Expert Details
Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
ID: 726245
Minnesota, USA
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.
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.
As his consulting is specifically related to medical device safety, most all contracts to date are required to be confidentialRisk Management
- design risk analysis and assessment per ISO14971
- risk meeting facilitationDesign Validation
- Design of experiments
- Authoring design validation test plansSubmission and compliance review
- EN IEC 60601 risk review
- NFPA 99 risk review
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1985 | Degree: BSME | Subject: Mechanical Engineering | Institution: University of Minnesota |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2009 to Present | Employer: Undisclosed | Title: Owner | Department: Undisclosed |
Responsibilities:He is consultant for Medical Device Industry specializing in design safety |
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| Years | Employer | Title | Department |
| Years: 1996 to 2009 | Employer: Medtronic Inc. | Title: Undisclosed | Department: Cardiac Pacing, Neuromodulation, Cardiac Ablation |
Responsibilities: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 |
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| Years | Employer | Title | Department |
| Years: 1989 to 1996 | Employer: Honeywell Commercial Flight Systems | Title: Undisclosed | Department: Inertial Navigation |
Responsibilities:Performance to specification and safety of manufactured inertial navigation systems |
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| Years | Employer | Title | Department |
| Years: 1984 to 1989 | Employer: Rosemount Engineering | Title: Undisclosed | Department: Sensors |
Responsibilities:Responsible for quality andperformance of Space Shuttle Main Engine temperature sensors |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2007 to 2007 | Country / Region: Germany | Summary: Negotiation discussions on device safety with TUV SUD, Munich Germany |
Career Accomplishments
| Associations / Societies |
|---|
| SAE society of automotive engineers RAPS regulatory affairs professional society |
| Licenses / Certifications |
|---|
| PE in Minnesota |
Additional Experience
| Expert Witness Experience |
|---|
| 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 |
| Training / Seminars |
|---|
| Attended ISO 14971 Risk Management by University of Southern California Attended Dangerous Document Writing Practices by UL University Given continuous training on Risk Management and Design Risk Analysis at Medtronic as job responsibility |
| Marketing Experience |
|---|
| 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 gauge acceptable level of device safety. Working as a risk management consultant in several device companies gives broad range of experience and knowledge. |
| Other Relevant Experience |
|---|
| 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 |
Fields of Expertise
510(k) document, Medical Device Reporting regulation, medical regulation, artificial cardiac pacemaker, disposable medical device, electronic medical device, medical device design, medical device hazard analysis, medical device product development, medical device safety, electrosurgical instrumentation, governmental registration process, implantable device, medical device, medical device auditing, medical device endurance testing, medical device evaluation, medical device reliability testing, medical pump, nerve stimulator, machine shop, aircraft control system design, medical device product improvement, medical device process validation, medical device mechanical stress analysis, medical device manufacturing quality control