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…   Read more»

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whether you rely on their internal QC or your QC to ensure product quality is also a very important…   Read more»

I definitely agree with what has been said about needing multiple reviews because there is usually some small aspect that can easily get overlooked at just one meeting, so it is necessary to have multiple reviews maybe it could be…   Read more»

I generally do agree with the others that one design review is probably not likely to be enough, and while technically following the law is likely not the best idea. Not only will this raise uncomfortable regulatory questions, but also…   Read more»

From working at my coop, I realized that the customers usually have many wants and they are usually not all realistic because they are simply asking for too much. Because of that there is a need for a clear conversation…   Read more»

Design teams, from my experience, tend to prioritize the most realistic aspects of a design. The end goal is to meet the customer’s requirements, yes, but at the same time, they cannot expect us to produce certain extraneous features that…   Read more»

Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. Therefore, it would be beneficial to consider the required validation methods as early as…   Read more»

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However, I believe that more generally speaking, anything that ensures the robustness of the feedback loop is the…   Read more»

This is definitely an issue that can occur. Validation should confirm that the final device meets documented user needs and intended use, not hypothetical  scenarios. When teams start adding extra testing or features outside the original user requirements, they risk…   Read more»

The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To maintain traceability, teams can utilize a design traceability matrix thank connects each user need to…   Read more»

The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & effects of the product. External factors like individual user performance can influence the product. This information…   Read more»

I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might not be able to seen later. Having several reviews helps ensure that the risks are identified early…   Read more»

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…   Read more»

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…   Read more»

I agree that multiple design reviews are needed, especially at major milestones like inputs, outputs, and validation. But to answer your question about how to ensure full traceability, I think the key lies in the systems teams use to document…   Read more»

I like how you mentioned the importance of using documents like the DID and DSD to turn user needs into measurable specs. Something that also works great for bridging that gap is Quality Function Deployment (QFD) which is basically the…   Read more»