Effective promotion and ethical communication relies heavily on how well the science is communicated. As was mentioned, marketing campaigns should be more closely aligned with the science, however not everyone may be well-versed with the technical or pharmacological aspects of…   Read more»

One factor that hasn’t been really mentioned which is important for medical device marketing is being able to capture the trust of the consumer, whether it be prospective patients or physicians. Storytelling in order to oversimply a product has its…   Read more»

To answer the question of what should the threshold of misunderstanding be, if you define a misunderstanding to be critical based on a risk that it poses to consumers through misunderstanding marketing content, then yes, that is an appropriate way…   Read more»

For long-term goals in order to remain an established company, going public is almost a requirement in my mind. A private company when it goes public should hit the ground running. As in, the company should already have some momentum…   Read more»

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates numerous poor financial decisions; it is never the result of one mess-up. A medical device can remain unprofitable,…   Read more»

One critical factor which could be overlooked with “extremely” innovative technologies would be the payback period. Payback period is the length of time estimated to break even from the development of a project. Tracking this period of time is important…   Read more»

Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focuses on being more proactive, while QC is more reactive. QA is there…   Read more»

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of “assumed” process in the documentation. In cases where employees work at a company for a fair amount of time, they…   Read more»

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their strategies in a way which makes the process quicker without sacrificing effectiveness. The QA/QC in the development stages tend to…   Read more»

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»