The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they were built for has changed dramatically.

The medical device industry came late to the software revolution, partly due to a culture that shunned the “move fast and break things” ethos of early tech companies, and partly due to a regulatory framework that has always seemed more aligned with waterfall project management than agile.

But medtech is going through a generational change right now. The industry may have been late to the software revolution, but now it’s at the center of it. Software in medical devices (SiMD) and software as a medical device (SaMD) are some of the fastest growing verticals in the medical device industry, and there are more software developers working in medtech than ever before.

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