Software product development for the healthcare industry is a complex task, and medtech developers often face great competitive pressure as well as a pressure to meet regulatory and data management requirements. Both may be supported by an Agile approach.
Since HealthCare.gov, the $500 million online insurance market of the United States Federal Government failed, there has been a lot of discussion on Waterfall and Agile software development, and their use in the healthcare industry.
As so many other government projects, HealthCare.gov was developed with the Waterfall approach. As a linear method, Waterfall does not allow the government to deliver a minimum shippable product to test and discover potential failures. Waterfall is still widely used in many industries and it works well in an environment where everything is routine and predictable. But in many businesses and especially in the healthcare industry, this is not always the case.
Harper Reed, the Obama for America campaign's CTO recommends a modern, incremental software development approach. Agile software development would have enabled HealthCare.gov to evolve over time in incremental steps, as real-world use necessitates. Agile is generally considered to avoid similar situations: releasing an end product that simply doesn’t meet customer expectations.
Related reading: Agile + IEC 62304: Using Agile in Medical Device Development
In the age of constantly emerging new standards and technologies, not having the right software to detect failures in time can be extremely costly, life-threatening, or both. While Agile has not always been considered safe for use in regulated development, FDA's 2013 endorsement of the methodology proves that it can in fact be used to develop compliant medical software.
Benefits of Agile for Medical Device Development and Healthcare Organizations
- Scalability – The large volume of data and the complexity of innovation and development (hardware, software, service) require a scalable method in order to control costs.
- Compliance – Compliance with medical regulations is key. Agile can deliver the necessary process control, traceability, and documentation.
- Agility – The ability to adapt to change is a key benefit of Agile. This method allows companies to adapt to changing requirements and emerging regulations without running over budget.
- Collaboration – Development data needs to be accessible from anywhere, any time. Collaboration across departments and disciplines improves product quality and enhances the process of development.
Download our case study below to find out how codeBeamer ALM supported the Agile transition of Medtronic Neuromodulation, a department of a global technology giant.