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 failures…   Read more»

@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, humidity exposure, or chemical balance. The reason I found this quite interesting…   Read more»

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 patient safety and regulatory compliance. Looking specifically at IEC 62304 (targeted…   Read more»

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), combination products have unique challenges for regulation, especially if one component (e.g., biologics) is working…   Read more»

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 drugs are often times developed via in-vitro testing for years before beginning…   Read more»

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 in charge of regulating the…   Read more»

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 standpoint. While conducting studies, both investigational research…   Read more»

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 studies were ultimately designed with the goal of FDA approval and integration in…   Read more»

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 aspect I would like to add, and that is the effect…   Read more»

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 early on in a project, it may…   Read more»

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 medical device project takes off and becomes abundantly successful,…   Read more»

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 have noticed that when choosing the right project…   Read more»

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. Ultimately, regulations create a baseline of safety…   Read more»

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, as well as some experience in academia in the same…   Read more»

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 offers greater flexibility in terms of ideation, project…   Read more»