Development of MDevSPICE® - the medical device software process assessment framework (original) (raw)
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Development of a Process Assessment Model for Medical Device Software Development
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by international standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate resources addressing distinct areas of concern. The result for medical device software developers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regulatory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integration of regulatory standards from the medical device domain with generic software development process models, resulting in a unified best practice framework for medical device software development. The process reference model for medical device software development is going to be published this year as IEC TR 80002-3, and the process assessment model for medical device software development is currently being validated through pilot studies in medical device industry. This best practice framework will help small software developers in their adoption of regulations-compliant best practices while reducing the overhead associated with understanding the long list of regulations and standards they need to adhere to when developing software for medical devices. This framework will also help the manufacturers in selecting their software suppliers assuring that the suppliers have adopted the best practices and are compliant with the medical device standards and regulations.
A Lightweight Assessment Method for Medical Device Software Processes
Communications in Computer and Information Science, 2014
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.
A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the de-velopment of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be developed following state of the art medical device software development processes. State of the art medical device software processes is understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This paper identifies how changes to the MDD affect medical device software development companies and recommen-dations are made as to how medical device software development companies can conform to the latest regulatory requirements. Additionally, the paper provides an overview of how Medi SPICE is currently being developed to provide organisations with a single point of reference for the practices that should be implemented in order to produce regulatory compliant medical device software.
Envisioning a Requirements Specification Template for Medical Device Software
Lecture Notes in Computer Science, 2014
In many health jurisdictions, software is considered to be medical device software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient's health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a 'good' MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.
Communications in Computer and Information Science, 2014
Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.
The Need for a Software Process Improvement Model for the Medical Device Industry
2007
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration ( CMMI®). Copyright © 2006 Praise Worthy Prize - All rights reserved.
Implementation of a lightweight assessment method for medical device software
This paper outlines the development and implementation of Medi SPICE-Adept. Medi SPICE-Adept is a lightweight assessment method that has been designed for usage with the Medi SPICE software process assessment and improvement model which is currently being developed for the medical device industry. While the Medi SPICE model is detailed and comprehensive in its approach there is industry demand for a lightweight medical device process assessment and improvement method. To address this requirement Medi SPICE-Adept has been developed. Details on how this has taken place and the procedures for implementing a Medi SPICE-Adept assessment are presented. Information is also provided regarding how a Medi SPICE-Adept assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed
The Significance of Requirements in Medical Device Software Development
2013
Software to be used in or as a medical device is subject to user requirements. However, unlike unregulated software, medical device software must meet both the user's requirements and the requirements of the regulatory body of the region into which the software will be marketed. Regulatory requirements are fixed and can be planned for; unfortunately, the same is not true with user requirements. As many medical device software development organisations are following traditional sequential Software Development Life Cycles (SDLC), they are experiencing difficulties accommodating changes in requirements once development has begun. Agile methods and practices offer the ability to overcome the challenges associated with following a sequential SDLC. Whilst the regulatory requirements are fixed, this paper presents these requirements and shows how they appear to mandate the use of a sequential SDLC. This paper also explains how agile methods and practices can be successfully adopted in the development of medical device software without hindering the process of achieving regulatory approval.
Addressing Regulatory Requirements In Medical Device Software Systems
Regulatory requirements are an indispensable part of Medical device related software systems as those systems are safety critical and its failure can be life threatening. For this reason, the medical device software systems must be reliable and must maintain international standards and regulations. As a result Regulatory Requirement is generally held responsible for the certification or license of the software as it imposes constraints and regulations on both the system and the organization. Since most of the systems are looking forward to automation applying Artificial Intelligence and machine learning techniques, these systems should adhere to strict law and order. But, due to the natural language created ambiguity, conflicts, informal definition and lack of understanding regarding this particular type of requirement resulted in frequent failure. And so business entrepreneurs of modern time put much emphasis on Regulatory requirements management to avoid law suit. Therefore, researchers are developing many new frameworks and methodologies to apply Regulatory requirements in medical device related systems. This paper discusses on the researches regarding the modern approach to address Regulatory requirements for safety critical medical device software. The results of this analysis can serve the research communities to understand problems regarding the topic, the parallel activities and their interrelation to reach a better solution, and future trend of interest for the researchers on Regulatory requirements.
To be able to survive in the long run the medical device industry of today needs effective development processes and ways to secure quality. These development processes and quality assurance processes must follow the different laws and regulations over the world depending on what market the organisations are established on. Organisations have been developing medical devices and systems over many years but now this type of products contain more and more software. The development of software is often appended in to the existing development and quality assurance processes and these processes may not be the most efficient and correct processes when it comes to software. This paper presents the results from an interview study with the purpose to survey how the medical device companies work today, what development processes and quality assurance techniques they use and how laws and regulations affect their way of working. Safety is very essential for the medical device organisations and all the interviewed organisations consider the software in their medical device as safety critical. Risk and risk analysis is an important part of the safety thinking and is frequently performed by the organisations. However established and systematic techniques to analyse risks of the medical devices are not so frequently used as expected. The intension is that the results from the study could be used as a help to find more adapted processes and techniques for software development in the medical device domain. The results have also been used to derive a set of requirements on new techniques and methods in the area. The derived requirements can serve as guidance to researchers aiming at improving processes, methods and techniques in the medical device domain.