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 Expert  723204

Expert in Biomedical Engineering; Medical Devices


Available for your Consulting and Expert Witness Needs

Illinois (IL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3)
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intellectual property

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
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biomedical device

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

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

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

Over 30 years experience in medical product design and development with 15 years experience in cGMP.
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Current Good Manufacturing Practice

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medical device inspection

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
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disposable medical device

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.

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FDA medical device regulation

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

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governmental registration process

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

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liquid silicone rubber injection molding

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

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medical device auditing

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.

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medical device

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medical device design

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medical device product development

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

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.

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medical device hazard analysis

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.
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medical device process validation

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.
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medical protocol

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
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medical regulation

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Medical Device Reporting regulation

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investigational medical device exemption regulation

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medical device evaluation

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510(k) document

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
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plastic medical device

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patent

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product failure


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Madison, Wisconsin.

Often requested
with this expert:

Biomedical Engineering, Manufacturing Engineering, R&D
Biomedical Material Technology
Medical Device Design and Manufacturing: Laboratory...
Expert Witness Services, Product Development, product...

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

Work History:
Years   Employer   Department   Title   Responsibilities

1999 to

 

(Undisclosed)

 


 

Technical Director

 

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

1994 to 1999

 

Neurocare Group

 


 

Group Technical Office and VP

 

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.

1991 to 1994

 

Packer Engineering

 

Biomedical

 

Director

 

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

1990 to 1991

 

(Undisclosed)

 


 

VP

 

Responsible for manufacturing and regulatory requirements for a medical device. Provided consulting services on medical device technologies to industry

1988 to 1990

 

Baxter Healthcare

 

IV Systems

 

Manager New Technologies

 

Responsible for assessing new technologies, commercialization of 'needle-less' technology and IV needles.

1975 to 1988

 

Kendall Healthcare

 

Medical Specialties

 

Manager

 

Responsible for product development and regulatory requirements for urological, anesthesia and critical care products


Career Accomplishments:
Associations/Societies

He presently is a member of IEEE & ISPE. Previous memberships in BME, IV Nurses Society, SPE, & Urodynamics Society


Publications:
Publications and Patents Summary

He has 32 publications and presentations and 18 US Medical Device Patents


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

Consulting Services:
Selected Consulting Examples:
  • Performs failure investigation and provides expert report on IP and product failures to legal industry.IP Projects: Catheter stabilizing deviceDental Instrument Implant Seeds Intrauterine pressure catheterVascular Catheters (3)Failure Investigation Projects: Dental Device Neurosurgical Shunt Patient Lift Sterilizer Surgical Cart Surgical Halo Vascular Catheters (5)Clients:Arrow International IncC. R. Bard Hu-Friedy Invacare Kendall Healthcare Medi-Physics-Amersham Medtronic Stryker Tyco Healthcare US Surgical Venetec InternationalDeNardis, McCandless, Miller & Brennan PLCHusch 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
Recent Client Requests:
  • Expert in liability risk assessment for the medical device industry.
  • Biomedical engineering expert for consulting on product construction.
  • Expert in medical devices for consulting on international market trends and opportunities.
  • Biomedical expert for consulting on FDA approval of sharps container.
  • Elastomer expert for consulting on natural rubber creep & set properties.
  • Urological device expert for consulting on Balloon Catheter for urethral stone removal procedures.
  • Expert in orthopedic devices for consulting to sell intellectual property patent.
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:
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.

Recent Litigation Client Requests:
  • Medical device engineering expert needed for consulting on Fox hollow catheters.
  • Medical device expert for consulting on quality of syringes.
  • Expert in catheterdesign for patent litigation.
  • Expert in catheters to consult on patent case involving Foley catheter.
  • Expert in Peripheral Balloon Catheters for a criminal case.
  • Expert for consulting on permissable reuse of catheters in a hospital setting and pricing of new versus reused catheters.
  • Expert for consulting on Endologix Powerlink Systems cathiter product liability case where patient died.
  • Expert in medical oxygen concentrator for consulting on oxygen concentrator.
  • Expert in Litigation, burn at grounding pad site.
  • Biomedical engineering expert for consulting on forced air heating blankets.
  • Medical product engineering expert witness for consulting on medical device cases.
  • Expert in medical devises for consulting on failure analysis of Endologix Powerlink catheter (SMDA).
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
1985 to 1988   Malaysia   Involved with technical due diligence for acquisition of latex manufacturing companies in Malaysia.

Technical responsibility for product development in Malaysian plant.

1994 to 1999   Puerto Rico   Responsible for regulatory requirements and product development at Puerto Rican plant.

For a short time was also responsible for operations at manufacturing plant

1988 to 1990   Ireland   Responsible for product development projects for Vein Access product line at Baxter

Market Research:
Over 45 new products released to market

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

Educational Services and Lecturer: Technology Assessment & Medical Device Start-Up Companies, Emerging Medical Technologies, Medical Product Development, & GMP and Regulatory Requirements for Medical Products

Supplier and Vendor Location and Selection

Involved with raw material selection, components sourcing and assembly with outside vendors

Other Skills and Services

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


 

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