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 Expert  726245

Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures


Available for your Consulting and Expert Witness Needs

Minnesota (MN)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III).

He has experience in the legal and safety requirements between 510k and PMA devices and differences between this and PMA.

He has significant experience in the reliability and safety aspects of pacemaker design and development. He has been on several development teams bringing new pacemaker designs to market He has significant experience in testing analyzing and creating work to comply with EN 45502 requirements and ISO 14971 requirements as they apply to implantable pacemakers.

He has significant experience in the reliability and safety aspects of single use cardiac ablation catheter and single use prostate ablation devices with regard to design and development. He has been on several development teams bringing new ablation designs to market He has significant experience in testing analyzing and creating work to comply with EN IEC 60601 requirements and ISO 14971 requirements as they apply to catheters and prostate ablation devices.

He has significant experience in the reliability, risk management, and safety aspects of electronic medical devices with regard to design and development. He has been on several development teams bringing electronic medical devices to market He has significant experience in testing analyzing and creating work to comply with EN IEC 60601, EN 45502, and ISO 14971 requirements as they apply to electronic medical devices.

He has significant experience in the reliability, risk management, and safety aspects of electrosurgical instrumentation with regard to design and development. He has been on several development teams bringing electrosurgical instrumentation to market He has significant experience in testing analyzing and creating work to comply with EN IEC 60601, EN 45502, and ISO 14971 requirements as they apply to electrosurgical instrumentation.

He has significant experience with risk management and safety regulations and submission requirements for medical devices. This includes FDA guidance requirements, notified body requirements, and audit.

He has significant experience in the reliability, risk management, and safety aspects of implantable devices including pacemakers, defibrillators, drug pumps, and neuro stimulators with regard to design and development. He has been on several development teams bringing implantable devices to market He has significant experience in testing analyzing and creating work to comply with EN IEC 60601, EN 45502, and ISO 14971 requirements as they apply to implantable devices.

He has significant experience in the reliability, risk management, and safety aspects of medical devices including pacemakers, defibrillators, drug pumps, and neuro stimulators with regard to design and development. He has been on several development teams bringing medical devices to market He has significant experience in testing analyzing and creating work to comply with EN IEC 60601, EN 45502, and ISO 14971 requirements as they apply to medical devices.

He has significant experience supporting medical device companies in FDA and notified body audits in the area of quality systems and risk management. This includes 483 responses and responses to minar and major findings.

He has significant experience in medical device testing to requirements (verification), testing to user needs (validation), and accelerated life testing such as HALT.

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510(k) document

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Medical Device Reporting regulation

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medical regulation

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artificial cardiac pacemaker

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disposable medical device

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electronic medical device

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medical device design

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medical device hazard analysis

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medical device product development

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medical device safety

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electrosurgical instrumentation

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governmental registration process

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implantable device

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medical device

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medical device auditing

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medical device endurance testing

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medical device evaluation

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medical device reliability testing

He has significant experience in the reliability and safety aspects of programmable implantable pump design and development. He has been on several development teams bringing new programmable implantable pump designs to market He has significant experience in testing analyzing and creating work to comply with EN 45502 requirements and ISO 14971 requirements as they apply to programmable implantable pumps.

He has significant experience in the reliability and safety aspects of neuro stimulator design and development. He has been on several development teams bringing new neuro stimulator designs to market He has significant experience in testing analyzing and creating work to comply with EN 45502 requirements and ISO 14971 requirements as they apply to neuro stimulators.

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medical pump

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nerve stimulator

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machine shop


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Minneapolis, Minnesota;  Saint Paul, Minnesota;  Rochester, Minnesota;  Burnsville, Minnesota;  Saint Cloud, Minnesota;  Eden Prairie, Minnesota;  Minnetonka, Minnesota;  and Eau Claire, Wisconsin.

