Balancing Agility and Discipline in a Medical Device Software Organisation

Communications in Computer and Information Science

Özcan‐Top

2016

Self Cite

Abstract. Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.

“…Additionally, few studies specifically emphasised the impact of agile adoption upon the company and the team culture [12].…”

Section: Use Of Agile In Highly Regulated Environmentsmentioning

confidence: 99%

Section: Agile Software Developmentmentioning

confidence: 99%

Agile – Is it Suitable for Medical Device Software Development?

Communications in Computer and Information Science

Özcan‐Top

2016

Self Cite

“…However, due to successes reported within other domains from implementing agile practices, an international working group was set up to investigate if agile practices could fulfil the requirements of IEC 62304. The Association for the Advancement for Medical Instrumentation working group found that “agile practices can be successfully adopted to develop regulatory compliant software” and produced AAMI:TIR 45:2012, which is an internationally accepted technical report called “Guidance on the use of Agile practices in the development of medical device software.” AAMI:TIR 45 provides general guidelines on how agile methods may be used to satisfy IEC 62304. To obtain a suitable development life cycle for MMAs, we have compared various potential MD software development approaches before deciding to develop an MMA framework where agile practices are combined with MDevSPICE while observing the guidelines of AAMI:TIR 45.…”

Section: Approach Used To Understand the Needs For Mma Development Frmentioning

confidence: 99%

Mobile medical app development with a focus on traceability

Regan

J Software Evolu Process

et al. 2017

Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability.

“…As this approach is not based on MDevSPICE there is an overhead on ensuring that all the regulatory practices are in place for each required standard together with the necessary documentation. Previous research on integrating agile practices into the V-model to streamline requirements changes found that this reduced the amount of rework required and helped deliver MD software in a more timely manner [24].…”

Section: Introducing Agile Practices Into the V-model Lifecycle (Nmentioning

confidence: 99%

Development of a software process framework to assist organizations developing mobile medical apps

2016 IEEE-EMBS International Conference on Biomedical and Health Informatics (BHI)

Lepmets

2016

Despite mobile medical apps becoming an increasingly important part of the healthcare industry, developers still find it challenging to understand what exactly is required when a mobile healthcare application fulfils the definition of a medical device both in terms of safety and security. To date, the authors have developed and piloted a medical device software process framework called MDevSPICE ® that integrates processes from various medical device software standards as well as generic software development best practice standards. This paper describes current research that extends the MDevSPICE ® framework to assist organizations developing mobile application software that meets the definition of a medical device and therefore has to be developed in compliance with medical device regulations. This can be a challenge for developers of mobile applications as such applications are normally developed in a much faster and less documented manner than traditional prescribed and plan driven medical device software development. We will describe our approach that increases the flexibility of the MDevSPICE ® framework through replacing rigid plan-driven practices with agile practices that are more suitable for the development of mobile medical applications.