Integrating lightweight software processes into a regulated environment
Medical software development is highly regulated with a focus on assuring product safety and efficacy. The regulations strongly recommend the use of process-centric life cycle models that implement and verify predetermined specifications. These heavyweight processes are adapted to ensure that the product meets its requirements and quality attributes. They are also easy to audit!
Lightweight software methodologies, such as Agile, are adapted to succeed when requirements are not known upfront. They may deliver good quality software but do not deliver the documentation or assurance that regulators look for.
Product innovation often involves developing software where the requirements are initially unknown or badly defined. In these circumstances a heavyweight process is difficult to apply efficiently, and a lightweight process alone is not acceptable!
In this talk we first examine why a lightweight process does not mix well into a regulated environment, and then we evaluate various approaches to integrating the methodologies. Finally we describe an approach that potentially allows light and heavy to co-exist and complement each other.
Adrian Barnes
Adrian Barnes
Adrian is a Principal Engineer at ResMed Ltd based in North Ryde. ResMed is a leading manufacturer of medical equipment for the treatment and management of sleep-disordered breathing and other respiratory disorders with over 1,500 employees worldwide. He has worked for 14 years in the medical industry, and before that had a long career in safety-critical software development. He has developed software for a diverse range applications from oil rig monitoring, hotel fire evacuation, and implantable defibrillators. In the 10 years he has worked with ResMed, Adrian has had a variety of roles ranging from technology development to line management. A major part of his current work in the Product Development group is providing guidance on software process and quality.
