Expert in Cardiovascular Devices: Vascular, Valvular Prostheses, Coatings
Expert's work in developing vascular grafts has given him a broad depth of knowledge with regards to the cardiovascular system. He has conducted research in the areas of vascular and valvular prostheses, developing devices with improved performance and blood compatibility.
Expert has researched, developed, and brought to market devices in the areas of cardiovascular devices (valves and vessels), orthopaedic devices (ligaments and tendinous replacements), and catheters. Several of his research programs have focused on the feasibility trials associated to disposable devices (such as intracranial pressure monitors). Much of his work has involved Class III type devices.
Expert has been actively engaged in the development of coating materials(collagen, PLA, silicone) yielding improved biocompatibility (i.e. reduced thrombotic potential). Much of his work in this area has focused upon the surface immobilization of heparin. In addition, he has been actively engaged in the in vitro, in vivo, and ex vivo testing of materials for thromboresistance.
Expert has worked with many types of prosthetic materials, including polyester, polytetrafluoroethylene (PTFE), collagen, polyolefins, and polyurethane. He is also familiar with the testing protocols associated with the evaluation of devices manufactured with each of the materials.
Expert has headed research and development activities for a number of companies including large organizations such as Baxter and smaller organizations such as BioVascular Inc. He is experienced with budgeting, project management, coordination of multiple research sites, staffing, reporting to management, assessment of results, development of testing protocols, and data analysis. Expert has significant experience interacting with clinicians.
Expert has broad experience in the development of Class II and III implantable devices using a range of materials including polyester, PTFE, urethane and silicone.
Expert has significant expertise in the development of both implantable and non-implantable biomedical devices. Products that he has successfully brought to the marketplace include cardiovascular devices (vascular grafts, valves, collagen coated grafts),collagen staple line buttressing materials, orthopaedic products and vascular sealants.
Expert's primary research focus has been in bio-medical devices. He has been successful in bringing products from feasibility testing to manufacturing. He brings a well balanced approach to his work recognizing the need for continual improvement while maintaining financial objectives for the products under development.
Work career has focused on the development of new and improved synthetic and biologically based vascular and valvular prostheses. Expert's research group developed and introduced to the market the world's first tissue based (pericardial) mitral heart valve. Expert has significant experience in the development and assessment of pyrollytic carbon heart valves as well.
Expert is an expert in the development of collagen based valve and vascular graft devices. He is familiar with crosslinking techniques used for the material as well as the evaluation of collagenous substrates.
Expert's experience includes the evaluation of a number of material considered for vascular graft coating applications including, collagen, PLA/PGA, silicone, and dextran. His experience also includes the immobilization and evaluation of heparin complexes.
Expert's experience includes heading research and development groups ranging in size. He is a well seasoned administrative individual with a practical perspective of the requirements of running a research and development group.
Though not academically trained in textile science Expert has a practical understanding of the intricacies of working with textiles for biomedical device applications. He has successfully developed woven, knitted, braided vascular conduits and sewing cuff materials for valvular prostheses.
He is familiar with the set up and running of textile equipment.
Expert has developed bovine carotid, and human umbilical vein substrates for vascular graft applications. His work has additionally included the development of small caliber tissue based vascular conduits for coronary and distal peripheral graft applications. He is familiar with commonly used digestion processes for tissue grafts as well as detergent extraction of substrate materials.
Expert may consult nationally and internationally, and is also local to the following cities: Minneapolis, Minnesota - Saint Paul, Minnesota - Rochester, Minnesota - Burnsville, Minnesota - Saint Cloud, Minnesota - Eden Prairie, Minnesota - Minnetonka, Minnesota - Eau Claire, Wisconsin
|Year: 1979||Degree: M.A.||Subject: Molecular Biology||Institution: Montclair State University|
|Year: 1974||Degree: B.S.||Subject: Biology||Institution: Fairleigh Dickinson University|
|Years: 1998 to 2001||Employer: Undisclosed||Title: Vice President||Department: Research and Development||Responsibilities: He is responsible for all departmental functions including budgeting, strategic planning, feasibility and development oversight and support activities.
Product lines are focused on cardiovascular devices including mechancial and tissue valve prosthesis, repair devices and tissue engineering efforts.
|Years: 1993 to 1998||Employer: Undisclosed||Title: Vice President||Department: Research and Development||Responsibilities: He was responsible for all aspects of administration of research and development function. Strategic planning to fill product pipeline and support activities. Products were primarily crosslinked tissue products.|
|Years: 1983 to 1991||Employer: St. Jude Medical, Inc.||Title: Manager||Department: Biomaterials/Vascular Graft Research and Development||Responsibilities: He was responsible for materials research and development efforts associated to pyrrolytic carbon.
He led development efforts focused on tissue vascular grafts.
|Years: 1978 to 1983||Employer: Meadox Medicals, Inc.||Title: Senior Research Scientist||Department: Research and Development||Responsibilities: He was focused on the development of new polyester graft constructions - woven double velours, intraluminal grafts, micro-knits etc.. He developed preclotting agents (coating materials) for vascular grafts ie. Hemashield. Competitive product analysis, development of support data for regulatory submission.|
|Years: 1977 to 1978||Employer: Machida America, Inc.||Title: Technician||Department: Research and Development||Responsibilities: He was responsible for development of new lens systems for fiberoptic endoscopes. He was also responsible for the development of accesories for use in conjunction with endoscopes.|
|Years: 1974 to 1977||Employer: G.A.F., Inc.||Title: Chemist||Department: Research and Development||Responsibilities: As a polymer chemist, he was responsible for the development of Poly vinyl chloride based products for the building industry. He also was involved in the development of improved extrusion formulations.|
|Associations / Societies|
|Expert is a member of the Society for Biomaterials. He has also been active on various committees responsible for developing standards for the vascular prosthesis industry (ASTM and its F4.04 Standards Committee for vascular grafts, and AAMI).|
|Publications and Patents Summary|
|He holds patents in the area of coatings for vascular grafts, orthopaedic implant devices, and drug delivery systems.|
|Expert Witness Experience|
|As an expert witness, he summarized technical details of preclotting agents for vascular grafts. He was also engaged as an expert witness to discuss bioresponses to pyrollytic carbon.|
|He has expertise in the selection of processing conditions and vendors for implantable textile products. He can also identify processing conditions and vendors for polymeric compounds.|
|He has acted as the technical interface for market introduction of vascular and valvular products including preclotted vascular conduits, staple line buttressing materials, valvular conduits.|
|German||Expert is proficient in German.|