Expert Details
Biomedical Engineering; Medical Devices
ID: 723204
Illinois, USA
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
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 |
|---|---|---|---|
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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
intellectual property, biomedical device, biomedical engineering, cannula, catheter tubing, Current Good Manufacturing Practice, medical device inspection, disposable medical device, FDA medical device regulation, foreign medical device regulation, governmental registration process, liquid silicone rubber, liquid silicone rubber injection molding, medical device auditing, medical device, medical device design, medical device product development, medical device premarket approval, medical device hazard analysis, medical device process validation, medical protocol, medical regulation, Medical Device Reporting regulation, investigational medical device exemption regulation, medical device evaluation, 510(k) document, plastic medical device, patent, product failure, biomedical device engineering