Adopting Agile Practices When Developing Software for Use in the Medical Domain

Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as: being contradictory to regulatory requirements; insufficient coverage of risk management activities and the lack of up-front planning. In addition, a comparison is performed between the perceived and actual barriers. Based upon the findings of the literature review and survey, it emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in

An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software

Adopting Agile Practices when Developing Medical Device Software

Agile 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. This implementation showed that not only can agile methods be successfully followed, but it also revealed that benefits were acquired. For example, the medical device software development project was completed 7% faster when following agile methods, when compared to if it had been completed in accordance with a plan-driven approach. While this implementation is confined to a single project, within a single organization it does strengthen the belief that adopting agile methods within regulated domains can reap the same benefits as those acquired in non-safety critical domains

The Impact of Regulatory Changes on the Development of Mobile Medical Apps

Mobile applications are being used to perform a wide variety of tasks in day-to-day life ranging from checking email, to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage, plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibly face criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation

Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

Peer reviewe

Investigating Agile Adaptation for Project Development

Agile methodologies adaptation in software companies is an accepted norm.Rapid application development and efficient deliverables being the premise. The changing business needs, cost effectiveness and timely delivery are catered to by agile methods. Different software development models are in the literature and also are being used by the industry. Few companies have adopted agile, few are gearing up for and few are in transition. We investigated agile presence in a software company.Project management is an evolving art with innovative methods being added up.The aim of this paper is to tease about project management challenges, agile, agile transition in companies and a comparison of conventional software engineering practices with agile process model.This paper takes stock of the current status of quality in software projects and to add on quality process improvement strategies. The results presented here are after a qualitative interview study with one cross function team using streamline development framework in agile development

Identifying Agile Practices to Reduce Defects in Medical Device Software Development

Medical Device Software (MDS) defects have caused death of patients and continue to be the major cause of recalls of medical devices in the US and Europe. Despite various approaches proposed to address defects, dealing with defects in MDS is an increasingly difficult task as MDS has become more complex to support a growing number of functions. To increase quality in any software development project, it is essential that defects are identified and addressed quickly in the early stages of the software development life cycle. Agile methods have been advocated to increase software quality by minimising defects through their agile practices. However, agile methods on their own are deficient in satisfying the regulatory requirements for the MDS domain. Instead, the common approach is to integrate agile practices into the plan driven methods. Consequently, frameworks have been developed to help developers in the MDS domain to accrue the benefits of agile development while fulfilling regulatory requirements. Despite the adoption of agile practices in MDS development, it is still unclear as to which agile practice(s) is effective and how it is applied to address MDS defects. The purpose of this research is to identify agile practices that can assist in addressing defects in MDS development. This will help MDS developers to select the appropriate agile practice(s) to address defects