The 12 Steps To Biomedical Innovation

The 12 step path from an idea to a successful innovation or commercial venture.

We’ve all had great ideas. Whether the insight comes to you in the shower, while driving to work, or in a dream, a new concept or thought pops into your mind and begs for attention. Very few ideas, however, actually see the light of day. The difference between an idea and innovation is what happens after you think of the new idea. Innovation is about inventing something that can create economic value in the marketplace. Ideas are commodities, but innovation is about finding and validating the business opportunity that both the leadership of the organization and its culture embrace and commit to and which is connected to its business strategy.   Implementing innovation is the hard work that goes into conceptualizing an idea to take advantage of a market opportunity and executing a commercialization plan that gets results.

 Today in health care, whether it be drugs, devices, diagnostics, healthcare IT or alternative care models,  successful innovation is about both predicting and observing patients’ wants and needs and satisfying them with new products and services.

 Now, more than ever, industry and health care entities need physicians to help them innovate to stay competitive. Our post-capitalist economy is driving leaders to harvest new ideas and the intellectual capital of their knowledge workers. Success depends on using processes for creating and analyzing new ideas.  Limited time and competition for resources requires prioritization.

The 12 Step Roadmap to Innovation

The path from an idea to a successful innovation or commercial venture is lined with mine fields that can sabotage success at any step. At Venturequest (http://www.venturequestltd.com ), my colleague, Courtney Price, and I have worked with multiple organizations in industry, academia and government labs.  We have developed and applied a 12 step process to increase the success rate for implementing innovation and creating new revenue streams. http://www.ncbi.nlm.nih.gov/pubmed/16615405 The process is designed to quickly eliminate ideas that don’t have a high likelihood of market success, that don’t fit with the strategic mission of your health care organization, or that involve too high a level of market, technical, intellectual property or implementation risk for the proposed return on investment. Our 12 Step Innovation Roadmap provides a framework for screening, incubating, commercializing, and benchmarking the success of new ideas and tested including tools and protocols for health care providers.  At each step of the process, a Go or No-Go decision is made about the opportunities. Sometimes the opportunity skips some of the steps based on the market and stage of development.  Below is a brief description of each step.

Idea generation consistent with the strategic plan

Ideas are a dime a dozen.  The challenge is finding ideas that match the business strategy, connect with senior management, and are embraced by the organization’s culture.  Such ideas leverage the core competencies of the organization as well as build on its intellectual assets including intellectual property, branding, new technologies, etc.  They both build upon sustainable core competencies as well as forecast future breakthroughs. Brainstorming or collecting new ideas that don’t match your facilities culture or its strategic plan will have a limited chance of success. 

Concept development and initial testing

Once ideas are selected that meet the above criteria, it is necessary to describe their uniqueness and determine if there could be a sustainable competitive advantage. A clear value proposition, i.e. the worth, importance or usefulness to your customers, should be clear early in the process.  As you obtain more information about the opportunity, the business concept will change over time in response to newly discovered market, competitive, and patient information. The next steps involve a series of iterations designed to refine your idea.

Seven-Step Opportunity Evaluation

After the concept is developed, it is time to quickly assess the potential opportunity by using a quick Seven-Step Opportunity Evaluation which takes less than 30 minutes to complete.  It addresses the problem being solved, the potential opportunity, and the market for the opportunity, potential revenue, required funding, intellectual property creation and protection, and stage of development.  It also identifies potential customers, competitors, and commercialization viability.  This quick analysis will help you define whether the business, industry or markets you propose to enter are appropriate. It will also help you define what kinds of people you will need to make your venture successful.

Model Opportunity

Once the concept is evaluated using the Seven-Step Opportunity Evaluation, it is time to discover the inherent strengths and weaknesses of the opportunity.  This software tool is based on 24 distinctive characteristics to objectively evaluate the opportunity.  The purpose of this protocol is to identify the Achilles’ heel of the concept. It was designed to assist physicians and researchers without a business education to objectively evaluate the opportunity.  As weak areas of the concept are improved, the better chances it has for success. If you identify potential risks or threats that cannot be address, then the idea should be abandoned. 

