Both structures definitely have their pros and cons, and I think the choice really comes down to the business’s growth plans and funding needs. For smaller businesses that want to remain tightly held ...

These are all great points, and I’d also add that building strong relationships with customers, vendors, and partners plays a key role in long-term success. Networking helps establish trust and create...

These are great points. I’d just add that LLCs are usually the go-to for entrepreneurs because of their simplicity and flexibility, especially for ownership and tax options. LLPs tend to fit more for...

Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between companies and regulatory bodies, ensuring compliance ...

I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is observed on multiple levels—internally by teams like...

These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products. I think the challenge lies in finding the right b...

These are good points about post-market surveillance and the UDI system. I agree that regulatory compliance doesn't stop at FDA approval- it's an ongoing responsibility. The UDI system, in particular,...

I couldn't fully follow along with the most recent comment on this thread because it was pretty lengthy without any paragraph breaks. As for the other comments, these all raise valid points about pote...

These are great points about the FDA’s challenge of balancing safety with innovation, especially when it comes to combination products. The blurred lines between devices, drugs, and biologics definite...

These are some good points raised about the complexity of material characterization and variability in biological responses. I agree, the challenges around biocompatibility testing, especially with co...

These are all great points, and I would also add that the role of regulatory consultants becomes even more critical as device complexity increases. For example, with the rise of combination products- ...

I agree with the points made earlier about the high costs being influenced by the materials, expertise, and precision required for dental implants. As mentioned, R&D plays a huge role too—especial...

Balancing scope and innovation is definitely challenging, especially in medical device development where timelines and regulations are strict. I think that it is key to distinguish between necessary i...

Variance does give us insight into whether a project is ahead or behind schedule, but it can also serve as a signal for deeper issues. For instance, consistent variances in the early stages could sugg...

I agree that while a PM in biomed engineering doesn't need deep technical knowledge, having a solid grasp of the basics is crucial. One thing I'd add is that in fields like biomed engineering, project...