These replies are great, and i’d also add that alignment between sales and marketing is key – when both teams collaborate effectively, the customer experience feels seamless. Marketing lays the foundation by creating interest and setting expectations, while sales delivers…   Read more»

These are all great points, and I would add that medical device marketing also needs to focus on transparency and education. With technology evolving quickly, it’s easy for patients or even healthcare professionals to feel overwhelmed by new products. Clear,…   Read more»

If I were to create a company, it would focus on developing sustainable healthcare technologies, specifically affordable diagnostic devices for underserved communities. My mission statement would be– innovating for equity: bridging healthcare gaps with accessible, sustainable technology.The company would focus…   Read more»

BME is a little bit of everything, and I think that’s great because you can essentially pick what aspect you’re interested in as a career. You get so many opportunities to develop those specific skills too, through degree tracks, elective…   Read more»

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 and avoid complicated tax filings, an S-Corp…   Read more»

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 creates a reliable support system, which can be crucial when…   Read more»

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 professionals like lawyers or accountants since they…   Read more»

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 with regulations and smooth product approvals. I’m…   Read more»

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 Regulatory Affairs, which act as an additional…   Read more»

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 balance of skill sets for each specific…   Read more»

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, is a crucial tool for improving traceability and responding quickly…   Read more»

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 potential bias in the FDA’s review process,…   Read more»

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 definitely complicate regulatory pathways and can slow down the approval process. This…   Read more»

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 complex materials or components from third-party suppliers, can be significant. I think the need…   Read more»

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- like drug-device hybrids or devices that incorporate software…   Read more»

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—especially since the field is still advancing. A lot of…   Read more»

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 innovation that improves safety or compliance and the ‘nice-to-have’ changes that could…   Read more»

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 suggest problems with initial estimates and…   Read more»

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, projects often involve a lot of…   Read more»

Grades and GPA do matter to an extent– if you are applying to graduate school, you need to have the grades to be accepted into a program. That academic experience is also a requirement for some jobs. I do think…   Read more»