Early Bird Pricing: $1295 until 1/3/25 {save $400}

Pre-Conference Training Day: Tuesday 2/19  8am-5pm


Topic: Medical Device Security Incident Response   $1695
Trainers:
  • Naomi Schwartz, VP of Services, Medcrypt
  • Axel Wirth, Chief Security Strategist, Medcrypt

Outline:
Although we strive for our organization's and our medical device product’s cybersecurity posture
to be as good as possible, inevitably the day will come when our defenses will fail and be
overcome by an attacker. That is where our incident response plan will be called on and put to
the test. Any typical IR process includes planning, identification, containment, eradication,
recovery, and closure. However, when medical devices and their supporting infrastructure are
affected, responsibilities and activities become more complex and require additional, non-typical
steps. 

In this session we will explain how different devices or systems can be affected by a security
incident and what a complete medical device IR blueprint should include within the context of
the medical device quality system - who is the entity responsible for responding, who may be
called upon as a supporting resource, and what IR activities are required in a given situation.
The course will consist of a half-day training session combined with a half-day group project and
tabletop exercise.

Naomi Schwartz, Vice President of Services, Medcrypt

Naomi Schwartz
Vice President of Services
Medcrypt

 

 

 

 

 

Naomi is the Vice President of Services at Medcrypt, a medical device cybersecurity specialty firm.  She is a former premarket reviewer and consumer safety officer at FDA’s CDRH, with 6.5 years of expertise in software, cybersecurity, interoperability, and wireless coexistence for connected diabetes devices.  She was the recipient of multiple awards at the FDA, including 5 Commissioner’s Special Citations, for outstanding service, group achievements, customer service excellence, and plain language communication at CDRH.  Naomi has been recognized as a team recipient of the Samuel J. Heyman Service to America Medals for Management Excellence. 

Prior to her time at FDA, Naomi spent 15 years as a defense contractor developing radar systems and jammers for live field tests with operational DoD assets.  Naomi holds a distinguished track record of ensuring cybersecurity and operational safety across the medical and defense sectors.

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Axel Wirth
Chief Security Strategist
Medcrypt 

 

 

 

 

 

Axel Wirth is a seasoned professional with a passion for medical device cybersecurity. He has been involved in the medical device industry for more than 40 years. Over the past 15 years, he has developed a deep understanding of the unique cybersecurity challenges posed by these devices. Axel has a proven track record of developing and implementing effective security solutions that ensure the confidentiality, integrity, and availability of medical devices and the sensitive data they manage. He is known for his exceptional problem-solving skills, technical knowledge, and excellent communication and leadership abilities.

As Chief Security Strategist, Axel Wirth provides strategic vision
and industry leadership to Medcrypt and its customers. In this role he
helps guide the company in critical security strategy decisions and
supports the adoption of security technologies to the healthcare
industry. He is committed to advancing the field of medical device cybersecurity and ensuring that patients receive the best possible care – safely and effectively. 

He is an active participant in industry and standards organizations, serves on boards and committees, and is a frequent speaker on subjects such as healthcare cybersecurity and privacy, medical device security, regulatory compliance, and related healthcare-specific topics.

As adjunct professor, Wirth teaches a Medical Device Cybersecurity course at the University of Connecticut clinical engineering graduate program as well as is the co-editor / co-author of two books on the topic. Further, he guides healthcare-focused cybersecurity startup companies as an advisory board member.

In recognition of his accomplishments, he has been awarded the “2018 ACCE/HIMSS Excellence in Clinical Engineering & IT Synergies Award” and the “ACCE 2019 Clinical Engineering Advocacy Award” as well as has been recognized as a Fellow by AAMI (Association for the Advancement of Medical Instrumentation) and HIMSS (Healthcare Information and Management Systems Society).

His extensive background in the healthcare IT and medical device industries includes engineering leadership as well as business development and marketing roles with Siemens, Analogic, Mitra, Agfa, and Symantec. His education includes a BS in Electrical Engineering (BSEE) from the University of Applied Sciences, Düsseldorf (Germany) and an MS in Engineering Management (MSEM) from The Gordon Institute of Tufts University.