Similarities and Conflicts Between Agile and Safety-Critical Software Developers


In the last two weeks, SoftComply went to the Atlassian Summit and to the Advamed Conference. Both, the software conference and the medical device conference were huge in their number of attendees as well as in the number of parallel sessions with interesting talks and wonderful networking opportunities. Yet, it would be hard to find more different mindsets between two tech-savvy communities.

Software companies, such as Atlassian, are agile and not only in their use of the software development method. It is the way people work in software companies in general. It is based on open communication across the entire company, team-based work culture and short cycles between work & rapid feedback to that work allowing quick improvements. Decision-making power is pushed away from the center allowing the teams to take the responsibility for their work.

Safety-critical domains like medical devices are highly regulated because their products cannot and should not be placed on the market before they have been approved as safe to use. This dictates a lot of requirements for the development of these devices. Due to these regulatory requirements, it is rare if not impossible for devices to get to the end user as swiftly as general software products do. This is a norm in the domain and it has also become the mindset of companies in the domain – processes are longer and feedback from users comes much later, making the improvements to products more expensive. Although we are dealing with more and more complex devices with several interoperable sub-systems, dialogue is rarely as open as in software companies.

An increasing amount of medical devices today include software, and there is also an increase in the amount of software as medical devices1. In order to take full advantage of the innovative possibilities software provides and to improve the safety of the devices in which software is embedded, the development and feedback cycles should be short rather than long. The communication between device manufacturer and software team(s) should be open to allow the design and development of truly innovative medical devices! A lot has been written about how best develop complex systems in safety-critical domains like medical or aviation industries as well as how to deal with complex situations. Communication is one of the most crucial ones. Like Atul Gawande states in his book, The Checklist Manifesto: “All you ask is that people talk to one another and take responsibility. This is what works in complex situations!”

While the world is moving towards life (and work) in cloud, safety-critical domains are still required to have control over their software and data for security purposes by hosting servers at their sites. This requires more resources from companies. Also, would a server admin be able to secure and safely update software in his server better than a designated team of admins of a cloud service provider?

Both software developers and medical device manufacturers are eager to help people to have better lives through innovations they bring to the world. There is a huge opportunity to have even more amazing innovations in health and medical device domain if these communities shared the mindset of team-based culture and open communication.

Read more about SoftComply Risk Manager

Read more about SoftComply eQMS


Leave a Reply

Your email address will not be published. Required fields are marked *