SaMD (Software as a Medical Device), Medical Device Design Control and the Need for US Guidance

I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”.  This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a lean, risk-based approach.

In my opinion, the FDA is not moving fast enough with the pace of SaMD innovation and the rise of the novel class of interventions called Digital Therapeutics.  The presentation addressed a quality management medical device design control construct that would allow the flexibility of software development based on agile methodology.  The presentation was well received, and because of the lack of US regulatory guidance, the presentation was based on other standards as references (e.g., AAMI TIR45, IMDRF, and IEC 62304).

The audience showed great interest and many questions were asked.   One of the questions, which still haunts most development startups, was “The implementation of a medical device quality management system is so burdensome.  Do you have any suggestions to make things easier?” My answer was to ensure you have a quality professional (internal or hire a consultant) that knows how to build a lean, risk-based quality management system that will allow the agile development process to flourish.  Agile practices have built in quality principles, provided that companies document what is being done.  In addition, startups should be mindful to use qualified/validated tools during the process.  For example, you may use in-house developed tools for regression testing but, be certain that tool is validated. You will be wasting a lot of effort and risk introducing bugs into your software if it is not.

Another tip is to purchase a validated tool to create your traceability matrix of design input requirements, to the design outputs (code), to the verification testing. This will be necessary to ensure that all of your requirements have been met.  It is also best practice to do formative Human Factors studies before you begin the design control process.  This will ensure the best possibility of identifying risks and provide a better library of user requirements when the design control process begins.

Nevertheless, the great thing about agile methodology is that you don’t have to have all of your user requirements identified up front, as is necessary with classical medical device hardware. You can develop your requirements, code and verification testing on an iterative basis, and as they are established, you can fill up the validated tool you will use as a traceability matrix throughout the development process.  These are just some of the tips that can help achieve a robust system and will, hopefully, appear in FDA guidance once it becomes available.

The conference covered a host of other topics such as Human Factors, FDA Precertification, Cybersecurity, European Regulatory requirements and much more.  The IQPC SDMD 2019 conference participation was larger than 2018, perhaps signifying a greater interest and I believe the 2020 IQPC SDMD conference will be even larger!

For further information on SaMD and Medical Device design control, please contact Lori-Ann Woodard, Medical Device Director at l.woodard@lachmanconsultants.com