On October 18, 2012, Professor L. Franklin Bost presented "Early-stage Development Factors and Current External Influences on Biomedical Device Innovation." "Translational science" and "bedside-to-bench-to-bedside" refer to the path of taking a identified unmet clinical needs, laboratory or benchtop idea through to developing and testing a product that meets FDA requirements as a safe and efficacious product. Connecting unmet needs and biomedical research to create beneficial, commercial and profitable products for healthcare is often a difficult process. A multidisciplinary team is required to navigate this process including: inventors, medical entrepreneurs, legal and regulatory professionals, design engineers, prototyping resources, and early-stage venture investors. Current changes in FDA regulatory procedures, patent processes, the medical device tax and reimbursment that are affecting all medical device innovation and development processes in the USA will be discussed.
L. Franklin Bost has significant industry experience in strategic planning, new product development, and senior management positions with P&L responsibility in medical, consumer and industrial companies. He is Professor of the Practice and Executive Director of Design Instruction in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. Professor Bost is Executive Director of the new Master of Biomedical Innovation and Development (BioID) Program and oversees the second year, Projects in Biomedical Engineering course, the BME Capstone Design courses. Bost is Director for Education and Outreach of the Translational Research Institute for Biomedical Engineering and Science (TRIBES) at Georgia Tech, and Director of Educational Programs for the Atlanta Pediatric Device Consortium (APDC).
Bost is also President and Chief Executive Officer of SpherIngenics, Inc., a company focused on stem cell delivery technologies for enhancement of therapeutic and reconstructive tissue applications. Previously, he was President of Porex Surgical Inc., which developed and manufactured implantable biomaterial products for craniofacial trauma, cancer reconstruction and soft tissue augmentation. Porex Surgical provided implantable devices to surgeons in craniofacial, oculoplastic, reconstructive, ENT, OMF, and neurosurgery in the USA and over 50 international countries. Previously, Mr. Bost held management and development positions with Porex Corporation, Becton Dickinson & Co. and American Hospital Supply. He serviced on AdvaMed's Technology and Regulatory committee from 1994 to 2006.
Bost holds an MBA from the University of North Carolina and Bachelor of Product Design degree from North Carolina State University.
The IEEE EMB Society is grateful to Professor Bost for giving this presentation.
On April 17, 2012, Craig R. Forest, Ph.D. presented "Automated patch clamping of neurons in the mammalian brain in vivo." Whole-cell patch clamp electrophysiology of neurons in vivo enables the recording of electrical events in cells with great precision, and supports a wide diversity of cellular morphological and molecular analysis experiments. However, high levels of skill are required in order to perform in vivo patching, and the process is time-consuming and painstaking. An automated in vivo patching robot would not only empower a great number of neuroscientists to perform such experiments, but would also open up fundamentally new kinds of experiment enabled by the resultant high throughput. We discovered that in vivo blind whole cell patch clamp electrophysiology could be implemented as a straightforward algorithm, and developed an automated robotic system capable of performing this algorithm. We validated the performance of our robot in both the cortex and hippocampus of anesthetized mice. Our robot achieves yields, cell recording qualities, and operational speeds that are comparable to, or exceed, those of experienced human investigators, and is simple and inexpensive to implement.
Craig Forest is an Assistant Professor in the Woodruff School of Mechanical Engineering at Georgia Tech with program faculty appointments in the departments of BioEngineering and BioMedical Engineering. From 2007-2008 he was a research fellow in Genetics at Harvard Medical School working with Prof. George Church. He obtained a Ph.D. in Mechanical Engineering from MIT in June 2007 at the BioInstrumentation Laboratory, led by Prof. Ian Hunter. He received a B.S. in Mechanical Engineering in 2001 from Georgia Tech and an M.S in Mechanical Engineering in 2003 from MIT. He was a Sandia National Laboratories MEMS Fellow and an NSF Graduate Research Fellow, and was recently awarded the Georgia Tech Institute for BioEngineering and BioSciences Junior Faculty Award (2010). In 2007, he was a finalist on the ABC reality TV show "American Inventor.” His research interests include genetic applications of bioMEMS, optics, and precision machine design.
The IEEE EMB Society is grateful to Dr. Forest for giving this presentation.
Last updated April 6, 2022.
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