Importance of Medical Device Design Controls – Part 1

Is medical device product development really all that different than product development of other products and technologies? If you take a moment to really think about this, the answer is not all that easy to address. From one perspective, no, the medical device product development process is by and large just like any other product development process. Sure, some of the work products and deliverables and regulatory requirements are different. But overall, the process is the same (or at least it should be): establish a business case, capture user needs, define requirements, figure out how to build it, prove that it is safe, prove that it works, prove you can make it. From another perspective, yes, the medical device product development process is vastly different than other product development processes. Why? Regulations, largely. Regulations that dictate what to do and when to do it in order to prove and demonstrate that a medical device is safe and effective.

In the end, the question is really not all that relevant. Sometimes we like to brag (and other times complain) that the rules we have to follow are strict and difficult. We brag when we think about how and who the medical devices we design and develop will be used. We complain when we are up against deadlines to get tasks done. Regardless, the rules of medical device product development are somewhat defined. Yes, sometimes those of us in the medical device industry are sometimes proud that we have our own unique lexicon of terms to describe product development. We refer to these rules as “Design Controls”—mostly because the U.S. FDA has defined the medical device design control regulations (refer to FDA 21 CFR part 820.30).

We can debate if Design Controls is synonymous with medical device product development or if Design Controls are proof and objective evidence that regulations have been met during medical device product development. I’ve been part of some very heated and passionate conversations on the topic. Interestingly, the answer does not matter. Regardless of your point of view about the relationship of Design Controls and medical device product development, I suspect we all accept that Design Controls are expected behavior when it comes to medical device product development.

Briefly, Design Controls includes: Design Planning, User Needs (although not explicitly part of regulations), Design Inputs, Design Outputs, Design Verification, Design Validation, Design Changes, Design Reviews, and Design Transfer. Some also throw in Risk Management. For now, I want to leave Risk Management out of this and revisit it later. Design Controls dovetail nicely with a natural progression through a product development process. A nice linear path. Just like product development is intended to be. Or at least this is how we often describe and depict the process. Do this and then that and so on. But medical device product development is most definitely NOT a linear process.

Again, this is a concept that can elicit heated and passionate conversations.

All medical devices on the market today at some point in time began as an idea to solve a clinical need. All medical devices on the market today at some point in time went through a product development process. And conceivably, within the past fifteen or so years, many medical devices likely have supporting Design Control documentation and records. Suffice it to say that Design Controls are the foundation of a medical device.

Interestingly, the topic of Design Controls is still very confusing to many within the industry. I think it is confusing because we (collectively speaking) have made it that way. We have married Design Controls to sometimes convoluted and complicated business processes. In other cases, we feel compelled and sometimes forced to follow the linear “rules” of Design Controls, that we have more rigidity than need be. When asked to think about Design Controls, many think of documents, tables, and spreadsheets. We seldom describe Design Controls for what they are: objective evidence to prove our medical devices are safe and effective. We have lost sight of the importance Design Controls truly plays in the health of the medical device industry.

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