Secure Product Development Frameworks for FDA Submissions

Secure Product Development Frameworks for FDA Submissions

A Secure Product Development Framework (SPDF) is a way of designing and engineering a product with security features in mind. This can make the development process much smoother and reduce the time it takes for the product to be released by avoiding revisiting areas to add security features. Implementing an SPDF can also strengthen security measures, as they will be integrated into the product early and referenced throughout the development cycle.

510(k) Submissions

510(k) submissions, or pre-market submissions, are enforced by the FDA to ensure that new medical devices are protected against cyber-attacks. The FDA mandates that medical device manufacturers meet certain criteria to prove that their devices will not be released with major flaws that could cause massive damage. This is crucial, as medical devices are implemented in sensitive environments where compromise could be catastrophic.

As part of preparing for a 510(k) submission, the FDA recommends that companies implement an SPDF during the initial planning phase for their device. Security can be complex, especially with new technologies being introduced at staggering rates. Having a security plan at every step of the process helps to prevent vulnerabilities from slipping through the cracks.

An SPDF also has the added benefit of reducing the time needed for secure development. If manufacturers do not consider security in the early stages of development, they may need to go back and redesign critical components with a new approach to mitigate vulnerabilities discovered at a later stage. Redesigning components completely will take time and can often be very costly.

This is not to say that properly implementing an SPDF will stop all vulnerabilities. Foreseeing what vulnerabilities will come up and go undetected can be hard. A proper SPDF will account for this uncertainty and include a plan for addressing vulnerabilities as they are uncovered. Later pre-market stages will look for vulnerabilities that are often harder to discover. Even after the product has been released to the market, problems that require major changes may arise.

SPDF Attributes

While an SPDF can be done in any number of ways to meet the unique needs of each device, there are a few basic concepts that can be a good starting point:

  • Risk Management – This is the basic process of identifying, assessing, and mitigating risks. Risk management is important throughout the entire lifecycle of a project and after the finished product has been released.
  • Regulatory Compliance – Besides accounting for general cybersecurity concerns, extra care must be taken to ensure that FDA and HIPPA guidelines are followed, and everything complies with best practices.
  • Security by Design – One of the most critical parts of an SPDF is ensuring security is considered at every process step. This can save time, money, and headaches from dealing with problems down the line.
  • Quality Assurance – Throughout development, robust testing should ensure all practices are followed and initial goals are met. This can also include security testing that will uncover more complex vulnerabilities.
  • Documentation and Traceability – The development process should be carefully documented. This can provide detailed records of what has been done and help provide a reference point for future testing and security management.
  • Post-Market Surveillance – Once a product has been released to market, it should be carefully monitored for any vulnerabilities that may be discovered. This also applies to 3rd party software implemented in the device. While they may have been secure during development, critical flaws discovered later can compromise the device.

When developing an SPDF, every aspect of a device must be carefully considered. Intended use cases can easily be flipped into methods of abuse by skilled attackers, and they may be hard to find early on. As the device progresses through the development process, the process might need adaptations to accommodate new considerations that may be uncovered.

Get Your DerivativeTo Market With Blue Goat Cyber

Our team can help streamline the 510(k) submission process and reduce the time needed to get your product to market. Our team is experienced in navigating the FDA requirements and can work with you to find the best security solutions for your product. We are here to help your team through the security process and protect you from cyber-attacks. Contact us to schedule a consultation.

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