcare providers. Device manufacturers are under mounting pressure from federal regulators and customers, including healthcare providers like hospitals, to ensure security and risk mitigation is built into the device throughout its life cycle.
Laws and regulations are moving down the supply chain to compel medical device manufacturers to prioritize and address cybersecurity issues with greater urgency. In turn, medical device manufacturers are putting pressure on their suppliers to comply with, and collaborate around, security best practices.
The U.S. Food and Drug Administration has identified medical device manufacturers as a key factor in addressing cybersecurity risk associated with medical devices. Suppliers should expect to see security demands trickle down, requiring components and parts you use to build medical devices be integrated into your overall cybersecurity strategy. Medical device suppliers and manufacturers alike will be expected to demonstrate their commitment to implementing strong security safeguards. This includes safeguards around the device itself as well as insulating production supply chains from disruption and downtime due to cyberattacks.
Suppliers and manufacturers alike will be expected to demonstrate their commitment to implementing strong security safeguards.
Meet the risk landscape with decisive action
If you’re a supplier of medical device components, don’t let cybersecurity risks impact your ability to remain competitive. If you’re looking to stay ahead of the curve on cybersecurity, here are some key actions to consider taking now:
1. First, understand that cybersecurity is not just an IT issue. Your cybersecurity strategy needs to be part of your overall strategic plan, from budgeting all the way down to assessing your organization’s security posture and identifying and implementing controls to address security risks.
Your cybersecurity strategy should start from the top and include executive leaders and your security team. If your company doesn’t have a dedicated security team, create a security committee or add security as part of the IT or risk steering committee, which should represent your risk and compliance areas and IT, even if your IT operations are outsourced to an external partner. This way, everyone understands the vision, objectives, and the organization’s defined plan for executing the strategy so it aligns with business goals while balancing security.
2. Build a strong cybersecurity program to reduce the impact on your operations of a cybersecurity incident. Consider using a framework like NIST CSF or a standard like ISO 27001 that provides overall governance and addresses risk at the organization level. Risk assessments are often a good starting point for a supplier that’s just beginning their cybersecurity journey.
As you consider frameworks, you need to continually mature your cybersecurity program, ultimately aspire to achieve a zero trust architecture throughout the organization. Zero trust assumes no user or device can be trusted by default; strict verification and authentication is required before gaining access to other devices, resources, or data. Very few organizations in any industry are there currently, but it’s the gold standard — and the future. The more safeguards you implement toward this goal, the stronger your security posture will be.
3. For medical device components, security should be integrated from the very beginning. Security by design proactively shows medical device manufacturers how your product provides a competitive advantage. It shows your products support manufacturer objectives, such as adhering to Federal Food, Drug, and Cosmetic Act guidance and providing proper information for the Manufacturer’s Disclosure Statement for Medical Device Security (MDS2).
Security by design proactively shows medical device manufacturers how your product provides a competitive advantage.
4. Cultivate strong relationships with the medical device manufacturers you work with and collaborate to build out a cybersecurity program that safeguards and mitigates risks to the components used in medical devices. Be prepared to invest to ensure your cybersecurity program meets your customers’ expectations. As the rules and regulations change for cybersecurity, suppliers should take a proactive stance — work closely with your customers to stay flexible and adjust as needed to support their medical device cybersecurity needs.
5. Stay on top of emerging cybersecurity threats in the medical device industry to ensure your business is protected, prepared to handle the threats, and able to show medical device manufacturers how you’re mitigating risk.
Also, stay apprised of expert guidance, policy discussions, and new regulations, including guidance issued by the U.S. Food and Drug Administration for improving cybersecurity in medical devices.
Further considerations for medical device suppliers and cybersecurity
The medical device industry is following a similar path to what we’ve seen in other regulated industries like financial institutions and automotive, where managing vendor and supplier risk is critical to a manufacturer’s cybersecurity program.
Medical device manufacturers need partners that:
Support their cybersecurity needs and requirements in a collaborative partnership.
Minimize the potential for operations disruption due to a cyberattack.
Provide well-documented security safeguards and controls to easily incorporate into MDS2, software bill of materials, etc.
Suppliers that don’t invest in cybersecurity will hurt their competitiveness. If you don’t invest, your customers will have to spend more on people, technology, and processes to cover the gaps. Increasingly, medical device manufacturers will be analyzing and assessing the risk and potential business impact if a supplier has a weak cybersecurity posture.
Suppliers that don’t invest in cybersecurity will hurt their competitiveness.
Suppliers must continue to adapt as industry needs change, and cybersecurity will be a high priority. It takes time, money, and organizationwide support to build a strong cybersecurity defense and a continuous process to mature your cybersecurity strategy and program. Start by performing an assessment to understand your current state of cybersecurity, validate your cybersecurity controls, and build out a strong, holistic cybersecurity foundation to support your customers — and your competitive advantage.
Enhance your knowledge: Explore our Cybersecurity Discussion Guide
