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.

Life Science Entrepreneurship: It's Not Just About The Patents

Life science entrepreneurship and commercialization is about much more than creating and exploiting the elements of intellectual property- patents, trademarks, copyrights and trade secrets.

There are several additional ways to work with industry and other partners in biomedicine. While licensing and spin outs seem to grab most of the headlines and get most of the attention from technology transfer and licensing managers and the investment community, biomedical entrepreneurs, whether they are academics or community-bsed, consult with industry, participate in research and development collaborations, design and contribute to clinical trials, and engage in knowledge transfer or knowledge exchange programs with industry.

Knowledge exchange programs create a platform where academics and industry scientists can work with each other. The three pillars of knowledge exchange are dissemination (pushing out information from the research base), research use (identifying a clinical problem, market need, or supplement a technological capability in the company) and knowledge brokering.

For example, at Kings College London, graduate life science students can elect to spend time with local bioscience companies, including such companies as Glaxo Smith Kline, Astrazeneca, and others, under the supervision of a company research and development expert and a faculty mentor. In addition, Kings faculty can spend a sabbatical working on a targeted problem in industry, while their counterpart in industry spends time at the the College.

Knowledge exchange programs, particularly for those with an academic basic or clinical research background, are a great way to build your networks , experience and knowledge base. To that end, the Society of Physician Entrepreneurs is organizing several bioentrepreneurship fellowships for those who want a better understanding of how devices and drugs are developed and get to market. This six month experience, sponsored by drug and device companies , will last for six months and costs will be shared by the company and the fellow. They are designed to provide the fellow with a wide breadth of experience in product design and management, regulatory affairs, sales and marketing, finance and all the other elements that result in biomedical innovation.

Innovation erupts when disciplines intermix. Knowledge transfer programs, whether internal or external, are a useful way for people to get a different view and get their creative juices flowing.

Cluster Theory: Geography Is Destiny

Geography is destiny, particularly when it comes to biomedical innovation.

The Kauffman Foundation and the Information Technology and Innovation Foundation have released The 2010 State New Economy Index, which tracks state performance on 26 indicators divided into five categories: knowledge jobs; globalization; economic dynamism; transformation to a digital economy; and technological innovation capacity. Most of the states have improved, with Massachussetts taking home the trophy.

Clusters are formal and informal geographically circumscribed networks that link participants with similar interests. Silicon Valley for IT, New York and London for finance, Hollywood for entertainment are examples. Bioclusters, linking inventors and researchers, service providers, industry representatives and public agencies, have erupted in every state in the US and most major industrialized countries. Their growth is driven by economic development, jobs and revenue for the regions that spawn them. If you are interested in bioentrepreneurship, follow Meyers Law: go where the innovation is. In most instances, that will be a cluster close to a major research university, populated with creatives and linked by an entrepreneurial ecosytem that provides money to early stage companies.

Harvard Business School Professor Michael Porter, one of the founders of cluster theory, defines a cluster as “a concentration of companies and industries in a geographic region which are interconnected by the markets they serve and the products they produce.” This nexus of acitivity is associated with high performance economies and regions. They are where the action is and that's where you should be if biomedical innovation is in your future.

If you want to act, go to Hollywood. If you want to hit it big in financial services, spend some time on Wall Street. If you want to learn biomedical innovation, pick a place with a proven track record of creating great companies and management alumni and hitch your wagon to a local star.

Physician Entrepreneurs, MBA's, and anti-MBA's

Does a Physician Entrepreneur need an MBA after their MD?

Once again, in a blog post from the Harvard Business Review, the endless debate about whether entrepreneurs should get an MBA rears its ugly head. The arguments typically fall into the "just do it" camp, as exemplified by a quote in the article "entrepreneurship is a matter of the heart, and education is a matter of the brain. It is difficult to teach a heart" v those in the entrepreneurial education universe who have spent their lives justifying entrepreneurship as a legitimate academic domain.

