Expert Details

Expert in Biomedical Engineering; Medical Devices

Expert ID: 723204 Illinois, USA

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IP Projects

Catheter stabilizing device
Dental Instrument
Implant Seeds
Intrauterine pressure catheter
Vascular Catheters (3)


Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression

Advanced Degrees in Biomedical Engineering. Over 30 years experience in biomedical product design and development, regulatory requirements and commercialization.

Product design, development, regulatory requirements, and commercilization experinces for cannula.

Product design, development, regulatory requirements, technology assessment and commercilization experinces for catheter tubing and products made from catheter tubing.

Over 30 years experience in medical product design and development with 15 years experience in cGMP.

Over 30 years experience in disposable medical product design and development in the areas Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression

Over 30 years experience in medical product design and development with 15 years experience in FDA reguirements in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression.

Member of FDA Medical Device panel as an industry representative.

Over 30 years experience in medical product design and development with 15 years experience in foreign medical device registration and import requirements.

Over 30 years experience in medical product design, development and manufacturing where catheters and other products were made of silicone.

Over 30 years experience in medical device industry. Trained ISO Auditor.



Over 30 years experience in medical device product design and development, commercialization and technology assessment. Experiences include Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression.



Over 30 years experience in medical product design and development with 15 years experience in Regulatory Submissions for FDA and CE Mark. Managed


Over 30 years experience in medical product design and development with 15 years experience in cGMP with Hazard Analysis a part of Product Design Control.

Instructor for a class where Hazard Analysis is one of the topics.

Over 30 years experience in medical product design and development with 15 years experience in cGMP with verification and validation a part of Product Design Control and manufacturing.

Over 30 years experience in medical product design and development with 15 years experience in cGMP with protocols being a part of Product Design Control and product evaluation. Instructor for a class where protocol writing is one of the requirements is one of the topics.

Over 30 years experience in disposable medical product design and development and regulatory requirements in the areas Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression

Over 30 years experience in plastic medical product design and development in the areas Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression

Array

Performs failure investigation and provides expert report on IP and product failures to legal industry.

IP Projects:
Catheter stabilizing device
Dental Instrument
Implant Seeds
Intrauterine pressure catheter
Vascular Catheters (3)

Failure Investigation Projects:
Dental Device
Neurosurgical Shunt
Patient Lift
Sterilizer
Surgical Cart
Surgical Halo
Vascular Catheters (5)

Clients:
Arrow International Inc
C. R. Bard
Hu-Friedy
Invacare
Kendall Healthcare
Medi-Physics-Amersham
Medtronic
Stryker
Tyco Healthcare
US Surgical
Venetec International

DeNardis, McCandless, Miller & Brennan PLC
Husch Blackwell Sanders, LLP (Welsh & Katz)
Kelley, Drye, & Warren, L.L.P.
Kenyon & Kenyon
Knobbe Martens Olson & Bear LLP
Latham & Watkins LLP
McBreen, Kopko, McKay & Nora
Morgan, Lewis & Bockius
Patton Ryan
Robins, Kaplan, Miller, & Ciresi L.L.P.
Sandberg, Phoenix & Von Gontard
Segal McCambridge Singer & Mahoney, Ltd.
Vandeventer Black LLP
Vedder, Price, Kaufman & Kammholz




Provides consulting services in medical device product development, regulatory and/or commercialization for products in Anesthesiology, -Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home Health Care, Monitoring Electrodes, Neurosurgery, Orthopaedic, Rehabilitation, Respiratory Therapy, Transducers, Urology, Vascular Compression

Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Madison, Wisconsin

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Education

Year Degree Subject Institution
Year: 1975 Degree: Ph. D. Subject: Biomedical Engineering Institution: University of Virginia
Year: 1972 Degree: MS Subject: Bioengineering Institution: University of Illinois, Chicago
Year: 1966 Degree: BS Subject: Physiology Institution: University of Wyoming

