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 Expert  725093

Expert in Biomaterials, Medical Devices, Drug Delivery, Nanotechnology, Due Diligence, etc.

Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medical device. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medical devices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a “do no harm” mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing “good,” that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that canchange therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existingmedical devices will facilitate the use of existing and new biomaterials for new medical device designs.



biocompatibility testing




biocompatible coating material


biocompatible material


biocompatible metal


biocompatible polymer


bioimplantable material


biomaterial toxicology


biomedical coating material


blood-compatible material

Expert has over 28 years managing the R&D and Business Development of medical and controlled drug delivery devices. He focuses on developing commercialization strategies of potentially disruptive technology as well as managing intellectual property development (30 issued US patents) and supporting patent litigation.

Expert is co-inventor of a medical device with long term non-thrombogenic coatings. He supports testing and regulatory submissions and performs due diligence evaluations of medical devices, biomedical materials (synthetic and biologic), biodegradable compositions, controlled drug delivery, nanotechnology, medical technology, and tissue engineering.

Expert is an expert in biomaterials, biocompatiblity and biomaterial databases (Committee Chair, ASM International, Materials for Medical Devices Database).

His medical device experience includes: Drug eluting stents and coatings, large and small diameter vascular grafts, mechanical and biologic heart valves, central venous catheters, wound dressings, sealants such as fibrin sealant, and percutaneous connectors.


catheter tubing


antimicrobial medical device


arterial graft


biodegradable plastic


medical device coating material


medical device evaluation


medical elastomer


medical polymer selection


metal material selection


polymer selection




thermoplastic material selection


thromboresistant material


vascular graft


elastomer selection


medical device patent


due diligence

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts;  Worcester, Massachusetts;  Springfield, Massachusetts;  Lowell, Massachusetts;  Cambridge, Massachusetts;  New Haven, Connecticut;  Hartford, Connecticut;  Waterbury, Connecticut;  Manchester, New Hampshire;  and Providence, Rhode Island.

Often requested
with this expert:

Medical Devices, Biomaterials, Due Diligence, Business...
Cardiovascular Devices: Vascular, Valvular Prostheses,...
Medical Device Product Development; Machine Design;...
Pharmaceutical and Biomedical Business Development,...

Year   Degree   Subject   Institution   Honors
1980   Ph.D.   Biomdedical Engineering   Case Western Reserve U.   Timken Honors Fellow
1978   M.S.   Biomedical Engineering   Case Western Reserve U.   Timken Honors Fellow
1975   B.S.   Metallurgy and Materials Science   Lehigh U.   Highest, Departmental, Phi Beta Kappa, Tau Beta Pi, Omicron Delta Kappa

Work History:
Years   Employer   Department   Title   Responsibilities

2007 to


(Undisclosed Consulting Company)



Consultant Biomaterials, Medical Devices, Drug Delivery, Nanotechnology


Focus has been on materials selection, drug eluting formulations, biocompatibility, and therapeutic polymers for start-up, small, and large medical device and drug delivery companies.

2005 to 2007


Advance Nanotech




Sr. VP


Manage the process of taking Advance Nanotech's academic investments from proof-of-concept into a product development path. Manage as a virtual company these external academic research teams by implementing project management tools and developing contracts and partnerships required to commercialize these nanoenabled products. The participation of Advance Nanotech's biosensor development effort, BiMAT, in FLUTEST, Part of the European Commission's Support to Combat the Spread of Avian Influenza, is an example of this partnership development.

2000 to 2005


Boston Scientific


Corp. R&D


VP Advanced Biomaterials


Head of center that leverages, evaluates and exploits biomaterials knowledge, expertise, and technology to cardiovascular stents, vascular prostheses, and cardiac implants. Provide thought leadership, external connections, and internal project support for emerging material technologies including bioactive polymeric materials, biodegradables, controlled drug delivery, smart materials and nanotechnology. 20 milestone patent award.

1995 to 2000


Edwards LifeSciences


Heart Valve Therapy




Manage four R&D groups to provide materials and bioscience expertise on product development teams for mechanical and bioprosthetic heart valves, annuloplasty rings, repair devices and tissue-engineered cardiac implants. Project Team leader for cardiothoracic implants leading to release of the Duraflo coated annuloplasty rings and new sewing ring for the Mira pyrolytic carbon bileaflet mechanical valve. Managed and upgraded materials and tissue research capabilities (including biochemical and biomechanical) to become the state of the art R&D within the heart valve industry. Managed international joint development program for medical implants and extramural research programs for a) biomechanical and biochemical characterization of bioprosthetic heart valves and b) state of art finite element model of heart. Provide expertise for technology assessment and implementation of new projects. Function also includes failure analysis on a range of cardiovascular devices. Patents issued and pending on cardiovascular implants. Implemented review of product opportunities based on a disease based strategy. Implementation of PERT team review of projects. Baxter Technical Awards: 1999: 1) Study of Calcification and Durability of Pericardial Bioprosthetic Heart Valves, and 1998: 2) Application of Duraflo Heparin Treatment for Implantable Annuloplasty Rings, 3) The StarRing, The Edwards Mira Sewing Ring. Member Baxter CVG Technical Strategy Team (1996), Innovation team (1999-present), Disease-based strategy team (1999-2000); Member Baxter Technical Council, Core Competency Champion (1998-2000), peer review team for Baxter Technical Awards (1997-2000) and Baxter Technical Leader (1998-2000).

