Pediatric Cardiology Needs Analysis

Like the drug industry, the medical device industry has often not focused on providing devices uniquely adapted for the care of pediatric patients. IPI and its Pediatric Hospital Consortium are beginning their broad review of pediatric medical device needs by focusing on cardiac care.

Cardiologists, cardiac surgeons and interventional radiologists dealing with pediatric patients often need to use devices that were not specifically designed for that application. Using devices designed for adults in children creates opportunities for problems related to wrong size and or flexibility of the device, wrong durometer (hardness) or surface characteristics, and inappropriate markings on the device delivery system. The potential consequences of implanting a device in a growing patient is a major long-term issue that is relevant to other clinical areas as well,

IPI and its Pediatric Hospital Consortium are conducting a needs analysis to identify modified or reengineered medical devices that are critically needed for use in the care of pediatric cardiac patients as well as new technology needs that are specific to pediatric care. The Consortium cardiac care clinicians and a national advisory panel will identify specific unmet needs for commercially available devices used in the care of pediatric cardiac patients and will establish priorities for the needed products. We will use an on-line market survey to further validate and quantify the needs. IPI will produce a Product Opportunity Analysis as a road map and business plan for commercializing these devices with the help of existing or new commercial medical device corporations.