An open test bed for medical device integration and coordination

Medical devices historically have been monolithic units - developed, validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single customizable displays, and coordinate the actions of groups of cooperating devices to realize ldquoclosed looprdquo scenarios and automate clinical workflows. However, it is not clear what middleware and integration architectures may be best suited for these possibly numerous scenarios. More troubling, current verification and validation techniques used in the device industry are not targeted to assuring groups of integrated devices. In this paper, we propose a publish-subscribe architecture for medical device integration based on the Java messaging service, and we report on our experience with this architecture in multiple scenarios that we believe represent the types of deployments that will benefit from rapid device integration. This implementation and the experiments presented in this paper are offered as an open test bed for exploring development, quality assurance, and regulatory issues related to medical device coordination.

1 Introduction

As medical devices have evolved over the years, digital technology has generally replaced or supplemented analog technology, driving an increased reliance on embedded and high-level software for the implementation of critical device functionality. For example, early pacemakers with CPUs included around 10,000 lines of code. Today, a modern pacemaker can include over 100,000 lines of code. Despite the increasing reliance on software, much of the code is still developed by engineers whose primary training is geared toward low-level hardware and firmware development - few are trained in state of the art software development technologies or formal quality assurance techniques.