Richard Wessels

Medical Device Engineer Richard J (Dick) Wessels 25/July/2019 SUMMARY OF EXPERIENCE 35 years experience in the Medical Device industry 26 years focused on the AIMD (active implantable medical devices) industry. 11 years as an ultra low-power analog design engineer 8 years as EMC / standards engineer 7 years as EMC / systems engineer 4 years as a systems design engineer for external medical devices 4 year as a design assurance engineer for external medical devices 1 year as a Technical Specialist for a Notified Body in the EU Member of various standards organizations involved in the development of new standards AAMI / ISO / IEEE Author and co-author of patents related to high power circuits, EMC mitigation and therapy delivery. Author and co-author of various papers, presentations and standards related to EMC of AIMDs. CONTACT INFORMATION: Dick Wessels Cell: (612) - Email:- Resume of Dick Wessels Jan 01 2018 Page 1 of 6 Detailed Information: WORK EXPERIENCE: IMRIS / Deerfield Imaging 3/27/2019 – Present  o o o Senior Quality Engineer Responsible for Tech file mitigation to comply with present day Medical Standards Work with Regulatory and R&D to bring any out of date testing up to date Responsible for Design Development Quality System procedures British Standards Institute (BSI) 4/2018 – 2/19/2019  Product Technical Specialist o o Review Design Dossier submitted for review by manufacturers  Ensure compliance to Essential Requirements of Active Implantable Medical Device Directive  Evaluate completeness and technical content of Design Dossier  Provide summary of work with technical opinion on acceptance or rejection Trained on:  Active Implantable Medical Device Directive (AIMD 90_385_EEC)  Medical Device Directive (MDD 93_42_EEC)  Medical Device Regulation (EU- MDR)  Medical Device Vigilence – Reporting and Requirements  Clinical Oversight ACIST Medical – Eden Prairie, MN 11/2015 –4/2018  Design Assurance: work with internal corporate quality system requirements o o o o o Responsible for creating Risk Management File for intravascular pressure measurement system  Preliminary Hazard Analysis  Use FMEA  dFMEA (functional and component based)  pFMEA Work with:  Outside test house on 60601-1 evaluation  Outside test house on EMC evaluations  Design Teams to develop Specifications, Protocols, Reports  Work with Manufacturing Teams to develop IQOQ Protocols, Reports Development component qualification protocols and reports Work with Quality department on audits of subcontractors for design services Work to Regulatory Department and outside Regulators to meet US, EU and International standards Resume of Dick Wessels Jan 01 2018 Page 2 of 6 St Jude Medical – Sylmar, CA: 1/2014 – 11/2015  Senior Systems Engineer o o o o o Extensive work evaluating the safety of AIMDs and MRI. Work included understanding the function of the 3 fundamental EM fields of MR scanners and the interaction of those fields with medical devices affecting patient safety and device function. Work closely with Quality Department to develop and execute System Verification plans regarding Proof of Safety evaluation for the operation of pacemakers and ICDs in MRI scanners. Developed and executed Design Verification plans to test individual aspects of exposure to MRI fields including RF rectification, force, torque, gradient field heating, gradient field rectification. Collaborate with Development Quality and Regulatory on tool creation, test execution and report development for submission of device performance to regulatory bodies worldwide. Read, understand and implement national and international standards as related to MRI PoS (Proof of Safety) including ISO 10974 and AAMI PC76. Smith’s Medical – St Paul, MN: 2/2012 – 1/2014   Design Assurance work to US, EU and International standards Work with internal corporate quality system requirements o o o Work with Design Teams to develop Specifications, Protocols, Reports Work with Manufacturing personnel on quality improvement projects Work with Quality department on audits of subcontractors for design services Medical Device Design Consultant: 1/2010 – 2/2012    Worked with various small startup companies to provide medical device design expertise. Work involved collaboration with researchers and business personnel to capture the design requirements of new or novel technologies. This work was done on a variety of timeframes. Since the size of the companies varied from 2 people to 12 or more, I was often acting as the electrical engineering department for them. The duration of these tasks could vary from a few hours to a month or so. It often involved juggling the work of a couple clients at the same time as individual company’s schedules waxed and waned. Minnetronix Inc, St Paul, MN Senior Systems Engineer 2007 - 1/2010  Collaborated with experts from within the company, experts from the customer clients and outside regulatory bodies. Evaluated system function and EMC / Safety testing to standards such as IEC 60601-1 and associated sub standards. o Blood analysis o Blood warming system o LVAD systems o Cryotherapy Resume of Dick Wessels Jan 01 2018 Page 3 of 6 Boston Scientific (Guidant) CRM, St Paul, MN Principal Engineer; EMC, Emerging Standards 2002 – 2007     All topics listed from 95 – 2002 Chairperson of Guidant’s Technical Standards Committee Develop system to monitor and incorporate latest versions of standards into work product Work with various outside organizations on EMC studies (OU, GTARC, Sloan – Kettering Cancer Institute, Nancy University (Paris)) Senior Engineer; EMC/Emerging Standards 1995 - 2002  Involved in US, European and International (ISO/IEC) product safety and EMC standards.  