Expert Details

Expert in Medical Device Technology, Design and Manufacturing

Expert ID: 729236 California, USA

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Expert is a seasoned engineer with over 25 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 fifty one issued US patents. 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.

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.I have provided marketplace, therapeutic and technology analysis of specific disease states and technology applications to investment analystsI have 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.I have provided analysis of regulatory pathway and IP landscape to early stage medical device start-up. I have served as an expert witness in six different legal suits in the areas of patent infringement, product liability and trade secret infringement.

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 - Hayward, California

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2010 to 2018 Employer: (Undisclosed) Title: Principal Department: (Undisclosed) Responsibilities: Independent technical consultant to the medical device community.
Years: 2005 to 2009 Employer: (Undisclosed) Title: Vice President, Research & Development Department: (Undisclosed) Responsibilities: 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.
Years: 2001 to 2005 Employer: (Undisclosed) Title: Vice President, Research & Development Department: (Undisclosed) Responsibilities: 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.
Years: 1993 to 2001 Employer: (Undisclosed) Title: Director, Research & Development Department: (Undisclosed) Responsibilities: 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.
Years: 2011 to 2012 Employer: (Undisclosed) Title: Sr VP, R&D Department: (Undisclosed) Responsibilities: Lead an organization through a period of rapid iteration while guiding a product for minimally invasive mitral valve repair through a series of clinical trials.

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.
Awards / Recognition
Awarded Boston Scientific Outstanding Patent Award for the year 2000, Awarded 1999 Boston Scientific Significant Contributor Award
Publications and Patents Summary
I have fifty one issued US patents.

Additional Experience

Expert Witness Experience
I have served as expert witness in a number law suits. Four of these have been patent infringement suits, one was a trade secret case and another was a product liability suit. I have also testified in product liability suit, and wrongful employment suit. I have been deposed numerous times and written numerous expert opinion reports.
Training / Seminars
Developed "e-learning" neurovascular training course for Boston Scientific employees. This included modules in physiology, disease states, treatment options and competitive products.
Vendor Selection
Numerous years of experience of vendor selection for a wide range of medical devices.
Marketing Experience
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.

Fields of Expertise

expert witness, 510(k) document, catheter, 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, medical device marketing, Food and Drug Administration compliance, implant coating material, medical device coating material, medical device corrosion, Current Good Manufacturing Practice, cannula, medical device liability, medical device inspection, medical device soldering, Medical Device Reporting regulation, medical device reporting, medical product manufacturing, medical tubing extrusion, CE Marking, medical device package integrity, medical device packaging standard, medical device packaging material, medical device premarket approval, medical device sterility, medical device package testing, foreign medical device regulation, stent, medical technology, medical device irradiation sterilization, medical device manufacturing troubleshooting, cost reduction, electronic medical device design, medical device sterilization, medical device reliability testing, medical device process validation, medical device packaging process, medical device packaging design, medical device mechanical stress analysis, medical device manufacturing quality control, Food and Drug Administration, biomedical device, surgical instrument, FDA medical device regulation, failure modes and effects analysis, biomedical device manufacturing

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