Something I’ve been thinking about in the device development is how tricky it is to balance the creativity of the engineer with regulatory compliance, I.e. finding the right balance between innovation and regulation. One one side, we as engineers rapidly want to prototype, test new materials and push design boundaries. And on the other side lies the strict FDA, ISO standards that guide the early stage of development. Sometimes it feels like these rules can slow down the creative side, but at the same time they’re there to protect the patients.
So this makes me wonder:
- Should we design and prototype fast and think about the compliance later? Or bring in regulatory considerations right from the start?
- How do small teams or early-developers manage this balance?
- Can thinking about the compliance from the start make the process smoother in the long run?
I’d love to hear your thoughts on how to approach this balance between innovation and regulations in device development.
Hello Kartikeya,
I think it's a great start to question the heirarchy of importance when it comes to creating new devices. I hope i can provide some insight based on my experience and hope to learn a proper way to manage these requirements.
I worked at a small company where we designed devices to automatically harvest chromosomes. There were about 4 engineers on the team and while we'd all have loved to finish these devices as fast as possible, a majority of our time was spent ensuring these devices were compliant with ISO 18485. We spent about 75% of our time filling out paper and about 25% contributing to the development of these devices. So to answer your questions:
1) While it would have been nice to engineer fast and worry about compliance later, it was always vital to set our pace based on compliance. We'd rather take our time to make sure it meets all required criteria rather than spend a bunch of time on a project only to find out it isn't compliant.
2) For the small team of 4 engineers I got to be a part of, the balance was leaning more towards paperwork and compliance. As I mentioned earlier, a majority of our work was filling out paperwork and ensuring compliance and a minority of work actually designing these devices. As unfortunate as all the paperwork was, I think this balance works best because it allowed us to be proactive and intentional with our actions.
3) When it came to a new project, our first meeting would be discussing the criteria we needed to meet for compliance and then discuss a realistic path to accomplish these goals. This allowed us to be proactive in our actions and "get ahead of the game". If we didn't create an actionable plan from the start, we would have constantly had to stop and go back to double check what we needed to be doing.
Sorry for the long response, I hope this answers your questions.
Ryan
I believe you make a key point: while innovation and regulation appear to be opposing forces, they must work together. Prototyping swiftly may drive innovation, but ignoring compliance early on typically results in costly redesigns later. For small teams, it appears that the ideal way is to keep rules in mind from the beginning, at least on a high level, while still allowing for iteration and testing. That way, you don't inhibit innovation while also avoiding hitting a roadblock when it comes to approval.
That’s a really good point. I agree that regulations can feel like they slow things down, but at the same time, they’re there for a reason. If we don’t think about compliance until later, it could mean redesigning a device completely or repeating studies, which would waste even more time.
For small teams especially, I think the balance comes from involving regulatory considerations early, but not letting them stop creativity. Maybe the best approach is to brainstorm and prototype freely, but always keep the main FDA and ISO requirements in the back of your mind. That way you don’t completely shut down innovation, but you also don’t go so far that you end up with a design that can’t pass approval.
When I think about whether compliance early on makes things smoother in the long run, I think it definitely does. Even though it might feel slower at the beginning, it probably prevents bigger delays later.
One aspect that is sometimes disregarded in my opinion, is how rules can sometimes really influence innovation rather than only restrict it. Human factors and usability testing, for instance, are required by law in the design of medical devices but can also inspire innovative solutions. Early consideration of how physicians or patients would use a device can encourage teams to create safer and easier-to-use solutions.
Digital tools like digital twins and virtual prototyping, could assist small teams achieve this balance. Software allows for rapid revision while maintaining documentation and FDA/ISO-compliant design process alignment. In this manner, compliance doesn't become a secondary concern, but it also doesn't hinder any attempts at creativity.
Do you think regulations should be viewed primarily as constraints that drive innovation (like in usability or safety engineering), or mainly as checkpoints to clear before a device moves forward?
