Design control plays a huge role in developing safe and effective medical devices, but problems can definitely arise when it isn’t followed properly. If design inputs aren’t well-defined or don’t clearly connect to user needs, the product might end up failing to meet its intended purpose. On top of that, if teams skip documentation or do it halfway, verification and validation become much harder later on, which can slow down approval and potentially introduce safety concerns. Even though the design control process can feel time-consuming, not taking it seriously usually creates bigger setbacks in the long run.

I think the biggest issue is that the device would fail in the market. If a product is poorly designed or has insufficient design controls, the product wouldn't really meet client needs. i think it would also have insufficient risk management as well since a poorly designed product would have poorly designed procedures and protocols. You also wouldn't be able to know verification or validation since you wouldn't know what the product is actually intended for. I think if a product is poorly designed or has insufficient design controls, it can lead to a whole list of consequences. That is why it takes a long time for a product to go through trials and testing before it actually goes on the market, because if it was bad and it was put in the market, it would reflect poorly on the company, do poorly in the market, and would ultimately drag the company down.

In medical device development, design control offers structure and traceability, but if the procedure is not strictly adhered to, problems might undoubtedly occur. One significant issue is inadequate documentation, which makes it nearly impossible to prove compliance during an FDA audit if inputs, outputs, and design modifications aren't adequately documented. Inadequate risk management is another problem; neglecting or hurrying through risk assessments can result in post-market or production-related safety issues. Inadequate design validation and verification can also result in products that don't satisfy user requirements or legal requirements, which can result in recalls, financial loss, and harm to the company's reputation. It's also worthwhile, in my opinion, to ask why you believe certain teams fail to implement design controls. Is it because of a lack of training, time constraints, or a possible undervaluation of the significance of documentation? And do you believe that putting in place automated traceability tools or digital design control systems could lower human error and increase overall compliance?

A recent (2024) example of insufficient design controls is Tandem Diabetes Care’s t:slim X2 insulin pump mobile app recall. The iOS version of the app had a software glitch that rapidly drained the battery for the pump, which caused it to shut down unexpectedly. This led to more than 200 reports of severe hyperglycemia and diabetic ketoacidosis. The issue showed a failure in software verification and system level validation, especially in testing how the app interacted with the hardware of the pump under real world conditions. It highlights the growing challenge of ensuring design controls extend beyond the device itself to include connected mobile applications and Bluetooth communication.

One issue that would arise is the failure of meeting its intended purpose. Without proper design controls, a product would most likely never make it to its end stages with proper functionality. Product recalls, risks, and general non-compliance would occur in these cases because the device was not made using proper design controls. For example, I worked in the pharma industry, which is different from medical devices but follows very similar procedures. Without design controls for our products, there is no traceability, which would lead to no way of knowing what to do and the proper steps to follow due to lack of documentation. The lack of design history, any changes made, etc. would result in the end product not only having incomplete functionality but would also cause there to be no way to have reproducibility of the product once again. Design controls are essential to ensuring that everything follows a proper process, the customer needs are met, and the end product is what you intended it to be and functions how it is supposed to. 

Improper implementation of design control might lead to several issues later on. Problems with the device may not become apparent until the end of development or even after it has been put on the market. It's quite difficult to determine where things went wrong or why a requirement wasn't satisfied if there isnt accurate documentation and traceability as delays, costly redesigns and patient safety hazards may result from that. Incomplete records make regulatory approval much more difficult too. 

Design control is definitely one of the most important parts of developing a medical device because it helps ensure safety, effectiveness, and regulatory compliance. But when it’s not applied properly, a lot of issues can come up. From what I’ve seen during my time as a quality control intern, one major issue is poor documentation. If design inputs, changes, or verification steps aren’t clearly recorded, it becomes difficult to trace where an error happened or prove compliance during an FDA audit. Another problem is when teams rush through the process to meet deadlines, which can lead to missing risk assessments or skipping proper validation testing. This not only increases the chance of product recalls but can also delay approvals since regulators might require additional evidence. Overall, insufficient design control affects both quality and efficiency in the long run. So, what do you guys think? How can companies make design control feel like part of innovation instead of just a compliance task?

Some of the consequences that may arise from the from faulty design controls is that the product can be more likely to fail and there is no fail safe options when it come to the fixing the broke product or taking it off the shelf. These rules are put in place to help with limiting of unclear and non-concise processes that can happen when producing a product that needs to work and not fail. By doing so the product is less likely to fail, and if it does the cause is more likely to be identified and be recalled correctly and efficiently for that line of the product. Have clear and concise requirement in place ultimately reduce that risk allow for a successful product to be placed into market.