Originally Published EMDM
May 2003
INDUSTRY NEWS
MEDTEC Ireland Devotes Daylong Session to Combination ProductsTraditional medical devices, no matter how well designed, have limitations. For example, they may be able to prevent new tissue damage from occurring in a patient who has suffered a heart attack or stroke, but they are powerless to restore function in tissue that has become necrotic. Hence, the immense promise of medical devices used in combination with drugs and biologics: not only can they stem new tissue damage, they may be able to restore previously lost functions. The technology and its regulatory ramifications will be the subject of a one-day session at the third annual MEDTEC Ireland Conference and Tabletop Exposition in Galway in September.
Combination products raise a host of complex issues from a regulatory and development perspective. Research and development teams must determine the feasibility of a given combination product in an environment where few benchmarks currently exist. Companies must also resolve challenging regulatory, clinical, and quality systems issues. This session will provide insight into these and other matters from both European and US perspectives. Case studies will illustrate the importance of good design planning and suggest methods for integrating the regulatory, clinical, and quality considerations into an overall development plan for drug and device combination products.
Copyright ©2003 European Medical Device Manufacturer
