Updated Jan 20, 2025
Much of the conversation about medical device cybersecurity focuses on the premarket submission. The Food and Drug Administration’s (FDA) newest rules, implemented in 2023, mandate what manufacturers must do to achieve approval. The guidance also includes postmarket management of cybersecurity in medical devices.
Let’s review what you must do postmarket and how you can do it efficiently and effectively.
What Is Postmarket Management of Cybersecurity in Medical Devices?
After you obtain FDA approval and the device is on the market, your responsibility regarding cybersecurity doesn’t end. The FDA requires that you continue to monitor devices and their security. You must report any adverse events, incidents, or other device issues.
Further, you must have a process for issuing patches when new vulnerabilities arise. Your premarket submission must address tracking and tackling aftermarket cybersecurity concerns.
Development of the process occurs premarket, but its execution may look different. That’s because the threat landscape is constantly evolving. Having a strong foundation of monitoring devices is crucial. How does it work in the real world?
How Can You Proactively Identify Vulnerabilities and Risks?
You don’t want to learn of a weakness in security after an incident occurs. It puts you in a position of playing defense. You’ll be better prepared by starting with a strong offense. Work with a company that specializes in medical device cybersecurity to provide:
- Regular vulnerability assessments that evaluate the device in the real world
- Penetration testing that occurs often to remediate issues before hackers can exploit them
- Risk management programs that tie in premarket and postmarket considerations
- Threat modeling to support protection, response, and recovery
By collaborating with an experienced firm to develop and hone these practices, you yield many benefits.
What Are the Benefits of Postmarket Management of Cybersecurity in Medical Devices?
Your core competencies revolve around developing medical devices that improve care and outcomes for patients. While you may approach this with secure by design strategies, collaborating with cybersecurity medical device firms ensures layers of protection to make sure devices are safe and secure once in use.
The benefits include:
- Assured continued compliance with FDA mandates
- The use of innovative technologies that find vulnerabilities early
- Less internal strain regarding cybersecurity requirements and improvements
- Access to the latest breakthroughs in medical device cybersecurity protections
- Understanding any new concerns or threats related to medical device interoperability
- Help with building a superior risk management process and framework
- Scalability as you develop and launch new devices
- Agility in responding to any new FDA requirements regarding security
How Can You Establish Postmarket Management of Medical Device Cybersecurity?
As noted, the postmarket response begins with the premarket submission, where you define the processes and steps you’ll take to ensure the security of the devices. These programs will change and must adjust to the risk landscape. It requires you to remain keyed into every new risk, which is a daunting task that takes time away from development.
Thus, your organization will make better use of its resources by working with a firm that concentrates on premarket and postmarket medical device cybersecurity. By starting the process with a firm, you can rely on their expertise and knowledge. They can even help you ensure the production of safer, more secure medical devices.
Keep in mind that this is a niche category of cybersecurity. Traditional cyber defense tools don’t work with network-connected medical devices. Integrating the right security solutions into the design, production, and postmarket monitoring elevates your protocols and practices beyond the minimum thresholds.
For more insights on postmarket medical device cybersecurity, request a consultation with our team today.
