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Provisional Program Speaker

Raeann Gifford, Visiting Scientist, IFM-Linköpings Universitet, Sweden and Manager Life Science, Acreo AB, Sweden

Raeann Gifford has over twenty years experience working in industry and academia. This includes completing the technical transfer of a CGM sensor from the University of Kansas, U.S.A. to a start-up, small retail business ownership, engineering operations, and technology innovation management. Raeann received her Ph.D. in Bioanalytical Chemistry from the University of Kansas (KU). She led an early stage technology innovation group at Bayer Diabetes Care in Tarrytown, NY.  Raeann built a multi-disciplinary group to evaluate external early stage bioanalytical technology, developed research alliances to expand research capability, and executed internal research projects.  Raeann has numerous publications and patents in the field of biosensor development.  She continues to pursue opportunities in biosensor development, early stage start-ups, and strives to facilitate bringing new technologies that benefit the health and well being of society to the market place, currently as a Manager of Life Science with Acreo AB, in Norrköping, Sweden.

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Presentation

The Industrial Challenge To Achieve Commercially Successful Biosensor Products

Abstract

The primary goal in producing commercially viable biosensors is manufacturing safe and efficacious devices in large quantities with precise control, for minimal cost, and proving that to a regulatory agency. However, there are many details that contribute to moving technology from a research laboratory to a final commercial product, which are outlined in this course. As the health care environment strives to lower cost, commercial resources require more efficiency and efficacy; therefore, for new health care technologies, such as drugs, therapies, and diagnostics (including biosensors) to be adopted there must be a cost benefit. For a new biosensor technology to be commercially successful, to justify the cost, a significant improvement in quality of health is essential, and preferably reimbursable. Thus, commercial producers will require specific biosensor technology characteristics, before considering investing in development.

To minimize the investment risk of new R&D endeavors industry will ask:

1. is there a market
2. is the technology feasible
3. can you legally make and sell the technology (intellectual property and regulatory path)
4. can it be manufactured in commercial quantities
5. is the cost of goods appropriate for the market?

For projects intended for commercialization these points only attempt to answer the value of initial investment, not what is required to get the technology into commercial use. To realize a final product, after these initial questions are answered satisfactorily, the detailed work of development begins; which includes scaling up the fabrication process, documenting every detail of production, and achieving regulatory approval. These hurdles for producing a commercial biosensor do not include making it work in a system, packaging, marketing, and sales. Given these perspectives, demonstrating functionality of a few (or higher) biosensors made in a laboratory, is a long way from producing millions for the marketplace.

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