I do agree with the emphasis on the balance between QA and QC, but I would like to integrate the discussion of cost and efficiency into the balance. If QA is done well, this would reduce the number of...

@krp67 I found your internship experience at Paramount Metal Finishings quite interesting, particularly the portion where you discuss how QC investigated whether rust issues were caused by drying, hum...

As embedded software is now a critical component of medical devices (e.g., insulin pumps and pacemakers), I have found that quality assurance processes extend beyond just functionality to encompass pa...

Something I would like to introduce to the discussion is the complexity of post-market surveillance and regulation for combination products. Contrasting standalone products (e.g., devices/drugs), comb...

Another important point of delineation lies in the fact that clinical trials for medical devices often incorporate a higher degree of iterative design than for pharmaceuticals. Pharmaceuticals or drug...

These are all great posts covering the various facets of regulation. One point that has not been raised is the contrast of regulation between the United States and countries outside the US. The FDA is...

I agree that it is critical to choose a model that offers translatability to ensure therapies/devices being tested will actually be safe in humans. However, I would like to bring up the ethical standp...

A topic that has not been addressed yet is how risk tolerance influences academic and industrial regulation. Typically, industries have faced stringent regulation and oversight, as pre-clinical studie...

The responses thus far have already encompassed the feelings of guilt and potential reputational impacts, in addition to financial consequences when research is not finished. However, there is another...

Variance can definitely be a problem of poor estimation, but it can also reflect the health of a project in terms of its human and organizational aspects. If there are consistent schedule variances ea...

I think the stakeholder groups brought up thus far are all legitimate options; however, a stakeholder group that is often overlooked in these discussions is regulators and healthcare providers. If a m...

To preface, I am still an undergraduate student, but I am somewhat familiar with various project management tools. Thus, I thought I would weigh in here. Specifically, in medical device development, I...

I do agree that firm regulations are critical to the medical device industry; however, I do think a balance needs to be struck between safety and the opportunity to bring innovations to market. Ultima...

As someone also interested in academia, I have thoughts about being a successful professor. I believe a successful professor should have prior experience outside of academia in their respective field,...

These are all excellent points regarding what defines academia and industry. However, I do have a different take. I personally do prefer academia over industry. As you all had touched upon, academia o...