Business Opportunity Assessment

The  Business Opportunity Assessment is a more in-depth review of the opportunity including market research and due diligence that includes IP analysis, opportunity development timing, legal liability issues, applications of the opportunity, barriers to entry, industry trends, growth potential, market positioning, competitive analysis, financial projections and pricing, resource requirement analysis, and licensing potential to name a few.   These are the important considerations to address if it looks like the opportunity has a strong commercialization potential.  This software tool is designed in a question and answer format which make it easy to complete a 360 degree assessment.

Market Validation

Once you have completed the Business Opportunity Assessment and have decided to proceed, the Market Validation process focuses on obtaining feedback on how the opportunity addresses specific market needs as well as taking a hard look at your competition. This step helps differentiate the opportunity from competing opportunities based on patient needs.  This process maximizes perceived patient benefits and eliminates extraneous features that increase costs.  This experience-based market learning is critical to market success and helps develops better business judgment for a Go or No-Go decision.

Revise Business Opportunity Assessment

Based on the results of the Market Validation, you can now revise your Business Opportunity Assessment and build a commercialization strategy.

Finalize the Commercialization Plan

By this time, you should have a good idea about whether you have a viable innovation. Since your idea will be competing for resources with other ideas, however, you will need to prioritize and decide which has the best odds for success. You will need to carefully hone your business model. You will now write your business plan that succinctly describes the story of your proposed business.   The good news is that by this time approximately 70 % of your business plan has been written.  

Write the Business Plan

Now it’s time to write your final business plan. Unfortunately, most entrepreneurs go immediately to this step first without using appropriate filtering systems.  This results in a business plan that has unvalidated assumptions and is rejected or leads to an enterprise that fails.

Solicit feedback and revise the Business Plan

After the business plan has been written, it is time to solicit feedback from respected advisors who will provide realistic options about the potential of commercializing the new opportunity.  Their opinions and suggestions should be incorporated into the final business plan. 

Present the Business Plan.

It is now time to present the Business Plan and get stakeholder approval and resources to launch new venture.

Execute the Business Plan

Congratulations. You’ve got the go ahead for your new idea. Now the work begins. Fortunately, your winning business plan based on the 12 step pathway will provide an operational road map to track and benchmark the efforts to commercialize the opportunity.  Your plan will provide you with the timelines and metrics for success. A strong Executive Summary should be distributed to the review board before the presentation and a succinct Elevator Pitch should be developed. 

Whether you are considering a product or service or process improvement, the 12 Step Plan is a useful guide to getting your idea to market quicker, for less cost and with more success.

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.

The 3 C's Of Working With Industry

The 3 C's: What you bring to the table as a physician.

If you are a doctor interested in working with industry, you'll need to take a look at your value propostition-what you promise to deliver- before sticking your toe in the water.

There are several places to contribute and participate in different roles. Fundamentally, however, whether you work in drugs, devices, diagnostics, healthcare IT or service innovations, as a physician you bring three things to the table that industry wants. I call them the 3 C's: content expertise, credibility and connectedness.

The first is your domain CONTENT and clinical expertise. Like no one else, you bring an understanding of clinical problems, patient issues, potential solutions, work flow processes, an understanding of the socio-economic landscape and a feel for what makes docs tick. Your contribution will be to help industry partners "live in your world" for a while and share your insights about barriers to adoption and penetration of new products and services.

Secondly, because of your experience, background and reputation, you bring CREDIBILITY to the enterprise. Of course, your value increases as you become a recognized thought leader, researcher, published author , blogger or leader in your specialty organizations. Sometimes, the initials after your name or your academic or organizational affiliations add value.

Finally, you bring CONNECTEDNESS to the value chain of innovation. The more you can build networks to inventors, suppliers, service providers, patients and potential customers, the more attractive you will be to industry as a marketing, product development or business development consultant or partner.

If you are interested in bioentrepreneurship, working with industry is a great way to get started and build a base of knowledge and experience. Sure, finding the right fit and opening the first door is not easy. You'll have to kiss a lot frogs to find your first opportunity. The more you bring to the table, however, the more likely you are to find your prince.