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 Expert  724773

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


Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.
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biomedical device

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biomedical product development

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device product development

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medical device

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medical device design

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medical device manufacturing

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medical instrument

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plastic medical device

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biomedical device design review

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biomedical device manufacturing

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biomedical instrumentation

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.

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design engineering

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new product design

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new product development

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product design

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design process

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integrated product development


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Providence, Rhode Island.

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

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to

 

Medical Development Partners, LLC. ("MDP")

 


 

Co-Founder, Partner

 

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

2002 to 2006

 

AlvaMed, LLC.

 


 

Co-Founder, Partner

 

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

1997 to 2001

 

Visualization Technology, Inc.

 

Engineering

 

Sr. Project Engineer

 

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


1996 to 1996

 

Behring Diagnostics, Inc.

 


 

Sr. Mechanical Engineer

 

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

1995 to 1996

 

Asyst Automation, INC.

 


 

Sr. Product and Sr. Project Manager

 

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)

1994 to 1995

 

Hewlett Packard, Corp.

 

Medical Products

 

Contract Design Engineer

 

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

1992 to 1994

 

Millipore Corporation

 

Biotechnology and Waters Divisions

 

Sr. Contract Design and Development Engineer

 

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.

1991 to 1992

 

Image Micro Systems, Inc.

 


 

Mechanical Engineering Manager

 

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.


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

MARQUIS' WHO'S WHO IN ENGINEERING & SCIENCE, 1992, 1994


Publications:
Publications and Patents Summary

He has 10 patents, 1 patent pending and 2 publications


Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Polyaniline expert for consulting on Polyaniline for measuring blood pH with accuracy of 0.02.
  • Expert in pacemaker signaling
  • Expert in wheelchairs for consulting on USA and European market.
  • Heat transfer modeling expert for consulting on heat transfer modeling of electromechanical medical device.
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 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.
Recent Litigation Client Requests:
  • Expert in lab analyzers to evaluate Abbott Aeroset chemistry analzers and and Axsym analyzer and their service records in a vetrinary setting.
  • Hospital facilites management expert witness for consulting on hospital shower seat.
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.

International Experience:
Years   Country / Region   Summary
2007 to 2007   Australia   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.
2007 to 2008   Hungary and Sweden   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.
2005 to 2005   Israel   Expert assessed the market opportunity for a Congestive Heart Failure diagnostic instrument on behalf of a start-up company.
2000 to 2001   Germany   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.
1995 to 1996   Netherlands   With a Dutch client Expert led development and integration of automation equipment into the client's integrated chip manufacturing.

Language Skills:
Foreign Language   Description
Hebrew   Understand somewhat
German   Some understanding

Market Research:
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.

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:
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 Yet.com 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.

Supplier and Vendor Location and 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,

Other Skills and Services

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


 

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