Expert Details

Expert in Medical Device Product Development; Machine Design; Biomedical Engineering

Expert ID: 724357 New Hampshire, USA

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Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. Research included materials, methods of molding, color changes, and effect to biocompatibility. His library contains many materials available for this purpose.

He has developed automated wire winders for resistor manufacturing, fully automated knitting machines for medical devices, robots, and fixtures for laparoscopic devices.

His thesis was written on Strength of Medical Thermoplastic Female Luer Fittings Exposed to Chemicals. He also has selected many materials for IV disposables, surgical instruments, and pharmaceutical equipment. Knowledge includes chemical resistance, mold/process capability, biocompatibility, and sterilization capability.

Medical device product development since 1992. He has over 30 patents and many awards for the development of medical devices in IV disposables, valves, staplers, suturing, laparoscopic devices, pumps, catheters, cardiovascular implants, mitral valve repair, stents, sleep apnea, pen injectors, syringes, mesh, medical textiles, and hernia repair area of the medical market.

He is involved in complete medical device product development from concept to production using FDA/ISO guidelines and procedures.

His company manufacturers medical devices for animal lab testing, prototypes, and human trials.

Molding of cannula, insert molding of stainless tubing (cannula), and designs using cannula are commonly used in his products.

He manufactures products for other companies under contract for limited prototype runs and small scale production only.

He is a leader in his field by always keeping manufacturing, quality, and cost in mind when designing products.

He is currently registered to apply for government grants and contracts.

He has a full machine shop that specializes in wire EDM, turning, and CNC machining.

He currently holds the record for the fastest development cycle from patent to production on all the products he has developed. Many years of experience working with key vendors, suppliers, prototype shops, and machine shops has resulted in a system and group of people that work efficiently and work intelligently to get a product developed quickly and within budget. Many times he takes parallel paths on portions of a project that he is uncertain on which saves time and money for the project.

Saint-Gobain: Consulted on Pure-Fit connector for sterile connections required with drug companies.Mardil: Developed Mitral Valve Repair device and organized manufacturing, animal labs, documentation, patent submission, testing, protocols, and reports.Patent Litigation: Acted as expert witness and fact witness for many cases that resulted in a win for most or a fair settlement in other cases. Ask for complete list of litigation cases. Novacept: Developed a knitting machine to knit a radio frequency (RF) endometrial ablation device used to cure menorrhagia in women. His company designed, patented, and built two unique machines that are still in use today. Cardinal Health / ALARIS Medical Systems: Supported new and existing patents and product development in North Carolina plant.

Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts - Worcester, Massachusetts - Lowell, Massachusetts - Cambridge, Massachusetts - Brockton, Massachusetts - Lynn, Massachusetts - Quincy, Massachusetts - Newton, Massachusetts - Manchester, New Hampshire - Nashua, New Hampshire

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Education

Year Degree Subject Institution
Year: 1988 Degree: BSME Subject: Mechanical Engineering Institution: University of New Hampshire
Year: 1995 Degree: MSME Subject: Mechanical Engineering Institution: NC A&T State University

