Virtual reality simulation for the optimization of endovascular procedures : current perspectives

Endovascular technologies are rapidly evolving, often - requiring coordination and cooperation between clinicians and technicians from diverse specialties. These multidisciplinary interactions lead to challenges that are reflected in the high rate of errors occurring during endovascular procedures. Endovascular virtual reality (VR) simulation has evolved from simple benchtop devices to full physic simulators with advanced haptics and dynamic imaging and physiological controls. The latest developments in this field include the use of fully immersive simulated hybrid angiosuites to train whole endovascular teams in crisis resource management and novel technologies that enable practitioners to build VR simulations based on patient-specific anatomy. As our understanding of the skills, both technical and nontechnical, required for optimal endovascular performance improves, the requisite tools for objective assessment of these skills are being developed and will further enable the use of VR simulation in the training and assessment of endovascular interventionalists and their entire teams. Simulation training that allows deliberate practice without danger to patients may be key to bridging the gap between new endovascular technology and improved patient outcomes

Integrating formal methods into medical software development : the ASM approach

Medical devices are safety-critical systems since their malfunctions can seriously compromise human safety. Correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards. However, these standards provide general descriptions of common software engineering activities without any indication regarding particular methods and techniques to assure safety and reliability. This paper discusses how to integrate the use of a formal approach into the current normative for the medical software development. The rigorous process is based on the Abstract State Machine (ASM) formal method, its refinement principle, and model analysis approaches the method supports. The hemodialysis machine case study is used to show how the ASM-based design process covers most of the engineering activities required by the related standards, and provides rigorous approaches for medical software validation and verification

Synthesis of Specifications and Refinement Maps for Real-Time Object Code Verification

Formal verification methods have been shown to be very effective in finding corner-case bugs and ensuring the safety of embedded software systems. The use of formal verification requires a specification, which is typically a high-level mathematical model that defines the correct behavior of the system to be verified. However, embedded software requirements are typically described in natural language. Transforming these requirements into formal specifications is currently a big gap. While there is some work in this area, we proposed solutions to address this gap in the context of refinement-based verification, a class of formal methods that have shown to be effective for embedded object code verification. The proposed approach also addresses both functional and timing requirements and has been demonstrated in the context of safety requirements for software control of infusion pumps. The next step in the verification process is to develop the refinement map, which is a mapping function that can relate an implementation state (in this context, the state of the object code program to be verified) with the specification state. Actually, constructing refinement maps often requires deep understanding and intuitions about the specification and implementation, it is shown very difficult to construct refinement maps manually. To go over this obstacle, the construction of refinement maps should be automated. As a first step toward the automation process, we manually developed refinement maps for various safety properties concerning the software control operation of infusion pumps. In addition, we identified possible generic templates for the construction of refinement maps. Recently, synthesizing procedures of refinement maps for functional and timing specifications are proposed. The proposed work develops a process that significantly increases the automation in the generation of these refinement maps. The refinement maps can then be used for refinement-based verification. This automation procedure has been successfully applied on the transformed safety requirements in the first part of our work. This approach is based on the identified generic refinement map templates which can be increased in the future as the application required

Complexity stage model of the medical device development based on economic evaluation-MedDee

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents' responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.Web of Science125art. no. 175

Computer- and robot-assisted Medical Intervention

Medical robotics includes assistive devices used by the physician in order to make his/her diagnostic or therapeutic practices easier and more efficient. This chapter focuses on such systems. It introduces the general field of Computer-Assisted Medical Interventions, its aims, its different components and describes the place of robots in that context. The evolutions in terms of general design and control paradigms in the development of medical robots are presented and issues specific to that application domain are discussed. A view of existing systems, on-going developments and future trends is given. A case-study is detailed. Other types of robotic help in the medical environment (such as for assisting a handicapped person, for rehabilitation of a patient or for replacement of some damaged/suppressed limbs or organs) are out of the scope of this chapter.Comment: Handbook of Automation, Shimon Nof (Ed.) (2009) 000-00

Foundations for Safety-Critical on-Demand Medical Systems

In current medical practice, therapy is delivered in critical care environments (e.g., the ICU) by clinicians who manually coordinate sets of medical devices: The clinicians will monitor patient vital signs and then reconfigure devices (e.g., infusion pumps) as is needed. Unfortunately, the current state of practice is both burdensome on clinicians and error prone. Recently, clinicians have been speculating whether medical devices supporting ``plug & play interoperability\u27\u27 would make it easier to automate current medical workflows and thereby reduce medical errors, reduce costs, and reduce the burden on overworked clinicians. This type of plug & play interoperability would allow clinicians to attach devices to a local network and then run software applications to create a new medical system ``on-demand\u27\u27 which automates clinical workflows by automatically coordinating those devices via the network. Plug & play devices would let the clinicians build new medical systems compositionally. Unfortunately, safety is not considered a compositional property in general. For example, two independently ``safe\u27\u27 devices may interact in unsafe ways. Indeed, even the definition of ``safe\u27\u27 may differ between two device types. In this dissertation we propose a framework and define some conditions that permit reasoning about the safety of plug & play medical systems. The framework includes a logical formalism that permits formal reasoning about the safety of many device combinations at once, as well as a platform that actively prevents unintended timing interactions between devices or applications via a shared resource such as a network or CPU. We describe the various pieces of the framework, report some experimental results, and show how the pieces work together to enable the safety assessment of plug & play medical systems via a two case-studies

Intelligent Sensors Security

The paper is focused on the security issues of sensors provided with processors and software and used for high-risk applications. Common IT related threats may cause serious consequences for sensor system users. To improve their robustness, sensor systems should be developed in a restricted way that would provide them with assurance. One assurance creation methodology is Common Criteria (ISO/IEC 15408) used for IT products and systems. The paper begins with a primer on the Common Criteria, and then a general security model of the intelligent sensor as an IT product is discussed. The paper presents how the security problem of the intelligent sensor is defined and solved. The contribution of the paper is to provide Common Criteria (CC) related security design patterns and to improve the effectiveness of the sensor development process

Developing a distributed electronic health-record store for India

The DIGHT project is addressing the problem of building a scalable and highly available information store for the Electronic Health Records (EHRs) of the over one billion citizens of India