The development cycle of medical software products is notoriously long - what can we do about that?

Posted by Mirjana Slapničar on Feb 20, 2018 10:02:00 AM
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Agile in Medical

For quite some time, a very common misconception was that Agile software development and medical software development are a contradiction in terms. This is an industry, after all, where adhering to regulations is practically as important as the product itself - even a breakthrough product is of little gain if it is not compliant and thus not marketable. 

The standard itself, though not stipulating the waterfall approach, may seem to enable and favour it. Agile, it seemed, with its definitely relaxed if not outright unruly attitude towards processes and documentation written down in Manifesto couldn't be the right way. Yet, it is tempting to try and reap the benefits Agile may bring in terms of speed and efficiency of software development and in better product design due to the direct involvement of product owners and rapid adjustments throughout the development.

While the medical field may not be most natural of environments for Agile, it can indeed be used beneficially and the key is to learn how to absorb the change efficiently process-wise. What it takes is to first look past several common misconceptions about Agile and medical software. It also requires an initial process planning - that the planning has no place in Agile is, after all, just a misconception too.

It helps to have previous hands-on experience with both Agile and medical software development, although the process still may not be straightforward and some help would not go amiss. It is definitely prudent to find help to tailor the appropriate approach by considering the product itself, its classification and other factors. It is certainly possible to search for your own way around, but our experience shows that this path is inevitably much less effective.

Using the right tool for the (right) job

Medical software development benefits strongly from using appropriate Application Lifecycle Management (ALM) tools. Apart from the obvious benefits, these tools have for software development in any domain, especially for more complex projects, they have an important additional benefit in the medical industry, helping us handle change and ensure traceability.

In Agile, this is particularly important as constant change is the very essence of Agile. Maintaining traceability through constant change is indeed even more challenging than ensuring it in the first place, especially with larger and more complex projects. An appropriate tool lifts a lot of the burden in that respect. We have experience with several ALM tools and, even more importantly, with configuring and using ALM across different types of medical projects and different types of lifecycles. After experiencing the issues of medical software development without an ALM tool, we are never looking back ...

Topics: Agile, Health, Medical Devices


dical industry comprises projects with complex software used in medical devices and systems that operate in a highly regulated environment, stipulated by regulations, laws, and standards. The requirement is to ensure the appropriate level of software quality, as it can greatly affect user and patients safety. Understandably, failure of such project can have a high cost, both socially and financially.

Can agile help? Find out in the free paper available on the link below.


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