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»

You bring up an important point regarding the cost of dental implants. I agree that the use of high-grade materials like titanium or zirconia, combined with advanced technology and specialized expertise, drives up the price. Additionally, another factor to consider…   Read more»

I agree that navigating ISO 10993’s biocompatibility requirements poses significant challenges, especially when dealing with complex materials and rapidly evolving medical technologies like nanomaterials and bioresorbables. In addition to the financial and time constraints mentioned, another hurdle is the global…   Read more»

I agree with the previous points on the importance of regulatory consultants in medical device development, particularly with their role in bridging communication between companies and regulatory bodies like the FDA. I would also like to highlight the importance of…   Read more»

Industry and academic research have different regulations mainly due to their end goals. Industry follows strict guidelines like FDA’s GLP since their products need to be market-ready and safe for patients, requiring detailed documentation and compliance. Academic research, though, is…   Read more»

Biocompatibility throughout a medical device’s lifecycle is super important, especially for long-term implants like joints or dental implants. Manufacturers can’t just rely on picking the right material; they also have to consider surface modifications, like roughening implants to help bone…   Read more»

One of the biggest challenges with ISO 10993 is definitely the cost and time involved in meeting all the biocompatibility requirements. Companies often struggle with figuring out the right tests, especially when dealing with new materials like nanomaterials or bioresorbables….   Read more»

It is difficult to say whether research for the future or the present is more important, both are necessary for the advancement of medical knowledge in society. I would make the argument that research for the future can have pitfalls where it…   Read more»

I’m actually quite surprised that no responses have brought up bioreactors yet. Yes, it is true that the Institutional Animal Care and Use Committee (IUCUC) have set up a system to make animal testing the most ethical it can be,…   Read more»

Extensive in vitro and in vivo testing is required to solidify the biocompatibility of a medical device throughout its entire lifecycle. Depending on the device, its life cycle within the human body could be varied from a few days to…   Read more»

There are similarities and differences in the desired qualities of an engineer in the industry versus a researcher in academia. Both fields require expertise in knowledge, however, academia prefers graduate level education. One can work in the industry with just…   Read more»

It seems as there are mainly students participating in this, that most are speaking from personal experience, as will I. I have had professors who are research lab leads and are conducting innovating research in their on campus labs. The…   Read more»

If I were to have the option to conduct research in academia or industry, I would choose academia. When researching in academia, you are given almost a free range of possibilities to peruse what interests you most. You are able…   Read more»

Generalizing professors and their interests is unjust, so it is safe to say that the answer to this question varies based on the professor, which we have all experienced first-hand as students. Some professors are solely concerned about their research…   Read more»

The Institutional Animal Care and Use Committees (IACUCs) exists to achieve the balance between necessary, safe animal testing and maintaining animal welfare, minimizing the use of animals in pre-clinical trials when possible. Although the IACUCs have federally required guidelines that…   Read more»

As one of the professors in the biomedical engineering department at NJIT once said, “biocompatibility is not a real word”. Obviously, it is a real word. He was trying to explain to his students that the human body will always…   Read more»

During my undergraduate studies, I did research in a brain trauma lab where we primarily used mice and rats. For every test we wanted to run, whether it involved administering substances or inflicting injury, we had to write and submit…   Read more»

I believe the extent of a professor’s passions in academia and research depends on the individual professor, but often professors have a mix of these motivations. I have had professors who have been deeply passionate about the subject they teach,…   Read more»

Building on the points already mentioned, another key difference lies in the documentation and reporting requirements between industry and academic research. In industry, it is essential for documentation to be detailed and structured, not only for regulatory compliance but also…   Read more»