I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of medical devices, but with constantly changing guidelines, having a perfect understanding of regulatory regulations for engineers is…   Read more»

I do think that if a reform is needed on the classification of medical devices in the FDA, the time to do it should be in the near future before too many problems arise in classifying “in between” medical devices. Less…   Read more»

I agree with the opinion that smaller startups should focus more on innovation than compliance since it can give them a good product to stand out. This lets them develop opportunities for receiving funding, which can allow for an easier…   Read more»

Starting research on time in industry is realistic, but fully completing research on time is less realistic. The deadlines in industry are often there to demonstrate that progress is being made to shareholders. Having shareholders that are happy with the…   Read more»

I do agree with the next step for pre-clinical research before testing on humans is the substitution of animal testing with computer simulations, but in reality I don’t think this will be happening any time in the near future (hopefully…   Read more»

The choice between novel and tested materials ultimately comes down to balancing the benefits versus the risks a company is willing to take to gain from a market. Materials that are already proven are most likely mass-produced in some capacity,…   Read more»

Over-planning sounds like it would lead to a more straight-forward project, however it could complicate risk management processes. While meticulous planning could account for many risks, there is always a chance something is overlooked. What if the alternative for a…   Read more»

As you mentioned, projects may not go exactly as planned, especially in medical device projects. A lack of organization can mean that a project fails to pivot quickly enough to address issues, delays, or regulatory problems. An organized project manager…   Read more»

I would say that the biggest obstacle in projects is making sure everyone does their fair share of work. Disagreements can be solved through discussion, and more than likely a solution will arise. When individuals have a disagreement about the…   Read more»

For transitioning between careers within BME, I would think that it is harder to transition from academia to industry, than from industry to academia. This makes me lean more towards industry. Academia and industry are two completely different working environments;…   Read more»

I believe that a successful professor should have some experience in industry, however successful can be defined by different definitions. For a professor who puts measures success by their teaching effectiveness, gaining industry experience prior to becoming a professor can…   Read more»

For an improvement in the industry, I think the use of AI is showing signs that is is helping accelerate progress in medicine. On the news, I read about a medical device company which developed AI-based software for identifying ovarian…   Read more»

As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either through public announcements or coordinating return…   Read more»

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instead of the pharmaceutical companies. The financial planning…   Read more»

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance pathway. For example, Canada and the US have a mutual agreement which essentially help approve new medical devices in both…   Read more»

Assuming that once a smaller companies has identified a suitable clinical trial management company to contract with, payment could become a key part in managing the contract between the two companies. With smaller companies, monetary resources may not be so…   Read more»

One factor which can make or break communication within a clinical trial and project is communication latency. The time from delivery to acknowledgement of a message can be critical when it comes to completing stages of a clinical trial and…   Read more»

One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical trials may be the quantity of patients a company may be able to find. For medical…   Read more»

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company called Inovio. They were developing a…   Read more»

WBS should be closely aligned with a company’s risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as well can make areas with more uncertainty more visible to…   Read more»