We work with outside companies that design/develop our commercial medical devices. So I indirectly come into contact with DHFs, but don't have an influence on the practices of the company we contract ...

Tech File is required regardless of the class of device in the EU, whereas in the US the FDA requires a 510(k)for Class II and higher. Another difference is the Tech File as Dr. Simon mentioned in lec...

Another difference between 510k submission and a technical file is that the 510K is for Class II and above in the US. Whereas the technical file is required regardless of the class of device in the E...

I agree with the posts mentioned above. Device companies have been seeking early approval in Europe for years because it is easier. I think the two main differences that make it easier to get approval...

Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term s...

I think the First Digital Pill in US, Abilify MyCite opens up concerns about patient privacy, but also paves the way for other digital pills. For example, etect Rx is a Florida company that makes anot...

I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER. When looking at the additiona...

I think if the company wants to be successful, they need to take the regulatory submission process seriously and not embellish how similar a device is to a predicate device. Substantial equivalence m...

Participation, the fifth P of marketing, is crucial when marketing a product. You need to engage your potential client(s). At Sloan we actively market are medical devices and we will meet with compani...

I work in the office of technology development at Sloan Kettering and oversee the medical device portfolio. The trends I see that Investors/companies are looking for: 1. DATA and 2. AI 1. The number o...

Yes, I used to work in the contracts unit at Sloan Kettering. I worked on Material Transfer Agreements (MTAs), Confidentiality Agreements (CDAs), Data Transfer Agreements (DTAs) Collaboration Agreemen...

I agree with the posts thus far that interpersonal skills are crucial to succeeding. As Ken Blanchard states" None of us is as smart as all of us". When working at a company you are going to interact ...

I work for Sloan Kettering, and the organization is matrixed. I work in the office of technology development in the licensing group, which would seem that it would be a functional organization. Howeve...

I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can be executed. I agree that it can be frustrating ...

Dr. Simon, I really enjoyed this course. I found the Regulatory and Quality lectures to be very informative and useful. I work more on the business side as Licensing Associate and getting a better und...