I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to have certain experience in middle management. Also, I have read the article that @kak33 posted and actually agree with the opinion stated in the article…[Read more]

I think I can do both. I’m more suited starting out in a middle management role then transitioning to upper management. It goes in line with what @Scott said where upper managers would be best if they spent some time with the company as a middle manager. I think that being able to complete/fulfill a task on a daily/weekly basis is a fulfilling…[Read more]

I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other…[Read more]

I agree with Mark about the formality, necessity, and process of a risk and with @dag56 about profit/risk scale. I think it would also be beneficial to have prior smaller meeting building up to this big scale meeting that Mark has mentioned. For examples, a meeting between all the engineers and scientist and PM to draw up the risks before all the…[Read more]

I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have mentioned the patients understand the risks of entering a clinical trial, but especially in the…[Read more]

As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics. A urinary catheter is an example of a…[Read more]