Medical Devices Summit Midwest

Afternoon Workshop Presentation:
A Medical Device Start-Up's Roadmap to Success: Navigating Corporate, Regulatory, and Intellectual Property Challenges

Presented by:

• Why IP is Important?
  
• How is IP viewed?
  
• How to build a strong portfolio
  
• Strategies based on the AIA

• Practical advice surrounding corporate issues and their importance
• How does IP factor into acquisition and investment?
• Monetization of assets
• Expansion of exit strategy
• How to deal with regulatory aspects?

• Provide historical context on CDRH and discuss how and why the program has evolved over time
• Discuss the current regulatory environment with focus on the 510(k) program
• Discuss device provisions and impact of the FDA Safety and Innovation Act
• Provide practical strategic and tactical advice for success in today’s regulatory environment
• Provide some thoughts on the future

• Enjoy coffee and pastries with your fellow attendees during these intimate discussions on a wide variety of topics
  
• Choose 2 half hour long workshops to attend and join other industry leaders as they host in-depth discussions on the hottest topics in the industry today.
  
• After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on a whole new topic. Walk away with vital strategies and solutions!

***********Workshop Table 1 Sponsored by: Cognition Corporation***********
Cockpit - Using Modern Tools to Win: Working with Medtronic

• Customer needs... user experience... stakeholder requirements... system features... safety... validation... and complete traceability, how in the world do you get it all done? Even harder, how do you get it all done efficiently and with the least pain? Whether you're a start-up or one of the big guys, modern tools are simplifying your burden. In this workshop, you will see what one of these tools looks like...and if you deal with the topics above and this example doesn't feel like it would simplify your life, then we'll buy you a beer.

Mitch Hayes, Vice President of Customer Success, Cognition Corporation
Susan Neadle, Director, Research & Development QA and Process Analytical Technology, Vistakon, a Johnson & Johnson Vision Care, Inc
Dan Kussman, Senior Research & Development Manager, Boston Scientific CORPORATION
Tom Savard, Director, R&D, St. Jude Medical, INC

***********Workshop 2 Sponsored by: TUV Rheinland Group***********
Session A: Sorting out the deadlines for Medical Equipment tests to 60601- 3rd Ed. (8:30-9:00 am)
Different countries and regions have different requirements and deadlines for bringing products into compliance with 60601-1 3rd Edition. This roundtable will lay out the deadlines and share details of the requirements in the USA, Canada, Europe, and other markets.

Session B - How to document Risk Management in order to meet 60601-1 3rd Ed. (9:00-9:30 am)
ISO14971:2007 is commonly used as the risk management standard for electrical medical equipment. This roundtable will examine the best ways to document your conformity to both ISO14971 and IEC 60601-1 3rd. Ed.

Speaker:
Dale Hallerberg, Technical Manager, Medical Product Testing, TUV Rheinland GROUP


***********Workshop 3 Sponsored by: TUV SUD AMERICA***********
The Recast, Review and Revision of the EU Medical Devices Framework: An Inside Look at Getting Ahead In a New Era

• Learn about the future of Risk-Benefit Analysis
• Gain an understanding of the proposed changes to the testing and documentation requirements
• The Call to Strengthen Regulatory Control and Surveillance. How will this affect you?

*********Workshop 4 Sponsored by: Omnilingua *********
Do You know What I Mean? Measuring Translation Accuracy for Regulatory, Product and Quality Managers

• Most manufacturers outsource translation of DFUs and IFUs and other technical documentation to suppliers
• With the sharp rise in exports how can Regulatory and Quality Managers ensure accurate, consistent and compliant translations are meeting global requirements?
• Dan Koenig of Beckman Coulter describes the results of several years’ experience in developing best translation practices to ensure quality

Daniel Koenig, Senior Process Coordinator, Beckman Coulter INC.
Johan Kerkhove, Client Services Manager, OMNILUNGUA WORLDWIDE, LLC

*********Workshop 5 Sponsored by: RCRI*********
Compliance 101 Workshop:  Sunshine Reporting Developing Proactive Strategies to Manage Physician Communication

• 24% of physicians surveyed by the Center for Medicare and Medicaid (CMS) in March 2012 felt they understood Sunshine Reporting requirements
• Understand how to prepare your sales reps to respond to physicians’ questions and concerns about disclosure
• Create a proactive plan for managing physician customer expectations regarding financial disclosure
• Get clarity on how developing the right physician disclosure and transparency communication plan will help you build a more effective compliance program

Speaker:
Mandy Klosterman, Vice President of Regulatory Sciences and Legal Services, RCRI

***After workshops conclude, the conference continues in our main ballroom***