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 with other…   Read more»

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. However, my role includes licensing a portfolio of…   Read more»

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 for upper management to make…   Read more»

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 understanding of the other roles/departments involved…   Read more»

When I first started at Sloan Kettering, I worked in the contracts unit which handled agreements including NDAs. Usually contracts units use in-house counsel to develop templates. Honestly most NDAs include are very similar 1-2 page documents with standard sections/terms….   Read more»

I used to work in the contracts group at Sloan Kettering and we would execute over 300 NDAs a year. As advice, I would say don’t be afraid to negotiate a NDA. Sometimes people just see an NDA and sign….   Read more»

As many have mentioned there is a big difference between an NDA and a patent. An NDA allows two parties to discuss confidential information. In industry if you have a product and you would like to discuss the confidential information…   Read more»

I agree with @gaberuiz13 that the organizational structure can lead to different company cultures and those in turn can have an affect on projects. There are many different types of companies and projects some might foster a better company culture…   Read more»

I agree with @hm243 that its healthy to have a some competition, but if becomes negative competition that could be detrimental to the company. I work in a functional organization structure in the licensing group. Our particular group is competitive…   Read more»

I currently work in a functional organization where as @aaq2 mentions, the functional head has a lot of power and make the decisions. As mentioned in lecture one of the main disadvantages is that we are one of many silos…   Read more»

I agree that #4 “Risk management is not a lifecycle process” and that it is a mistake to think that once the development process is completed that the risk management documentation ends. I agree with @smk45 that it should be…   Read more»

One Factor is Disease chronicity as described in “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” For example if a patient has a chronic disease but they have “adapted to their illness”…   Read more»

As many have stated ISO 14971 is the major ISO regulation governing Risk Management.I agree with @thuytienleco that the major phases include: risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, evaluation of overall residual risk acceptability, risk…   Read more»

I agree with comments above that verification is important to ensure that all specifications originally laid out in the inputs are implemented correctly and comply with previously determined regulations/standards. As Dr. Simon mentions verification checks that ” inputs= outputs”. I…   Read more»

As mentioned in the slides a Verification Protocol consist of: Taking all the outputs, making a test for each one, and listing all the tests in a document. My example of a verification test will be surgical gloves. As mentioned…   Read more»

Trouble adding link to comments: nishithdesai /fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medical_Device_Industry

I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases…   Read more»

In learning more on the FDA website about design controls, I found the International Medical Device Regulators Forum, which is a global approach to monitoring the manufacturing of medical devices in order to improve their safety and oversight at an…   Read more»

It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards…   Read more»

Test-having trouble posting multiple sentences. disregard.