I agree with the different backgrounds addressing different roles such as statistican, regulatory submission expert or a biomedical engineer attached ...

The value of clinical studies in my opinion, looks at the larger picture of society. We would all probably agree that if a product, medical device or ...

So I agree with your comments regarding that medicine involves situations where values come into conflict. I also think that the regulators such as th...

I think most folks would sense if they are being manipulated during a sales cycle or reading marketing literature. In the healthcare industry, working...

Most companies in the healthcare industry have created mission and vision statements like Stryker, Novartis and Pfizer. They have cascaded that approa...

I have also seen in the pharmaceutical side similar approaches with physicians giving presentations on the use of the product and results. I personnal...

I understand how you have evaluated BMS. Clearly they have had some rough patches in their history but so has many biopharmaceutical organizations. I ...

Actually this is a great topic. I am currently evaluating options but I probably going to the LLC route. I am providing consulting in the cell and gen...

I understand what you are saying with regards to the company's mission and vision. Having work for both large and small organizations, currently worki...

This reminds of me of another reply I made earlier. Quality should be shared across the organization. While a quality organization is important to ens...

I agree with the concept that quality control is not solely a final product testing process. The ability to merge quality control testing in-line, on-...

The value of digital transformation with the various technologies such as IIOT, Artificial Intelligence, etc. to the "Quality" of medical devices woul...

I think innovation can be conducted especially with physicians and health care providers, but thinking of the product life cycle of a medical device, ...

So my perspective is that FDA seems to be harder on larger firms than smaller ones. Having worked with big companies such as Roche, Merck and Pfizer, ...

I worked on a combination product a few years ago for Pfizer. it was Xyntha a drug for Hemophilia A patients. The key to the product was to make a sim...