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Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the application. Most have been in spinal orthopedics, but he has helped develop information for cardiovascular submissions. He was director of a cardiovascular research lab for six years, and helped manufacture parts for the Cleveland Clinic and University of Washington artificial hearts. He conducted contract R&D for the University of Utah program and is currently working with the World Heart program.


Expert has helped prepare presentations for an orthopedic panel meeting, done background checks on the panel members that would be reviewing the device, and prepared responses to questions arising from the meeting. He has helped design and arrange for materials and device testing and participated in the design and review of clinical trials leading up to the submission and panel meeting.

Expert has taught biocompatibility at both the University of Akron (including a laboratory) and at Cleveland State University. He has helped select materials and designed a wide range of orthopedic and cardiovascular devices when there has been biocompatibility issues. He has interacted with the FDA on biocompatibility issues. These issues include the use of new polymers in implants, selection of appropriate tests, and the design of tests in areas where no standard tests exist or where alternate biocompatibility testing protocols are available (e.g. long-term carcinogenicity via 2-year rat test or the newer transgenic mouse test). He has selected biocompatibility test laboratories, designated testing protocols, contracted work to the test labs, and has been the sponsors representative on the testing. Expert is on the ruling council of the Society for Biomaterials and is active in a number of areas in the society.

Expert has evaluated, for mechanical and biocompatibility issues, alternate titanium and stainless steel alloys for use in orthopedic implants. He has evaluated metallic surgical explants for corrosion and failure mechanisms and metallic - carbon fiber composite pairs for corrosion potential. This has included interaction with the FDA on the design of composite devices with potential fretting wear of adjacent metal. He has contracted for the nitriding and deposition of other surface coatings (e.g. Plus 7 coating for comparison) for metal implant components and instruments, and has followed the progress of diamond-like coatings to reduce corrosion and wear and to keep sharper edges on instruments.

Expert has conducted extensive evaluations of potential polymers for use in surgical implants. He has a Ph.D. in macromolecual science and has taught various biocompatibility courses at the University of Akron and Cleveland State University. He has designed and developed a wide range of polymer related implants and assisted other companies in the selection of appropriate materials for their devices. He has authored book chapters and review papers on the selection of polymeric materials for medical applications. Expert has worked with the FDA to select appropriate biocompatibility testing for various devices and materials, selected testing labs, contracted for their services, and been the study monitor on resulting contracts.

Expert has helped design and bring to market a very wide range of biomedical devices, primarily in the orthopedic and cardiovascular areas. He has conducted manufacturing as well as device design problem solving and reviewed patent infringement issues on biomedical devices. He helped found a biomedical engineering department at a major university and taught artificial organs and prostheses courses. He has been the principal scientist (and at times Director of R&D) of a rapidly growing orthopedic company and has been involved with the design, development and commercialization of many biomedical devices. He has helped in the selection of testing methodologies and protocols for everything from artificial hearts to ultrasonic testing gels.

Expert helped found the Biomedical Engineering Department at the University of Akron and taught there for six years. He has been a consultant in the development of the biomedical engineering doctoral program at Cleveland State University and continues to teach part of an annual biocompatibility course there. Expert is a long-term member of the Society for Biomaterials and is currently on the executive council of the society. For the past eight years, he has also been on the commercialization cabinet of the Edison BioTechnology Center, funded by the state of Ohio, which helps review potential projects for funding. He currently works as a biomedical engineering consultant, primarily in the orthopedic and cardiovascular areas.

