31 W ALNUT STREET LYNNFIELD, MA 01940 HOME: +1 781 334 4143 MOBILE: +1 603 930 6776

AXEL WIRTH, CPHIMS, CISSP, HCISPP [email protected]

SUMM ARY Healthcare and Life Sciences Technology Professional  Thought leader and subject matter expert: Health Information Systems, Regulatory Compliance, Medical Devices, Cybersecurity, Data Privacy, mHealth, IoT, and Healthcare Consumerization.  Successful international career spanning Engineering, Marketing, Business Development, and Sales across Health Technology and Life Sciences: Imaging, Diagnostics, Health IT, Integration and Interoperability, Cybersecurity, and Regulatory Compliance.  Demonstrated track record of leading international and interdisciplinary teams, building customer and OEM relationships, developing strategic partnerships, and managing business acquisitions.  Extensive international experience in Europe, Asia, and North America. Bilingual: English and German.

PROFESSIONAL EXPERIENCE SYMANTEC CORPORATION, Cambridge, MA

2008 – present

Distinguished Technical Architect  Thought and industry leadership on key Health IT topics including Medical Device Cybersafety; HIPAA Compliance and Audits, mHealth, and Consumerization.  Cooperation with government agencies and industry organizations to establish standards and best practices: FDA, NIST/NCCoE, ANSI, HIMSS, IHE PCD, MDISS, IEC/ISO, AAMI, ACCE. National Healthcare Architect Developed strategy to apply Symantec’s portfolio of cybersecurity, information privacy, data protection, and IT infrastructure solutions to the healthcare provider and vendor markets:  Supporting business leadership, sales, and sales engineering with solutions architecture, healthcare-specific know-how and strategies. Consistent YoY revenue growth and quota attainment.  Providing thought leadership to the Health IT Industry through conference presentations, expert panels, whitepapers, magazine publications, and social media.

AGFA HEALTHCARE CORPORATION, Greenville, SC

2002 – 2008

Sr. Director, Marketing and Business Strategies HIS/CIS, Americas Tasked with strategic business expansion and bringing Agfa’s ORBIS Clinical Information System (CIS) to the US and Canadian markets:  Product gap and market analysis to support regionalization; developed business and marketing plans and analyzed strategies for market entry including organic and non-organic options.  Developed organizational and support infrastructure: implement processes, policies, tools, training programs, and sales strategy. Marketing Director, Agfa Healthcare Leading Product Management teams in various Health IT subspecialties: Cardiology information systems; diagnostic reporting and speech recognition. Full product line responsibility and management of global business. Managed acquisition and integration of company with complementary product portfolio.

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Axel Wirth

MITRA INC., Waterloo, Ontario (a wholly-owned subsidiary of Agfa-Gevaert, N.V.)

2002 - 2003

Senior Account Executive, OEM Client Services Business and account responsibility for Mitra’s RIS/PACS integration and workflow Broker:  Managed relationship with major players in the industry; annual OEM license revenue of $4M+.  Responsible for commercial, product, and support issues: Negotiated supply contracts and resolved issues with existing agreements and business relationships.

ANALOGIC CORPORATION, Peabody, MA

1997 – 2002

OEM Sales and Marketing Manager, Ultrasound Division Responsible for Analogic's Ultrasound OEM business, including management of international customer base and development of new business.

SIEMENS MEDICAL SYSTEMS, ULTRASOUND GROUP, Issaquah, WA

1992 – 1997

Program Manager, Ultrasound Defined next-generation multi-tier ultrasound product family. Coordinated launch of joint development program in cooperation with international partner. Product Manager, Diagnostic Ultrasound Accountable for Siemens’ Private Office portfolio of Ultrasound systems. Provided product specification, development schedule, marketing plan, and supported launch in all international markets. Exceeded sales targets, generating over $300M revenue over product lifetime.  Conducted market research, cost and competitive analysis, customer focus groups.  Authored market requirements, software, and system specifications; oversaw engineering and manufacturing by Japanese partner.  Directed global launch: Regulatory filings, marketing campaign, product training, sales strategy, and competitive positioning.

SIEMENS AG, MEDICAL SYSTEMS GROUP, Erlangen, Germany

1981 – 1992

Engineering Manager, Digital X-Ray Systems Managed joint Computed Radiography (CR) system project in cooperation with FujiFilm Medical, Japan. Senior Engineer, Medical Research Laboratories, Biosensor Group Research project to assess feasibility of and application for a magnetoencephalography/-cardiography biomagnetic detector system. Analyzed system performance metrics, designed key system components, and cooperated with academic research partners to establish clinical trial protocols. Development Engineer, Physiological Signal Processing Projects: Neonatal respiratory monitoring; EKG-triggered and respiratory-gated MRI data acquisition; EKGcontrolled kidney stone lithotripsy; CT motion artifact suppression. Awarded several patents.

