I agree with both participants that medical device marketing techniques must adapt, especially with technology and engineering. Building on this, the Marketing & Sales lecture highlights that medical device marketing must always satisfy customer demands, which include healthcare professionals and…   Read more»

While it’s clear that nonprofit organizations focus on public benefit, and the cost structure for a medical device or pharmaceutical company presents significant challenges, I think it’s also important to consider the unique niche that nonprofit tissue banks can fill…   Read more»

Interesting points, everyone. While I agree that a sole proprietorship isn’t a corporation, it’s crucial to highlight that the key difference stems from the concept of liability and how the business is treated legally. In a corporation, owners (or shareholders)…   Read more»

I agree that FDA advisory committees must consist of a variety of experts; yet, I would also add that manufacturing and regulatory considerations are just as vital as clinical and statistical knowledge. Regarding necessary knowledge, members should not only have…   Read more»

Regarding the need of quality assurance (QA) and control, everyone has raised excellent arguments. Furthermore, I believe that one can’t overlook the vital part supplier quality management plays. Audits and inspections are essential for guaranteeing compliance—not only inside but also…   Read more»

Maintaining system interoperability with third-party applications is another difficulty when switching ERP/QMS systems. Integrating specialized solutions for maintenance management or supplier management with a new ERP/QMS system might be difficult.Data silos can result from systems not communicating, making it hard…   Read more»

You’ve highlighted important aspects of the FDA and CDRH’s roles in regulating medical devices. One additional point to consider is the significant role of post-market surveillance in the regulatory process, particularly for higher-risk Class II and III devices. The FDA…   Read more»

I agree that harmonizing regulatory filings is essential, and building a core dossier is an effective approach. One challenge not yet mentioned is the need to manage post-approval variations across different regions. After initial approval, regulatory agencies such as the…   Read more»

I agree with your points about the FDA’s role, and I think another significant challenge is the complexity of regulating combination products, like drug-releasing stents or cell-seeded scaffolds. These products often blur the lines between devices, drugs, and biologics, making…   Read more»

Absolutely, I agree that regulatory consultants play an invaluable role in guiding companies through the complex landscape of medical device development. Beyond the critical support in the preclinical phase that you’ve outlined, another area where consultants prove crucial is in…   Read more»

The regulatory environments for pre-clinical research in industry versus academia exhibit notable differences driven by their end goals and the nature of their outcomes. In the industry, the process is heavily regulated to ensure that medical products meet stringent safety…   Read more»

I agree with your point, and the lecture reinforced the importance of starting the execution phase only after thoroughly completing the Initiation and Planning phases. The Initiating Phase is essential for gathering all necessary information. By using existing project documents,…   Read more»

I agree that navigating the medical device development process from concept to market is indeed intricate and requires a deep understanding of regulatory, quality, and clinical aspects. The comprehensive programs offered by medical device schools are invaluable in providing this…   Read more»

I definitely see similar changes coming to biomedical companies as we’ve seen in other fields like software engineering and automotive technology. For instance, AI is already transforming medical devices, with advancements such as autonomous robotic surgery and sophisticated prosthetics. AI-powered…   Read more»

In addition to the personal and professional benefits that have been discussed, I believe the academic benefit of student-teacher relationships lies in the development of critical thinking and adaptability in both parties. When students and teachers engage in a meaningful…   Read more»

I agree with your point about the importance of having adequate medical personnel and facilities to conduct trials effectively, which can be difficult for some companies to manage in-house.In addition to potential size and resource constraints, another common reason a…   Read more»