Past Consulting Projects

· Evaluated premature failure modes and related device process manufacturing problems for diaphragms a heart assist device.

· Evaluated elastomer selection and device design followed by specific testing on an inter-gastric balloon that was failing prematurely.

· Evaluated claims of patent infringement on a vascular catheter.

· Evaluated background and proposed biological safety testing methodology on a new rubber.

· Evaluated material and process problems encountered in dip casting a latex biomedical product.

· Evaluated premature failure by environmental stress cracking of an artificial heart pump casing.

· Evaluated process problems resulting in the separation of layers of elastomeric tubing.

· Pointed out potential materials availability problems in the development of a long-term implant.

· Determined the composition of a competitive product (adhesive) and suggested modifications in a current formulation.

Orthopedic Product Development and Commercialization

For spinal interbody fusion cages, I invented a new pseudorandom composite structure, coordinated testing of a polymer never before used in the biomedical area and refined cage and instrument designs. The cages are now implanted in over 20,000 patients, approved in Europe and Japan, and in the USA.
Developed (with surgeons) and oversaw implantation of worlds first polymer composite spine plates, wrist wedges, ankle stabilization spool, skull plate, intermedulary rod, vertebral bodies, and injection molded composite screws. Also first artificial sacrum from titanium.
Co-invented and directed development of first artificial spinal discs to be implanted in USA. These discs were the subject of a Johnson & Johnson worldwide clinical trial and USA IDE. Some initial custom spine discs implants now over 12 years post-op.
Worked with surgeon to develop and have manufactured special spine ligaments that have been implanted in patients above a fusion to reduce adjacent segment degeneration.

Invented and molded bilaminar compliance chamber diaphragms from butyl rubber and Hexsyn for the Cleveland Clinic Foundation artificial heart programs for required high fatigue life and low gas permeability.
Evaluated the effect of flexing surfaces on clotting and platelet/white cell deposition in artificial hearts.
Directed a Ph.D. student’s dissertation on the fluid dynamics of artificial hearts in conjunction with NASA Lewis Labs and the Cleveland Clinic.
Evaluated permeability of silicone fluid and blood components through Biomer diaphragms with the University of Utah.
Evaluated a potential method of treatment of implant associated (slime layer) infection.
Developed and used an accelerated fatigue testing methodology for rubbers in the artificial heart program.
Developed mamographic examination of rubber components for determination of inclusions.
Evaluated various ultraclean carbon blacks for potential use in heart pump diaphragms.
Evaluated and implemented synthesis techniques to yield higher molecular weight polymer.
Evaluated alternate monomer systems to replace a monomer no longer available.
Evaluated alternate curing systems to find one that developed proper mechanical properties while reducing potential toxicity/carcinogenicity problems.

Evaluated relative carcinogenicity of a number of chemical compounds where limited data was available for direct comparison using the same test systems.
Developed and validated by field testing wide spectrum passive and active monitors for ppb levels of airborne carcinogens. Passive dosimeter was capable of detecting 1 ppb with one hour sampling.
Developed a field soil tester for PCBs.
Conducted interlaboratory validations of several analytical methods using 20 laboratories each.
Managed research on environmental fate of chemicals in soil, development of blood and urine tests for a rocket fuel, and establishment of a mutagen/carcinogen-testing laboratory.