Cyber Physical Systems – Situation Analysis - Energetics Meetings ...

Cyber Physical Systems – Situation AnalysisDRAFT – March 9, 2012KEY DRIVERSadditional calculations to produce interpretable answers. It is not uncommon for multiple devicessynthesize data, and act on their observations. Rising health care costs, an aging population, anddiminishing medical professional resources are driving health-care providers to seek technologicalinnovations to maintain or improve patient care as efficiently as possible. A high cost is usuallyassociated with traditional (hospital, clinic) care settings, particularly for interventions that do not demandthe resources of a full-service hospital. This has led to increasing interest in alternatives such as homecare, assisted living, and commoditized convenient care settings. Such emerging health care venues havethe potential to become major consumers of innovative, commoditized, and cost-effective medical andlaboratory technologies.Today‘s medical device architectures lack interoperability. The typical device employs proprietarysystems and relies on trained professionals to operate the device and interpret system output, whichfrequently requires to be connected to a patient at one time (e.g., in an operating room), in which caseclinicians must monitor all devices independently, Clinicians frequently consult others present to interpretthe readings. This is an error prone process and it can be affected by stress, fatigue, and other humanfactors.risingWhen we consider medical devices, two fundamental enabling component technologies must beaddressed: the hardware and the software. The hardware mostly consists of specialized embeddedsystems or, more recently, systems on a chip. Hardware architectures for medical devices include wiredand wireless interfaces, facilitating networked communication of patient data. However, ad hoc efforts byprofessionals and clinicians to aggregate data across devices designed to operate separately can lead tounintended or accidental results. There is a need to manage networks of devices in an automatic andsecure manner.The software development methods follow established approaches in software engineering. Softwaredevelopment in the medical device arena is driven by the growing interest in such capabilities as homehealth care services (aging populations), delivery of expert medical practice remotely (telemedicine), andonline clinical lab analysis. This, however, shows the important role of advanced networking anddistributed communication of medical information in the health systems of the future. However, softwaredevelopment methods in the established practices are not adequate for the high-confidence design andmanufacture of very complex, interoperable medical device software and systems. The systems include―intelligent‖ prosthetics that anticipate movements and modify themselves appropriately, minimallyinvasive surgical devices, implants that process signals and provide output for a neural circuit, andnanotechnology-derived microscopic controllers affecting organs.Today‘s verification and validation (V&V) efforts are driven by system-life-cycle development activitiesthat rely primarily on methods of post-hoc inspection and testing; these approaches, although adequate fora thermometer or pressure measuring device, are not appropriate for the diverse and complex interactionsbetween different components in the medical devices of the future. Many of those devices have timeconstraints and/or constraints that rely on analysis of input signals coming from the patient.Dealing with such problems represents a challenge for the current and future generations of medicaldevice experts. This is because today‘s engineering foundations and the set of scientific principlesavailable for designing artifacts interacting with the world are not sufficient for enabling the design, V&Vof high-confidence medical device CPS. Innovations in control theoretic modeling, in distributed wireless55