Expert Details

Expert in Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants

Expert ID: 721781 Ohio, USA

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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.

Expert may consult nationally and internationally, and is also local to the following cities: Cleveland, Ohio - Toledo, Ohio - Akron, Ohio - Youngstown, Ohio - Canton, Ohio - Lorain, Ohio - Lakewood, Ohio - Elyria, Ohio - Pittsburgh, Pennsylvania - Erie, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1974 Degree: Ph.D. Subject: Polymer Science Institution: Case Western Reserve University
Year: 1971 Degree: MS Subject: Macromolecuar Science Institution: Case Western Reserve University
Year: 1969 Degree: BME Subject: Mechanical Engineering/Materials Institution: General Motors Inst. (now Kettering)

Work History

Years Employer Title Department Responsibilities
Years: 1997 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: Expert does independent consulting for spinal orthopedics, cardiovascular, and analytical companies, and occasionally, lawyers.
Years: 1989 to 1997 Employer: AcroMed Corporation Title: Sr. Scientist (also Director of R&D) Department: Responsibilities: He was the senior scientific person helping the company grow from $16M to $95M with various titles/functions. He conducted and directed research, development, and commercialization of polymer, polymer/carbon fiber composite and elastomer based spinal orthopedics products, with emphasis on artificial spine disc and spine fusion devices. He assessed potential business opportunities in the Technology Assessment and Business Acquisition Department.
Years: 1983 to 1989 Employer: The University of Akron Title: Associate Professor & Dir. Cardiovascular Lab Department: Biomedical Engineering Responsibilities: He helped found the Biomedical Engineering Department. He taught biomaterials, biocompatibility, artificial organs and prostheses. He directed students, technicians, and post-docs. He conducted research on accelerated rubber fatigue testing of rubber, blood-materials interactions, permeability of elastomers, hemodynamics of artificial hearts, heart preservation techniques; synthesis & production of artificial heart rubber components for Cleveland Clinic and the University of Washington.
Years: 1975 to 1983 Employer: Monsanto Research Corporation Title: Senior Research Chemist & Contract Manager Department: Responsibilities: He managed over 30 biological and analytical research contracts for a variety of government agencies (~$1,000,000/year). He conducted and directed research (and proposal writing) on many topics including ambient air analysis and development of accelerated fatigue tests for elastomers. He taught computerized information retrieval techniques to 100 staff members.
Years: 1971 to 1972 Employer: Queen Mary College Title: Research Associate Department: Responsibilities: Between his M.S. & Ph.D. degrees, he assisted Professor Andrews in conducting environmental stress crazing tests.
Years: 1964 to 1969 Employer: Packard Electric Division, General Motors Corporation Title: Engineer Department: Responsibilities: He worked in the plastics laboratory solving day to day problems and conducted research on flammability of polymers used in electrical wiring harnesses. He also worked in many other departments as co-op student.

Government Experience

Years Agency Role Description
Years: 1981 to 1983 Agency: DoD Role: Contract Manager with Secret Clearance Description: Was a contract manager on DoD secret government contracts.
Years: 1982 to Present Agency: NIH Role: Reviewer Description: He was a scientific and administrative reviewer on several NIH contracts.

International Experience

Years Country / Region Summary
Years: 1996 to 1996 Country / Region: The Netherlands Summary: Expert spent time at an AcroMed subsidiary evaluating spine fusion cages. He made the final determination on whether manufacturing flaws were sufficient to keep them from being used clinically.
Years: 1990 to 1997 Country / Region: Japan Summary: He developed spine products specifically for introduction in Japan. Expert worked with regulatory personnel, surgeons, and the Japanese Ministry of Health to obtain product approval. He interacted with Japanese subsidiary personnel to solve problems.
Years: 1997 to Present Country / Region: Canada Summary: Expert engages in continuing consulting on the development of a left ventricular assist pump. He loaned a sophisticated elastomer fatigue-testing machine to the company for some of the testing.
Years: 2003 to 2003 Country / Region: Isreal Summary: Expert evaluated potential elastomers and plastics for a urinary bladders sling that had failed in testing. He located appropriate materials and established appropriate contacts.
Years: 2003 to 2003 Country / Region: Australia and New Zealand Summary: Expert conducted a total review of a new type of cardiac assist device, evaluating device design, finite element analyses, materials selection and other aspects. He then met with the clients and wrote a summary to be used for venture capital acquisition.

Career Accomplishments

Associations / Societies
Expert is a member of the Society for Biomaterials and the American Society for Testing and Materials.
Professional Appointments
Expert has been the Chair or Vice Chair of the Biomaterials and Medical Products Commercialization special interest group of the Society for Biomaterials. He was the Executive Editor (U.S.A.) of the international journal, Bio-Medical Materials and Engineering, Pergamon Press. Expert served on the Editorial Advisory Board of Medical Plastics and Biomaterials, Canon Communications, Inc.; and has been a member of the Commercialization Cabinet, Edison Biotechnology Center (State of Ohio). He served on the Scientific Advisory Council and on the Executive Advisory Committee.
Awards / Recognition
Expert was awarded the C. William Hall Award for lifetime achievements in the field of biomaterials by the Society for Biomaterials. He was one of thirty University of Akron faculty honored for "Significant Accomplishments in Teaching, Research, and Public Service" . He was one of ten U.S. scientists selected for participation in the Second Joint USA/USSR Symposium on Circulation and the Artificial Heart. He was one of seven U.S. scientists selected for participation in the Third Joint USA/USSR Symposium on Artificial Heart Research and Development.
Publications and Patents Summary
He has approximately 100 publications, book chapters, and patents.

