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. I can tell you from experience that you can definitely redline and negotiate an NDA. As others have mentioned, be sure to read the definitions of…[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 with other parties for example other companies you make work with or license the product, in order to keep the…[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 in a functional organization or maybe a collaborative teams in a project-based organization or maybe…[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 because we want to see who can get the most/best (lucrative) license deals done in a year. I think…[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 which can be detrimental to sharing information and culture. I work in the licensing group, but then you have contracts legal…[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 treated as a “living” document. As Dr. Simon discusses in lecture there should risk management documents in DHF: Risk…[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” and it doesn’t effect their daily lives as much they are less likely to tolerate…[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 management report, production& post-production. I also…[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 also agree with @srg56 that its important to have realistic…[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 in lecture PDCA- Plan, Do, Check, Act.
1. Make a test for it- Durability-Puncture test (tensile test, and forces and…[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 especially with medical devices for validation to be done. Validation is key in determining and…[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 international level. They have developed specific documents for advancing a Medical Device Single…[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 of safety and quality for most medical devices. However this expected to change with the…[Read more]

Test-having trouble posting multiple sentences. disregard.

As @JP528 and many others have described the guidelines that the FDA lays out to make sure that you designed a safe product that meets the user needs and requirements as stated in FDA 21 CFR 820.30. I found an interesting website regarding Design controls in the US. and also making the comparison to FDA clauses for Design Controls to ISO 13485…[Read more]

Test-ab

According to the FDA, “the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.”
I came across this int…[Read more]

@srg36 there is a difference between inventorship and ownership. Even if an employee comes up with an invention at most hospitals and research institutions you assign you rights to the employer. This is actually usually included when you sign your employee agreement on your first day with HR. At sloan, if you create an invention while you’re an…[Read more]

I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have mentioned the patients understand the risks of entering a clinical trial, but especially in the…[Read more]