After medical device manufacturers have brought their product(s) to market, they may be required to undertake 522 post-marketing surveillance studies. They are also subject to filing Medical Device Reports under appropriate circumstances. Manufacturers may receive complaints about the product(s) from patients, physicians, hospitals or other providers. All of this information held by the manufacturer may trigger various reporting responsibilities to, or other actions concerning, various constituents including the FDA, medical community, and shareholders or investors.

In this session the panel will discuss with the attendees:

• How does the information derived from these different sources interrelate?
• How should a manufacturer manage signals from the field such as the frequency of adverse events reported from 522s, MDRs or complaints, and what level(s) of adverse events should act as triggers for a manufacturer to consider a recall, or disclosure to its shareholders or investors?
• Is the trigger for reporting to shareholders (investors) the same as that for disclosing to the government?
• How do you manage investors who have direct access to physicians through “expert networks” and may have access to information you have not disclosed publicly?
• What should a manufacturer do to manage this flow of information, especially since the whistleblower provisions of Dodd-Frank have given employees serious incentives to disclose perceived potential problems that someone might believe should have been disclosed to the SEC?
• How does the Supreme Court’s decision in Matrixx, dealing with disclosure to shareholders, affect a manufacturer’s consideration of these issues?
  
  

Brian Halak
Partner, Domain Associates
Dr. Halak joined Domain in 2001 and became a Partner in 2006. He currently serves on the Board of Alimera Sciences, Carticept Medical, Corridor Pharmaceuticals, Dicerna Pharmaceuticals, Eddingpharm (Cayman), GI Dynamics, and Oraya Therapeutics. He was previously on the Boards of Esprit Pharma, until the company was acquired by Allergan, and Vanda Pharmaceuticals. From 2000 to 2001, Dr. Halak was an Associate with Advanced Technology Ventures where he participated in the firms investments in Plexxikon, Percardia and Emphasys. From 1993 to 1995, he was a Consultant at the Wilkerson Group where he developed strategy for pharmaceutical and medical device companies. Dr. Halak is currently a member of the Investment Advisory Council for Ben Franklin Technology Partners and BioAdvance, both seed-stage investment groups in Philadelphia. He also serves as an advisor to Elm Street Ventures.

Mark Klausner
Managing Partner, Westwicke Partners
Prior to founding Westwicke Partners in 2006, Mr. Klausner worked on Wall Street for over 17 years in a variety of senior positions in investment banking and equity capital markets. For the first six years of his career, he worked as a generalist in investment banking at Smith Barney, Citibank and Merrill Lynch. In 1995, he accepted a position in the Health Care Investment Banking Group at Alex. Brown & Sons. In 1999, Mr. Klausner joined the Equity Capital Markets Group to head Equity Origination for the Health Care sector. He was promoted to Managing Director in 2001. In 2004, Mark joined Wachovia Corporation as a Managing Director and Head of Equity Origination for the Health Care and Technology industries. At Westwicke Partners, Mark works with companies in all sectors of the health care industry advising them on effectively communicating their message to Wall Street, building a high quality institutional shareholder base and developing and maintaining strong sell-side analyst relationships. Mark also serves as an independent advisor to private companies as they navigate the initial public offering process.  During his investment banking career, Mr. Klausner worked on over 100 capital raising and strategic advisory transactions with an aggregate value of over $20 billion. He received his MBA from The Darden School and his BA in Economics and Computer Science from Colgate University. He lives in Baltimore, MD with his wife and four children.

John Reiss
Partner, Saul Ewing
Mr. Reiss concentrates his practice in health care matters including developing and implementing various forms of provider networks and managed care arrangements; corporate, partnership and contractual arrangements and ventures; Medicare, Medicaid, and other insurance coverage and payment issues; developing and implementing compliance audits and plans; FDA drug and device issues; certificate of need, licensure and other regulatory matters; and medical staff credentialing, disputes, and patient care problems. Previously, Mr. Reiss served as the Director of Office of Health Regulation, U.S. Department of Health and Human Services. There, he was responsible for reviewing federal regulation of hospital, nursing homes and HMOs to reduce the regulatory burden and ensure public benefits were provided in the most efficient way with the least disruption to providers of care. From 1975-1979, Mr. Reiss served as Assistant Commissioner for the New Jersey State Department of Health, where he was responsible for development of the DRG prospective payment system for hospitals and for other regulation of health care facilities. While serving in the educational community, Mr. Reiss was Associate Professor of Economics at Stockton State College and also held the position of Assistant Professor of Economics at Allegheny College. A frequent lecturer and author, Mr. Reiss has spoken before many organizations at the national, state, and local levels regarding legal, governmental, health care, and environmental issues.

Marta Villarraga
Principal, Exponent, Inc
Dr. Villarraga specializes in spine biomechanics and in failure analysis of medical devices. She has experience with orthopedic, spinal, reconstructive surgery, and diagnostic medical devices from product liability, intellectual property, regulatory compliance, and product development perspectives. Dr. Villarraga also has experience in evaluating quality control issues as applied to medical devices and pharmaceuticals, with an emphasis in contamination, manufacturing compliance, and finished device evaluations. Dr. Villarraga has extensive experience with root cause analysis investigations and compliance issues related to medical device recalls. Dr. Villarraga’s research experience and interests include implant and tissue retrieval analysis, use of animal models for evaluating orthopedic device performance, and the use of experimental and finite element stress analysis techniques to characterize the mechanical behavior of bone, other biological structures, and orthopedic implant devices. Dr. Villarraga serves on the Editorial Board of the ASTM International Journal of Testing and Evaluation, on the Monograph Editorial Advisory Board of FDLI, and has also been a reviewer for the Journal of Biomechanical Engineering, Clinical Orthopedics and Related Research, Clinical Biomechanics, Clinical Neurology and Neurosurgery, and Journal of Biomedical Materials Research.

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This seminar is sponsored by Exponent, Inc., Saul Ewing, LLP, and UCKIZ