Implementation of a hybrid low overhead assessment method for medical device software development

The need for software is increasingly growing in the medical device industry. Even though the primary concern of medical device software development is safety, medical device software development organisations are also concerned with time and budget overruns, plus ensuring that the customer requirements are fulfilled. At present the medical device software industry lacks strategies to combine adhering to mandatory regulatory guidelines with increasing the quality of the software developed. Software process improvement (SPI) assists software development organizations to increase their software quality, and assessments are an integral part of this process. Unfortunately, software process assessments are often expensive and time consuming. Additionally, they often provide companies with a long list of issues without providing realistic suggestions. The goal of this paper is to describe the implementation of a new low-overhead hybrid assessment method that has been designed specifically for medical device software development organisations wishing to improve their software development practices. This assessment method combines the SPI models of the Capability Maturity Model Integration (CMMI) and ISO/IEC 15504-5 with medical device software development regulations

Development of the Medi SPICE PRM

As the importance and complexity of medical device software continues to increase there is growing demand for effective process assessment and improvement in this domain. To address this need the Medi SPICE process assessment and improvement model is being developed. Regulatory compliance is both an important and challenging aspect of medical device software development. Particularly as new regulations are being released and existing standards revised due to the attention that software is receiving within the health domain. To comply with these latest developments the Medi SPICE Process Reference Model (PRM) is being developed to conform with ISO/IEC 12207:2008 and the forthcoming release of ISO/IEC 15504-5 (currently under ballot). This paper outlines the development of the Medi SPICE PRM. It also provides details of the schedule for the full release of the Medi SPICE model

Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle

Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews

Med-Adept : a lightweight assessment method for the Irish medical device software industry

In this paper we describe how a lightweight assessment method was developed to educate Irish software development organisations in relation to becoming medical device software suppliers

MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE

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 extending relevant practices from Automotive SPICE

Configuration management process improvement for the medical device industry

This paper outlines how the goals, practices and capability levels for the configuration management (CM) process area within a software process improvement (SPI) framework have been developed. This framework addresses an opportunity to integrate the regulatory issues and SPI mechanisms so as to achieve improvements that are critical to the development of software for medical devices [1]. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [2] (US requirement), and the European Commission under its Medical Device Directives (MDD) [3] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components

The need for a software process improvement model for the medical device industry

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

Med-Trace: traceability assessment method for medical device software development

Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments

The development of a low-overhead assessment method for Irish software SMEs

This paper describes the development of ,Adept', a low-overhead method of software process appraisal specifically targeted at Irish software small-to-medium-si2ed enterprises (SMEs). The method explicitly focuses on organisations that have little or no experience of software process improvement (SPI) programmes. Historically, it has been difficult for software SMEs to find the resources, in both time and money, necessary to engage properly in SPI. To alleviate this, we have created a low-overhead and relatively non-invasive solution to support SMEs in establishing process improvement initiatives. The paper initially describes how Adept was developed and then illustrates how the method is currently being extended to include an on-line tool that may be used by the appraised organi2ation to perform follow-on self-assessments

The gamification of SPICE

Abstract. Process Improvement has been used for decades as a means to become better and more efficient. Whilst many organizations have used considerable resources for process improvement, investments in process improvement have not always led to changes and improvements expected. One most important aspects of management is to motivate the work force. However, management often fails to deliver. In fact, because management often uses extrinsic incentives to motivate their work force, it often ends up decreasing people’s intrinsic motivation to work. The transformational moment has arrived where we need to re-think the traditional ways to foster engagement in process improvement. Gamification offers a solution for transformational change. By using game psychology and the principles of gamification it is possible to translate the traditional enthusiasm for play and social media engagement into the workplace as a basis for both succeeding with and accelerating the uptake of improvement. Gamification as a solution offers the opportunity for better user engagement, faster feedback of achievement and more visible progress indicators of process improvement