Addressing the Challenges of Combination Products: Moving to Integrated Interoperable Solutions

Monday, April 8 2013
8:00 am – 5:00 pm

Location: ahey Hospital & Medical Center, Burlington, Mass.

Medical device products, no matter how well designed, can only do so much to address the clinical problems that are seen today. In order to more effectively address clinical problems in the future from a cost, quality and time-to-market perspective, many medical devices will need to be used in conjunction with pharmaceutical and biologic products to create “combination products.” Today these combination products are a specific class of FDA-regulated medical products. Our special full-day seminar will feature Dr. Andrew Von Eschenbach, former FDA commissioner, and a series of distinguished panels to address the current and future needs in introducing combination products.

Learn more and register here.

The many challenges facing medical device company leaders in pursuing combination products will be discussed including:

  • Product definition, market sizing and creating interest from investors in combination products
  • Incorporating pharmacology or biology devices with medical devices which can improve the performance of the device
  • Demonstrating to regulatory groups including the FDA and EU that a combination product is superior to what is currently available
  • Getting the FDA to classify combination products in a timely fashion
  • Getting a reimbursement that can justify the investment in a timely fashion
  • Clinical case studies

Who Should Attend:

  • Scientists, engineers, designers, product developers, R&D staff; in short—professionals and their technical teams who are immersed and/or preparing for the difficult task of working closely with diversely educated colleagues of other disciplines to complete a product project—and are looking for more insight
  • Physicians working with device companies who wish to further their appreciation of forthcoming products and the many considerations in bringing these to clinical use
  • Directors and new product marketing decision-makers who have faced these challenges will benefit from being exposed to other problems and solutions to add to their experiences
  • Service providers who join teams of multidiscipline (ad hoc or in full status) to be able to better appreciate the impediments to integration of a solution
  • Product developers who would value the opportunity to observe the case history of a successful process to conclusion

Learn more and register here.

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