Both of your points highlight the diverse motivations for participating in clinical trials, from access to innovative treatments to contributing to medical research. One additional factor that I think...

In clinical trials, several key players, including sponsors, investigators, Contract Research Organizations (CROs), and Institutional Review Boards (IRBs), each have distinct roles and responsibilitie...

While clinical trials provide valuable data, they often miss important issues that only emerge through post-market research. For example, long-term side effects may not become apparent during the rela...

Engineers can leverage their technical expertise in customer-facing contexts through sales and marketing roles in the medical device business. These positions entail more than just typical sales; they...

If I were starting my own business, I would specialize on designing cutting-edge biorobotic prosthesis for people with mobility problems. My company would be a biomedical engineering firm. The followi...

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 medi...

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 importan...

When setting up a corporation, one important decision is whether to go with an S-Corp or a C-Corp structure. Both offer limited liability and can raise capital, but they differ in terms of ownership r...

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 i...

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 knowledg...

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. Audi...

Maintaining system interoperability with third-party applications is another difficulty when switching ERP/QMS systems. Integrating specialized solutions for maintenance management or supplier managem...

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 p...

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 di...

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. Thes...