Expert Details
Medical Device Product Development; Machine Design; Biomedical Engineering
ID: 724357
New Hampshire, USA
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 the 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 about which saves time and money for the project.
Saint-Gobain: Consulted on a 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 a 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 the North Carolina plant.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1995 | Degree: MSME | Subject: Mechanical Engineering | Institution: NC A&T State University |
| Year: 1988 | Degree: BSME | Subject: Mechanical Engineering | Institution: University of New Hampshire |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| 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 |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1990 | Employer: Harris Graphics Corporation | Title: Design Engineer | Department: Design Engineering |
Responsibilities:Web offset printing press design. |
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| Years | Employer | Title | Department |
| Years: 1987 to 1988 | Employer: Materials Lab, Inc. | Title: Analyst | Department: |
Responsibilities:Analyzed and designed plasma ar cutters. |
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| Years | Employer | Title | Department |
| Years: 1986 to 1987 | Employer: Walker Power, Inc. | Title: Mechanical Designer | Department: |
Responsibilities:Designed textile wrap-spin machine |
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| Years | Employer | Title | Department |
| Years: 1979 to 1986 | Employer: KRL Electronics, Inc. (Bantry Components)/ Solarmetrics, Inc. | Title: Technician | Department: |
Responsibilities:Designed automated resistor equipment, inventory management, assembled and tested solar controls and air-wrap systems. |
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Career Accomplishments
| Associations / Societies |
|---|
| ASME – American Society of Mechanical Engineers since 1988 ASM International – American Society of Metals International since 2020 BMWCCA – BMW Car Club of America since 1998 AOPA – Aircraft Owners and Pilot Association since 1999 MDG – Medical Development Group since 2006 Eureka Medical – Medical Device Advisory Board since 2006 PCA – Porsche Club of America since 2006 Big Brothers Big Sisters (BBBS) – Big Volunteer & Contributor – Since 2008 BBB – Better Business Bureau of New Hampshire since 2010 MassMedic – Massachusetts Medical Device Industry Council since 2011 BRP – Bombardier Recreational Products - Platinum Owners Club since 2011 NEHC – New England Helicopter Council since 2014 Medical Device & Manufacturing (MD&M) Conferences HAI – Helicopter Association International since 2015 PD Aviation, LLC – Helicopter Rentals & Pontoon Boat Helipads H2L Medical Technologies, LLC – Catheter Systems Community Garbage Cleanup Committee Seacoast Education Endowment Dover (SEED) – Contributor / Fund Raiser – Since 2017 UNH STEM (Tech Camp) – Mentor and Contributor – Science, Technology, Engineering, & Mathematics – Since 2016 All Electronic Toll (AET) - NH State NH Bio-Made Industry and State Partnerships Board (ISPB) – Board of Directors Kyle Van Noy Valor Foundation - Executive Board Member – 2019 SCCA – Member with a racing license since 2019 SRO – Member with a racing license since 2020 FIA – Racing and Entrant license since 2020 NCR-PCA – North Country Region Porsche Club of America - 2020 |
| Licenses / Certifications |
|---|
| PE in NH PE in NC PADI - Scuba Certification NH Department of Safety - Boating License FIA / SRO / SCCA / USAC - Racing Licenses FAA - Pilot License – Fixed Wing & Rotorcraft |
| Professional Appointments |
|---|
| Board of directors: Inventors Workshop, Inc. Advisory board: Eureka Medical, Inc. Medical Device & Manufacturing (MD&M) Conferences – Chairman Community Garbage Cleanup Committee Chairman All Electronic Toll (AET) - NH State Chairman NCR-PCA – VP of North Country Region Porsche Club of America |
| 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 |
|---|
| Patents: 36 Publications: 4 Lectures: 3 Published Patent Applications: 38 |
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 a full list of litigation experience. 27 cases to date (as of mid-2021). |
| 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 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