The reliance on embedded software is increasing as medical devices are achieving higher and higher levels of sophistication. Despite widespread discussions of the benefits that adopting Agile could bring to software development companies, some medical device developers still hesitate to make the transition from Waterfall to Agile.
While the advantages of Agile seem obvious, developers are wary of adopting this modern methodology simply because it would involve abandoning their tried and tested Waterfall processes. Understandably so: they have traditionally used these Waterfall processes to ensure compliance with the many standards and regulations that apply to medical device development. These standards, such as IEC 62304, IEC 60601, ISO 14971, and various FDA regulations such as Title 21, aim to ensure the safety and reliability of medical devices, and require developers to enforce mature processes, and document the execution of certain safety measures and procedures.
Related reading: Using Agile in Medical Device Software Development
However, non-compliance is no longer a valid concern, as with adequate process control measures, Agile is able to support compliance as much as any Waterfall method, while also increasing the efficiency of development, cutting time to market, and yielding a variety of other advantages. In this blog post, we'll go over how Agile can be used in the development of safe, compliant medical embedded software.
Process control in the development of medical devices
Processes are of vital importance in the medical field. Ensuring patient safety is a goal above all in medical device development. Quality assurance, safety, access control, as well as risk management processes are fundamental requirements in the lifecycles of such safety-critical devices. Failure to comply with the regulations and standards that stipulate these requirements means that a product can't even be put out on the market.
Related reading: HFMEA, Risk Management & ISO 14971 in Medical Software Development
However, with adequate measures and software tools to support process control, Agile can indeed be used to develop safe and reliable medical products. This is the message conveyed by FDA's 2013 endorsement of Agile, which has played a major role in propelling the adoption of this methodology among players in the medical device space.
Process enforcement, documentation & reporting
In a traditional Waterfall model, the process is laid out in advance, meticulously checked for errors, and executed in a linear (sequential) manner. While effort-intensive and suboptimal in efficiency, this approach helps reduce the chance of errors, and facilitates the documentation of each stage of the lifecycle.
At first sight, Agile's incremental and iterative approach, with parallel processes and flexibly operating self-governing teams, may seem more difficult to track and document. The trick is to grow with Agile, internalize the cultural changes it entails, and replace your old toolset with an integrated Agile ALM solution that allows you to reap the benefits of Agile without having to worry about the perceived drawbacks.
A modern, integrated ALM solution such as codeBeamer ALM will help you:
- enforce compliant processes
- ensure traceability and transparency throughout the lifecycle
- automate documentation to facilitate compliance audits.
codeBeamer enables you to blend Agile with legacy processes, using a Hybrid Agile-Waterfall solution. Intland's Medical IEC 62304 Template leverages codeBeamer's capabilities to let you define, enforce and automate the execution of complex workflows with adequate permission and change control, and triggered actions and notifications. Due to its single-repository architecture, codeBeamer ALM ensures complete traceability throughout the lifecycle. To help verification audits and collaboration with regulatory bodies, custom reports may be easily exported in various formats.
Intland's Medical IEC 62304 Template comes with preconfigured issue trackers, reports, and workflows to support compliance throughout the entire lifecycle. The template can be flexibly customized to suit individual development and compliance needs.
Configure your own processes, dashboards, and exportable reports with codeBeamer ALM to support the efficient development of safe and reliable medical devices.