Opal Group: Medical Devices Summit – Minneapolis 2017

 

Opal Medical Devices Summit – 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.

 

Agenda

 

Monday, June 26,2017   ︱  Tuesday,June 27,2017
7:00am	Exhibitors Setup
7:30am	Continental Breakfast & Registration
8:15am	Chairman’s Welcoming Remarks
8:30am	Best Practices for Compliance with the new ISO13485:2016 In the first half of 2016 we’ve 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? Moderator John Petrovich, Senior Vice President Business Development and General Counsel, Alfred Mann Foundation for Scientific Research Panelist Angelica McParlane, Site Quality Manager, GE Healthcare
9:30am	Cyber Security—End User Expectations FDA’s 2015 warning on remotely controlled infusion pumps and recent MedStar Health breach, and more recent investigation of the St. Jude Medical’s 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. Moderator Art Manion, Senior Vulnerability Analyst, CERT Panelist Michael Seeberger, Principal System Engineer, Boston Scientific Panelist Andrew Bomett, Manager, Product Cybersecurity, Boston Scientific Panelist Darin Andrew, Senior PKI Architect, Digicert Inc. Panelist Kevin McDonald, Director of Clinical Information Security, Mayo Clinic Panelist Ryan Winn, Director Information Systems, Munson Healthcare
10:45am	Morning Coffee Break – Meet the Panelists of the Cyber Security Discussion
11:05am	Cyber Security– 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’s direction on cyber security—regulation 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’s exposure to future liabilities caused by the hacking incidents. Moderator Carl Anderson, Vice President, Van Scoyoc Associates Panelist Suzanne Schwartz, Associate Director for Science and Strategic Partnerships, FDA Panelist Steven Abrahamson, Senior Director, Product Cyber Security, GE Healthcare Panelist Jim Jacobson, Chief Product and Solution Security Officer, Siemens Healthineers Panelist Beau Woods, Deputy Director, Cyber Statecraft Initiative, Atlantic Council
12:15pm	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’t we see more of much needed development in this difficult to navigate space? Moderator Charles Ledonio, Director of Spine Research, University of Minnesota Panelist Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations Panelist Tom Kramer, President and CEO, Kablooe Design Panelist Chris Maeder, Program Manager, New England Pediatric Devices Consortium
1:05pm	Lunch
2:00pm	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
2:45pm	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
3:35pm	Refreshment Break
3:50pm	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. Panelist David Ternes, Fellow - System R&D, Device Innovations, Boston Scientific Panelist Dr. Paul Iaizzo, Professor of Surgery; Integrative Biology and Physiology; and the Carlson School of Management, University of Minnesota Panelist Michael Finch, Associate Professor, Carlson School of Management; Co-Founder, MILI, University of Minnesota Panelist Michael Bateman, Senior Scientist, Coronary & Structural Heart Research & Innovation, Medtronic
4:40pm	Device Connectivity – 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
5:30pm	Day One Closing Remarks

 

Contact us at:

 

Sherry Shin

Email: sshin@opalgroup.net

Tel: 212.532.9898 ext. 345