Often requested
with this expert:

Medical Device Regulatory Submissions
Medical Devices; Product Development, Manufacturing,...
Plastic Injection Molding, Medical Device Design and...
Medical Device Design and Manufacture

Education:
Year   Degree   Subject   Institution  
1985   BSME   Mechanical Engineering   University of Minnesota  

Work History:
Years   Employer   Department   Title   Responsibilities

2009 to

 

(Undisclosed)

 


 

Owner

 

He is consultant for Medical Device Industry specializing in design safety

1996 to 2009

 

Medtonic Inc.

 

Cardiac Pacing, Neuromodulation, Cardiac Ablation

 

Risk Management

 

Variety of positions from Engineer, Senior Principal Engineer, Manager/Supervisor, with focus on Risk Management. Several Medtronic Divisions including Cardiac Rhythm Disease Management (CRDM), Electrophysiology Systems (EP Systems), Gastroenterology and Urology (MGU), and Neuromodulation (Neuro) Last Position held: Responsibility for Risk Management for the Medtronic Neuromodulation business sector

1989 to 1996

 

Honeywell Commercial Flight Systems

 

Inertial Navigation

 

Team Leader - final callibration and test

 

Performance to specification and safety of manufactured inertial navigation systems

1984 to 1989

 

Rosemount Engineering

 

Sensors

 

Intern and then Engineer

 

Responsible for quality andperformance of Space Shuttle Main Engine temperature sensors


Career Accomplishments:
Associations/Societies

SAE society of automotive engineers RAPS regulatory affairs professional society

Licenses/Certifications

PE in Minnesota


Consulting Services:
Selected Consulting Examples:
  • As his consulting is specifically related to medical device safety, most all contracts to date are required to be confidential
  • Risk Management- design risk analysis and assessment per ISO14971- risk meeting facilitation
  • Design Validation- Design of experiments- Authoring design validation test plans
  • Submission and compliance review- EN IEC 60601 risk review- NFPA 99 risk review
Recent Client Requests:
  • Expert in initial phase of medical device development in field of NeuroModulation.
  • Regulatory affairs expert for consulting on diagnostic cardiac catheter (EP).
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:
State Court: - Case regarding non-payment of grant money - won case and collected on grant money - Case regarding defective lug nut as cause for accident - won case and collected damages
Recent Litigation Client Requests:
  • Expert for consulting on permissable reuse of catheters in a hospital setting and pricing of new versus reused catheters.
  • Expert surgical staple guns for consulting on product liability.
  • Medical device expert needed for consulting regarding a shoulder pain pump.
  • Expert in Litigation, burn at grounding pad site.
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
2007 to 2007   Germany   Negotiation discussions on device safety with TUV SUD, Munich Germany

Market Research:
13 years experience in implantable and non-implantable medical device risk mitigation in the design, development, and submission process gives an excellent background from which to gage acceptable level of device safety. Working as a risk management consultant in several device companies gives broad range of experience and knowledge.

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

Attended ISO 14971 Risk Management by University of Southern California Attended Dangerous Document Writing Practices by UL University Givencontinuous training on Risk Management and Design Risk Analysis at Medtronic as job responsibility

Other Skills and Services

Judgment of risk management activity and the devices role in cause of harm in this area requires unique and significant experience in medical device design, manufacture, and post market surveillance. Knowledge of actual risks that occur in clinical study and full market release along with a correspondingly in-depth knowledge of the devices function and physiological use is also essential to forming a position on adequacy and defensibility of risk management or device safety. An in-depth understanding of the international standards and policies in this area combined with some understanding of the legal system is also essential. He has an extensive understanding and 13+ years of experience with CRDM, Neuro, and MGU products •Their design, labeling, and functional risk controls •Their design constraints and compromises related to risk •Their intended and off label use and its impact on risk He has extensive understanding and 13+ years experience with risk management policy and procedure. •In policy and procedure compliance •In policy and procedure content and understanding and applicability to Neuro product •In providing and authoring training material •In actual design and development risk management activity •In post market surveillance risk management activity He has a good, fundamental, understanding of the legal system •Licensed Professional Engineer so can be used as an expert in legal proceedings


 

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