Clinical research is a a complex multidisciplinary process that takes collaboration amongst clinicians, researchers, regulatory experts, and engineers. As biomedical engineers, we apply design princip...

I think one the most obvious reasons for participants to volunteer or willing join a clinical study is the financial compensation (or equivalent) they may receive for their time in the study. Not all ...

I think whether or not you need a clinical background in this specific field is highly dependent on the role you are taking. For example principle investigators certainly should have clinical experien...

As mentioned by others before me, there is certainly a psychological element when companies design their branding whether that be their logos, colors, or websites. This is no different in the medical ...

Marketing and design are different disciplines within industry, but have commonality in the sense that they both strive to understand the people using their product. Design has to take into account hu...

In present times, device innovation no longer guarantees product success, and more often than not, it is the marketing or pitching of products that determines whether or not the device makes it to mar...

I think for medical device companies the decision to go in the route of an S Corporation or C corporations depends on what the company values and their plans for growth or development. In the early st...

Having some exposure to the corporate veil from an engineering law class, I think the corporate veil is very important for owners of a company to be able to separate the liabilities of a company from ...

So I think to some degree there is definitely an moral question here over whether or not it is unethical for a company to withhold a medical device if it does not meet a 70-80%, especially if this dev...

So, I believe that its hard to definitively say which should have more resources allocated to the other. Both are equally as important in my opinion to ensuring product safety of the device. Quality a...

I have always believed that QA and QC are fundamentally important for well functioning device and or company. My thought have not really changed after the lecture and they've really only been reinforc...

As we are aware, medical device development is a long and in depth process from early prototyping, to clinical trials, and evaluations before its eventual release to market. Within every stage of deve...

I think the FDA handled the vaccine rollout as best as they could given the circumstances at the time. Like many others have said here, it wasn't a perfect rollout, but it was quite well done given th...

The FDA medical device classification system (Class 1, 2 and 3) have been in place for many years and is based upon the level of risk a device poses to a patient. However, with the advance of technolo...

I think that its really hard to say if one side dominates over the other in terms of whether regulations slow down medical device development or help innovation. I think regulations equally slow down ...