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Invention to Application

Class:

            Invention to Application: Healthcare Research Commercialization

            HLTHMGMT 491

            BME 362

 

Instructors:

            Barry Myers, MD, PhD, MBA

            Sr. Assoc. Dean and Professor of Engineering with appointments

            in Surgery, Anatomy, and Business administration

            Director of the Center for Entrepreneurship and Research Commercialization

           

Melda Uzbil, BS, MEM

Coulter Project Director,

             Coulter Translational Partnership Program

             Department of Biomedical Engineering

 

Invention to Application Board (ITA):

            Kevin Schulman (HSM, DCRI, Medicine)

            Howard Rockman (Medicine)

            Barry Myers (BME, Surgery, HSM)

            Jeff Glass (MEM, Duke)

            Jesko von Windheim (CEO – Industry)

            Rose Ritts (Exec. Director, Office of Licensing and Ventures)

            Brian Annex (Medicine)

            Sean McCarthy (Pappas Ventures)

            Jan Bouten (Aurora Ventures)

 

Readings:

            Innovation specific primary scientific literature.

 

            Market specific secondary market research.

 

‘Knowing “What” to Do is Not Enough: Turning Knowledge into Action.’  Pfeffer, J., and Sutton, R.I., California Management Review, 42(1): 83-108, 1999.

 

‘The Venture Financing Process.’ Salzman, A.E., and Doerr, L.J., in Start-Up & Emerging Companies, Harroch, R.D., Ed. Law Journal Seminars-Press, Chapter 7, 1-30, 1993.

 

“How to Write a Great Business Plan.” Sahlman, W., Harvard Business Review, July-August, 98-108, 1997.

 

“Disruptive Technologies: Catching the Wave,” HBR #95103, 43-53, 1995.

 

“Debunking the Myths of New Product Development,” By R.G. Cooper, Research-Technology Management, July/August, 1994

           

            Customer and competitor questionnaire.

 

            Sample one-page business plans.

 

            Venture Performance data.

 

“Intellectual Property: The Practical and Legal Fundamentals.” Fields, T.G., Jr. Originally published in Idea, 79-128, 1994.

 

Grading:

            Written submissions and presentations (50%)

            Final business plan and presentation (20%)

   Primary market research (10%) – includes phone or face-to-face interviews with experts, opinion leaders, potential customers and industry.

   Class participation (10%) – includes attendance, instructor’s evaluation and feedback from inventors and Associate Directors at the OLV office.

            Peer grading (10%).

           

 

The goal of this experiential class is for students to integrate and expand their prior learning and draw on the experiences of teammates in order to understand and screen a group of real-world research projects based on their commercial potential and then to develop comprehensive business plans for one chosen opportunity. This is accomplished with the aid of in class instruction, research faculty interaction, and mentorship from the Duke University ITA Board.

 

This year-long in-class experience provides a real-world, vertically ntegrated, truly heterogeneous team learning experience. Student teams are constructed from MBA, graduate Biomedical Engineering, Engineering Management, medical, and medical basic science students. Students apply for admission and are interviewed. Students are admitted based on experience and to ensure the creation of heterogeneous teams with a broad set of management and technical training.

 

Five Duke University faculty research innovations are identified for each in-class team. Research faculty are chosen based on the suitability of the technology and their willingness to mentor student teams. The course provides didactic lectures on the relevant topics throughout the year. These include:

 

            Business management and technology management team interaction

            Application of statistical methods to research innovation

            Understanding technology and identification of product-market opportunities

            Regulatory pathway (drug and device)

            Reimbursement

            Intellectual property

            Primary and secondary market research and the customer

            Entrepreneurial start-up outcomes and the need for advantage

Business planning & launch strategy

Venture capital

            Accessing venture capital and non-dilutive funding

            Valuation in early stage technology

            Understanding exit strategies

 

These are augmented by weekly student presentations and discussion (“portfolio reviews”) in which relevant applied science principals are discussed and issues are treated as mini-cases for in-class discussion. By choosing real-world opportunities, students experience first-hand and learn to adapt to the failures that can occur in new ventures. These include goal malalignment, immergence of competing technology, regulatory challenges, valuation uncertainty, out-license strategy changes and the inevitable consequence of failing to remain on plan. By choosing real-world technologies over prepared cases student’s level of commitment is significantly increased and they obtain first hand experience analyzing developing commercialization plans.

           

Emphasis is placed on synthesis of learning and oral and written presentation for critical review by the ITA Board. The course is divided into three modules following which student-team presents to the Board for critical review. Students interact with the Board throughout their experience. Modules include:

           

Module 1: Students learn to synthesize complex technology and present in a concise fashion (portfolio review). Students perform technology assessments and screen five opportunities to select two for further analysis. Students learn the underlying technology, develop possible technology à products à market alternatives and then screen them based on a top-level evaluation of market, customer, team, stage, and ability to execute. They learn to plan a long-term program (one-year project).

 

Module 2: Students learn to develop disclosures that do not violate patentable claims. They develop specification sheets and questionnaires and conduct preliminary primary market analysis. They perform primary market research and screen from two to one technology opportunity. They are introduced to the business plan as a source of advantage.

 

Term 3: Business plan development. Students engage in a long discussion of the elements of business plan and the nuances that distinguish great plans (with advantage) from average plans. They develop a strategy to move from technology to product, complete their market research, competitive analysis, regulatory pathways, management structure, financial requirements, marketing strategy, launch strategy, milestones, and time-line.


Individual classes include student presentations (portfolio review) and didactic lectures.

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