Additional Experience

Expert Witness Experience
Expert has conducted background research for several legal and patent cases and in one case was deposed as an expert witness. In most cases, the research allowed the lawyers to reach satisfactory results without further litigation.

Expert on Spine Implant Patents: ‘363 and related spine fusion cage patent cases. ‘057 patent case on dynamic spine fusion rods. The case was settled

Expert on Hip and Knee Explant Failures
Occasional expert on artificial hips, especially ceramic on ceramic and metal on metal devices. Also some work on total and hemi-knee implants. Provided advice on failure modes, interpretation of potentially biased hip articles in the literature, microscopic analysis and photographic & photomicrographic documentation of failed hip components on an as-requested basis for several law firms. Have found several orthopedic components manufactured out of specification.

Testimony History
Theft of trade secrets case – Testified in jury trial about the product development process in spinal products, as related to his concept of an expandable spine fusion cage. Testified that MDs often submit concepts that companies develop into products.

Testified in jury trial about structure of vascular grafts. Based on my expert reports, claims 1-19 in which I was primary expert were not pursued in trial, so I was only on the stand for 1 ½ hours in 6 week trial.
Spinal implant manufacturing contract dispute – Testified to a judge arbitrator on aspects of spine implant manufacturing and commercialization.

Depositions
Was deposed twice on the Medical case mentioned above.
Was deposed several times on the Bard v Gore patent case mentioned above.
Was deposed on instrument design for spine cage implantation
Was deposed as Director of R&D on class action lawsuit about VSP system marketing

Written Opinions Related to Hips
Conducted microscopic examination of a failed hip stem, ceramic cup and polyethylene liner and opined to lawyer that 340 pound patient and selection of titanium stem contributed to failure.
Conducted microscopic examination of a failed polyethylene acetabular cup and based on wear tracks, opined to lawyer on the likely sequence of events leading to failure.

Some Other Consulting on Failed Implants
Various – Failed ceramic and metal/metal hip components and products
2015 – Failed heart assist device – determined failure mode and made suggestions
2014 (tentatively resolved) – Failed out of specification hemi-knee inserts
2013 – Failed cranioplasty plate
2012 – Failed thumb spacer (assisted the company)
2010 – Failed biodegradable screw.
2007 – Failed out of specification knee patella
2005 – Failed spine cage surgery (assisted the company and in deposition testified that the spine surgery instruments were not too sharp and did not contribute to the severed vena cava in surgery)
2004 – Failed long bone plate
2002 – Failed shoulder joint prosthesis
2001 – Failed shoulder screw
Earlier – Failed heart assist pump, failed spine plates, screws, fusion cages, and discs
Training / Seminars
Taught over 50 scientists and engineers the basics of literature searching.
Vendor Selection
Expert has experience selecting vendors in several areas. Biocompatibility: Expert specified tests and selected vendors for testing several new materials.
Analytical: He evaluated and selected 20 labs each for verification of EPA test methods on 5 contracts.
Manufacturing: He evaluated and selected companies to synthesize polymers and to manufacture implants.
Product Development: He evaluated and selected companies for prototype manufacture, coating, mechanical testing, and manufacture of implants and instruments.
Marketing Experience
He worked with marketing staff to develop technical handouts on new products. He also helped staff booths at technical shows.
Other Relevant Experience
Expert has assisted in the development, commercialization and clinical use of a broad range of human implants.

Fields of Expertise

510(k) document, investigational medical device exemption regulation, medical device premarket approval, biocompatibility, biocompatibility testing, biomaterial toxicology, biocompatible material, biocompatible metal, biocompatible polymer, bioimplantable material, biomedical device, medical device design, biomedical engineering, biomechanical engineering, carcinogenicity, composite material selection, thermoplastic material selection, plastic medical device, polymer selection, elastomer selection, medical elastomer, medical polymer selection, rubber selection, implantable device, medical device, medical device corrosion, medical device endurance testing, medical device manufacturing troubleshooting, medical device product development, medical device product improvement, medical device testing, artificial heart, orthopedic product, business acquisition, analytical research, blood analysis, hip replacement, in vivo toxicology, Current Good Manufacturing Practice, nerve stimulator, composite material testing, artificial joint, bone healing, medical composite, autoclavable plastic material selection, biocompatible coating material, oxygenator, polymer selection for chemical compatibility, medical device sterility, bioactive ceramic material, composite material mechanical property, medical device hazard analysis, stent, medical device sterilization, medical device reliability testing, medical device process validation, medical device mechanical stress analysis, medical device manufacturing, blood-compatible material, composite material failure, polymer toxicology, biotoxicology, orthosis, prosthetic material, biodegradable plastic, medical instrument, toxicology, thromboresistant material, surgical instrument, skin substitute, prosthesis, neurotoxicology, medical pump, mechanical organ, irradiation sterilization, environmental toxicology, composite material processing, composite material, biocompatible ceramic, biocompatible adhesive, artificial organ

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