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U.S. Department of Health and Human Services

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Research Project: Medical Device Interoperability

Over the past two decades, advances in computing technology have brought many benefits to medical device users and patients. The technology trends over that time include an increase in computational horsepower coupled with a decrease in component size, the cost of memory, and power consumption. More recently, network technology and the Internet have extended their reach to virtually every medical device that can benefit from the ability to share information. These technology trends have enabled expanded feature sets, allowing diagnostic and therapeutic equipment to be tailored to a range of specialized clinical situations, home care, and portable applications.

On the other hand, there is a hidden cost to all of these benefits: the challenge of managing ever-increasing complexity in the design and use of medical devices. A significant effort of DESE researchers is to develop research platforms to explore the safety implications of this complexity. Part of the motivation for this is the recognition that improved product designs are the key to reducing adverse events and post-market compliance issues.

This research effort focuses on the challenges and benefits of interconnecting medical devices from different manufacturers into a seamless network, commonly known as the medical device interoperability initiative. Achieving interoperability of devices requires a paradigm shift, as medical devices which previously have been end-products in the medical device marketplace — or vertically integrated into a system by a single manufacturer — may now become components in a larger multi-vendor system, often referred to as “best of breed”. DESE researchers are playing a leading role by focusing attention on key safety and effectiveness considerations and helping to develop standards to ensure a level playing field. From a regulatory perspective, determining how to apportion responsibility for system performance among the various component vendors is a challenge requiring judicious application of systems engineering principles to augment CDRH’s traditional regulatory models.