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…   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…   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…   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…   Read more»

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 regulatory agencies and ensures that the clinical…   Read more»

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 trials. Some PIs have relationships with industry and…   Read more»

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 identify and have the…   Read more»

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 to introduce a product/line to the market…   Read more»

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 devices you never see any television…   Read more»

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 robotic systems. Today, there are more than 4,100 Intuitive Surgical…   Read more»

Medtronic It’s important to have a vision and mission statement to provide direction, it is the foundation of a company. Vision is a general broad statement that communicates the company’s values. Whereas a Mission statement defines how the company will…   Read more»

As many have stated, the main difference between a private and public companies, is that public companies have stocks that are traded publicly and there are many stakeholders in the company. Another difference is that in private companies, the shareholders…   Read more»

If I had my own device/biotech company, I would do the paperwork to set up a corporation-C corp. The advantages of setting up a corporation were discussed in the lecture; you can sell shares to raise money, you can get…   Read more»

Reading this question I thought instantly of Martin Shkreli the 34-year-old chief executive of Turing Pharmaceuticals, who had raised the price of the life-saving drug Daraprim from $13.50 to $750 per pill. Mr. Shkreli was accused of defrauding investors in…   Read more»

I agree with @bb224 and @asimbana that for a medical device company of mid-size with 50 people and $10 million in revenue they should be an Inc so they have the ability to go public and spark some interest and…   Read more»

I did some research on Amgen Inc. Amgen is up 6.84% in sales with 5.8B in revenues with Net Income of $2.2B. Quarter Financials as of June 2017 Gross Profit margin 81.26% – Amgen is doing well, .81 is close…   Read more»

This is a little out of my scope of my job, but I was just at conference and the large device companies use different systems. For example Cognition has a platform called Cockpit, which a risk management and design control…   Read more»

I interned one summer at Pfizer in their Analytical Science and Technology lab for 10 -weeks researching the prediction of product quality attributes using NIR, FT-IR, and Raman spectroscopy. There were many protocols and SOPs to follow to ensure the…   Read more»

I do not work in industry, but I’m currently at the 2017 American Medical Device Summit in Chicago. I spoke with Liz Iversen who is the SVP, Chief Quality and Regulatory Officer at Philips. After FDA Recalls and shutting down…   Read more»