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Entries in FDA (2)


A Typical Medical Device Company

CEO's are scared.

I asked a friend of mine , the CEO of a medical device company enjoying a dominant market position , if he was considering hiring any additional sales and marketing people. Having recently made the decision to relocate his manufacturing from one European location to another in Asia, I thought he might be in need of some international sales talent.

Not only was the answer NO. It was damned NO. He responded  that "I think we are a typical company right now. Our revenues actually jumped over 15% this year, but we're sitting on the biggest cash position we've ever been in since the companies start. BUT...we have no idea about the unknowns. Obamacare scares us. The possibility of a falling dollar or inflation  not only scares has hurt us and costs us more to manufacture  at our European facility. So, we simply sit tight"

Reading about the 9.8% jobless rate, the flat economy, the budget deficit and other bad news is one thing. The human impact is another. My experienced, very talented unemployed friends continue to crank out resumes and network incessantly, while American competitiveness in the global bioscience innovation community continues to deteriorate.

A recently released report, "FDA Impact on US Medical Device Innovation" reinforces the point and notes that the average medical device company responding to their survey of 204/1023 device companies spent $31 M to get a 510(k) device approved by the FDA and $94 M to get pre-market approval. In addition,while it took 54 months to get PMA approval in the US, it took 11 months in the EU.

That said, keep in mind that the best time to innovate is during hard times like these. Great companies emerge from recessions. Talent is available, people are willing to take risks, suppliers are eager to cut deals, and there is always a need for a better mousetrap.


The Anatomy & Physiology Of Bioentrepreneurship

Free education resources for physician bioentrepreneurs.

Measuring competencies of professionals , particularly doctors, has undergone significant change in the last few years. For example, The Accreditation Council for Graduate Medical Education has formulated competency based education guidelines for graduate medical education that includes the three elements of structure (anatomy), process (physiology) and outcomes. Residency training programs and their directors are now being held accountable for measuring competencies of trainees and graduates in the areas of 1) medical knowledge, 2) patient care, 3) practice based learning and improvement, 4) systems-based practice, 5) professionalism, and 6) interpersonal and communications skills.

Suppose we were to apply a similar thinking to how we train bioentrepreneurs? In an article we published in 2008 (JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 14. NO 1. 2–12 JANUARY 2008) my co-author Patrick Hurley and I reported an overview of bioentrepreneurship education programs in the US and proposed some core learning objectives for those completing bioentrepreneurship education programs. Not unlike the ACGME guidelines, we tried to identify learning objectives related to some general competencies, suggested ways to use increasingly more dependable methods of assessing graduate’s attainment of thesecompetencies throughout their program, and recommended we begin to use outcome data to facilitate continuous improvement of programs.

Furthermore, we proposed core learning objectives that would drive curriculum development and standardization. Since bioentrepreneurship requires an extensive repertoire of knowledge, skills and attitudes, we proposed that bioentrepreneurs should demonstrate a defined set of abilities in the areas of legal environment, marketing, finance, leadership and organizational behavior, clinical trials design and implementation, communication skills, new product development and management, international business and entrepreneurship, regulatory affairs and quality systems, strategic planning and business development, manufacturing , emotional and social intelligence skills, and professionalism and ethics.

That’s a lot to learn. Like medicine, it take a lifetime of continuous learning and practice, and you never get it completely right. However, as your attending used to tell you, by building on solid fundamentals and continuing to add to your experience and knowledge base, you should improve as long as you learn from your mistakes.

So where do you get this information without paying through the nose (remember, I’m an ENT doc)?
For some free resources to get you on your way, I’d suggest:

  1. The Society of Physician Entrepreneurs Resource page
  2. Bioentrepreneurship ezine
  3. Biotechnology education resources
  4. Multiple newsletters, blogs and information sites at the Biotechnology Industry Organizaton and the Medical Devices Manufacturers Association and the Advanced Medical Technology Association.
  5. The FDA website

If you are serious about getting more bioentrepreneurship education, make a new year’s resolution to access these FREE sites on a regular basis. It will help you understanding the anatomy and physiology of bioentrepreneurship and equip you with the education you’ll need to start seeing businesses in the clinic. Now, outcomes are different story altogether.

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