Struggling with cybersecurity planning, execution, and postmarket surveillance? Asking yourself, “what does FDA expect?  If it is any consolation, most medical device manufacturers are right there with you! But we have noticed that many struggles likely could have been avoided. The good news is that cybersecurity is on your radar – likely that is why...Read More

… declares the table of contents for an article, subtitled Software problems are responsible for 20 recalls a month in IEEE’s Spectrum magazine December 2025 issue (the article is available without an IEEE account: https://spectrum.ieee.org/medical-device-recalls) The article includes several summary charts about U.S. Food and Drug Administration (FDA) medical device recall data back to 2005,...Read More

Why Software Keeps Failing is the title of the editor’s page for IEEE’s Spectrum December 2025 issue. The answer to “why software keeps failing”? Lessons are learned but not applied. From the editor: In 2005’s “Why Software Fails,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software failures, Charette noted, “The biggest...Read More

It is no secret … medical device manufacturers and Health IT groups face a tremendous challenge with cybersecurity. There are high regulatory and market expectations of activities and documentation. Keeping up with the cybersecurity state of the art requires prioritization and investment. A common complaint we hear is, “navigating cybersecurity for medical devices and medical...Read More

Improving medical device software development isn’t just about adding or modifying. The simplest approach is to NOT do things that don’t need doing. This is a key theme we cover in our training and consulting. “Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and...Read More

Developing safe and effective medical device software is not easy. Doing that efficiently AND meeting regulatory compliance requirements is even harder. Many companies are implementing agile or lean software development methods to improve results. But can those methods also be compliant at the same time? Yes! There is a caveat, however … agile approaches “out...Read More

The Agile & Compliant February courses have early registration discount deadlines are coming up soon: Americas: 14 January 2025 EU et al: 21 January 2025 Pacific: 28 January 2025 Full details and registration form at https://www.softwarecpr.com/2024/12/1st-quarter-2025-agile-compliant-courses-scheduled/Read More

I got a cancellation notice today for my driver’s license renewal appointment. Reason? “Internet down statewide and will not be resolved today.” The outage was actually worldwide. You probably saw news reports or were affected by it. A software update by cybersecurity firm Crowdstrike caused some Windows systems to stop working. Outages didn’t just affect...Read More

I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...Read More

By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...Read More

Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...Read More

“Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies. However, “agile” also remains difficult and elusive for many. This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives. First, let’s address agile and medical device development in...Read More