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 Expert  729236

Expert in Medical Device Technology, Design and Manufacturing

Available for your Consulting and Expert Witness Needs

California (CA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert is a seasoned engineer with over 20 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open procedures and devices used in body cavity surgery. He has brought numerous devices from initial conceptualization through to commercialization. His greatest areas of strength include: initiative, creativity, working in a multi-disciplined team environment, written and verbal communication, and technical judgment and problem solving. He has a track record of exceptional creativity manifested in thirty-seven issued US patents with nineteen additional pending. He has experience and flexibility to succeed in the full range of endeavors from early stage hands-on start-ups to large, matrixed, multi-national organizations. He also has significant experience and expertise in the areas of: project management, patent and project portfolio and budget management and analysis, and development of design control systems.

He currently supports and advises existing endeavors and early stage start-ups in the areas of assessment of prior art IP and strategic analysis and development of new IP. In this capacity he has served as an expert witness in multiple IP litigation cases. Expertise also includes assessment of technology feasibility and product design relative to existing predicates, and potential regulatory pathways based on possible design and indication for use options. Also, he provides cost, labor and timeline analysis for prototype development and ultimately commercialized product. Previous projects have also included project management leadership of activities to create on-line in-house technical training modules for a major medical device manufacturer.


510(k) document




disposable medical device


electronic medical device


implantable device


medical device


medical device design


medical device endurance testing


medical device evaluation


medical device hazard analysis


medical device manufacture clean room


medical device manufacturing


medical device product development


medical device product improvement


medical device safety


medical device shelf life


medical device testing


medical product


therapeutic device

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California;  San Francisco, California;  Sacramento, California;  Oakland, California;  Stockton, California;  Fremont, California;  Modesto, California;  Salinas, California;  Santa Rosa, California;  and Hayward, California.

Often requested
with this expert:

Medical Devices, Biomaterials, Due Diligence, Business...
Implantable and Non-Implantable Medical Device Risk,...
Specialty Chemicals and Plastics, Marketing and Business...
Hydrogel Science and Technology for Drug Delivery, Medical...

Year   Degree   Subject   Institution  
1979   MS   Chemical Engineering   University of Rochester  
1977   BE   Chemical Engineering   Cooper Union  

Work History:
Years   Employer   Title   Responsibilities

2010 to 2010


Expert Consulting Services




Independent technical consultant to the medical device community.

2005 to 2009


Aragon Surgical


Vice President, Research & Development


As second employee of venture backed start-up: • Specified, acquired and implemented facility and equipment resources in order to initiate and ramp-up R&D activities in new facility. • Partnered with Director of Quality Affairs to implement Design Control System and documentation at very early stage in order to assure efficient resource utilization and avoid future regulatory compliance issues. • Managed Intellectual Property portfolio and aggressively covered technology space by initiating seventeen patent applications within first two years. • Within 26 months of A Round funding successfully launched first product (Q4 2007). Second product launched in Q1 2009. Third product launched in Q3 2009 with fourth in Q4 2009. This produced a portfolio of products with superior performance capabilities compared to pre-existing “gold standards” in both the laparoscopic and open surgery RF electrosurgery space.

2001 to 2005


Boston Scientific


Vice President, Research & Development


Took on progressively larger roles in managing and mentoring Boston Scientific's growing and expanding R&D activities and technology portfolio during this period. Functional areas of responsibility include products in the areas of: vascular access, vascular occlusion, thrombectomy and stenting.

1993 to 2001


Boston Scientific/Target Therapeutics


Director, Research & Development


Developed technologies and products for minimally invasive neurovascular, and peripheral vascular therapies. These included devices that were the first FDA cleared alternative to craniotomy for treating intracranial aneurysms. Target continued to have a dominating position in this therapy by continuously "raising the bar" on therapeutic safety and efficacy with a continuous stream of new and improved devices and technologies.

Career Accomplishments:
Professional Appointments

Was the industry representative for the aneurysm therapy discussion panel at the Jackson Hole Neurointerventional Peer Review Conference four consecutive years.


Awarded Boston Scientific Outstanding Patent Award for the year 2000, Awarded 1999 Boston Scientific Significant Contributor Award

Publications and Patents Summary

He has thirty-seven issued US patents with nineteen additional pending.

Consulting Services:
Selected Consulting Examples:
  • Developed "e-learning" on-line neurovascular training course for Boston Scientific employees. This included modules in physiology, disease states, treatment options and competitive products. Served as knowledge matter expert, story board and script writer as well as project leader/coordinator of activities of physiology modeling experts and software engineers.
  • He has provided marketplace, therapeutic and technology analysis of specific disease states and technology applications to investment analysts
  • He has provided analysis of existing patent portfolio to client who was looking to enter medical device space and provided recommendations of where portfolio could be bolstered.
  • He has provided analysis of regulatory pathway and IP landscape to early stage medical device start-up.
Recent Client Requests:
  • Expert for consulting on Electrosurgical instrument design.
  • Expert in Medtech Coatings.
  • Expert in Writing a 510K.
  • Heat sealing expert for consulting on heat sealing cord blood final product package.
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:
He has served as expert witness in multiple patent infringement suits. He has also testified in product liability suit, and wrongful employment suit. He has been deposed numerous times and written numerous expert opinion reports.
Recent Litigation Client Requests:
  • Expert in RF Technology for litigation case involving false claims of machine to tighten skin.
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.

Market Research:
He has extensive experience in therapeutic trends for vascular disease such as stroke, anuerysms, occlusive disease, and body cavity procedures such as: bowel resection, bariatric volume reduction surgery, hysterectomy, appendectomy, cholecystectomy, and other procedures.

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:

Developed "e-learning" neurovascular training course for Boston Scientific employees. This included modules in physiology, disease states, treatment options and competitive products.

Supplier and Vendor Location and Selection

Numerous years of experience of vendor selection for a wide range of medical devices.


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