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 product drug or medical device a stronger message and…   Read more»

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 oncological space including the acquisition of Celgene….   Read more»

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 organization who is a LLC also at…   Read more»

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 matter as well as reliability and consistency….   Read more»

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, manufacturing, supply chain, marketing, everyone needs to develop and support…   Read more»

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 is vital to ensure better quality with real-time communication…   Read more»

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 the last forty years. The ability to communicate and share information…   Read more»

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 support of an on market product, is…   Read more»

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 more than what I…   Read more»

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 syringe….   Read more»

I do not think the concept of animal testing is unethical in general. However, it could become unethical if we treat the animals inappropriately by not designing the experiments correctly. For example, reducing the number of animals for testing by…   Read more»

Very interesting debate. As others have stated both are necessary. Short term and long term research is needed for the patients and stakeholders of medical devices. As long as academia and industry both participate in medical device development both will…   Read more»

So as far as biomaterials go, the selection process has both a technical perspective but from a project management perspective needs to align marketing/sales, cost, scheduling. regulatory and risk. The project manager needs to develop a collaborative process to evaluate…   Read more»

I agree but I also think a good project manager needs a few critical characteristics. One would be able to organize the scope, cost, schedule and resources. Being able to create a plan of the critical project elements and be…   Read more»

I think project management of medical devices has some few unique aspects in relation to other types of projects. i would like to discuss three areas; product complexity, uncertainty and risk/product liability. Medical devices are becoming more complex with regards…   Read more»

I have been involved in several combination products and what I find interesting is that the pharma drug development and the device development seem to be treated as separate projects. An example is the drug product formulation is done first…   Read more»

Most of my work experience has been in industry with several pharmaceutical companies and now cell and gene. I can understand how many students feel comfortable with the academic world and for some this is the right decision. I think…   Read more»

Okay let me bring in a different way of looking at this. Generalists versus specialists. Due to creating new knowledge whether in BME or in any field, there will always be a tendency to want to initiate specialization. I would…   Read more»

I think one of the biggest impacts is the limited supply of components to manufacturing especially from Asia. The crisis has impacted organizations to underproduce with plant shutdowns. Supply chains will need to deal with more inventory and multiple suppliers…   Read more»