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 study is conducted in accordance with Good Clinical Practices (GCP). I think its exciting to have…[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 perform a lot sponsored studies. I think lower level positons such a junior level monitor, junior…[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 ability to understand the customer needs and customer responses and how to address those needs. As you mentioned in lecture for d…[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 but make it for a limited time and volume. So customers feel like they are getting an exclusive o…[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 commercials. Whereas pharmaceutical companies use a lot of television commercials for marketing drugs. In the…[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 da Vinci systems installed at hospitals globally, and those systems were used to…[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 deem success- what the company needs to accomplish to consider it successful and is geared to…[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 are usually involved in the management of the company. Private companies are generally…[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 loans more easily, limited liability, you can pay dividends, stable when shareholders leave or die. As also discussed there will…[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 two hedge funds he managed by misleading them about losses suffered on its investments,…[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 attract investors (VCs, etc). The company should be incorporated in Delaware since they have more favorable corporate and tax laws. As @thu…[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 to the ideal 1 so they are efficiently spending
Operating profit margin 46.93% – (Operating income is $2.7B) So operating income is 49% of…[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 platform for medical device, and pharma development teams.

21 CFR 820.40 instructs companies to establish and maintain…[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 integrity of the testing. From making sure the instrumentation was properly working and…[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 their Cleveland plant in 2014 they have restructured and put in place new division heads and Liz has worked closely with…[Read more]

I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower risk. For example in 2010 Johnson and Johnson underwent a quality control reorganization after both the House…[Read more]

Yes, if this goes through Congress the increase in medical device user fees would affect small/midsize companies. However as the FierceHealthcare article mentions, it is unlikely that it will go through.

This article states “The fees are part of an $1.3 billion increase to all user fees that would replace the need for a new budget authority each…[Read more]