Work History

Years Employer Title Department Responsibilities
Years: 1998 to Present Employer: Undisclosed Title: President Department: Responsibilities: • Medical device product development and consulting (formerly Innovative Engineering, Inc. in North Carolina)
• Developed cardiovascular, surgical, intravenous, endoluminal, percutaneous devices including market analysis and benchmarking.
• Consulting on real-time bedside blood glucose level analyzer and disposable cartridge, peritoneal dialysis pumps, safety syringes, disinfecting caps, auto-injectors, urinary catheters, insulin pumps, subcutaneous ports & catheters, bed rails, and bone anchors.
• Failure analysis of hernia mesh stapler and cervical screws & plates
• Developed sleep apnea or CPAP device and trachea tube device.
• Developed catheter dressing
• Invented and developed Programmable Electrode Array Knitter (6,158,250) to manufacture RF mesh for endometrial ablation device
• Development of medical textiles and knitting machines
Years: 2005 to 2006 Employer: Mitralign, Inc. Title: Director of Biomedical Engineering Department: Biomedical Engineering Responsibilities: Development of mitral valve anchor and locker implants. Patent analysis and invention disclosures.
Years: 2002 to 2005 Employer: ONUX Medical, Inc. Title: Manager of Design Engineering Department: Engineering Responsibilities: Development of percutaneous translumbar abdominal aortic aneurysm stent fixation device using Nitinol spring. Development of disposable laparoscopic Salute Q-ring hernia fixation device. Development of manufacturing equipment for above devices. Invention disclosures and patent submissions.
Years: 1992 to 2002 Employer: IVAC/imed/Eli Lilly/ALARIS/Cardinal Health/CareFusion/BD Title: Sr. Principal Design Engineer Department: Disposables Engineering Responsibilities: All medical intravenous IV disposable development including needle-free valves. Concepts through to production using FDA/ISO standards. Invention disclosures to patent litigation and depositions.
Years: 1990 to 1992 Employer: Draper Corporation Title: Mechanical Design Engineer Department: Engineeirng Responsibilities: Development and manufacturing of knitting machines and looms for tirecord and sock industries.
Years: 1988 to 1990 Employer: Harris Graphics Corporation Title: Design Engineer Department: Design Engineering Responsibilities: Web offset printing press design.

Career Accomplishments

Associations / Societies
American Society of Mechanical Engineers
Licenses / Certifications
PE in NH
PE in NC
Professional Appointments
Board of directors: Inventors Workshop, Inc.
Advisory board: Eureka Medical, Inc.
Awards / Recognition
USCA for Best of Surgical & Medical Instruments
Medical Design Excellence Award
Prototype Design Award
NSPE New Product Award
NC Govenors New Product Award
Medical Design Excellence Award
Publications and Patents Summary
11 patents

Additional Experience

Expert Witness Experience
Multiple patent litigation and liability cases with experience with depositions, jury trial testimony, bench trials, hearings, injunction proceedings, ITC hearings. Work includes research on prior art, device testing, reports, photos, and video all completed using an onsite fully equipped medical research lab. Ask for full list of litigation experience.
Training / Seminars
Lectured MD&M Seminars on The Science of Successful Product Design. Attended Patent & Copyright Law, Contract Law, Polymer Science, Decoupled Molding, and Deposition seminars. Chairman of MD&M Conference in (Undisclosed) and continue to teach medical device product development process via webinars.
Vendor Selection
He has extensive experience running his entire business with quality vendors and machine shops. He is able to weed out and find good vendors quickly to deliver products in a timely manner and often use 2 vendors in parallel to assure a job gets done. His business would not be successful if it wasn't for his vendors.

Fields of Expertise

antimicrobial medical device, assembly machine design, automated machine design, industrial machine design, machine, machine design, machine design review, precision machine design, special machine design, autoclavable plastic material selection, elastomer selection, high-temperature rubber, liquid silicone rubber, liquid silicone rubber injection molding, medical polymer selection, polymer biocompatibility, polymer selection, polymer selection for chemical compatibility, rubber selection, thermoplastic material selection, biomechanical engineering, biomedical device, disposable medical device, implantable device, legal patenting, medical device, medical instrument, new product development, plastic medical device, plastic product development, surgical instrument, biomedical device design review, biomedical instrumentation, biomedical product development, Current Good Manufacturing Practice, design process, device product development, new product development management, product development cycle time, medical device manufacturing automation, biomedical device manufacturing, medical device manufacturing, cannula, contract manufacturing, design for cost, design for manufacturability, integrated product development, governmental registration process, machine shop, rapid product development, aortic aneurysm, hernia, biomedical device engineering, hernia surgery, commercialization, new consumer product development, cytotoxicity testing, intra-aortic balloon pump, biocompatibility testing, applied mechanics, machine installation, medical pneumatic compression device, joint venture, durable medical equipment, medical filter, force ratio, microbial control product development, stent, non-impact printing product development, electrical product development, material product development, machine safety, high-pressure sterilization, biocompatibility, computer workstation design, adhesive selection, engineering design productivity, bioengineering, medical pump, irradiation sterilization, concurrent engineering, biomedical engineering, biomechanics, biocompatible material

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