Expert has worked with the FDA to gain approval for a spine fusion cage made from a new carbon fiber reinforced thermoplastic polymer composite material. Testing included both short term and two-year rat carcinogenicity testing. "Solid State Tumorigenicity" became an issue, and he collected the world's literature on the topic, consulted with other experts in the field (co-viewed many histology slides), and helped resolve the potential problem. For an artificial spinal disc, he designed an "inside out" simulated disc using the unique carbon, black-filled rubber, adhesive system, and anodized titanium materials of the disc, but in a shape appropriate to long-term carcinogenicity testing. He solicited bids for testing and approved testing protocols. He also discussed in detail with the FDA, the advantages, disadvantages, and problems associated with carcinogenicity testing using the newer transgenic mouse model. He has evaluated extensive testing data on yet another carbon fiber filled thermoset system for a different major orthopedic company. Earlier, Expert evaluated all significant airborne chemicals for the EPA to select the 20 most significant carcinogenic chemicals in order to develop sampling methodology for the chemicals. This included obtaining and reviewing original toxicity documents for all of the chemicals and developing a new relative potency algorithm to deal with the wide variety of mutagenic/carcinogenic test systems in use, airborne degradation rates for the chemicals, and emission rates from different sources. Test sites were selected with the highest concentrations of carcinogens. Wind direction isopleths were generated to select the best sampling sites for sampler and analytical validation.

Expert has evaluated commerical polymers and composites several different times to select appropriate candidates for orthopedic implants. He ordered samples and evaluated 2D and 3D knitted, woven, braided, pseudorandom and fabric layup fiber orientations along with chopped, injection molded samples to achieve desired composite properties in different projects. He has interacted with NASA Glenn/Lewis Lab personnel on composite material selection and the potential evaluation of composite fiber orientation versus mechanical properties. He helped develop two different thermoplastic composite materials into implants now approved by the FDA. For a different major orthopedic company, Expert recently spent significant time and effort reviewing a thermoset composite material for potential use in the USA and compiling a material master file. He has also evaluated the potential of polyethylene/polyethylene composites, self reinforced polylactic acid composites, and titanium matrix composites for orthopedic use. He has published on the similarity of aerospace and biomedical environmental effects on the degradation of composite materials. Expert has patents on a new pseudorandom material construction and on braided composite structures and devices made from these materials.

Expert has written book chapters and review articles on elastomer selection for biomedical applications. He has evaluated alternate elastomers for artificial spinal discs, selecting two different elastomers - both of which have been implanted in patients under FDA IDEs. He has evaluated elastomers for artificial heart diaphragms and developed (with $1M NIH funding) accelerated fatigue tests in order to evaluate the fatigue resistance of alternate elastomers. His 100-station environmentally-controlled fatigue tester for rubber samples is currently on loan. He has worked on silicone fluid and water permeability testing of alternate elastomers for LVADs, and (under secret DoD contract) air and relative gas permeability of polymers and elastomers. He has an extensive listing of data available for a variety of properties of materials (including elastomers) that he has collected from over 140 different sources.

Expert has designed a wide variety of implantable devices, many of which have been used in patients. In the orthopedic area, these clinically implanted devices include both lumbar and cervical functional artificial spinal discs, artificial vertebral bodies, spine fusion devices (anterior, posterior, cervical, lumbar, & thoracic), a carbon fiber/polymer composite skull plate, a composite ankle stabilization spool, composite wrist stabilization splints, composite spine stabilization plates with titanium nitrided nuts and screws, a titnaium artificial sacrum and associated plates, polymeric spine ligaments, a composite intermedulary rod for use in the femur, long bone composite plates, composite screws, cannulated metal screws, and a wide variety of stainless steel and titanium plates, screws, rods, wires, and a screw/wire combination. He has followed the artificial hip area extensively. In the cardiovascular area, he has been involved in the design and implementation of LVADs, TAHs, pumping aortic patches, and a new heart salvage device. His doctoral dissertation was on the structure/function of blood clotting proteins and he has conducted research on blood platelet/surface interactions and blood/material interactions in flexing applications.

Expert has responded to doctor's concerns about corrosion products found at the junction of medical implant metal interfaces. He has researched mixed metal corrosion (different stainless steels and titanium/stainless couples) and metal/carbon fiber composite corrosion potential. He had to make the determination (twice) on whether to recommend that a doctor re-operate on a patient after surgery to replace inadvertently implanted stainless/titanium constructs. He dissuaded a company from making a long-term blood contact device from tungsten, based on corrosion concerns. He has taught biocompatibility and biomaterials courses in graduate schools at both the University of Akron and Cleveland State University.

