September 2025 Newsletter – AI tools for Medical Device Development
Recently I’ve discovered more AI tools intended to help with regulatory compliance and below I’ve listed a couple of them that illustrate the potential in two crucial areas. I’ve also been involved recently in multiple discussions about improving risk management which has broadened my horizons in this crucial area for medical devices.
Better Risk Management
Posting about FMEA is apparently a good way to trigger lots of arguments online as I discovered over the summer. The silver lining to the arguments was that I received some very insightful comments on the use and misuse of design FMEA for medical devices. I’ve collected those comments in this article which summarizes the issues around FMEA for medical device risk management and why FMEA alone is insufficient.
If you’re developing a software-intensive medical device, there will be many changes during development and after initial product launch. Performing rigorous risk management in an environment of rapid design changes is quite a challenge. In this article I describe methods and tools for risk management that can keep pace with rapid design changes. Don’t use a static approach for a dynamic problem!
Better Design Controls with AI
ALEX is a set of AI-enabled software tools which function as an engineering assistant. The tools assist product teams with multiple development tasks including analyzing alignment of higher level requirements and lower level requirements, analyzing alignment of requirements with respect to applicable standards (such as 60601 standards), and ensuring complete test coverage for verification of requirements. As someone who’s spent long hours reviewing and re-reviewing thousands of requirements, I think these tools offer the potential of enormous time savings. Take a look at the IntelliU website for more information about ALEX and how to get a free demo: https://intelliutech.com/
Better Post-Market Surveillance with AI
For medical device companies, performing comprehensive and frequent post-market surveillance can be very time consuming and difficult, even for large companies with many regulatory specialists. The Orca1 Digital Intelligence tools enable even small companies to do extensive searches across multiple databases. Orca1 can be configured to provide continuous monitoring, analyzing real-world data, to detect emerging risks, trends, and compliance issues across your product portfolio. https://app.orca1di.com/login/index.html
Better SaMD Development
Software as a Medical Device (SaMD) products do not involve hardware or manufacturing but their documentation is still complicated and it can be difficult to know what is truly required for compliance. To help reduce the confusion, I created this SaMD Documentation Map which illustrates the formal documentation needed for a typical SaMD product.
Upcoming Events
- MPO Summit – SEP 18-19 at San Francisco Airport Marriott
- Advamed MedTech Conference – OCT 5-8 in San Diego
- DeviceTalks West – OCT 15-16 in Santa Clara Convention Center