Here are some things I’ve been working on lately that I think will be valuable to others working with medical devices. This issues includes Cybersecurity Documentations, AI for Medical Device Compliance and a Rapid Compliance with IEC 62304 Case Study.
Cybersecurity Documentation
If you’re concerned about cybersecurity documentation for an upcoming FDA submission, take a look at this explanation written in plain terms. Medical Device Cybersecurity: Best Practices, FAQs, and Examples
And if you’re interested in more links to online resources for cybersecurity, I’ve collected my favorite ones at the end of my blog post about the new FDA cyber guidance. Getting Started with the New FDA Cybersecurity Guidance
My Collaboration with the MAHD Team
I’ve been helping clients incorporate agile methods into their medical software development for many years. Agile can provide significant, long-lasting benefits such as improving customer focus and value, flexibility in responding to changes, more predictability in project schedules, and finding defects earlier in development. However, adapting the methods to medical device development is tricky, especially when hardware is involved. It can also take many months of experimentation to make it work well. Fortunately, I recently discovered the Modified Agile for Hardware Development (MAHD) Framework, a ready-made product development process that aligns well with the needs of medical device companies. Unlike typical agile-for-software, this framework fully supports risk management, clinical testing, design transfer, regulatory submissions, and other special medical device development needs.
Wrapping up our last MPO Columns with Russ Singleton
For the past year, I’ve teamed up with Russ Singleton, a very experienced R&D executive, to write a monthly column in the MPO Magazine on how to manage the development of complex medical devices. Complex, software-intensive medical devices require a different product development approach than non-complex devices. Through a dozen columns, we’ve covered the challenges of complex medical devices from several angles. Here are the latest columns:
- Managing Compliance for Complex Medical Devices – structuring a quality system to manage complexity and scale
- The Power of Small in Developing Complex Medical Devices – how to split a massive development project into a series of Micro Projects
- The Power of a Common Vision – how to increase the focus and productivity of a product team by aligning on a shared vision.
Rapid Compliance with the IEC 62304 Medical Software Standard
As a consultant, I try to help my clients put in place the right processes before they’re needed. But sometimes, I’m brought in during a crisis when processes must be fixed and documentation created very rapidly. That was the case with a client working on their first digital health product. Clinical testing was scheduled to begin soon and the project needed to be brought quickly into compliance with the IEC 62304 medical software standard.
Using AI for Medical Device Compliance
AI seems to be changing everything in our world and even compliance documentation is now being changed by AI. Recently, I worked with the Ketryx ALM system to help a client with their design controls and DHF documentation. I was able to leverage a new Ketryx AI feature that automatically creates software test cases based on software requirements. The results were both surprisingly good for many test cases and absolutely wrong for a few test cases. Overall, I found it a good productivity boost as long as you have an experienced professional review and correct the final output. That seems to be the case with lots of AI tools these days. I expect them to improve considerably in the near future, but even at the current level of performance, this would have saved me so much time years ago when I was a test engineer!
https://www.ketryx.com/blog/ketryx-ai-agents
For the past few months, I’ve been collaborating with Monik Sheth of Ultralight Labs (recently acquired by Greenlight Guru) on a series of blog posts about the advantages of using “The Hub” for medical device development. The Hub refers to a platform approach to managing product data and documentation instead of using a set of documents and spreadsheets. The platform provides a single source of truth and speeds up many aspects of design controls and risk management. It also enables AI features to further accelerate development and compliance documentation, such as assistance in tracing, risk analysis, and ensuring test coverage. This blog describes how to use The Hub to speed up V&V.
What’s been your experience with AI usage?
What AI tools have you found most useful and what did you use them for?
Where do you see the most valuable usage of AI tools in the future for medical device development?
Upcoming Events
Mastering EU and FDA Cybersecurity Requirements for Medical Devices – webinar by Christian Rosenzweig (Johner Institut) and Axel Wirth (Medcrypt) – JUN 25
Leveraging Automation to Deliver High-Quality MedTech Software – webinar by Orthogonal Software – July 17
MPO Summit – San Francisco Airport Marriott – SEP 18-19