Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn't pass regulation be rejected immediately, and the constraints would force for more unique innovations that still manage to be within regulations. This is how having clearly defined structure on what problem a project should solve can benefit the project scope as a whole. That being said, depending on the phase of the project, having different levels of detail up until the finalization of the design might help with allowing for some innovations. Like having a core general structure that gets more defined and detailed and has less room for innovation as the project goes on, allowing for possibilities to be explored in the beginning and eventually get phased out. At what point during a project do you think companies should tighten their design controls?

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each stage of the design process. Creating a medical device without a genuine user need or large enough market demand defeats the purpose of innovation. Careful planning also helps prevent scope creep, which means avoiding the temptation to add unnecessary “nice-to-have” features later on in the process. From my experience completing my senior project that followed a design control framework, I found that developing well defined, justified design inputs and specifications actually accelerated innovation by providing a structured foundation to build from. These inputs ensure that the final product functions as intended and can be manufactured correctly. It’s also worth noting that many design control regulations are intentionally vague, outlining only the minimum requirements needed to comply with FDA standards. This flexibility allows companies to develop their own internal processes and standards, thus enabling creativity and innovation within a compliant framework.

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to ensure that the device is working as intended and it is properly meeting the users needs. While these can be somewhat frustrating, in the long run they help prevent issues from occurring down the line and help to streamline the design process and make it easier for any adjustments that need to be made in the future. Documentation which is a major aspect of design control is also crucial for innovation. Comprehensive design history files, which arise as a result of proper design controls, allow for a smoother and faster approval pathway during regulatory submissions which creates a clearer and more predictable pathway to market. Both of these aspects of design controls ensure that the product is effective and safe for the patient who will be using them. Maybe most important to the innovative process is that design controls prevent project creep from occurring by helping manage and control the scope of the project which if out of hand leads to slower innovation during the project.  I think the only time design controls can hinder a project and impact innovation negatively is if it is improperly implemented. An example I can think of is improper documentation methods that impact traceability, which in turn takes away from innovation and ultimately slows down the design process and takes considerably more effort from the team. As a whole, I think design controls when properly implemented are a net positive for innovation in the medical device industry. 

I agree with everyone that design controls don’t have to kill creativity - it really depends on how teams use them. One idea I haven’t seen mentioned yet is how design controls can work alongside agile methods. Some med-tech startups do short design “sprints,” where they test small prototypes and update documentation as they go. It keeps things compliant but still leaves room for quick changes and new ideas.

I also see design controls as kind of a safety net for innovation - they let teams take risks and experiment, knowing there’s a system in place to catch problems early. With newer digital tools that handle version control and documentation automatically, design controls can actually make innovation faster, not slower.

What do you all think - could blending agile practices with traditional design controls be the best of both worlds?

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, and risks before going too far in development. That structure can prevent redesigns that can be costly and compliance issues later on. On the other hand, if companies apply design controls too early, they can slow creativity and make people too afraid to take risks. I think balance is key and nothing needs to be taken too far.

I do agree with the idea that these controls are slowing down innovation because it is preventing harm, but also maybe even causing people to think creatively in case their idea gets rejected initially. The idea of these measures is to ensure that people do not get hurt using these products and that is why these regulations are in place, it can definitely be frustrating, but this is meant to help. It is a good way to catch issues from the early stages, so that the team can fix any problems and create a better product. The point of the regulations is catching mistakes and then allow people the chance to improve on the product, they are not meant to deter them from continuing, but this helps to ensure that people are not getting hurt from using the products. Also, the earlier the team is in their design work, they can more easily make changes because once the idea has been perfected and mostly completed it can be a lot tougher to actually make adjustments to meet the requirements. The initial slow steps make it easier and faster later on in the process, so the team does not need to make major changes. Also, without these regulations there would be a lot more products in the market that are possibly going to cause more harm, but also it makes the work of FDA employees easier as they do not need to deep review more products that are not even ready for testing, but can put their focus on products that are more likely to be pass the requirements. 

That’s a really thoughtful point — and one that a lot of people in medical device design struggle with. Design controls can definitely feel like barriers when you’re trying to move quickly or experiment with new ideas. Having to document every requirement, test, and change can slow down early creativity. However, those same controls are what keep innovation safe, traceable, and scalable once the idea moves toward production. In many ways, design controls don’t have to kill innovation — they can guide it. By clearly defining user needs and risks early, teams can avoid wasting time on unworkable ideas later. It’s often about timing: during the concept phase, you can brainstorm freely, but once a direction is chosen, design controls make sure it’s built right. So rather than seeing them as red tape, it’s better to treat them as a framework that protects good ideas and ensures they survive real-world scrutiny.

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse effects (lower risk). At times, some regulations may seem too much and may cause certain project timelines to run longer than needed and cost more than needed. Although there can be minimal changes made, they are important to the safety of the patients and the overall functionality of the devices themselves. In this way, design controls form a set of guidelines to follow so that there are not as many problems in the future. It in a sense guides the engineers to determine a competent process to create the device while also considering other things like risk, adverse effects, product viability, stability, and many more factors. Thinking about these types of factors and planning them prior to going in and just making something out of thin air makes the process much easier, much more organized, and provides traceability. Design controls effectively help not only the consumer but also the producer ensure safety and efficacy for all. Although they are not the end all of the regulations, they serve as the premises for how to design the device at hand and what needs to be done in order for the device to be functional and accepted by the FDA. Inputs, outputs, design, review, validation, verification, etc. all serve important roles in ensuring the device does what it is supposed to do while minimizing risk and allowing for traceability, and therefore design control serve as a basis for creating these devices.

While design controls under regulations like ISO 13485 and FDA 21 CFR 820 can feel restrictive, they actually play a dual role in innovation. On one hand, they slow things down by adding documentation, formal reviews, and verification steps that can burden small teams and limit rapid prototyping. Yet, on the other hand, these same controls help innovation by enforcing disciplined thinking — defining user needs clearly, identifying risks early, and maintaining traceability from idea to validation. This structure prevents costly redesigns and ensures that creativity results in safe, effective devices rather than untested ideas. In practice, design controls don’t have to stifle innovation if applied flexibly; when scaled appropriately to the project phase, they become a framework that supports smarter, safer, and ultimately faster development rather than mere regulatory red tape.

When it comes to the design controls be in place, I find that it will in fact lead to better results and help with innovation of the products as it places rules in place to limit the amount of risk that can happen. By doing so it allows for the process of the and rules to be in place to limit the amount of corners that can be cut, allowing  for a safer product to be released. The only thing that can be bad about them is that they can slow down the over all process as there are more steps that need to be taken, as there are many control that need to be satified before it can be release for testing. By allowing there to be documentation of all the product, it allows for a recall to happen a lot quick and knowing all of the units that were affected by it and allow for them to be pulled and taken down a lot quicker. By doing so it creates less risk and allow for more innovation to happen as the bad products can be pulled while the good ones can be sold.