Expert developed (with $1M NIH funding) an accelerated fatigue test for elastomers being evaluated for artificial heart pump diaphragms. He has contracted for the fatigue testing of numerous orthopedic implants, including metallic, composite (with differing types and orientations of fibers), and elastomer based implants. For example, extensive fatigue testing of artificial spinal discs were conducted at various commercial and university laboratories under differing conditions of loading, environmental factors, orientation, and frequency. Adhesion had been determined after differing surface treatments and with alternate adhesives using peal and shear tests. He evaluated elastomer fatigue failure in cardiovascular heart assist devices, and selected materials based on the testing.

Expert has assisted a variety of companies evaluate manufacturing problems, including gastric balloons, heart assist devices (both LVADs and aortic patch pumps), and vascular grafts. As senior scientist of a major spine orthopedics company, he was involved in a very wide assortment of manufacturing problems, including everything from evaluation of alternate manufacturing techniques, acceptance criteria for slightly flawed implants, adhesion problems, consolidation problems, and tooling replacement timing. Expert has had to solve many manufacturing problems associated with elastomers including development of optimum synthesis methods, compounding, molding, and post-treatment processes. In many cases, Expert has had to select appropriate tests in order to determine the nature of the problems encountered. The problems have ranged from long-term research problems to acute time-constraint problems, such as finding the origin of metallic inclusions in carbon fiber composite implants ready to ship for implantation.

Expert has been involved in all areas of product development. Beginning with conceptual designs, sometimes starting with actual "dinner napkin" sketches, he has also been involved with individual and large structured team oriented design projects, almost all aspects of product development (including CAD/CAM, finite element analysis), metrics of product development selection, manufacturing development, and scale-up. In addition, he has worked with product testing and evaluation, custom implants, FDA clinical trials and product development, large-scale build-up, and commercial introduction and marketing of a wide variety of products.

Expert has been involved in materials and device testing, and in even more instances, the contracting out of medical device testing. The important thing here is determining what needs to be tested. This is often done in consultation with the FDA. Many times there are testing standards that can be followed, but with new devices, designing the testing scheme to be followed will often determine the success of failure of a product.

Expert was director of a cardiovascular research lab at the University of Akron for six years, and helped manufacture parts for artificial hearts at the Cleveland Clinic and University of Washington. He conducted contract R&D for the University of Utah program, and is currently working on various aspects of the World Heart/Novacor/Edwards program. He supervised a post-doctoral fellow working on heart preservation for transplantation and a doctoral student working on fluid dynamics of artificial hearts. His doctoral dissertation was on the structure-function of blood clotting proteins, his post-doc on blood platelet/surface interactions, and he has worked on various vascular graft hemocompatibility projects.

Expert engaged in on- and off-site consulting for multi-national company. He evaluated potential problems with a material technology they had purchased and assembled a FDA material master file.He engages in continuing on- and off-site consulting with a small orthopedic company. Among other tasks, Expert put together a 510(k) submission for a device made from a new material and evaluated fatigue, biostability and biocompatibility issues for potential new products. Expert engages in continuing off-site consulting for a start-up cardiovascular company developing a new device. He kept the company from using an inappropriate material in the device and helped select replacement materials for the critical part and several other less critical parts. He evaluated processes suitable for manufacturing the device.He engages in continuing on-site and off-site consulting for a major cardiovascular company. Expert assisted in the selection of critical materials for the application. He reviewed GMP implementation. He found alternative materials and processes to solve a major potential problem. He tracked down information helping identify a component failure. He conducted similar analysis of prototype failure for another small cardiovascular company, also identifying potential problems with scale-up and commercialization. Expert assisted an analytical services company several times in identifying appropriate testing to be conducted on different types of biomedical products and implants. He assisted another analytical company in identifying ways to get more biomedical analytical work.