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Axel Wirth

EDUCATION 1988

MS, Engineering Management THE GORDON INSTITUTE, Wakefield, MA (now: The Gordon Institute of Tufts University, Medford, MA) “Michael Scott Memorial Award” for outstanding academic achievement.

1980

BS, Electrical Engineering UNIVERSITY OF APPLIED SCIENCES, Düsseldorf, Germany

CERTIFICATIONS 2011

CPHIMS HIMSS - Healthcare Information and Management Systems Society, license #2123

2012

CISSP

ISC² - International Information Systems Security Certification Consortium, license #427602

2014

HCISPP

ISC² - International Information Systems Security Certification Consortium, license #427602

MEMBERSHIPS AND VOLUNTEER ACTIVITIES IEEE (Institute of Electrical and Electronics Engineers) HIMSS (Healthcare Information and Management and Systems Society) IHE PCD (Integrating the Healthcare Enterprise, Patient Care Device Domain) ANSI IDSP (Identity Theft Prevention and Identity Management Standards Panel) AAMI (Association for the Advancement of Medical Instrumentation) ACCE (American College of Clinical Engineering) IEC/ISO TC215 (Health Informatics, Joint Working Group 7 – Medical Devices) AAMI Biomedical Eng. & Technology (BI&T) Editorial Board: June 2016 – May 2019 HIMSS Privacy & Security Committee: July 2017 – June 2019

PUBLICATIONS “CyberInsights” regular bimonthly column on cybersecurity topics BI&T Magazine; July 2016 - ongoing “Safeguarding Information and Resources against Emerging Cybersecurity Threats” AAMI Horizons; Spring 2014; Roundtable Participant “Privacy Considerations for the Medical Device Ecosystem” 24x7 Magazine; Feb. 2012; A. Wirth E. Sloane “Cybercrimes Pose Growing Threat to Medical Devices” Biomedical Instrumentation & Technology (BI&T); January/February 2011; Vol. 45, No. 1, pp. 26-34; A. Wirth

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Axel Wirth

“Focus On: Network Security” Interview with 24x7 Magazine, Oct. 2010; A. Wirth

CONFERENCE PRESENTATIONS “Implementation of the ‘NIST Framework for Improving Critical Infrastructure Security’ for Strengthening Security throughout the Total Product Lifecycle”; “Risk Assessment Tools for the Medical Device Operational Environment” FDA Public Workshop: Moving Forward: Collaborative Approaches for Medical Device Cybersecurity; Silver Spring, MD; January 20-21, 2016; Panelist “Medical Device Cybersafety - Separating Hype from Substance”; Conference opening Keynote Cybersecurity for Healthcare and Medical Devices; Minneapolis, MN; Sept. 30, 2015 “Biomedical Device Security: New Challenges and Opportunities” NCHICA 11th Academic Medical Center Conference; Chapel Hill, NC; June 2015; F. Hudson, Internet2; D. Bruemmer, Mayo Clinic, A. Wirth, Symantec “Big data gathering, sharing and ownership: The future of connected health” MD&M MedTech World; Boston, MA; May 2015; Panelist “Cyberthreat Landscape - Framing the Problem”; “Information Sharing and Risk Assessment”; “Cybersecurity Solutions – Path Forward” FDA Public Workshop: Collaborative Approaches for Medical Device and Healthcare Cybersecurity; Arlington, VA; October 21-22, 2014; Panelist “Addressing the Challenges with Medical Device Cyber Security” AAMI/FDA International Conference on Medical Device Standards and Regulations; Herndon, VA; March 2012; N. Paul, PhD, Oak Ridge National Laboratory/University of Tennessee, A. Wirth, Symantec “Medical Devices in the Age of Cyber Crime & Cyber Threats” CMIA (California Medical Instrumentation Association); Brea, CA; Jan. 2012; A. Wirth “Anatomy of a Breach: Medical Devices under Cyber Attack” AAMI Conference and Expo; San Antonio, TX; June 2011; A. Wirth

OTHER Provided “Introduction to Cybersecurity in Healthcare” to graduate students in the UConn Biomedical Engineering Program; 2013 and 2015

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