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 Expert  723840

Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals

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's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO.

In addition to filing and prosecuting patents, he also has experience working with other attorneys in various US and European intellectual property disputes.

Because he can draw upon both his extensive technical and business background, and his legal and IP background, he is particularly good at identifying underlying issues and legally relevant facts that might otherwise be missed.


intellectual property


intellectual property dispute




patent law


legal practice

Before becoming a patent attorney, Expert was a medical-device and biotechnology executive with a strong R&D background in biotechnology, and medical electronics.

At Johnson and Johnson (LifeScan), he played an important management role in the team that developed the original One-Touch(tm) blood glucose monitoring system (medical device for diabetes therapeutic drug monitoring), which eventually had sales of over a billion-dollars per year.

He then subsequently founded a VC backed medical device (cardiovascular therapeutic drug monitoring) company. As founding CEO (later Chairman and CTO), he took the concept from the initial “gleam in the eye” stage through fund raising, team formation, development, clinical trials, 510(k) approval, launch and final sale. His responsibilities included anything that impacted the technical competence of the company. In addition to being a member of the board of directors, his executive responsibilities included heading up Research and Development, managing the company's intellectual property portfolio, ensuring that clinical trials were conducted properly, supervising the VP of quality assurance and regulatory affairs to be sure that the company met all FDA mandates, supervising the VP of operations to be sure that the company's products were manufacturable, and reviewing and approving all marketing materials and product labeling for accuracy.

Expert's unusually broad background has given him a unique perspective and understanding of how nearly all aspects of medical device technology, regulation, finance, business and legal issues interrelate.






biomechanical engineering




biomedical device


biomedical device design review


biomedical device manufacturing


biomedical engineering


biomedical product development


canons of claim construction


claim (patent)


patent claim construction


patent claim construction brief


clinical engineering


device code




direct infringement


drug delivery


drug development


drug regulation


Food and Drug Administration


FDA medical device regulation


Food and Drug Administration regulation


Food and Drug Administration validation


induced infringement


medical device


medical device reliability testing


medical device testing


medical instrument


patent infringement


pharmaceutical drug


medical device coding


medical device patent


biomedical instrumentation


electronic medical device


in vitro diagnostics Food and Drug Administration code


medical diagnostics

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.

Year   Degree   Subject   Institution   Honors
1974   BA   Physics, Biology   University of California, Santa Barbara  
1980   PhD   Molecular Biology/Biophysics   University of California, San Diego  
2011   JD   Law   Taft Law School   Honors

Work History:
Years   Employer   Department   Title   Responsibilities

2012 to




Patent Associate


Patent Attorney


Legal practice focusing on intellectual property.

2002 to 2012


CliniSense Corporation





Founded medical device and IP consulting company, focusing on stability monitoring technology, medical diagnostics instrumentation, and intellectual property

1991 to 2001


Avocet Medical, Inc.





Chief Technology Officer of venture backed point-of-care medical device (diagnostics) instrumentation company. Responsible for all technical operations, managing company IP patent portfolio

1985 to 1991


LifeScan (Johnson & Johnson)






LifeScan a J&J company focused on point-of-care medical diagnostics (blood glucose) monitoring. 1: Led operations group that developed the original One-Touch manufacturing process; 2: Led R&D team that developed technology for successful SureStep product.

1984 to 1985


Bayer (Miles Laboratories)




Senior Research Scientist


R&D troubleshooter for manufacturing and quality control problems for Bayer point-of-care diagnostics products

1982 to 1984


Baylor College of Medicine




Assistant Professor


Taught medical students. Research in structure of cell nucleus using monoclonal antibody technology and computer bioinformatics technology.

1980 to 1982


National Institutes of Health


Laboratory of Immunology


Arthritis Foundation Postdoctoral Fellow


Studied function of immune system "Ia" regulatory molecules using monoclonal antibody technology

Career Accomplishments:

American Association for the Advancement of Science, American Intellectual Property Law Association, IEEE


California Bar registration, USPTO Patent Bar registration.

Professional Appointments

Reviewer, Vaccine journal. Adviser University of California, Santa Barbara CCS.


Best research paper award by AAMI (American Association of Medical Instrumentation). SBIR grant awards, UCSB distinguished alumnus,

Medical/Professional Internships

Arthritis Foundation Postdoctoral Fellow at the National Institutes of Health

Publications and Patents Summary

He has 19 publications and 26 patents (25 issued, 1 pending).

Selected Publications and Publishers  
 - Drug Delivery Technology  
 - Elsevier/Vaccine  
 - Drug Delivery Reports  
 - International Biopharm  
 - Cannon Communications/IVD Technology  

Government Experience:
Years   Agency   Role   Description
1980 to 1982   National Institutes of Health   Postdoctoral Fellow   Immunology research

Consulting Services:
Selected Consulting Examples:
  • Development of a vaccine stability monitoring device for a major (international) vaccine company. Evaluate vaccine stability profile, devise algorithm that best fits this profile, deliver & validate monitor.
  • Evaluate patent infringement case for major medical instrumentation company. Research design of infringing device, research patents, prepare opinion documents.
  • Extensive on-site experience with Beckman-Coulter. Biomedical instrumentation design and review, Intellectual property review, design of new immunochemical reagents (resulting in a patent assigned to Beckman-Coulter).
  • Extensive on-site experience with Panasonic. Biomedical instrumentation design review. Software algorithm development.
  • Expert witness for various intellectual property and product safety design cases.
Recent Client Requests:
  • Medical diagnostics expert for consulting on industry insight for point-of-care medical diagnostics.
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:
Experience evaluating other products for potential patent infringement, and writing opinion briefs based upon analysis of technology and analysis of patent claims. Also experience doing expert witness for due diligence and process negligence.
Recent Litigation Client Requests:
  • FDA labeling expert for consulting on medical device labeling.
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:
Founded two medical device companies: This requires researching market needs, devising plan to meet market needs, and supporting product launch with publications and seminars.

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:

Taught course in high-tech company formation at the University of California, Santa Barbara (2006).

Lectured in biomedical instrumentation design at Keck Institute (2006).

Many in-house seminars for Beckman-Coulter, Panasonic, Avocet Medical, and Johnson & Johnson

Supplier and Vendor Location and Selection

Extensive vendor selection experience: Have had 20+ years as highest level person responsible for selecting/authorizing/approving components and vendors for biomedical instrumentation and reagents.

Other Skills and Services

15+ years intellectual property (IP) experience managing medical device patent portfolios. Registered patent agent. Personal portfolio of 30 patents (20 issued, 10 pending).

Extensive experience with FDA regulations and quality assurance.


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