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 ``closed loop'' 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, and regulatory regimes have not yet been developed that allow manufacturers to bring systems of cooperating devices (each approved individually beforehand) to market.
This project provides open-source Medical Device Coordination Framework (MDCF) for exploring solutions related to designing, implementing, verifying, and certifying, systems of integrated medical devices. Below are some highlights of the infrastructure:
Communication between devices utilizes a flexible publish-subscribe middleware architecture.
A model-based programming environment is used for rapid development of systems of integrated devices from libraries of reuseable building blocks.
User interfaces for activities including clinical device coordination, device coordination script development, device driver installation, system performance monitoring.
A collection of mock medical devices are provided to facilitate experimentation.
Strategies/examples for incorporating real devices are provided.
To read more about the foundations of this paradigm of medical systems, see the following paper co-authored by members of the MDCF, clinicians, regulatory authorities, standards authors, and industry representatives.
This project is a joint effort between researchers at Kansas State University, University of Pennsylvania and engineers at the US Food and Drug Administration (FDA).
The contents of this web-site should not be interpreted as an endorsement by the FDA of any particular technology, software infrastructure, or direction for regulatory policy. However, we expect experience with frameworks like the one presented here to provide science-based input to ongoing regulatory policy and standards development efforts.