Expert Details

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

Expert ID: 725093 Massachusetts, USA

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Expert has extensive experience leading and managing the R&D of medical, controlled drug delivery, and tissue engineered devices. He is an expert on commercialization of Medical Devices and the Effect of Covid 19 on Medtech. He has a focus on developing commercialization strategies of potentially disruptive technology as well as managing intellectual property development (44 issued US patents). Expert has experience with patent litigation. Expert has strong skills in assessing emergent technologies and products, incubating emergent technologies and identifying “White Space” opportunities and how they may impact future medical therapeutics, particularly in these times of change. His consulting casework over the past few years has been with technologies, established and emerging companies ranging from orthopedic, cardiovascular, less invasive devices, wound care, and opthalmic devices with a range of unique technologies ranging from nanoenabled, magnetic nano-particle drug delivery, bioactive, biocompatible and thromboresistant coatings, electrospun polymers, injectable polymers, therapeutic NO and statin releasing polymers, Point of Care Diagnostics and both drug and cellular combination devices. He has reviewed the emergence of nanoenabled sensors and the impact in the evolving field of personalized medicine.

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 has a strong core competence in Drug Delivery utilizing synthetic, biologic and biodegradable materials to control the release of small and large molecules. He also is an expert in the use of coatings for drug delivery and nano-enabled drug delivery. Many of his patents relate to drug delivery and he has been an expert in drug eluting stent patent litigation.

Expert supports the product development process (eg stage-gate processes) including testing and regulatory submissions; due diligence evaluations of medical devices, combination devices, tissue engineered constructs and nanoenabled therapies; materials selection for medical and combination devices based on synthetic, biologic, and biodegradable compositions; formulation of controlled drug delivery coatings; design and interpretation of biocompatibility and thrombogenicity studies; failure and explant analysis; expert opinions on the biocompatibility and thrombogenicity, including effects of wear, of devices and nanoformulated therapies; and opinions on IP. He has managed groups up to 30 people. Expert is co-inventor of a medical device with long term non-thrombogenic coatings.

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 can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medical devices will facilitate the use of existing and new biomaterials for new medical device designs.

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.

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, Deposition, Expert Reports, Testimony, Reexams

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 - Providence, Rhode Island

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Education

Year Degree Subject Institution
Year: 1980 Degree: Ph.D. Subject: Biomdedical Engineering Institution: Case Western Reserve University
Year: 1978 Degree: M.S. Subject: Biomedical Engineering Institution: Case Western Reserve University
Year: 1975 Degree: B.S. (with Highest Honors) Subject: Metallurgy and Materials Science Institution: Lehigh University

