Standalone Software as an Active Medical Device

Abstract.One stated objective of the European Union is to encourage SME's expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software -software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME's, entering the medical device software development domain, by the use of design patterns to generate "How-to" artefacts, overcome the challenge of demonstrating compliance.

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“…The requirements of IEC 62304 have been listed and cast as solutions. 4. The solution to the problem is to establish a software development plan.…”

Section: Structure Of the Design Patternsmentioning

confidence: 99%

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304

Rust

Flood

McCaffery

2016

Communications in Computer and Information Science

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“…There has been very limited adoption of software process improvement within the medical device domain [4]. In addition existing generic SPI models, such as the CMMI® and ISO/IEC 15504-5:2012 (SPICE), do not provide sufficient coverage to achieve medical device regulatory compliance [25] [2] [13] [1].…”

Section: Software Process Improvement Within the Medical Device Domainmentioning

confidence: 99%

“…Although this is only one example, recent trends show that an increasing number of medical devices are being recalled due to software failures. Due to the increasingly important role of software in these devices, software is now included in the EU's definition of a medical device [4] subjecting it to the same processes and standards as other medical devices.…”

Section: Introductionmentioning

confidence: 99%

A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps

Flood

McCaffery

Regan

et al. 2014

Communications in Computer and Information Science

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Abstract. For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify "what" must be achieved without specifying "how" this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medical device manufacturers. In this work we present a concept for a Software Process Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap from a set of requirements such as the aforementioned standards and guidance documents.

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“…As part of this amendment the EU recognized the importance of software and revised the directive to include the provision that software can now, in its own right, be classified as a medical device. As a result software can now be subjected to the same regulations and standards as other medical devices [10].…”

Section: The Role Of Software In Medical Devicesmentioning

confidence: 99%

MeD UD – A Process Reference Model for Usability Design in Medical Devices

Flood

McCaffery

Casey

et al. 2013

Lecture Notes in Computer Science

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Abstract.A critical component to the success of software systems is the incorporation of the end user. Ensuring that the end user can use the system effectively and efficiently is an important consideration. Failure to do this can lead to user error which in turn can have serious or even fatal consequences. To address this issue in the medical domain, where the risk to patient and user safety is quite high, a number of standards and guidance documents promote the use of Human Factors and Usability Engineering techniques during the development of devices. In this paper we introduce MeD UD (Medical Device Usability Design) -A Process Reference Model (PRM) for evaluating usability engineering in the medical device domain. Through a process assessment utilising the MeD UD PRM, medical device organisations can improve their usability design processes to achieve more usable products, reduce the risks associated with user errors and efficiently meet the medical device regulatory requirements. Keywords IntroductionThe development of technology in recent years has allowed for medical devices to provide more effective and efficient patient care. These results can be attributed, in part, to the increasing role of software within medical devices. Through the use of software, complex configuration changes can be implemented easily. In 2006, it was noted that software was now incorporated into over half of the medical devices for sale on the U.S. market [1]. A side effect of the increased complexity of medical devices is the increased chance of human-error. Errors, slips and lapses can occur in every aspect of human activity. When these mistakes occur with medical devices the results can be fatal. In 2007, Ms. Myra Jean Garman took her own life to escape the pain she suffered as a result of the misapplication of a medical device. Ms. Garman, who was suffering from breast cancer, was left in severe pain after she was given twice the recommended dose of radioactive seeds on five separate occasions. The state regulators attributed the over radiation to a mistake on behalf of a physicist who had entered an incorrect magnification factor into the treatment planning computer.[2] Ms. Garman is unfortunately not an isolated incident. In New Jersey 36 cancer patients were over-radiated and a further 20 received substandard treatment due to human-error during the application of a medical device [2].Errors like these can be reduced through the use of usability engineering. Usability engineering is the "application of knowledge about human behaviour, abilities, limitations, and other characteristics related to the design of tools, devices, systems, tasks, jobs, and environments to achieve adequate usability" [3]. The incorporation of human aspects into the design process enables designers to develop interfaces in accordance with the users' expectations and needs which can improve the overall user experience and reduce the likelihood of human error.Software Process Improvement (SPI) frameworks such as SPICE [4] or CMMI [5] allow organisa...

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Standalone Software as an Active Medical Device

Cited by 19 publications

References 6 publications

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304

A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps

MeD UD – A Process Reference Model for Usability Design in Medical Devices

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