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»

One aspect that is sometimes disregarded in my opinion, is how rules can sometimes really influence innovation rather than only restrict it. Human factors and usability testing, for instance, are required by law in the design of medical devices but…   Read more»

I agree that species similarity and ethical considerations are central, but I think another key factor is how well an animal model can replicate not just the structural, but also the functional and behavioral complexity of a disorder. For example,…   Read more»

I agree with both of you that pre-clinical research protects patients and eventually saves time and money, but I believe that their credibility-building value is also crucial. Without strong pre-clinical data, regulators, physicians, and even investors won’t proceed with a…   Read more»

I agree that pre-clinical work frequently entails a lot of moving parts before the “real science” ever begins, which makes the organizational and approval side seem like a road block. The conflict between thoroughness and quickness is what caught my…   Read more»

The emotional intelligence aspect of leadership in these circumstances is, in my opinion, something that is important. If team members feel underappreciated, conflicts may worsen even after a project manager provides a detailed explanation of the cause. Long-term disputes can…   Read more»

In the creation of medical devices, engineers and managers have complimentary roles, and I wholeheartedly agree. My personal experience with research projects has shown me that when trials must be repeated for precision, the technical side of things can occasionally…   Read more»