Guidant/CRM representative on the AAMI Pacemaker Committee and AIMD EMC subworking group.  Guidant/CRM representative on the HIMA (now ADVAMED) EAS (Electronic Article Surveillance) technical working group.  Work with design teams on EMC testing of implantable products.  Worked with FDA OST and University of Oklahoma on Cellular Phone testing of implantable defibrillators. Analog Development Engineer; MINI / VIGOR / VENTAK P-  Design, development and verification of high voltage power supply (700VDC), low power CMOS telemetry, pacing supply and EMI protection circuits for implantable product with 3.2VDC battery. EMI testing and verification of product to CENELEC requirements.  Technical Background:        7 years working in EMC labs with medical devices and in designing flight control systems 10 years design and evaluation of analog circuitry for the pacemaker industry including ASIC and hybrid work. 12 years as an expert in the pacemaker industry in the following areas: o EMC of AIMDs and external support equipment o Development and application of industry standards 2 years as a senior systems engineer for a contract design and manufacture company of medical electronics. Work covered extensive range of products and complexities. 2 years working as Systems Engineer on the MRI compatibility evaluation of ICD, pacemaker and neurostimulator systems. 2 years working as Design Assurance / Quality Engineer on intravascular pressure measurement system to evaluate FFR. Member of IEEE technical specialty groups Resume of Dick Wessels Jan 01 2018 Page 4 of 6 Professional Experience:  Investigation of devices as potential ElectroMagnetic Compatibility (EMC) issues with AIMDs -specializing in pacemakers and implantable cardioverter/defibrillators (ICDs), with experience extending to other AIMDs such as neuro stims, pain therapy etc.  Collaborated with experts from various companies and regulatory bodies to setup tests for evaluating the potential for interference between various daily electric signal sources and implantable devices. The results were used in setting test limits in various national and international test standards  Awarded a Technology Assessment Grant for investigating an innovative, high-risk concept related to EMC of ICDs and pacemakers.  Mentored college engineering students. They received real-world work and direction targeted to contributing in a substantial way to active projects.  Chairperson of Guidant’s Technical Standards Committee  Member of Guidant's Technical Advisory Committee  Perform EMC tests and mitigate EMC issues on avionics systems. Standards Expertise     Involved with: o ISO (International), CENELEC (European), AAMI (United States), ANSI (United States) Standards Development work included: o Functional verification, EMC, mechanical tests, labeling, documentation. Experienced with: o ISO 10974, PC76, IEC 60601 -1 (2nd and 3rd editions), FCC Part 15 and Part 18 o IEEE C95.1 on human exposure to electromagnetic energy o ISO/IEC 60601-1, particular and specific related standards. Worked with representatives from US FDA and BSI on a regular basis when developing standards and submitting products for approval Standards Development:         ANSI/AAMI PC69:2000, "Active Implantable Medical Devices - Electromagnetic Compatibility - EMC test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators". AAMI TIR21: 1998; "Systems Used to Forecast Remaining Pacemaker Battery Service Life". ANSI/AAMI PAC49/(R)2000, Pacemaker Emergency Intervention System AAMI PC73/Ed. 1, "Essential Design and Performance Requirements for Four-pole Electrical Connectors Intended for use on Implantable Cardiac Pacemakers and Defibrillators." AAMI ES1:1993; Safe Current Limits for Electromedical Apparatus. ISO 11318:2002, Cardiac Defibrillators - Connector Assembly DF-1 for Implantable Defibrillators - Dimensions and Test Requirements ISO 14708: "Implants for Surgery - Active Implantable Medical Devices, Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer". EN45502-1, - 2-1 and -2-2 "Active Implantable Medical Devices. Part 1, 2 and 3: Standards for testing, evaluation and labeling of AIMDs including pacemakers and ICDs. Resume of Dick Wessels Jan 01 2018 Page 5 of 6 Presentations:  LifeSciences Alley presentation January 27, 2009: “EMC Testing of Medical Devices - A regulatory update and approach to adding risk analysis to the test process”  DMD Conference April 15, 2008 University of Minnesota: “ Beyond Standards: The Need to Investigate the Changing EM Environment During New Product Development”  IEEE EMC Symposium: 08/2002: "Implantable Pacemakers and Defibrillators: Device Overview and EMI Considerations"  University of Minnesota, 04/2002, Biomedical Engineering Lecture Series: "Device Overview of Implantable Pacemakers and Defibrillators"  American Society for Testing and Materials (ASTM), 10/2001, "Pacemakers and ICDs - A Technical Description". Patents:    Inventor: US Patent 7,693,574 "System and Method for Discriminating High Frequency Electromagnetic Interference from Cardiac Events" April 6, 2010 Co-inventor: US Patent 5,869,970 "Power Management System For An Implantable Device" 1999 Co-inventor: US Patent 8,473,051 B1 “Low-Energy Atrial Cardioversion Therapy with Controllable Pulse-Shaped Waveforms” June 25, 2013 Publications: IEEE: 2002 - "Implantable Pacemakers and Defibrillators: Device Overview and EMI Considerations" Education: Iowa State University: BSEE 1981 University of Minnesota: Graduate work in Numerical Analysis, Advanced filtering and Power Electronics. Contact Information; Dick Wessels (Cell) (612) - email;- Resume of Dick Wessels Jan 01 2018 Page 6 of 6