I’ve noticed that some people suggest engineers should prioritize compliance from the outset, while others believe creativity should take precedence and compliance can be addressed later. I can see both sides of this. Thinking about FDA rules early might save time in the long run because you won’t design something that has to be completely redone later. It could also make the process smoother by avoiding surprises when it’s time for approval.
But at the same time, I worry that if compliance takes over too soon, it could shut down some of the most creative ideas before they even have a chance to be explored. Engineers might start limiting themselves, thinking, “This won’t pass anyway, so why bother?” Some of the best innovations probably come from ideas that looked risky at first but were shaped into something compliant later.
It feels like this is really about finding the right balance. Perhaps projects should begin with a “wide-open” creative phase, where new ideas can flow, followed by a reality check where the team incorporates regulatory considerations. That way, creativity isn’t lost, but you also don’t end up with a device that can’t be approved.
What do you think is better for the device development process — giving engineers full freedom at the start and adjusting later, or building compliance into every step from the very beginning? And do you think the best answer might depend on whether it’s a small startup or a big company with more resources?
Balance and reality are key to success, indeed.
A combination of both would work. When developing a device, you have two things to worry about: the customer’s requirements and federal regulations. In this case, engineers must maintain a balance between keeping their clients content while ultimately creating a compliant product.
Engineering is an art form that applies physics and design principles to create a specific function, but in a way that only the designers can visualize. Rather than relying only on a textbook definition, they can complete the same tasks by applying concepts such as modularization, simplicity, and elegance. But this creative side must always be tempered by regulatory requirements — especially with brand-new products, where the CDRH class designation system can dictate what is feasible.
Engineers developing a product, whether an improvement/imitation of one created before or in 1976, or one freshly conceived, need to balance their creativity within the bounds of regulatory fitness. In layman’s terms, go nuts in the beginning, then whittle down what may not pass through the RFD and IDE. This can be especially complicated when dealing with combination products that would need to release existing or new drugs.
Small startups may have a more difficult time being creative, since they’ll need to establish credibility. They can be as creative as possible while consulting a third party or internal regulatory department/person or submitting “pre” pre-IDE and pre-IDE questions to the FDA throughout the process. That way, they can guarantee that their product will meet requirements.
For larger companies, they may have a dedicated regulatory department that would advise them throughout the process. As they may also be established in the market, they may come under more or less scrutiny from the FDA, depending on whether they release a device with an existing predicate or a novel device. In any case, they will likely be less creative and will usually follow regulations to release their product more quickly than smaller companies.
I think the classification that the project will be in can also affect how early or late creative freedom should be considered. Since different classes will have pathways with varying qualifications they need to follow, the classes that require fewer steps can afford to have more creative leeway earlier in their product. For example, working on a Class I or II device, especially if there's a predicate, the 510(k) pathway can give engineers more room to be creative with the early phases, experimenting with the form or features while making sure the core function is untouched. With Class III devices, where a PMA is required, a clinical study will almost always be required, and engineers with have to shift their focus about risk-benefit tradeoffs and trial designs before a prototype is even made. The FDA's classification system already indirectly shapes how much freedom engineers can have with innovation with their product. Do you think the FDA's classification system has a right balance between encouraging innovation and protecting patients?
I think that compliance should at least be considered from the outset. I think that disregarding compliance at the start and attempting to simply get rid of parts that won't get past the FDA could easily lead to huge problems. While it might be possible to simply remove parts or features of a project because they have minimal interaction with the rest of the device, you could just as easily run into a situation where the feature that would not be compliant is too interconnected to the rest of the device to be ditched. This is especially true for devices that you intend to be class 1 or class 2. Designing your device without compliance in mind may end up getting your device upgraded to the next class which would be especially bad if you are going for a class 2 and end up straying too much beyond the predicate. As others have said larger companies will have dedicated compliance departments so this may be caught before it becomes too much of an issue but if this situation happens at a smaller startup and is submitted to the FDA then this could kill the whole project as developing a class 3 device is far more expensive than a class 2. I actually disagree with Bryan here as I think that a class 3 device might let you have more creative freedom since you are stuck doing the clinical trials, and all the extra work anyway, whereas with class 2 devices you are stuck within the confines of what the predicate is. Ultimately, while I do think the large cost barrier for class 3 devices stifle creativity and progress, it is absolutely necessary to protect patients from poor or even dangerous products.
I think the best thing to do depends on the project and whether or not it's a small startup or a larger company. For small startups, I think it makes sense to focus on the innovation first which allows engineers to examine new ideas before introducing compliance requirements. This can help the engineers stand out in a market that is competitive and it allows them to adjust if alterations are necessary. Since they usually have processes that are already established and the risk is higher, building compliance in each stage of development can reduce costs and save time. The right method would be to balance creativity and compliance requirements in a way that aligns with the company.
I agree with the opinion that smaller startups should focus more on innovation than compliance since it can give them a good product to stand out. This lets them develop opportunities for receiving funding, which can allow for an easier compliance path in the future. The trade-offs a large company takes in terms of compliance usually lies in their innovation and time-to-market. Larger companies don't want to take up too much risk as developing an innovative medical device takes money and a lot of time. For larger companies, dedicating these resources towards existing products involves less risk, but results in less innovation. One fact when it comes to startups is that once a product receives traction, larger companies could come and buy out the startups. With this in mind, it could be more beneficial for startups to focus more on innovating than micromanaging compliance. I believe it could be a win-win situation when done in good faith. Startups often want to be acquired by a large company, and large companies are always looking for new business opportunities.