Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications associated with it to provide the correct…   Read more»

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note everything that was done from the initial design to the finished product….   Read more»

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadline for the finished product is…   Read more»

If I were a manager updating design controls, I’d start by improving communication and training before changing any documents or systems. Too often, people see design controls as roadblocks because they don’t fully understand how they fit into the bigger…   Read more»

I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they shouldn’t completely merge. Doing both together can help teams spot issues early and make adjustments before things get…   Read more»

I agree that vague feedback can be hard to use, but I think teams can still learn a lot by watching how customers actually interact with a product instead of just relying on what they say. Observation and prototype testing…   Read more»

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…   Read more»

I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, going back to revise the DID or DSD can slow everything down. But I personally don’t think companies…   Read more»

I was thinking about this too! From what Dr. Simon explained, design verification is all about making sure our design outputs match the design inputs, and design validation checks that those inputs truly support the user’s needs. I do think…   Read more»

For my capstone project, my group and I created a wound healing hydrogel for cutaneous wounds. The main issues in design and development were the design of the mold used to shape the hydrogel (this was my job) and finding…   Read more»

I don’t think that there is ever a time when a team decides to log more inputs for predictive measures. If they did that, they would have to log more outputs. If the team has more ideas of possible risks,…   Read more»

I am not aware of any companies that encourage their employees not to record unsuccessful instances associated with the medical device in the verification report. If a company does do this, when they submit the Design Verification File, which is…   Read more»

Without strong design control, medical device can become risky because it helps keep the whole process organized and safe. If it’s not done properly, many problems can happen, like design mistakes or unsafe products reaching patients. For example, if a…   Read more»

Yes, I definitely feel safer knowing that validation and verification are key parts of the medical device development process. The process verifies that all devices fulfill their design requirements while providing safe and efficient performance in actual operational environments. The…   Read more»

Risk management operates together with design verification and validation to detect all possible hazards which get evaluated and managed from start to finish during medical device development. The activities of risk assessment and mitigation receive coordination through three main techniques…   Read more»

Medical device development needs design control as its fundamental requirement to confirm that products meet safety standards and quality benchmarks and user requirements. Design control systems that operate with insufficient strength or improper application create major issues which result in…   Read more»

Both the placebo and nocebo effects provide valuable insight into how psychological factors influence physiological outcomes in clinical research. I find the placebo effect more beneficial overall because it helps researchers determine how much of a treatment’s success can be…   Read more»

Biomedical engineers play an increasingly central role in clinical research as the boundary between medicine and technology continues to narrow. Traditionally, engineers were seen as providing technical support to clinicians—designing devices, processing data, or developing software tools. However, the modern…   Read more»

I think biomedical engineers play a much more active role in clinical research today than ever before. As technology and data analytics become essential to clinical trials, engineers are helping to bridge the gap between the technical and clinical sides….   Read more»