Medical Devices Summit West 2013

• In this expert panel you will be able to walk through upcoming, (both planned and possible), changes planned for our healthcare system and how you can best prepare yourself
• What impact does the current political climate in Washington have on the device industry?
• Impact the FDA has on current device industry climate, including changes to establishment registration process impact
• Unpacking the details of the medical device user fee law and the goals and objectives for FDA performance

• In view of the new First-Inventor-to-File patent filing system, this panel will discuss filing strategies that will develop intellectual property assets to protect market share, enhance the value of medical device companies, and improve competitive positioning
• The panel will discuss how startup companies can take advantage of new mechanisms created by the America Invents Act together with existing mechanisms to build value and increase likelihood of investment or acquisition
• In addition, the panel will describe exemplary filing strategies that may be implemented immediately for companies of all sizes
• We will also discuss how inventors can assist their companies by considering variations and alternatives to block competitors and protect market share

• Uncover the components and details that go into a successful assurance case
  
• Receive a high level walk through of an assurance case
• Understand the purpose of Assurance cases in accordance with FDA

Erik Hilliard, Director of Business Development, Sterling Medical Devices

• Dealing with the Real Hierarchy of Harms, Hazards, and Causes
  
• Prioritization of Risks
  
• Risk Management and Traceability
  
• The Big Picture - Residual Risk
  

• 'Crossing the Valley of Death' what has, should and will drive the development of new medical device technology?
• More than ever it’s important to 'incorporate the endgame', and be up to date on reimbursement issues
• How companies are evaluating how meaningful a product is in the lives of future patients

David Vulcano, AVP, Clinical Research, Hospital Corporations of America
Neelima Firth, Director of Strategic Planning & Development, Alfred Mann Foundation for Scientific Research
Ami D. Gadhia, JD, LLM, CLP, Director- Physical Sciences & Engineering, Johns Hopkins

• Contain costs and increase your reimbursement potential by developing devices which focus on patient usability and interaction between providers
• The impact of retailing and sharing data across multiple platforms
• The importance of behavioral and healthcare data
• Leveraging technology and connectivity to change the paradigm from sickness to health

Dennis Robbins, Director of Health Policy, PEARL at NYU, National Research Network
Kevin Dorrance, Chief, Internal Medical Service, Walter Reed Military Medical Center
Jay Leiner, CTO, NEUVERUS HEALTH

• How will changes made through the AIA, which include altering the definition of prior art, affect international patent filing strategies?
• Current strategies and considerations for enforcing patents in Europe contrasted with enforcement in the U.S.
• How will procuring and enforcing patents in Europe change now that the European Union has voted to create a Unitary Patent System (UPC)?

Kathleen A. Daley, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Tina E. Hulse M.D., Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Aaron L. Parker, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

• Linking maintenance to achieving operational excellence
• Reducing cycle time and conversion costs
• Minimize loss and optimize supply chain efficiency
• Six Sigma Process for developing an Asset Management Master Plan

• §820.30 compliance is not optional
• Don’t forget about the DMR
• What should be included into the DHF?
• What is the difference between design validation and design verification?
• Identifying design inputs and outputs
• Design transfer, are you ready?

• ISO 14971: have we become too lax in our criteria? Are we mitigating risk purely to 'meet the grade’ or to revolutionize patient care?
• Integrating thoughtful risk management processes into early product development: 10 easy steps!

• Understand how past history, recent developments, and FDA guidance may impact your product's pathway through the Agency
  
• Learn more about the “Assurance Case” and recent developments regarding “Special 510(k)” submissions
  
• Get advice from experts on practical steps to get your 510(k) through without unnecessary delays
  

Daniel Dillon, Regulatory Scientist, MED Institute of Cook Medical

• Learn how digital health is engaging all realms of the healthcare industry in developing new solutions for patients, providers and device manufacturers
• Hear the impact that mobile medical devices will have on the healthcare landscape; from evolving technologies to FDA approval

• Learn about effectively communicating healthcare information between devices and settings in this cross disciplinary panel
• Medical devices are subject to multiple standards that are not always in accordance with one another: learn from leaders about how to effectively navigate these criteria