The Unique Path of Development Through Introduction of Novel Wireless Health Products

Abstract

This presentation will describe the development approach and enabling technology for new products that provide unprecedented capability for healthcare. As for many technology development initiatives, the new product is enabled by advances in areas including transducer technology, analytics algorithms, and embedded computing performance. In contrast to conventional electronic products, the path of development of Wireless Health products differs in fundamental ways. This requires clinical trials in earliest stage development that guide critical design choices from architecture to algorithms. Then additional clinical and non-clinical trials providing verification that meet exacting requirements of regulatory agencies. Finally, this path is only feasible as a result of guidance to engineering from clinicians dedicated to creating new solutions that serve a global healthcare need. This presentation will describe award winning product innovations including Wireless Health products that have now successfully entered the market with proven impact on delivery of care, cost of care, and patient safety demonstrated by independent and international trials. This presentation will also describe a contrasting example of a new product, the first external monitor of human digestion. This system, recently receiving FDA clearance, is now serving an ever expanding and diverse applications. Finally, the opportunities that lie ahead for Wireless Health devices that include monitoring and guidance will be described.