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Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in clinical laboratories, as well as surgical and other simpler clinical instruments used in various clinical settings. His role included identifying unmet needs, developing concepts, sometimes leading to patents, breadboad fabrication, initial functional testing, organizing and maintaining Design History Files, prototyping, testing, performing risk analysis (primarily FMEAs), verification testing, running design reviews, working on pilot build, transfer to manufacturing and assist in validation as required.
Recent work includes design and /or development of a pain management microarray electrode (recently commercialized and shown on the CBS Evening News), assisted a specialist in designing a microneedle device for drug delivery, analyzed and designed a spring drive system to pump hydraulic fluid for a drug delivery device, and designed and fabricated a minimally invasive surgical instrument and system, with an initial application in cardiac surgery.
Additional recent work included primary market analysis and strategy of a handheld imaging device, gap analysis of an established cardiology equipment company's regulatory documentation, and work with a coating processor to determine and assist in determining target OEM clients for additional business.


Expert, as Entrepreneur, Inventor, Consultant and Engineer, has over twenty five years of experience in business development, project management, design engineering, analysis, manufacturing engineering and product introduction in the medical product industry. This experience was gained while working in areas of surgical instrumentation, production automation, implants, laboratory automated instrumentation, and drug delivery devices.


In the early 1990’s Expert founded a company focused on developing remote controlled instruments for minimally invasive surgical applications. Other experience includes work with Corning Glass Works, Hewlett Packard, Johnson & Johnson, Millipore Corporation, Orion Research, Visualization Technology, Inc. (now part of GE Healthcare), Waters Corporation and several start-up and early stage companies, primarily in the technical development of laboratory analyzers, and invasive devices.


Accomplishments include development of automated minimally invasive surgical instruments (3 patents) which resulted in the formation of Automated Medical Instruments, Inc. Expert also led or participated in the design and/or development of an automated DNA pellet preparation system (4 patents), an automated DNA sequencer/imager system, a snap-lock knee implant, an image guided surgery system with accessories (1 patent), a micro-osmometer, a blood gas analyzer, a unique display cover for use in a sterile field (2 patents) and numerous other products. More recent projects include the development of a drug delivery pump, design of a microneedle device, also for drug delivery, and design of a micro-spike array for a pain management instrument. Expert’s accomplishments have contributed to over $800 million in sales revenues for clients and employers.


As entrepreneur and inventor he continues to work with users, including clinicians. These clinician connections help Expert and his colleagues search for and understand unmet clinical needs, and thereby develop new concepts and intellectual property. They also help to validate these concepts to determine if they satisfy unmet needs. Expert is most concerned that development of new products have proven efficacy, deliver true added value to the market, and maximum return on investment for investors.


In 2001, along with numerous colleagues, Expert co-founded and was the first President of a medical device networking forum. In 2003, he co-founded a for-profit consulting company. In 2006 Expert helped co-found Medical Development Partners, LLC ("MDP"). Expert has helped AlvaMed and MDP develop a significant client base, complete numerous projects, which satisfied or surpassed client requirements, and establish each company as a major resource for development of medical products. Expert continues to consult on and develop various medical products. His involvement includes business assessment and strategy, project management, intellectual property landscape analysis and strategy, product development, design, analysis and problem solving.


Expert helped develop an initial Market Analysis preparing for a foreign imaging company's entrance into the US medical market. He arranged and conducted physician surveys. He contributed to the final report, which included the various markets in which the instrument could be sold. He helped recommend strategies to the client. He designed, sourced a key vendor, and managed the development of a key micro-electrode array component for an early stage pain management company. That product was shown on the CBS Evening News in late 2007 in early commercialization. . For a well funded, early stage drug delivery company, Expert initially:
1. Designed and fabricated a glucose sensor system;
2. Helped design and fabricate a microneedle delivery device;
3. Analyzed, designed and sourced vendors for a spring driven drug delivery pump. This last device has been through early clinical trials. Expert helped an established cardiac equipment company assess and remedy their regulatory documentation problems, thereby meeting regulatory standards. Expert developed a cost effective replacement component and filling system for an established life science company's Biotechnology product. This included:
1. Managed design and development of Process Equipment for cost reduction and improved efficiency of
precast gel cassettes for electrophoresis applications in the Biotechnology market.
2. Responsible for the design of plastic molded components and welding process to develop a plastic cassette, which replaced a more expensive, glass assembly. New breakaway concept.