Fergal McCaffery

The Gamification of SPICE

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.

Barriers to Adopting Agile Practices When Developing Medical Device Software

Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles of agile software development. A software development project is only considered to be truly agile if these values and principles are followed. However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology such as XP difficult to achieve. This paper outlines how we identified the barriers to agile adoption in the medical device software domain through performing a survey. These barriers include: lack of documentation; maintaining traceability; regulatory compliance; lack of up front planning and the process of managing multiple releases. Based on this research recommendations are also made as to how these barriers can be overcome.

Standalone Software as an Active Medical Device

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way.

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.

How Can Software SMEs Become Medical Device Software SMEs

The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transition.

Adopting Agile Practices when Developing Medical Device Software

Adopting Agile Practices when Developing Medical Device Software nAgile methods are gaining momentum amongst the developers of non-safety critical software. They offer the ability to improve development time, increase quality and reduce development costs. Despite this, the rate of adoption of agile methods within safety critical domains remains low. On face value agile methods appear to be contradictory to regulatory requirements. However while they may appear contradictory, they align on key values such as the development of the highest quality software. To demonstrate that agile methods could in fact be adopted when developing regulatory compliant software they were implemented on a medical device software development project.

Traceability-Why Do It?

Traceability of software artifacts, from requirements to design and through implementation and quality assurance, has long been promoted by the research and expert practitioner communities. However, evidence indicates that, with the exception of those operating in the safety critical domain, few software companies choose to implement traceability processes, in the most part due to cost and complexity issues. This paper presents a review of traceability literature including the implementation of traceability in real organizations. Through both analyzing case studies and research published by leading traceability researchers, this paper synthesizes the motivations of the organizations for implementing traceability. Given the importance of traceability in the regulated domain of safety critical software, the paper compares the motivations and benefits for organizations operating inside and outside of this domain. Finally, based on an analysis of the disparate case studies, the paper re-assesses the value of traceability motivators for more widespread adoption by firms outside of the safety critical sector.

Building a maturity & capability model repository

A complicated and time-consuming phase in the development of Maturity/Capability Models (MCMs) is the identification of existing relevant source models as, currently, information on existing MCMs is provided in very different forms and levels of detail on diverse web sites, publications etc. In this paper, we present our ongoing research on developing a web-based repository to store and provide overview information on MCMs as a continuous knowledge management effort maintained within the Software Process Improvement (SPI) community. Such a centralized repository containing metadata on MCMs is expected to facilitate the identification of relevant models (as well as parts) and provide a systematic basis for the development/evolution or customization of MCMs.

Verification & Validation in Medi SPICE

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

FIRST: Common-Sense Process Scopes for Starting a Process Improvement Program

One of the main challenges for ICT organizations is to initiate a well-structured process improvement program. This is particularly the case when adopting a maturity & capability model (MCM) as it brings with it costs associated with internal appraisals, and the realization that in order to achieve a particular maturity level (ML) a number of processes within the Process Reference Model (PRM) will need to be successfully implemented. Some initiatives have been proposed in the last decade, such as the RAPID initiative, but there is still some resistance to adopting MCMs such as CMMI or SPICE (ISO/IEC). This paper will propose the FIRST (Fast Improvement aSsessment sTep) approach, providing a minimum, common-sense set of processes to be appraised during the initial gap analysis which will form the foundation for the design and deployment of an improvement plan, which will be particularly useful for Small-Medium Enterprises (SMEs) and Very Small Entities (VSEs), that are coherent with ISO Management Systems requirements.