Work History

Years Employer Title Department Responsibilities
Years: 2008 to 2012 Employer: ASM International Title: Course Faculty Department: Responsibilities: Material Processes for Medical Devices (MPMD), “Materials Selection: Meeting Functional Requirements of Medical Devices." Workshop cosponsored by ASM International and Society for Biomaterials
Years: 2007 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: 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.
Consultant focus: Biomaterials, Medical Devices, Drug Delivery, Nanotechnology, COVID-19 Effects, COVID-19 RADx solicitation
Intellectual Property and Patents – Expert Witness, Expert Opinions, Reexams
Years: 2005 to 2007 Employer: Advance Nanotech Title: Sr. VP Department: Biopharma Responsibilities: Management and incubation of 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.
Years: 2002 to Present Employer: Undisclosed Title: Adjunct Asst. Professor Department: Dept. Biomedical Engineering Responsibilities: Biomaterials in the Design of Medical Devices.
Years: 2000 to 2005 Employer: Boston Scientific Title: VP Advanced Biomaterials Department: Corp. R&D Responsibilities: Head of center that leverages, evaluates and exploits biomaterials and drug delivery 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 including nanoporous coatings. 20 milestone patent award.
Years: 1995 to 2000 Employer: Edwards LifeSciences Title: DIRECTOR R&D, MATERIALS AND TISSUE TECHNOLOGY Department: Heart Valve Therapy Responsibilities: 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.
Years: 1993 to 1994 Employer: St. Thomas University Title: Adj. Professor Department: Dept. in Manufacturing Systems and Engineering Responsibilities: Biomaterials in the Design and Reliability of Medical Devices; Guest lecturer on Cardiovascular Implants, Biomedical Engineering, U. Minnesota
Years: 1992 to 1995 Employer: Schneider USA Title: Principal Research Scientist Department: Coronary Stents Responsibilities: 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.
Years: 1990 to 1992 Employer: St. Jude Medical Title: Manager Research Programs Department: Heart Valves Responsibilities: 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.
Years: 1988 to 1990 Employer: Harbor Medical Devices Title: Director Research Department: Responsibilities: 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 titanium 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.
Years: 1985 to 1990 Employer: Worcester Polytechnic Inst. Title: Asst. Adjunct Professor Department: Dept. Mechanical Engineering Responsibilities: Supervise student research and courses on Biomedical Materials and Artificial Organs.
Years: 1985 to 1988 Employer: Arthur D. Little Title: Sr. Consultant Department: Product Technology Responsibilities: 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.
Years: 1984 to 1985 Employer: Bard Cardiosurgery Division Title: Engineering Research Manager Department: Responsibilities:
Years: 1983 to 1990 Employer: University of Lowell Title: Adjunct Professor Department: Dept. of Plastics Engineering Responsibilities: Supervise student research and courses on Polymers in Medicine and Polymer Science.
Years: 1981 to 1984 Employer: Bard Implants Div. Title: Senior Project Engineer Department: Responsibilities: Corporate proposal writing, staff hiring, implementation and management of in-house and external small diameter graft program. Managed internal program for biologic implant devices including collagen processing and characterization. Managed team consisting of Ph.D. biochemist, M.S. Biomedical Engineer, a plastics engineer, technicians, and representatives of manufacturing, QA/QC and regulatory affairs. Responsibilities included PERT committees, screening committee for new products, and reporting progress to corporate R &D committee.
Years: 1980 to 1981 Employer: Franklin Research Center Title: Research Chemist Department: Dept. Physical and Life Sciences Responsibilities: Proposal writing. Developed and tested hydrogel coated, sub-micron magnetic microspheres for cell separations. Applications included purified cell cultures for monoclonal antibodies and islet cell purification for insulin producing cells. Participated in FDA sponsored review of safety and efficacy of cardiovascular catheters.
Years: 1972 to 1973 Employer: Naval Facilities Engineering Command Title: Engineering Student Trainee Department: GS-3 Responsibilities: Engineering Student Trainee, GS-3, Naval Facilities Engineering Command, Norfolk, VA, Electrical Engineering Div.; Engineering Student Trainee, GS-4, Naval Research Laboratory, Washington, DC.

International Experience

Years Country / Region Summary
Years: to Present Country / Region: Italy Summary: 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

Career Accomplishments

Associations / Societies
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 (200x-present) - Roundtable on Biomedical Engineering Materials and Applications (BEMA) of the NRC (representing ASM Internations, 200x- 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
- Science Advisory 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

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

Editorial Board, J. Biomedical Materials Res.

Extensive list of professional activities. Available upon request.
Publications and Patents Summary
PATENTS and PUBLISHED PATENT APPLICATIONS: 97

6 Books, 69 articles, chapters, and presentations, 42 technology reviews and commentaries

Technical Publications, Peer Reviewed Publications and Presentations: 74

Additional Experience

Expert Witness Experience
Witness as Inventor for Boston Scientific - US Patent which Boston Scientific prevailed in a patent-infringement battle with rival Cordis.

Acting as expert witness in ongoing litigation.
Training / Seminars
Gives several symposiums, classes, presentations on a global level.
Vendor Selection
Identification of vendors for micronizing pharmaceutical components of drug delivery systems.

Vendors for molding medical grade silicones.
Selection of vendors for biocompatibility testing.
Marketing Experience
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.
Other Relevant Experience
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.

Fields of Expertise

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