I agree with the different backgrounds addressing different roles such as statistican, regulatory submission expert or a biomedical engineer attached to the clinical study for provide technical suppor...

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 drug were developed and approved without a definit...

So I agree with your comments regarding that medicine involves situations where values come into conflict. I also think that the regulators such as the FDA have put in place regulations to temper the ...

I think most folks would sense if they are being manipulated during a sales cycle or reading marketing literature. In the healthcare industry, working with professionals such as physicians we need to ...

Most companies in the healthcare industry have created mission and vision statements like Stryker, Novartis and Pfizer. They have cascaded that approach down to divisins and departments if the company...

I have also seen in the pharmaceutical side similar approaches with physicians giving presentations on the use of the product and results. I personnally think the "word" of physicians gives the produc...

I understand how you have evaluated BMS. Clearly they have had some rough patches in their history but so has many biopharmaceutical organizations. I think they have made some major changes in the onc...

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 gene therapy industry with another consulting organiz...

I understand what you are saying with regards to the company's mission and vision. Having work for both large and small organizations, currently working for a LLC, I would suggest that size will matte...

This reminds of me of another reply I made earlier. Quality should be shared across the organization. While a quality organization is important to ensure testing or auditing is performed, manufacturin...

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-line and merge with manufacturing process controls...

The value of digital transformation with the various technologies such as IIOT, Artificial Intelligence, etc. to the "Quality" of medical devices would have similar impact to other technologies over t...

I think innovation can be conducted especially with physicians and health care providers, but thinking of the product life cycle of a medical device, starting with the idea generation all the way to s...

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, the kind of questions and challenges we receive is...

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 simplified dosage for home use with a dual chamber sy...