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 Expert  721781

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

Available for your Consulting and Expert Witness Needs

Ohio (OH)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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.

510(k) document


investigational medical device exemption regulation

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.

medical device premarket approval

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.



biocompatibility testing


biomaterial toxicology


biocompatible material

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.

biocompatible metal

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.

biocompatible polymer


bioimplantable material

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.

biomedical device


medical device design

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.

biomedical engineering


biomechanical engineering

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.

composite material selection


thermoplastic material selection


plastic medical device


polymer selection

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.

elastomer selection


medical elastomer


medical polymer selection


rubber selection

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.

implantable device


medical device

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.

medical device corrosion

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.

medical device endurance 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.

medical device manufacturing troubleshooting

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.

medical device product development


medical device product improvement

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.

medical device testing

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.

artificial heart


orthopedic product

Show Secondary and Basic Areas of Expertise
Expert or 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;  and Erie, Pennsylvania.

Often requested
with this expert:

Medical Technology
Silicone Medical Devices and Implants, Product Development,...
Medical Products Packaging: FDA Package Validation,...
Biomedical Engineering, Manufacturing Engineering, R&D

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

Work History:
Years   Employer   Department   Title   Responsibilities

1997 to


(Undisclosed Consulting Company)


Synthetic Body Parts




Expert does independent consulting for spinal orthopedics, cardiovascular, and analytical companies, and occasionally, lawyers.

1989 to 1997


AcroMed Corporation


(now J&J DePuy AcroMed)


Sr. Scientist (also Director of R&D)


Expert 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.

1983 to 1989


University of Akron


Biomedical Engineering


Associate Professor & Dir. Cardiovascular Lab


Expert 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.

1975 to 1983


Monsanto Research Corporation



Senior Research Chemist & Contract Manager


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.

1971 to 1972


University of London, England


Queen Mary College


Research Associate


Between his M.S. & Ph.D. degrees, he assisted Professor Andrews in conducting environmental stress crazing tests.

1964 to 1969


General Motors Corporation


Packard Electric Division




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.

Career Accomplishments:

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 since it was founded in 1998. was the Executive Editor (U.S.A.) of the international journal, Bio-Medical Materials and Engineering, Pergamon Press from 1990 - 1996. Expert served on the Editorial Advisory Board of Medical Plastics and Biomaterials, Canon Communications, Inc. from 1994 - 1998; and has been a member of the Commercialization Cabinet, Edison Biotechnology Center (State of Ohio) since 1997. He served on the Scientific Advisory Council from 1992 to 1994 and on the Executive Advisory Committee from 1992 to 1996.


Expert was awarded the C. William Hall Award for lifetime achievements in the field of biomaterials by the Society for Biomaterials in 2015. He was one of thirty University of Akron faculty honored for "Significant Accomplishments in Teaching, Research, and Public Service" in 1984-1985. He was one of ten U.S. scientists selected for participation in the Second Joint USA/USSR Symposium on Circulation and the Artificial Heart (Houston - September l98l). He was one of seven U.S. scientists selected for participation in the Third Joint USA/USSR Symposium on Artificial Heart Research and Development (Moscow, USSR - June 1985).

Publications and Patents Summary

He has approximately 100 publications, book chapters, and patents.

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

Consulting Services:
Selected Consulting Examples:
  • 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 identifiy 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.
Recent Client Requests:
  • Expert in intota for consulting on Coating development for orthopedic implant.
  • FDA biocompatibility expert expert for consulting on biocompatibility testing of Chronoflex C.
  • Expert in Medical Devices Forum
  • Expert in FDA master files polyethylenes blood contact implant for consulting on cardiovascular implant material.
  • Expert in Pneumatic Diaphrag Failure.
  • Expert in polyurethane biocompatibility test database for consulting on Biocompatibility of a Two Part Cast Polyurethane.
  • Fastening expert for consulting on Product Development.
  • Expert on FDA regulations relating to non-drug topical and transferal patches.
  • Expert in formulation chemistry for consulting on dermal patch for cosmetics.
  • Gastric balloon biomaterial expert for consulting on gastric balloons.
  • Expert in Materials selection recommendations for medical rehabilitation device/garment.
  • Expert in Class room training 1 day - bandages and wound dressing products.
  • Expert in in the manufacturing and toxicity of tecothane to assist with FDA submission.
  • Expert in Pebax for consulting on degradation of Pebax after accelerated aging.
  • Expert for consulting on Elastomeric materials for use in diaphragm pump
  • Expert in Health applications of Polymeric Materials.
  • Expert in a dermatology drug delivery for Rx derm products.
Click the green button above to contact Expert or Expert for a free initial screening call regarding your expert consulting needs.  Expert or Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert or Expert is free.

Expert Witness:
Expert Witness Experience Summary:
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 satisfactoy results without further litegation.
Recent Litigation Client Requests:
  • Expert surgical staple guns for consulting on product liability.
  • Orthopedic expert for consulting regarding orthopedic screw failure.
  • Failure analysis expert needed for consulting on a hip implant failure.
  • Expert in medical spinal implants to discuss mechanical and biomedical requirements and mechanical/manufacturing tolerances, quality control issues, etc...for litigation.
  • Expert in biomechanical engineering for consulting on sacral screw.
  • Surgical screw expert for consulting on testing and evaluation of broken screw.
Click the green button above to contact Expert or Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert or Expert is free.

International Experience:
Years   Country / Region   Summary
1996 to 1996   The Netherlands   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.
1990 to 1997   Japan   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.
1997 to   Canada   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.
2003 to 2003   Isreal   Expert evaluated potential elastomers and plastics for a urinary bladders sling that had failed in testing. He located appropriate materials and established appropriate contacts.
2003 to 2003   Australia and New Zealand   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.

Market Research:
He worked with marketing staff to develop technical handouts on new products. He also helped staff booths at technical shows.

Click the green button above to contact Expert or Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert or Expert is free.

Additional Skills and Services:

Taught over 50 scientists and engineers the basics of literature searching.

Supplier and Vendor Location and 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.

Other Skills and Services

Expert has assisted in the development, commercialization and clinical use of a broad range of human implants.


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