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. Wh...

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 d...

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 ...

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...

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 int...

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...

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 managem...

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 we...

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 ...

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...

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 throu...

@Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III dete...

For an antibiotic-releasing hip-stem Device Type: combination device The primary mode of action: Hip-stem, structural replacing a bone- holding up a hip. Agency has governance over it: CDRH Class: Cla...

As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP's regulatory authority to cover all tobacco products, including...

I agree with many like @gaberuiz13 and @su65 that academic research is for the passion and thrill of discovery and answering questions for unknowns in their field. However I think there is a generaliz...