Study the Accidents, So You Don't Become One

Every climber interested in getting home safely has probably read their fair share of accident reports. You read the reports so you don't become one. Medical device engineers, like climbers, must study the problems of the past to make the most safe and effective products for the future.

Some say it's never too late to learn … I don't think that really applies here. Medical device engineers, like climbers, are constantly assessing and managing risk, and a large part of success is the preparation you do in the beginning. Integrating the hard lessons of others early into your design process ensures you don't suffer the same fate.

The Knowledge Is Out There

Every so often the news carries a horror story of someone getting into trouble on a mountain and the rescue that ensues. Some people, perhaps, read it for the shock value, but if you're a climber, you read it for the lesson it holds. Publications like Accidents in North American Climbing or the reports published by Yosemite Search and Rescue (YOSAR) and other organizations around the world contain a wealth of knowledge that you don't want to learn the hard way. The same goes for medical devices. A lot of companies have learned a lot of hard lessons over the years, and that knowledge is out there.

I think my worst nightmare as a medical device engineer is finding out that a patient has been harmed, not by my lack of foresight, but by my lack of knowledge. As hard as we try, nobody can conceive of everything that could possibly go wrong. That is why we put systems and procedures in place to guide us toward the best possible outcome.

I'm old enough to remember the days when drawings were still done on a drafting table and the old guy in the corner was kept around solely for his institutional knowledge. There wasn't the internet or AI filled with all the world's knowledge — there was that guy, who had been there for 40 years. He knew you were wasting your time if you tried to do it this way, or that your design was going to run into problems later in the field when a doctor used your delicate instrument as a pry bar. The FDA saw the value in this knowledge and set out to collect and share it for the benefit of all. Nowadays, there's no excuse for not knowing the lessons of the past. The information is there; it's just a matter of having the right tools to process it and use it effectively.

Recalls Are a Design Input, Not a Checklist Item

Studying medical device recalls is a key tool in ensuring your device is safe and not destined to suffer a similar fate. A common mistake is to consider this a checklist activity for right before your regulatory submission — that is much too late. If you want to make your device inherently safe by design and manufacture as ISO 14971 dictates, then identifying what has and could go wrong needs to be one of the first steps.

Checking the FDA recall database should not be a regulatory deliverable. Studying the failures of the past needs to be an indispensable part of designing an inherently safe product.

When a medical device is recalled, whether due to a software glitch, a brittle plastic housing, or a misleading user interface, tools like redpoint can integrate those hard-learned lessons of the past directly into your engineering development workflow. This data represents real-world clinical exposure, high-stress hospital environments, exhausted nurses, misread displays, and the unforeseeable events you worry about.

When you analyze recalls of similar devices early in the design process, you aren't just doing homework, you're identifying critical edge cases, hidden failure modes, and high-risk use errors. Lessons that cost other companies millions, maybe even people's lives. Lessons that need to be taken seriously. An engineer has a great responsibility to do their due diligence, but, all too often, we just want to get to the fun part and start building and testing some stuff. Jumping in like that can cost you big in the end.

We've all probably experienced how much harder and more expensive it is to change something once it is in production. Something that would cost 30 minutes and a couple of dollars to implement when prototyping costs you a month and tens of thousands after V&V, maybe a year and hundreds of thousands once it's in production. All because you picked a material that you later learned doesn't hold up to how hospitals actually clean it. Or perhaps a connector that always seems to be breaking on similar devices … and now it's breaking on yours.

Make It Easy on Yourself

These are problems you could have known about. It doesn't take much, but you still have to do some work, and redpoint was designed to make it as easy and effective as possible. Redpoint seamlessly integrates analysis of FDA recalls into the design control process so that you don't miss that thing you should have known about from the beginning.

If you've read to this point, you might as well just sign up and see what it can do for you. Even the free version is pretty helpful, and you can export your data anytime. What's holding you back? Money, time? It will save you both. Doing things right from the start always does.

If using redpoint allows your team to spot a single use error, catch one obscure failure mode, or prevent a single potential recall early in the design phase, the platform just paid for itself — not just for this project, but for a lifetime x 100.