In recent years, developers of healthcare and medical device software have increasingly been adopting Agile development practices. In this article, we’ll take a quick look at the benefits of Agile methods and why they’re critical for any company developing healthcare software today.

In the past, most medical device companies developed software using the “Waterfall” model. Under the Waterfall model, every stage of software development ⁠— product definition, designing, coding, testing, etc. ⁠— takes place in sequence: testing only happens after coding is complete, coding only happens after the design stage is complete, and so on.

There are some advantages to this model: it’s clear and organized, and it can make sense for projects whose scope and requirements are completely predictable from the beginning, with little chance of unexpected developments.

But projects like that are not typical for healthcare software development ⁠— particularly in the case of new technologies and new devices. The healthcare industry has also seen rapid changes in recent years due to new international security and privacy regulations, and companies need to be able to respond quickly in order to stay relevant.

Agile software development has emerged as a leading development methodology because it keeps the advantages of Waterfall development ⁠— clarity and organization ⁠— while enabling rapid, high-quality development that can respond quickly to changing requirements.

In the Agile development process, work is divided into short “sprints”. Instead of designing, coding, and testing the final product in a single round, Agile projects develop the product incrementally. In each sprint, or round of development, a minimal number of new features are designed, coded, and tested. Each sprint has a defined duration (usually in weeks) with a running list of deliverables, planned at the start of the sprint. At the end of each sprint, the team can review and evaluate the results, using the insights gained as feedback for planning the next sprint.

There are many benefits to this short feedback loop. It means that companies can quickly develop Proofs of Concepts and Minimal Viable Products (MVP) ⁠— crucial for startups and for medical software developers who need to be able to demonstrate a product to investors and to the healthcare organizations they hope to interoperate with. In addition, because planning occurs in sprints, each sprint can be designed to incorporate changes in regulatory requirements like GDPR and HIPAA. It also allows medical software developers to be able to react quickly to new technologies and new requirements from potential partners, and to keep up the pace in today’s rapidly changing healthcare scene.

The short feedback loop also means that companies can react immediately to any new cybersecurity threats that emerge ⁠— which is a must in an industry that handles sensitive patient data. Medical software needs to be rock-solid, especially given the need for HIPAA and GDPR compliance. Agile development means that testing is prioritized and integrated into every stage of the development process, so reliability and security are never an afterthought.

Agile development is especially valuable when working with external development teams. When companies work with external developers, it’s crucial that they feel confident that they are fully aware of, involved in, and in control of the development process. Agile development allows for maximal transparency: the short development loop means that companies can quickly observe the results of new changes and provide feedback on the product at every stage. The increased predictability of Agile development processes also mean that outsourcing companies can be more confident about avoiding cost overruns and delays.

At Matrix Medika, we specialize in Agile development because it allows us to develop software quickly, transparently, cost-effectively and securely, while empowering our clients to be fully involved in real time at every stage of the development process. We make cybersecurity and regulation planning a central part of every sprint, so our clients can confidently expect secure products ready for FDA and CE approval. Our experience and expertise let us deliver world-class solutions with a development process our clients can trust. To learn more, contact us today!