Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design review at each major milestone during the…   Read more»

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to ensure that the device is working as intended and…   Read more»

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 studies, but some do provide participants…   Read more»

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 experience or come from a clinical background. These individuals…   Read more»

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 device industry, colors are not simply chosen at…   Read more»

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 human factors like ease of use and clinical applications,…   Read more»

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 stages of the company,…   Read more»

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 their own personal assets….   Read more»

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 device is…   Read more»

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 assurance is more proactive and prevents…   Read more»

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 reinforced by the information provided in lecture. I…   Read more»

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 the circumstances. I…   Read more»

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 innovation but also benefit innovation and…   Read more»

Cutting corners in industry or in research, especially in preclinical trials, is an incredibly dangerous practice and should not be common place. Even if there are budget or deadline constraints, corners should not be cut. Cutting corners ultimately compromises the…   Read more»

Animal testing is certainly a contentious topic with some claiming it is unethical and calling for animal testing to end while others claim it is a necessary evil for the betterment of science and technology. Testing on any living creature…   Read more»

I think that utilizing different species is not necessarily a bad thing when it comes to preclinical studies. As many have pointed out already it is important to recognize that there will be differences in how different animal and species…   Read more»