Relevance of hazards in exoskeleton applications: a survey-based enquiry

Exoskeletons are becoming the reference technology for assistance and augmentation of human motor functions in a wide range of application domains. Unfortunately, the exponential growth of this sector has not been accompanied by a rigorous risk assessment (RA) process, which is necessary to identify the major aspects concerning the safety and impact of this new technology on humans. This situation may seriously hamper the market uptake of new products. This paper presents the results of a survey that was circulated to understand how hazards are considered by exoskeleton users, from research and industry perspectives. Our analysis aimed to identify the perceived occurrence and the impact of a sample of generic hazards, as well as to collect suggestions and general opinions from the respondents that can serve as a reference for more targeted RA. Our results identified a list of relevant hazards for exoskeletons. Among them, misalignments and unintended device motion were perceived as key aspects for exoskeletons' safety. This survey aims to represent a first attempt in recording overall feedback from the community and contribute to future RAs and the identification of better mitigation strategies in the field

Relevance of hazards in exoskeleton applications:a survey-based enquiry

Exoskeletons are becoming the reference technology for assistance and augmentation of human motor functions in a wide range of application domains. Unfortunately, the exponential growth of this sector has not been accompanied by a rigorous risk assessment (RA) process, which is necessary to identify the major aspects concerning the safety and impact of this new technology on humans. This situation may seriously hamper the market uptake of new products. This paper presents the results of a survey that was circulated to understand how hazards are considered by exoskeleton users, from research and industry perspectives. Our analysis aimed to identify the perceived occurrence and the impact of a sample of generic hazards, as well as to collect suggestions and general opinions from the respondents that can serve as a reference for more targeted RA. Our results identified a list of relevant hazards for exoskeletons. Among them, misalignments and unintended device motion were perceived as key aspects for exoskeletons’ safety. This survey aims to represent a first attempt in recording overall feedback from the community and contribute to future RAs and the identification of better mitigation strategies in the field.</p

A Software Process Improvement Roadmap for IEC 62304: an Expert Review

Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high level consists of the Activities and Tasks necessary for the im-plementation of the standard, while the low level contains the Design Patterns and How-to artefacts linked to the Tasks. This paper presents the findings from the expert review of the high level roadmap

Implementing a Medical Device Software Risk Management Process by ISO 14971 in compliance with Agile Principles

The development of medical device software is strictly regulated by competent authorities. In addition to producing significant medical benefits, the medical device software can be a potential source of serious safety hazard to patients or healthcare professionals. The International Standard ISO 14971 was created to minimize the risks related to treatment of patients with the medical devices. Although agile software development has become a widely used method for developing software products, medical device manufacturers and regulators have been uncertain whether these practices are appropriate for the regulated environment. The purpose of this thesis is to research similarities and differences between ISO 14971 risk management process and agile principles. Furthermore, the aim is also to provide guidance and produce practical ideas for the implementation of the risk management process that meets the regulatory requirements and follows agile values and principles. The risk management standard ISO 14971 was thoroughly analyzed in order to find all process requirements. Similarly, the agile practices were studied through the Agile Manifesto and other essential resources of the field. The synthesis of the two concepts was produced based on the information gathered. The ideas produced in the research are presented as an example development process model which can be used as a reference implementation. The relatively high abstraction level of the model secures the generalizability of the research. When designing the risk management process implementation, it is essential to thoroughly understand the goals and principles of the regulatory framework. By following the guidance and instructions provided in this thesis, medical device software manufacturers should be able to create the applicable risk management process and to claim conformity to ISO 19471

A roadmap to ISO 14971 implementation

Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap