Expert Details

Expert in Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing

Expert ID: 724773 Massachusetts, USA

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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.

Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts - Worcester, Massachusetts - Springfield, Massachusetts - Lowell, Massachusetts - Cambridge, Massachusetts - Brockton, Massachusetts - New Bedford, Massachusetts - Hartford, Connecticut - Manchester, New Hampshire - Providence, Rhode Island

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Year Degree Subject Institution
Year: 1977 Degree: Master of Engineering (ME) Subject: Mechanical and Biomedical Engineering Institution: Dartmouth College
Year: 1973 Degree: Bachelor of Science in Mechanical Engineering (BSME) Subject: Mechanical Engineering Institution: Worcester Polytechnic Institute

Work History

Years Employer Title Department Responsibilities
Years: 2006 to Present Employer: Undisclosed Title: Co-Founder, Partner Department: Responsibilities: Expert's responsibilities include:
1. Business Development generating client opportunities.
2.. Assist in closing sales.
3. Manage and Participate in various projects including the following areas:
- Market Analysis
- Business Strategy
- Intellectual Property Analysis
- Product Development
- Project Management
Years: 2002 to 2006 Employer: AlvaMed, LLC. Title: Co-Founder, Partner Department: Responsibilities: Expert's responsibilities included:
1. Business Development generating client opportunities.
2.. Assist in closing sales.
3. Manage and Participate in various projects including the following areas:
- Market Analysis
- Business Strategy
- Intellectual Property Analysis
- Product Development
- Project Management
Years: 1997 to 2001 Employer: Visualization Technology, Inc. Title: Sr. Project Engineer Department: Engineering Responsibilities: Expert was responsible for managing projects, other engineers and technicians, designing and developing systems and components for minimally invasive image guided surgery systems. He utilized various CAD and computer systems for product development and managing projects. He communicated with physicians, manufacturing, marketing, quality and management.

Lead project team in development of new Image Guided Surgery System, which was a new platform, from which multiple surgical applications were launched. Helped write specifications.
Supervise project and design team of electrical, mechanical, software and documentation.
Interface with management, marketing, customer service, manufacturing, RA/QA.
Interface with client surgeons and marketing to set product requirements.
Designs developed per IEC 60601 and UL 2601 regulations.

Helped develop and became instructor of FMEAs; helped develop Verification procedures.
Helped develop Design History Files for various products
Worked on verification protocols; one was method for determining accuracy of tracking focal plane of surgical microscope

Years: 1996 to 1996 Employer: Behring Diagnostics, Inc. Title: Sr. Mechanical Engineer Department: Responsibilities: Expert's responsibilities included:
Managed design and development of Automated Diagnostic Clinical Assay Systems; Assisted Manufacturing engineering to resolve technical manufacturing issues; Resolved Engineering Change Orders (ECO) and Discrepant Material Reports (DMR); Analyzed problems and developed test methods to resolve critical drive belt problems.
Left because company closed facility
Years: 1995 to 1996 Employer: Asyst Automation, INC. Title: Sr. Product and Sr. Project Manager Department: Responsibilities: Expert's responsibilities included:
Conceptualize and develop new Integrated Circuit Wafer Stockers;
Lead team of 10 Engineers and Designers for client projects; Representative on Business Process Engineering Team; Lead development of two major wafer storage and retrieval system upgrades; Lead development of Reticle Stocker Systems; Interface with customers to coordinate requirements; Develop and manage Project Plans including schedules and manpower loading; Lead development of dual triple and quad stocker systems; Initiated Engineering Change Orders (ECO) and Resolved Discrepant Material (DMR)
Years: 1994 to 1995 Employer: Hewlett Packard, Corp. Title: Contract Design Engineer Department: Medical Products Responsibilities: Expert's responsibilities included:
Using ME30 CAD System, design Instrumentation and remote mounts for video display equipment (qualified for UL544) used in Hospital Catheterization Laboratories
Years: 1992 to 1994 Employer: Millipore Corporation Title: Sr. Contract Design and Development Engineer Department: Biotechnology and Waters Divisions Responsibilities: In Waters Division Expert was responsible for the design and redesign of liquid chromatography instrumentation for cost reduction.

In the Biotechnology Group Expert was responsibilities included:
Managing design and development of process equipment for cost reduction and improved efficiency of precast gel cassettes for electrophoresis applications in the Biotechnology market.
Designing plastic molded components and developing welding process for plastic cassette, which replaced a more expensive, glass assembly. New breakaway concept also developed for user safety and ease of use.
Years: 1991 to 1992 Employer: Image Micro Systems, Inc. Title: Mechanical Engineering Manager Department: Responsibilities: Starting as a contract design engineer, Expert joined the company as an employee and rose to Mechanical Engineering Manager. His responsibilities included:
Managing (10) engineers and designers in development of laser ablation systems; Responsible for mechanical design of optical components, stages, and assemblies including packaging utilizing Anvil 1000 for a High Power Excimer Laser Ablation System.

International Experience

Years Country / Region Summary
Years: 2007 to 2007 Country / Region: Australia Summary: Working with consulting colleagues, Expert developed an initial market analysis plan, to prepare an early stage imaging company's entrance into the US point-of-care medical market. He arranged and conducted physician surveys. He co-wrote the final report, which included the various markets in which the instrument could be sold. He recommended strategies to the client. Product is being intorduced to US in 4th quarter 2008. Expert has had additional projects and client requests for work.
Years: 2007 to 2008 Country / Region: Hungary and Sweden Summary: Expert helped to assess the market opportunity for a neonatal instrument in the US. Expert also helped a colleague to assess if there was potential for coordinating these two different instruments into a joint commercial effort in the US.
Years: 2005 to 2005 Country / Region: Israel Summary: Expert assessed the market opportunity for a Congestive Heart Failure diagnostic instrument on behalf of a start-up company.
Years: 2000 to 2001 Country / Region: Germany Summary: Working with two medical microscope companies, Expert led the integration of their surgical microscopes with another company's image guided surgery system. This work included managing the project and team of software, electrical and mechanical engineers. Expert was also directly involved in development and integration work, performimg mechanical design, managing fabrication and working with software to complete integration. Products were commercialized in 2001.
Years: 1995 to 1996 Country / Region: Netherlands Summary: With a Dutch client Expert led development and integration of automation equipment into the client's integrated chip manufacturing.

Career Accomplishments

Associations / Societies
BES (Biomedical Engineering Society);
MDG (Medical Development Group)
Licenses / Certifications
Engineer-in-Training (EIT)
Professional Appointments
President of MDG (Medical Development Group) 2004 - 2007; Board Member 2007 - Present
Awards / Recognition
Publications and Patents Summary
He has 10 patents, 1 patent pending and 2 publications

Additional Experience

Expert Witness Experience
He worked on a case involving a clinic suing an instrument manufacturer, accusing them of providing poor quality products which were critical to the laboratory's services and contributed to the clinic's failure and eventual shutdown. His responsibility involved reviewing service reports and related materials to determine if the manufacturer acted responsibly per industry standards.
Training / Seminars
While employed with Visualization Technology, he developed training sessions for FMEA (Failure modes and effects analysis) to train employees and utilize the material as a tool while performing risk analyses.
Expert presented a seminar on CAD and its application in Medical Device Development in the early '90's.
He moderated a session on Medical Devices at the 2006 Intellectual Property Conference.
He is planning a Panel on 'Novel Applications in Neurotechnology' for the Medical Development Group's June, 2008 Forum.
He is scheduled to moderate a Panel on Medical Robotics at the Medi2008 Medical Conference in September 2008.
Vendor Selection
Expert has sourced many vendors including in fabrication and related tasks for the development of medical and automation equipment. He has searched and sourced numerous standard and specialty, precision machine shops (metal and plastic) molders, casters, inspection, test and equipment suppliers. He has visited plants when appropriate, developed relevant specifications,
Marketing Experience
Since staring consulting practices in 2001, Expert has been very involved in creating a vast network of medical device specialists. He co-founded the Medical Development Group (MDG) in 2001, which has hundred's of medical industry specialists. If he cannot answer a question he knows whom to contact to find an answer.
As part of his co-founding of two medical device consulting companies, Expert has been very engaged in numerous medical device companies and industries.
Expert continues to consult 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.
Other Relevant Experience
Because of his networking skills and the large network he has developed, Expert can help clients find key personnel for employment or further consulting.
In addition, Expert prides himself on his conceptual and analytical skills in helping solve problems. He can approach a problem from a top down approach, bottom up or whatever is required.
Finally, he has a can do attitude that most often assures his ability to work with colleagues, clients and other associates

Language Skills

Language Proficiency
Hebrew Understand somewhat
German Some understanding

Fields of Expertise

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