Opal Medical Devices Summit – Minneapolis 2017

The Commons Hotel, Minneapolis, MN
June 26, 2017 - June 27, 2017

5 days left

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.

Current as of June 21, 2017

7:00am

Exhibitors Setup

7:30am

Continental Breakfast & Registration 

8:15am

Chairman’s Welcoming Remarks

8:30am

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.

Moderator

Wayne X. Wang, Lead Biostatistician, Nonin Medical Inc.

Panelist

Darin Andrew, Senior PKI Architect, Digicert Inc.

Panelist

Siddharth Dani, Principal Data Scientist, Medtronic

Panelist

Tarek Haddad, Senior Principal Statistician, Medtronic

9:30am

Cyber Security—End User Expectations
The FDA’s 2015 warning on remotely controlled infusion pumps, MedStar Health breach, investigation of the St. Jude Medical’s Merlin@home Transmitter, and ransomeware attacks like WannaCry are grim reminders of institutional vulnerabilities. The competitive drive to market and meaningful use have led to pitfalls in cyber security seen in legacy devices today. How big is the legacy device problem? How difficult is integration and monitoring of connected devices? How should we coordinate testing and reporting of device vulnerabilities? Our esteemed experts will explore current reality in this part of the cyber security landscape.

Moderator

Art Manion, Senior Vulnerability Analyst, CERT

Panelist

Michael Seeberger, Principal System Engineer, 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

10:40am

Morning Coffee Break – Meet the Panelists of the Cyber Security Discussion

11:00am

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

Panelist

Matt Russo, Senior Director, Product Security, Medtronic

12:10pm

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

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?

Shawn P. Malloy, Engineer III, Technical Development, Biogen

2:45pm

Real World Vulnerabilities in a Clinical Environment: Mitigation Strategies to Existing Medical Device Quality & Compliance

Paul Dant, Cybersecurity Research and Engineering, Connected Healthcare, Arxan Technologies

3:00pm

Refreshment Break

3:45pm

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.

Moderator

Cory M. Tschabrunn, Technical Director, Experimental Electrophysiology, Harvard-Thorndike Electrophysiology Institute, Beth Israel Deaconess Medical Center, Harvard Medical School

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

4:55pm

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?

Tom Waddell, Chief Executive Officer, Waddell Group

5:30pm

Day One Closing Remarks

7:45am

Continental Breakfast & Registration 

8:15am

 Chairman’s Welcoming Remarks

8:30am

Technology Transfer

Ami Gadhia, Technology Transfer and Patenting Specialist, NIH

Vaughn Schmid, Associate Technology Portfolio Manager, University of Minnesota Office of Technology Commercialization

9:30am

Preclinical Device Testing in Cardiac Electrophysiology: How to Evaluate Safety and Efficacy?

Cory M. Tschabrunn, Technical Director, Experimental Electrophysiology, Harvard-Thorndike Electrophysiology Institute, Beth Israel Deaconess Medical Center, Harvard Medical School

10:30am

Refreshment Break

10:50am

Funding Early Stage
Funding for early stage development has been drying up in recent years. Who is currently funding and what are some of the innovative options. What are some of the regulatory milestones that make your company more attractive to the investors.

Moderator

Nicholas Mourlas, Sr. Director New Ventures, Johnson & Johnson Innovation

Panelist

Cameron Plummer, CEO, Innurvation

Panelist

Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations

Panelist

Michael Arneson, Chief Executive Officer, Co-Founder, Matrix II

12:00pm

Closing Remarks

1star
The Commons Hotel, Washington Avenue Southeast, Minneapolis, MN, United States


Deluxe King $209
Deluxe Double/Double $209
*Prices exclude taxes and are subject to applicable state and local taxes (currently 13.4%)
  • Rooms are available only to those participants who are registered conference attendees.
  • The name on the form will be the name of the guest room.
  • Rooms are allocated on a first come first serve basis. Room types/rates are subject to availability.
  • Rooms will not be guaranteed without a credit card.

Registration Pricing

Standard Rate
Employees of Medical Device Manufacturers , Government and Academic faculty* $495
Service Providers $995

*Excluding contract manufacturers and other service providers.
Subject to Opal Group's approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by Opal. Opal reserves the right to allocate places and to refuse applications or to charge a normal attendance fee once the number of complimentary places has been exceeded.

Sponsorship, Exhibition & Speaking Opportunities 212.532.9898 info@opalgroup.net