Use Case Scenarios for Medical Devices

Julian M. Goldman, Harvard Medical School, CIMIT and Continua Health Alliance

Abstract

Medical devices have traditionally been designed to operate independently using proprietary electronic data interfaces for system integration. With the increasing complexity of the healthcare environment, stand-alone, proprietary devices and systems no longer provide an acceptable solution. Medical devices must easily integrate with other vendors’ equipment, software, and systems in order to improve healthcare quality, reduce healthcare costs, and provide for more comprehensive and secure management of health information. As interoperability standards and technologies are developed, it is important to drive solutions from a needs-perspective rather than a technology perspective. Toward that end, we have been eliciting high-level clinical scenarios to inform interoperability solutions. This includes identifying adverse events that could have been avoided through the integration of medical devices and systems, compiling a repository of interoperability use cases that can be shared, and developing a clinical requirements acquisition and analysis methodology that enables use case scenarios to be specified at the level of detail needed to derive engineering requirements.

Biography

Dr. Julian M. Goldman is Director of the Program on Interoperability at CIMIT (Center for Integration of Medicine and Innovative Technology), a practicing anesthesiologist in the Massachusetts General Hospital “Operating Room of the Future”, and a Physician Advisor to Partners HealthCare Biomedical Engineering.

Dr. Goldman founded the Medical Device “Plug-and-Play” Interoperability Program (MD PnP) in 2004 to lead the adoption of open standards and technology for networking medical devices to support clinical solutions for improving patient safety and healthcare efficiency.

Dr. Goldman served as an officer in the FDA Medical Device Fellowship Program, chairs the Use Case Working Group of the Continua Health Alliance, leads several ASTM, ISO, and IEC medical device standardization activities.

Dr. Goldman received his Medical Doctorate from S.U.N.Y. Downstate Medical Center in New York in 1985, and performed anesthesiology residency and research fellowship training at the University of Colorado School of Medicine in Denver. His research fellowship concentrated on artificial intelligence applications for medical monitoring, and anesthesia simulation. Following training, he worked in private practice before joining the teaching faculty at the University of Colorado. Dr. Goldman departed the University of Colorado as a Tenured Associate Professor in 1998 to work as Vice President of Medical Affairs of a medical monitoring company, where he directed global research, and worked closely with the engineering team on enhancing product usability and clinical performance. He joined the Department of Anesthesia and Critical care at the Massachusetts General Hospital and Harvard Medical School in 2002.