B-049 Accelerating the Delivery of Regulated Medical Software

Abstract Background Today*s medical devices have a significant amount of embedded software that must pass regulatory approval. Historically this process has been manual, costing organizations a significant amount of money and time to get software prepared and through the regulatory process. Methods Our research has identified methods for automating the collection, secure storage, and attestation of software compliance information that meets FDA regulatory requirements for embedded software. These methods allow organizations to define regulatory policies in software, automatically collect evidence on whether these policies have been adhered to, store immutable evidence that is digitally signed and cannot be altered. and track compliance results in real-time. This process can be integrated with any software delivery process (often called a DevOps or DevSecOps process) to ensure appropriate compliance information is collected during every release of the software. The information produced by these methods can be used by internal and external auditors to validate regulatory compliance Our studies measured the impact on time and cost of applying these methods to two different medical device software development efforts. The first study was done on software embedded within a heart pump device product that offers hemodynamic support to the heart. The product allows the heart to rest and recover by temporarily assisting the pumping function of the heart to efficiently deliver blood and oxygen to the entire body. The second study was done on software embedded within a blood glucose monitoring product that allows patients to see their glucose level and where it*s headed in real time. This makes it easier to make in-the-moment decisions about food and activity. Results Results from our first study that applied our methods to a heart pump product with embedded software:Reduction in software delivery time of 75% vs. delivery times of previous software versionsEstimated cost savings of $2.25M in software development costsFDA approval granted for this device Results from our second study that applied our methods to a blood diagnostic product with embedded software:Reduction in software delivery time of 85% vs delivery times of previous software versionsFDA approval granted for this device Conclusion A focus on automating the compliance process for the software embedded within safety-critical medical devices can save significant amounts of time and money without jeopardizing FDA approval. Additional research is being performed to further optimize this process and expand it to other safety-critical systems markets.