Work History

Years Employer Title Department Responsibilities
Years: 1999 to Present Employer: Undisclosed Title: Technical Director Department: Responsibilities: Consulting & Contract Services
- Technology Assessment Of Products and Processes
- Regulatory & Quality—QSR, QM, submissions, audits, failure modes, & documentation
- Start-up and Business Plans and Intellectual Property for new medical device companies
- Expert witness—failure investigation and IP

Educational Services
- Lecturer: Technology Assessment & Medical Device Start-Up Companies, Emerging Medical Technologies, Medical Product Development, & GMP and Regulatory Requirements for Medical Products
Years: 1994 to 1999 Employer: Neurocare Group Title: Group Technical Office and VP Department: Responsibilities: Responsible for product development, regulatory, and manufacturing operations for a medical device company manufacturing and selling neurosurgical products.
Technical responsibilty for due diligence, licensing and technology transfer of new medical devices and companies.
Years: 1991 to 1994 Employer: Packer Engineering Title: Director Department: Biomedical Responsibilities: Responsible for technology assessment of new concepts for both small and large medical device companies.
Conducted failure investigations of medical products and provided expert opinions to legal services
Years: 1990 to 1991 Employer: Laytech, Inc Title: VP Department: Responsibilities: Responsible for manufacturing and regulatory requirements for a medical device.
Provided consulting services on medical device technologies to industry
Years: 1988 to 1990 Employer: Baxter Healthcare Title: Manager New Technologies Department: IV Systems Responsibilities: Responsible for assessing new technologies, commercialization of 'needle-less' technology and IV needles.
Years: 1975 to 1988 Employer: Kendall Healthcare Title: Manager Department: Medical Specialties Responsibilities: Responsible for product development and regulatory requirements for urological, anesthesia and critical care products

Government Experience

Years Agency Role Description
Years: 1994 to Present Agency: NIH Role: Consultant Description: Reviews and provides expert opinions on SBIR grants
Years: 2001 to 2005 Agency: FDA Role: Industry Representative Description: Provide industry perspective on medical device issues for the General Hospital Products Panel

International Experience

Years Country / Region Summary
Years: 1985 to 1988 Country / Region: Malaysia Summary: Involved with technical due diligence for acquisition of latex manufacturing companies in Malaysia.

Technical responsibility for product development in Malaysian plant.
Years: 1994 to 1999 Country / Region: Puerto Rico Summary: Responsible for regulatory requirements and product development at Puerto Rican plant.

For a short time was also responsible for operations at manufacturing plant
Years: 1988 to 1990 Country / Region: Ireland Summary: Responsible for product development projects for Vein Access product line at Baxter

Career Accomplishments

Associations / Societies
He presently is a member of IEEE & ISPE. Previous memberships in BME, IV Nurses Society, SPE, & Urodynamics Society
Publications and Patents Summary
He has 32 publications and presentations and 18 US Medical Device Patents

Additional Experience

Expert Witness Experience
Have been retained as an expert for medical product liabilty for medical devices where reports and depositions have been required.

Have been an expert in US patent infringement and invalidity for medical devices where expert reports, depositions and trial presentation have required.
Training / Seminars
Educational Services and Lecturer: Technology Assessment & Medical Device Start-Up Companies, Emerging Medical Technologies, Medical Product Development, & GMP and Regulatory Requirements for Medical Products
Vendor Selection
Involved with raw material selection, components sourcing and assembly with outside vendors
Marketing Experience
Over 45 new products released to market
Other Relevant Experience
Managed engineers, scientists, regulatory professionals & plant personnel
Short term consulting assignments on, technology assessment, QSR, QM, regulatory, complaints, QSR, documentation, product failure investigation, failure mode analysis (FMEA), and audits.
Due diligence on 10 companies – 6 purchased & Licensed 4 technologies
Network of Centres of Excellence-Canadian Regenerative Medicine Network- Expert Panel & Stem Cell Network- Expert Panel
Regulatory submissions-US and International; Fifteen (15) 510(k)s & CE Mark for 138 product codes

Fields of Expertise

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