By Santhosh Nair
There were a lot of great takeaways from the Medical Devices Summit that I attended last week in San Diego. Wind River solutions architect Pete MacKay gave an excellent presentation about medical devices design, cloud and Android that was very well received and Intel ECG presented on embedded security and isolation/protection in medical device design. Wind River had a booth where Michel Chabroux and Gabriel Quiroz showcased our Atlantis platform for connected medical devices – they demonstrated data traversing from an edge device (a weighing scale), all the way through the aggregator device to the final application.
Throughout the event, the topic that seemed to be on everyone’s mind was compliance. Not surprisingly, conversations around regulations and compliance overshadowed many of the technology discussions. Most of these talks centered on how to manage risk in your development process, the importance of having excellent design controls in place, managing suppliers and variance in your supply chain logistics, and how to navigate the regulatory maze and not get caught up in the trivia.
Medical device manufacturers are focused on managing risk for creating safe and effective devices for the market. Having a solid risk management process, deploying tools and workshops to iron out the risks in product design, development and safety, and mitigating risk are critical to getting a device approved for the market. You may even get to market, but a lack of solid processes and structure will not keep you there for long. So what does that mean for suppliers of software and services? They need to invest in processes and compliance that help ease the customers’ pain — this means having a solid software development process and having the ability to provide traceability and artifacts for the software that they provide.
Overall, a key takeaway from the show is that having a solid compliance story is essential to being a credible player in the industry. In fact, Wind River is doing a lot on the compliance front. So, stay tuned for more compliance-related breakthroughs for our various platforms – as well as compelling compliance collaborations to develop assurance cases for medical devices. It’s an exciting time to be in the medical space!