Join industry experts as they explore development trends in biomaterials in this FREE Webcast, “Biomaterials Trends: HACs,” hosted by MD&DI. Learn about the latest technologies employed to prevent hospital-acquired conditions (HACs) such as those found at surgical sites and those introduced from beds, gowns, and other sources in hospitals. Experts will discuss Centers for Medicare Services (CMS) payment restrictions for HACs. The session will explore reimbursement issues, biocompatibility testing, and technology applications. An interactive Q&A session will follow the presentation.
Web event:
Biomaterial Trends: HACs
Date:Â Â Â Wednesday, May 27
Time:Â Â Â 2:00 p.m. EDT
1:00 p.m. CDT
11:00 a.m. PDT
Duration:Â Â Â 50 minutes
Who should attend:Â Â Â Product development teams and reimbursement specialists for medical devices.
Ted Mannen, member of Epstein, Becker & Green |
 Ted Mannen is based in Washington, D.C., where he specializes in reimbursement and health policy as a member of the law firm of Epstein Becker & Green, P.C., and as a managing director of that firm’s consulting affiliate, EBG Advisors, Inc. He is also managing director of ContentHealth LLC, for which he edits the health policy web site, HealthHombre (healthhombre.com).
Mannen has advised a large number of device and diagnostics companies on introduction of new health care technologies into reimbursed markets. |
|
| Daniel McLain, PhD, CNS, DABFE, cofounder and president of Walker Downey & Associates Inc. |
 Daniel McLain is cofounder and president of Walker Downey & Associates Inc., an evidence-based product safety and development consulting firm located in the heart of the third coast scientific and biotechnology community—Madison, WI. He received his PhD in nutritional toxicology and preventive medicine from Cornell University (Ithaca, NY). McLain has more than 25 years of experience in toxicology, drug and device development, vaccine development, statistics, and risk assessment. He has specific expertise in medical device material biocompatibility, immunotoxicology, and developmental and reproductive toxicity (DART). He is the the current convener of ISO 10993—Biological Evaluation of Medical Devices—Part 11: Systemic Toxicity Evaluation. He has contributed to and has meaningful personal experience with IND, BLA, 510(k), GTAC, and CTD preparation. He is experienced with the design, conduct, analysis, and reporting of preclinical safety and pharmacokinetic studies for drugs, devices, biologics, and combination products, as well as with the international regulatory submissions associated with them. McLain is a Diplomate and Fellow of the American College of Forensic Examiners (DABFE, Toxicology) and the American College of Nutrition (FACN), and is a board-certified nutrition specialist (CNS). Additionally, he is an active and contributing member of the Society of Toxicology (25-years), the Regulatory Affairs Professional Society (16-years), ISO/AAMI (13-years), and the American Society for Quality (13-years). |
|
| Christopher D. Roberts PhD MBA, Head of Clinical Support, International, Smith and Nephew Wound Management |
 Christopher D. Roberts PhD MBA is head of clinical support, international for Smith and Nephew Wound Management. He is a trained medical microbiologist and served as VP of Global Clinical Research at Smith and Nephew Wound Management for more than 20 years. He has taken on a specialist role to support the international sales teams, ensuring clinical and scientific evidence is understood and aligned appropriately. He has a keen interest in the role of topical antibacterials for management of infected or at-risk wounds, the use of topical wound coverings in burn wound management, and tissue engineering. Roberts has presented at many global wound-healing events and has published a number of articles in peer-reviewed journals. He was presented with a lifetime achievement award at the World Union of Wound Healing Societies Toronto in June 2008. |