1992 to 1995


Schneider USA


Coronary Stents


Principal Research Scientist


Managed team composed of a senior principal engineer , polymer chemist , two chemists and a technician, as well as extramural research programs centered on improvement of angioplasty catheters and metallic endovascular stents by use of new materials and technologies. Major efforts entailed the development of devices and methodologies to reduce restenosis. Technology assessment of medical devices and biomedical materials and acquisition of external technology. Internal consultant on biomedical materials. Oversight of QC laboratory. Patents and Patents Pending in controlled drug delivery from endovascular stents, super-elastic nitinol angioplasty/guidewire, drug delivery catheters, and polyamide elastomer angioplasty balloon.

1990 to 1992


St. Jude Medical


Heart Valves


Manager Research Programs


Implemented and managed research programs related to heart valve thrombo-embolism, enhanced recellularization on heart valve sewing cuffs, and bioprosthetic calcification in order to develop the next generation heart valves and programs related to anastomotic initmal hyperplasia, and small diameter vascular grafts. Use of cell adhesion peptides and proteins to reduce vascular tissue proliferation. Technology assessment of medical devices and biomedical materials and acquisition of external technology.

1988 to 1990


Harbor Medical Devices



Director Research


implemented programs utilizing controlled delivery technology to improve implantable vascular access ports, catheters and percutaneous connectors. Conceived, prototyped, scaled-up, including commercial release, within one year, a controlled release heparin coating for use on central venous catheters (patents issued). Developed sintered titatnium constructs with a gradient of pore sizes. Managed outside research program including development of animal protocols and budget administration as principal investigator on a NIH SBIR grant for percutaneous connectors.

1985 to 1988


Arthur D. Little


Product Technology


Sr. Consultant


Designed and tested implantable drug delivery devices; Technology and market assessment of medical devices (including cardiovascular, orthopedic and wound managment), biomedical materials and controlled delivery devices. Proposal writing, management of contracts and project teams for implantable drug delivery systems based on biodegradable and non-degradable formulations, evaluation of cardiovascular implants, failure analysis of polyurethanes, evaluation of controlled release technology for protein based drugs, optimization of the fatigue life of a commercial bone cement, and evaluation of orthopedic implant devices.

Career Accomplishments:

Fellow of the American Institute of Medical and Biological Engineering (since 1998); International Society for Applied Cardiovascular Biology; Society for Biomaterials; ASM International; American Heart Assc.

Advisory Boards: Board of Scientific Advisors - Pathology Experts LLC (2007-presnet); Roundtable on Biomedical Engineering Materials and Applications (BEMA) of the NRC (representing ASM Internations, 2007- present); Advisory Group to Consortium for Cancer Nanomedicine, Northeastern University; Industrial Advisory Board, Center for Biomodular Multi-scale Systems (CBM2); Industrial Advisory Board, New Jersey Center for Biomaterials (NJCB), Chair of IAB NJCB 2004-2005; Science Adviosory Board, U. Mass. Boston; Industrial Advisory Board, Dept. Biomedical Engineering, Case Western Reserve University; Long Range Steering Committee, Society for Biomaterials; Harvard-MIT Division of Health Sciences & Technology Advisory Council 2005.

Professional Appointments

Fellow of the American Institute of Medical and Biological Engineering (since 1998)

Editorial Board, J. Biomedical Materials Res.

Publications and Patents Summary

44 Issued US Patents. About 40 published patent applications.

4 Books, 69 articles, chapters, and presentations, 36 technology reviews and commentaries

Selected Publications and Publishers  
 - Kluwer/Academic Landes  
 - Toxicologic Pathology  
 - Acta Biomaterialia  
 - Nature Nanotechnology  

Consulting Services:
Selected Consulting Examples:
  • Verify the thromboresistant properties of a new therapeutic polymer: Designed and implanted AV shunt model that definitively answered the question. Effort included the characterization of the materials from a physiochemical and surface property perspective.
  • Identify biocompatible coatings for a unique soft tissue implant. Provided documentation used for investors. Worked with vendors on protocols for implant and post implant analysis.
  • Identification of key parameters of a competitive implant product and how they related to the chemistry of the formulation. By a process of deengineering, a reformulated composition allowed a competitive product with minimal regulatory impact.
  • Patent Expert: Drug Eluting Stents, Depostion, Expert Reports, Testimony, Reexams
Recent Client Requests:
  • Expert in Medtech Coatings.
  • Expert in development of novel antimicrobial coatings (device/drug).
  • Expert in controlled release antimicrobial dental products for consulting on use of novel antimicrobial incorporated into dental sealant.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Witness as Inventor for Boston Scientific - US Patent 6,120,536, Sept. 19, 2000 which Boston Scientific prevailed in a patent-infringement battle with rival Cordis.

Acting as expert witness in ongoing litigation.

Recent Litigation Client Requests:
  • Expert in medical devices needed to review medical device patents.
  • Medical device engineering expert needed for consulting on Fox hollow catheters.
  • Pharmaceutical litigation expert for consulting on heparin litigation case.
Click the green button above to contact 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 is free.

International Experience:
Country / Region   Summary
Italy   Part of a due diligence team from a US corporation to perform due diligence on implant products including fabrication, testing, life evaluation, failure analysis, and implant retrieval

Market Research:
Has written extensively on development of new technology and markets as well as heading groups translating technology into product platforms. Insight on medical device patents.

Click the green button above to contact 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 is free.

Additional Skills and Services:

Gives several symposiums, classes, presentations on a global level.

Supplier and Vendor Location and Selection

Identification of vendors for micronizing pharmaceutical components of drug delivery systems.

Vendors for molding medical grade silicones.

Selection of vendors for biocompatibility testing.

Other Skills and Services

Observing strategic trends and identifying the spectrum of technologies that can become competitive within these emerging markets. Understanding the importance of disruptive technologies in medical technology


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