I agree that clearer limits might help, but one thing that hasn’t been mentioned is how inconsistent a single numerical cap would be across regions. A $100 meal can be modest in one city and unrealistic in another, so even…   Read more»

One thing I don’t think has been brought up yet is how verbal agreements become risky simply because people change. Teams shift, managers leave, and projects get handed off. Without written documentation, the original intent of a verbal agreement can…   Read more»

One thing I think hasn’t been mentioned yet is that a consulting agreement can become risky even when the contract itself looks perfectly compliant. Regulators don’t just look at what’s written, they look at how the relationship actually plays out…   Read more»

Another important factor is the extent to which the team’s members influence whether leadership or management works better. Different personalities respond to different styles. Some engineers thrive under clear structure, checklists, and predictable expectations because it helps them stay focused and…   Read more»

I think a big reason teams struggle to connect Design Controls with Project Management is simply that most engineers were never really trained in PM tools to begin with. Design Controls feel familiar and safe, so teams naturally default to…   Read more»

Something I think doesn’t get talked about enough is how much the environment affects whether someone actually feels comfortable speaking up. It’s not always about if we should raise the concern, but sometimes it’s about whether we get shut down…   Read more»

One issue I see with depending too much on FMEAs is that they are predicated on the idea that failures occur one component at a time in predictable ways. However, contemporary medical devices do not malfunction in neat, linear sequences,…   Read more»

One thing that often gets overlooked is that risk isn’t just tied to the device design but it’s tied to the patient using it. Two people with the same pacemaker can have completely different reactions due to comorbidities, genetics, drug…   Read more»

Sometimes a mitigation doesn’t make the product safer overall, it just transfers the risk to a different user group, workflow, or failure mode. For ex., adding too many alarms on a medical device can reduce one specific hazard, but it…   Read more»

Everyone’s shared great technical solutions, but another issue behind documentation fatigue is how people interact with the process, not just the tools themselves. When updates feel like busywork instead of part of the project’s story, engagement drops.   Organizations could…   Read more»

Everyone’s made great points about prediction limits and company oversight. Another major gap is that verification and validation don’t really reflect real-life patient diversity. The DePuy implants may have passed lab tests, but they didn’t consider how factors like bone…   Read more»

While many have raised valid points about adaptive algorithms and overconfidence in structured systems, I think a modern “Therac moment” could result less from technical gaps and more from ethical and organizational blind spots. Current design controls ensure functional safety,…   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»

One thing I’d add is that CRAs help maintain safety and data integrity not just through monitoring, but through ongoing site training and communication. Even with ICH-GCP standards, different sites vary in experience, so CRAs make sure staff understand why…   Read more»

I think digital tools and AI are helping find eligible patients faster, but one challenge that still gets overlooked is the actual burden of participating. Even if someone wants to join, things like transportation, work schedules, childcare, or needing a…   Read more»

I feel like biomedical engineers play a more active role in clinical research rather than just a supportive one. Yes, they help design devices and analyze trial results, but they also make sure those technologies can actually work in real…   Read more»

Dexcom is another company that has been doing great and growing. It’s a business known for its continuous glucose monitoring (CGM) devices, and has had impressive development in recent years. With the help of international growth and expanded insurance coverage,…   Read more»

I think your description of it as “serious science meets stand-up comedy” is really accurate. Especially for those who are not very knowledgeable about science, storytelling undoubtedly makes complicated devices more understandable. But who the story is for, in my…   Read more»