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

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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
Cyber Physical Systems – Situation AnalysisDRAFT – March 9, 2012control algorithms, safety and security, as well as provably correct software development through formalmethods appear to be necessary.CURRENT STATE OF THE TECHNOLOGYThe past 25 years have witnessed the transformation of the designs of medical devices from analog todigital. Analog designs were simple, with simple user interfaces and limited functionality. The primarymethod of controlling risk to the patient was human intervention. The device was used while the specialistwas present, handling the device. Because of established business models these devices tended to last along time.Today, innovations in technology and new ways of connecting devices to each other have completelychanged the landscape of this field. Microprocessors, actuators, sensors of different kinds and softwarecan all be put together easily in ways that they scale up. For example, some of the more complex devicescan have a million lines or more of code.Most devices contain embedded systems that rely on a combination of proprietary, commercial-off-theshelf(COTS) and custom software or software-of-unknown-pedigree (SOUP) components. Whilegeneral-purpose computing systems, such as PCs, execute a wide variety of functions and are easilyreprogrammed, an embedded system may be thought of as a special-purpose computer system designed toperform dedicated functions. An embedded system is usually subject to resource-limitation constraints aspart of a mechanical device and, because they are not intended to be reprogrammable, implemented inread-only memory. Embedded systems are becoming critical in medicine because they increasinglycontrol functions of, and communicate with, patients themselves as well as engineered systems.These systems are highly proprietary and increasingly dependent on software to provide greater levels ofdevice robustness and functionality. Embedded system design allows the real time acquisition andinterpretation of signals of various kinds, and for this reason it has enabled current technology. However,the machine becomes dedicated and difficult to integrate into a network where it gives out informationwhile it also receives information of different kinds. With general purpose computers becoming faster andsmaller, the market may favor general computing as opposed to specialized. Nevertheless, in today‘senvironment medical devices continue to rely on competent human intervention as the ultimate riskcontrolmeasure.To better analyze the state of the art, let us consider hardware architectures and software development.Hardware: Current device architectures are highly proprietary, not interoperable. Embedded systems are,for the most part, open-loop. Closed-loop systems tend to be implantable devices. Examples of suchdevices include implantable cardioverter defibrillators (ICDs) or cochlear prosthetics. In current devicesany network communication is largely for the purpose of diagnostic output. Both complex instruction setcomputer (CISC) and reduced instruction set computer (RISC) architectures are commonly used.Multicore and system-on-a-chip (SoC) architectures and flexible reconfigurable architectures, such asfield programmable gate arrays (FPGAs), are becoming more common in device designs.Software: Current software development methods range from older methods such as structuredprogramming to object-oriented programming paradigms where objects are instantiated at run-time.Formal methods-based design and analysis that have flourished in computer science are not widely used.To demonstrate that a device will perform as intended the techniques used should be Human resource-56
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