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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. ...

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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 require...

@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 ...

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 testin...

Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks ...

It is rare for new inventions to arise out of a clinical trial, because there is a protocol that you are to adhere to and it leaves little room for innovations, but sometimes it does happen. If you ar...

If it was a sponsored clinical trial, I would be the sponsor as @ppp23 and @mark mentions, the sponsor selects the PI, prepares and submits clinical trial application and amendments to the appropriate...

I work at Sloan Kettering Cancer Center. We perform a lot of clinical trials. Most if-not all PIs for prospective clinical trials, have clinical experience and have been involved in other clinical tri...

EI is integral in being successful in selling. I agree with @aaq2 of the definition of EI and the importance of EI in Marketing as illustrated in Kidwell’s paper. For a company or sales rep to identi...

Like @julienneviuya mentioned, pop-up shops are a very popular way to gain customer participation. From Kylie Jenner’s lip kits to Pringles, NYC is a hub of pop-up shops. Pop-up shops allow a company ...

In my other post I performed a SWOT analysis on Intuitive Surgical, the market leader in robotic systems. Intuitive is most known for the da Vinici robotic systems. It's true that for most medical dev...

I would pick Intuitive Surgical. Intuitive Surgical is a leader in minimally invasive robotic-assisted surgery, especially known for the da Vinci systems. They have the most units in operation among r...

As we discussed in lecture, a SWOT Analysis is used to measure a company's Strengths, Weaknesses, Opportunities, and Threats. Pick a medical device company/product and perform a SWOT analysis.