SAnToS and KSU Department of Engineering Researchers Receive NSF/FDA Grant on Verification of Medical Device Plug-and-Play

Posted November 20th, 2007 by hatcliff
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KSU College of Engineering researchers, led by Dr. John Hatcliff from the SAnToS Lab at KSU Computing and Information Sciences Department have been awarded a grant from the National Science Foundation (NSF) to apply SAnToS verification tools to a medical device plug-and-play research prototype framework developed by US Food and Drug Administration (FDA) engineers. This research framework serves to provide insight into regulatory issues associated with future medical device systems, and systems of systems. Dr. Robby and Dr. Dan Andresen from the KSU CIS Department and Dr. Steve Warren from KSU Electrical and Computer Engineering (EECE) Department join Dr. Hatcliff on a grant from NSF's FDA Scholar-in-Residence program. This program provides funds for a post-doc to carry out research of interest to the FDA with significant periods of residence at FDA collaborating with FDA scientists.

"We are very pleased to be working with researchers from KSU on this effort", said Paul Jones -- Senior Systems/Software Engineer in the FDA's Center for Devices and Radiological Health. "Systems of networked plug-and-play medical devices are emerging as a strategy for achieving greater integration of monitoring devices and patient record systems and increased automation of medical procedures. Unfortunately, current verification and certification paradigms are failing to keep pace with the complexity and need for compositional certification found in envisioned medical plug-and-play frameworks. KSU researchers are world leaders in the areas of software specification and verification of compositional systems, and we are looking forward to working together with them to develop solutions to challenges faced by FDA and medical device manufacturers."

The Medical Component Design Laboratory (MCDL), led by Dr. Steve Warren in EECE, has extensive experience designing and prototyping wearable plug-and-play medical components for home health care. The components are designed to work in a plug-and-play fashion. To achieve this goal, the IEEE1073 standard (MIB, Medical Information Bus) was adopted for all devices involved, including a pulse oximeter, an ECG, a datalogger, and a basestation. These Bluetooth-enabled devices construct an ad-hoc network good for home environments.

Dr. Warren is working to help the IT community understand the potential revolution within medical device industry. "Rapid advances in technology have fundamentally altered the manner in which many informational, financial, and scientific services are provided", said Warren. "While technological advances up to this point have contributed to a steady increase in the quality of health care, we now seem to be on the cusp of the type of revolutionary changes in the domain of health care systems that have transformed other sectors of nation’s infrastructure and economy."

The KSU team has listed a number of innovations that they expect to see within the medical domain:

  • Pervasive networking will enable integration of national networks, regional health care centers, local hospitals and clinics, primary care physician offices, home computing, and body-area networks.
  • Health-care IT infrastructure will be oriented around “systems of systems” architectures built around middleware information backplanes that integrate and blend monitoring and treatment devices which stream data into medical records to be subsequently automatically mined to extract knowledge that can be used to drive a host of activities such as automated treatment and dosing, and long-term research of human health and treatment effectiveness.
  • With information technology as a catalyst, health care systems will increasingly exhibit collective intelligence built upon the intelligence of individual devices and other components, automatic data mining and knowledge gathering.
  • Operating rooms and other diagnostic and treatment contexts will shift from a collection of fixed monolithic devices to plug-and-play components that enable flexible and rapid re-configuration of diagnostic, recording, and treatment systems
  • Increased computing power of embedded processors will continue to enable device functionality to be migrated from software to hardware with a flexible boundary between the two driven by business/market pressures.
  • Precision robotics and high-speed networks will speed advances in telemedicine and robotic surgery technologies.
  • As generations of technology-savvy healthcare consumers enter retirement, these consumers will embrace and even demand sophisticated home healthcare monitoring, treatment, and records systems integrated with national information databases (e.g., prescription drug information systems) and local hospital and primary care systems.

"One of the problems facing both FDA and device manufactures is that current FDA guidelines describe how complete monolithic systems should be verified by vendors and approved by the FDA", explained Dr. Hatcliff. "There are no guidelines nor accepted techniques for how to certify individual components as might exist in a plug-and-play framework and how to guarantee that systems assembled from individual component, possibly in unanticipated configurations, will behave as expected. We're excited to be working directly with FDA engineers to apply techniques for specifying and verifying properties of components and their integration that we have developed in previous Department of Defense projects. Our goal is to construct an "open source" medical device plug-and-play research framework that can be verified to very high levels of assurance".

To learn more about SAnToS and MCDL work, visit the following web-sites: