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 gui...

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" med...

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 fu...

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 sha...

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 an...

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...

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 alwa...

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,...

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. Whe...

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. Academi...

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 e...

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-bas...

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 throug...

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 instea...

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 mut...