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Opal Group: Medical Devices Summit 鈥 Minneapolis 2017

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Medical Devices Summit

Opal Medical Devices Summit 鈥 Minneapolis 2017
The Commons Hotel, Minneapolis, MN
June 26 - 27, 2017
About Conference
In today's highly regulated environment, medical device and combinations product manufacturers cannot ignore even the smallest challenges at every stage of development--or during use in healthcare and clinical settings. Fortunately, Opal Group's Medical Devices Summit Midwest is here to provide a platform for a bench-to-bedside discussions every medical device and combination product professional needs.
The Medical Devices Summit Midwest attracts professionals from Medical Device, Pharma, Biotech and Drug Delivery who will learn new strategies for concept development, navigating the regulatory landscape, and managing risk and maintaining quality throughout the product life cycle.
Monday, June 26,2017   锔  Tuesday,June 27,2017
Exhibitors Setup
Continental Breakfast & Registration 
Chairman鈥檚 Welcoming Remarks
Best Practices for Compliance with the new ISO13485:2016
In the first half of 2016 we鈥檝e moved from ISO 13485 :2003 to ISO 13485:2016.
With the new standard in place, what are some of the most significant highlight?
What steps should an organization take to facilitate a seamless transition during next 3 years?
John Petrovich, Senior Vice President Business Development and General Counsel, Alfred Mann Foundation for Scientific Research
Angelica McParlane, Site Quality Manager, GE Healthcare
Cyber Security鈥擡nd User Expectations
FDA鈥檚 2015 warning on remotely controlled infusion pumps and recent MedStar Health breach, and more recent investigation of the St. Jude Medical鈥檚 Merlin@home Transmitter are a grim reminder of institutional vulnerabilities. The competitive drive to market has produced pitfalls in cyber security seen in legacy devices today. How big is the legacy device problem? How difficult is integration and monitoring of the connected devices. Our esteemed experts will explore current reality of cyber security landscape.
Art Manion, Senior Vulnerability Analyst, CERT
Michael Seeberger, Principal System Engineer, Boston Scientific
Andrew Bomett, Manager, Product Cybersecurity, Boston Scientific
Darin Andrew, Senior PKI Architect, Digicert Inc.
Kevin McDonald, Director of Clinical Information Security, Mayo Clinic
Ryan Winn, Director Information Systems, Munson Healthcare
Morning Coffee Break 鈥 Meet the Panelists of the Cyber Security Discussion
Cyber Security鈥 Regulation
Changes to the healthcare operating environment are prematurely exposing connected medical devices to adversarial hazards they were not designed to withstand.
Do we understand FDA鈥檚 direction on cyber security鈥攔egulation vs recommendation. What cultural changes does a medical device manufacturer need to implement to give their developers a chance to incorporate strong cyber security during the ever-present drive to the market. How to minimize your organization鈥檚 exposure to future liabilities caused by the hacking incidents.
Carl Anderson, Vice President, Van Scoyoc Associates
Suzanne Schwartz, Associate Director for Science and Strategic Partnerships, FDA
Steven Abrahamson, Senior Director, Product Cyber Security, GE Healthcare
Jim Jacobson, Chief Product and Solution Security Officer, Siemens Healthineers
Beau Woods, Deputy Director, Cyber Statecraft Initiative, Atlantic Council
Exploring challenges and opportunities when developing cost effective pediatric and adult devices
With Pediatric Device Consortia Grant Program in place the FDA has awarded 3.535 million dollars in 2015. Albeit awareness campaigns why don鈥檛 we see more of much needed development in this difficult to navigate space?
Charles Ledonio, Director of Spine Research, University of Minnesota
Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations
Tom Kramer, President and CEO, Kablooe Design
Chris Maeder, Program Manager, New England Pediatric Devices Consortium
Combination Products Realm
One of the challenges of combination products is to create processes that will deal efficiently with the unknown. What are some of the solutions for dealing with the unknown? What are some of the compliance requirements in combination products when dealing with pharma?
Tieming Ruan, Principal Engineer, Biogen
Giridhar Thiagarajan, R&D Engineer, CR Bard
Charles Ledonio, Director of Spine Research, University of Minnesota
Presentation: Meeting the Unmet Need:  Product Development Planning and Execution Ten Critical Success Factors
John Petrovich, Senior Vice President Business Development and General Counsel, Alfred Mann Foundation for Scientific
Refreshment Break
Medical Device Innovation and Manufacturing
From a startup to a large organization, our expert panelists will discuss challenges of moving from early stage development to manufacturing, including strategic approaches to developing and protecting your intellectual property, overcoming technical and regulatory hurdles, and navigating through the intersection of innovation and law.
David Ternes, Fellow - System R&D, Device Innovations, Boston Scientific
Dr. Paul Iaizzo, Professor of Surgery; Integrative Biology and Physiology; and the Carlson School of Management, University of Minnesota
Michael Finch, Associate Professor, Carlson School of Management; Co-Founder, MILI, University of Minnesota
Michael Bateman, Senior Scientist, Coronary & Structural Heart Research & Innovation, Medtronic
Device Connectivity 鈥 Internet of Health
The benefits of going wireless are tremendous and when paired with the new wave of wearables these solutions will revolutionize care and treatment.
To successfully implement wireless technologies developers have to choose the right approaches-solutions and understand the options for wireless.
Successful implementation has to address the security concerns.
Siddharth Dani, Principal Data Scientist, Medtronic
Day One Closing Remarks
Contact us at:
Sherry Shin
Tel: 212.532.9898 ext. 345
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