This debate reminds me of conversations going on now about residency training requirements, duty hours, residency selection criteria (a recent journal article described how a professional management consultant inventoried what first year residents do and then suggested ways to structure interviews to identify and recruit them) and how we provide accelerated levels of education and training. As both a business and medical educator and someone with some experience in starting companies, I come to the same conclusion about nature v nurture: you can teach someone how to do surgery, but you can't teach them how to be a surgeon. I think the same holds true for entrepreneurship. Sure, there are certain behavioral traits and personality qualities that are correlated with entrepreneurial success. However, when it comes to understanding how to get 510(k) FDA approval, or how to read and analyze a term sheet, or how to create a value proposition, feasibility analysis or business plan, I'd rather take the easy road and learn from the mistakes others have made.

Some think entrepreneurs are born, others that they are made, and still others that they are self-made. Like medical students who choose surgery or a surgical subspecialty as a career choice, entrepreneurs who want additional education tend to be remarkably self-selective and successful. Those would-be entrepreneurs with boundless self-confidence, enthusiasm, intelligence and self-awareness will be successful despite their MBA's. However you parse the words, take someone with what it takes, add a first class education and the networks that result, and, in my view, the result is greater than the sum of the parts. There are many ways to the finish line. Just do what trips your trigger.

Creating A Medical Application For The iPhone

Medical applications for the iPhone.

I recently received an email from a doctor in India who wanted some advice about a medical iPhone app he created. I encouraged him to post the idea on the linkedin site for the Society of Physician Entrepreneurs and harvest the "wisdom of the masses". Shortly thereafter, he posted a beta version of the app, a clinical simulation tool similar to case of the week, and asked users to provide feedback. A few weeks later, another email relayed that "My iPhone application has been a smashing success - I've had close upon 7000 downloads so far and it is the 7th most popular medical application in the United States". In addition, he was chosen to present his startup idea to the Mumbai Seedcamp at http://seedcamp.com/pages/mumbai10

Here's a useful article about how to get your iPhone app approved and how to make money from the idea. This is yet another example of the Long Tail theory and how you can benefit.

Are You An Entrepreneur?

I read a great post recently by Anthony Tjan entitled Entrepreneurial DNA: Do You Have It? on the Harvard Business blog.

In the article, Mr. Tjan argues that entrepreneurs have a distinct profile that is obvious to those familiar with it.  He says,

"Entrepreneurs hold an idealism and risk profile that makes them fundamentally different. They don't think about security--in fact they are often uncomfortable with it. And they have the guts to bet it over and over again. They think less about what they lack and more about what they can achieve with what they have. In a sea of ambiguity, they forge ahead with an incredible fortitude."

It's an interesting read and good food for thought for any physician considering entrepreneurship as a career.

Start-ups: Y Combinator and the Trough of Sorrow

Medical startups & the Medical Fusion Conference

Paul Graham is the director of a venture capital fund that has begun 145 new companies and developed a cult following in the tech community.  Graham and his fund, Y Combinator, were profiled recently in Inc. magazine.

The article, entitled The Start-up Guru: Y Combinator's Paul Graham, is great for those who are interested in start-up companies.  Graham is transparent about the difficulties of starting a company from scratch and his description of life in a start-up rings true for those who have ever been through the experience.  According to Graham,

"Everyone has a problem with your product, and people are constantly calling to complain about things you cannot possibly fix. Then there is the fact that you are doing everything for the first time, which creates a crippling sense of uncertainty, as well as a persistent fear that a single bad decision could doom the whole enterprise. There are squabbles with co-founders and combative negotiations with investors and that gut-wrenching period when you realize that success isn't going to come quickly or easily -- Graham calls it the Trough of Sorrow. Graham's start-up days are more than a full decade behind him, but he can't help recalling them with a shudder. "It's like talking to someone who went to war," Graham says. "It sucks to run a start-up." "

For physicians interested in entrepreneurship, the Medical Fusion conference is a good way to be introduced to how medical expertise can be leveraged in unique ways.