Posted by: Josh Many who work on medical device projects never really get training in basic business. Those who have business degrees will find this module to be quite elementary, but it is often the ...

Hi Marvin, I agree that there are a number of challenges that the physician might face while trying to develop a medical device. I also agree that the cost and regulatory considerations are chief chal...

Like Marvin said, I think some of the main challenges surround securing funding and navigating the regulatory landscape. Additionally, I think the physician might encounter challenges in the developme...

In my experience working in a regulated production setting, the QC and QA teams have existed essentially as two sides of the same quality coin. Quality control typically proactively executed their dut...

When evaluating the biocompatibility of a prospective biomaterial, the types of tests required for initial evaluation include cytotoxicity, sensitization, irritation, genotoxicity, implantation, and c...

In a situation like this, issues and pitfalls I would guard against, surround the logistics and continuity of a study being outsourced and conducted 1000 miles away, as well as the potential for bias ...

If I were managing a medical device project that focused on the delivery of medication to a patient, two modes of delivery I might consider would be application via surface device or implant device. T...

Hi Dr. Simon, I think the drug-eluting vascular stent is a great example of a combination therapy and the overlap between bioengineering and biomedical engineering. Stents, commonly applied as vascula...

To me, the executing phase seems like the most important part of the project life cycle. While insufficient management of the other stages could result in a less than ideal outcome, insufficient proje...

Looking around at Bioengineering and Biomedical Engineering program curricula at the BS and MS levels, I noticed that generally, the bioengineering courses applied traditional engineering concepts to ...