LIFE SCIENCE
HEALTHCARE
Interest Group
Welcome
New Challenges for Medical Device and Equipment
Manufacturers and Hospitals
RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL Equipment
LIFE SCIENCE
HEALTHCARE
Interest Group
ABOUT GABA
Who We Are
• GABA is a member-driven non-profit organization that fosters transatlantic
knowledge-sharing and networking among German-American and Californian
business and tech communities. GABA is dedicated to encouraging GermanAmerican business and trade.
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Our programs address critical business, technical and leadership issues, with
different industry groups providing specific resources and exchange.
What We Offer
• Meet with our members through an online membership database and in person
at our weekly, monthly and annual networking events.
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As a GABA member you receive many benefits and discounts.
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If you are looking for specific services or you want to initiate a project together
with GABA members, contact our experts with your request for proposal.
LIFE SCIENCE
HEALTHCARE
Interest Group
ABOUT GABA Life Science / Healthcare Interest Group
California and Germany stand out as well established centers for the life science and healthcare
industry. Some of the key areas that are strongly represented are:
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biopharmaceuticals
healthcare and diagnostics
bioprocesses and biomaterials
It is essential for global enterprises to tap into the network of complementary companies
represented in both of these geographical areas. Cooperation and mutual learning are vital
factors in bringing products to market.
The GABA Life Science / Healthcare interest group is dedicated to enabling and fostering alliance
networks between German and US companies.
Seminars, workshops, and conferences are supporting the exchange of business information and
enabling synergy by providing a forum for personal contact. On request, our members can
provide market analysis and customized consultancy.
Our web site is designed to suit these purposes. Our member database provides a concise profile of
every interested company. GABA members can access this database with a personal login and
password and find companies that fit their needs. This type of database allows for networking
and cross-Atlantic exchange.
LIFE SCIENCE
HEALTHCARE
Interest Group
Tonight’s AGENDA
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Oliver P. Christ, Co-founder and CEO, PROSYSTEM USA LLC, San Diego, CA
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Aruna Ranaweera, Ph.D, Stryker, Corporate Process Owner – Design Controls & Risk
Management, San Jose, CA
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Simone McCormick, Esq., Senior Associate of Murphy, Pearson, Bradley & Feeney,
SF, CA
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Allen Hobbs, Ph.D., Health IT Strategy & Policy; Kaiser Permanente, Oakland
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Juergen Stettin, CEO PROSYSTEM AG, Hamburg, Germany
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Q & A Session
LIFE SCIENCE
HEALTHCARE
Interest Group
Intro
New Challenges for Medical Device and Equipment Manufacturers and Hospitals
RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES
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Networked information technology in the healthcare sector is evolving rapidly. Worldwide,
health care practitioners have an increased need to connect medical devices to IT networks,
and have to ensure that each patient's right to data integrity and confidentiality and their
safety is respected.
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The current revision of international safety standards for medical electrical equipment (IEC
60601-1/A1) and the new standard on risk management for IT networks used for medical
treatments (IEC 80001-1) together present a new collaboration challenge for hospitals, medical
device manufacturers and information technology providers.
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We'll address these challenges tonight with experts in hospital IT strategy, medical equipment
risk management, legal issues, project management and consulting
and discuss why it is so important to risk manage health IT solutions;
How we can optimally protect the privacy and integrity of patients' records and
how hospitals and medical device / equipment manufacturers can benefit from the latest safety
standards.
LIFE SCIENCE
HEALTHCARE
Interest Group
Oliver P. Christ
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Dipl.-Ing. Oliver P. Christ is CEO Healthcare of PROSYSTEM AG
Mr. Oliver P. Christ has been active in International Standardization for more than
21 years.
In Germany he is Chairman of four National Committees two on “Human Factors /
Usability for Medical Devices”, one on “Risk-Management for Medical Electrical
Equipment” as well as for “Software for Medical Devices and Networked-Medical
Systems”.
He represents Germany within International Standard Committees on
Programmable Electrical Medical Systems (since 1992), Human Factors (since 1996),
Risk Management (since 1996) Software Life Cycle Processes (since 2002), and RiskManagement for IT-networks incorporating Medical Devices (2006) published as IEC
80001-1 in October 2010.
The company PROSYSTEM AG was founded by Mr. Oliver P. Christ together with his
business partner Dr. Juergen Stettin in 1999 and is located in Hamburg, Germany
having an US-based office in San Diego, California.
He studied Control Engineering at the University of Darmstadt, Germany
LIFE SCIENCE
HEALTHCARE
Interest Group
Aruna Ranaweera, Ph.D,
• Aruna Ranaweera, Ph.D, Stryker, Corporate Process Owner Design
Controls & Risk Management, San Jose, CA
• Aruna Ranaweera is the Associate Director of Design Engineering
Processes at Stryker Corporation.
• For the past 7 years at Stryker, Aruna has worked in both Product
Development and Quality Assurance and he is currently the Corporate
Process Owner (CPO) for both Design Controls and Risk Management.
• Aruna holds a BSE in Mechanical Engineering from Princeton University
and an MS and PhD in Automatic Control Systems from the University of
California, Santa Barbara.
• Aruna resides in San Francisco.
LIFE SCIENCE
HEALTHCARE
Interest Group
Simone McCormick, Esq.
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Simone McCormick, Esq., Senior Associate of Murphy, Pearson, Bradley & Feeney,
SF, CA
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Simone McCormick focuses her practice on representing businesses and
professionals in products liability, personal injury, and medical and legal
malpractice claims as well as business disputes.
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Ms. McCormick counsels entities and individuals in compliance matters and offers
risk management services, including pre-litigation investigations.
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Ms. McCormick has successfully handled disputes at all stages of litigation.
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She has published numerous papers and is a member of the American Bar
Association, the State Bar of California and the Bar Association of San Francisco and
the German-American Business Association GABA.
LIFE SCIENCE
HEALTHCARE
Interest Group
Allen Hobbs
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Dr. Hobbs is a Analyst with the Department of Health IT Strategy and Policy for Kaiser
Permanente (KP). He is currently responsible for coordinating and facilitating KP’s input
and involvement in federal cyber security policy. He is also responsible for coordinating
and facilitating input and involvement related to mobile device security policy and
federal regulations.
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Dr. Hobbs actively participates in several standards organizations including: Health Level
Seven (HL7), Institute of Electrical and Electronics Engineers (IEEE), World Wide Web
(W3C), International Organization for Standardization (ISO), Continua Alliance, HITRUST,
the National Health Information Network (NW-HIN) and the ONC S&I Framework. He is a
co-chair with the Health Device Working Group for HL7 and an advisor and participant
with the Medical Device Innovation, Safety, and Security Consortium (MDISS).
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Prior to joining KP, Dr. Hobbs was a Visiting Scholar at Stanford University and
conducted research in cognitive neuroscience and informatics. He has approximately 30
years experience in healthcare delivery, teaching and research.
LIFE SCIENCE
HEALTHCARE
Interest Group
Juergen Stettin, MD PhD.
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Dr. Juergen Stettin, CEO PROSYSTEM AG / PROSYSTEM USA LLC
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Juergen has a background as physicist with a PhD in physics as well as a MD in
medicine.
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He has been in Software development for medical devices for over 25 years and has
experience with almost all major medical device manufacturers.
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Among many positions in the medical device industry he was CEO of the Olympus
group. Since 1999 he has a chair for Clinical Engineering at the University of
Applied Sciences Hamburg, Germany.
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Since 2006 he is adjunct professor at Virginia Tech University.
LIFE SCIENCE
HEALTHCARE
Interest Group
Q
&
A