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»

Differentiation can rely less on the product itself in a time where many devices have similar features/functions and more on how businesses use patient outcomes and real-world data to create an engaging narrative. By using digital biomarkers, patient testimonials, or…   Read more»

Your explanation of the transition from LLC to S-Corp to C-Corp is great; it makes a lot of sense, particularly for a business in the medical equipment industry where scalability is important. The potential impact of regulatory constraints on the…   Read more»

I agree that cash flow, which indicates a company’s capacity to continue operating on a daily basis, is frequently more significant than profit. The impact of timing is frequently disregarded, as even successful companies may experience difficulties if cash inflows…   Read more»

Although I agree that each ownership structure has advantages, I find it interesting how a company’s innovation strategy and risk tolerance can vary depending on whether it’s private or public. The amount of risk that public firms are prepared to…   Read more»

One angle I think hasn’t been mentioned yet is how minor errors can actually reveal the “compliance culture” of a company. Even if labeling or paperwork issues don’t affect the class III device directly, the FDA can see them as…   Read more»

You both raise great arguments regarding how, depending on the company’s resources, the FDA can either encourage or impede innovation. I agree that funding and initiatives like Breakthrough Devices benefit smaller businesses, but I wonder if there’s another aspect that…   Read more»

I get what you mean about regulatory sounding repetitive, but I think there’s more to it than just paperwork. If a company wants to sell in different countries, the regulatory team has to figure out how to meet all the…   Read more»

I agree that quality assurance and risk management depend heavily on documentation, monitoring, and audits, but I believe that adaptability is another important component that is sometimes disregarded. Projects frequently encounter unforeseen regulatory changes, supply chain problems, or design failures…   Read more»

I agree that being overqualified can open doors for promotions or leadership opportunities, but I think one challenge that doesn’t get mentioned enough is job satisfaction. If you’re constantly under-stimulated or not using your full skillset, it can lead to…   Read more»