Building Medical Software Compliance on Atlassian Tools

What is Atlassian Summit?

The biggest annual event of Atlassian will take place next week with hundreds of Atlassian users and developers descending to San Jose to listen to the success story of one of the fastest growing enterprise software technologies today.

Their high-velocity distribution model drives an exceptional customer scale by making affordable products available via their convenient, low-friction online channel, the Atlassian Marketplace. Their model is especially convenient for small organization as the license fees are tiered, so that companies can afford Atlassian software products as they grow.

The success of Atlassian software resonates best with the old saying “at the right place at the right time”. Atlassian platform came to market when the traditional software development tools and platforms had outgrown the development methods and mentality of both the software companies and the software developers. Companies were ready for open, collaborative, easy-to-use, integrated and flexible tools to support their entire organization and the growing distributed teams. On top of that, Atlassian has built tools that developers themselves can further tailor and customize for their needs instead of having to buy expensive consulting and support services.

Traditional Software Platforms vs Atlassian

Atlassian explains, in their IPO Prospectus, that there are several market trends that the traditional software development platforms did not cater for, allowing for the Atlassian tools to become so popular:

1. Software is everywhere and increasingly in everything, and organizations of all types and sizes face an existential imperative to drive software innovation.

2. Software developers have become more essential and influential, and the demand for software development talent has grown.

3. Software teams today must iterate and move faster than ever before, and are becoming the model for modern workforce collaboration across all teams.

4. Software is becoming increasingly complex making collaboration across teams and locations vital for all teams.

5. Software projects are increasingly more cross-functional requiring cross-organizational collaboration and knowledge sharing which has not been supported by the traditional productivity tools.

6. Employees are increasingly empowered to “bring their own software” to organizations today that has led to the user-driven viral adoption of new types of consumer-style software products within organization.

Traditional software development technologies are costly, extremely complex, not particularly user friendly and not easily integrated with other software systems used in an organization. Most of these software development tools are designed solely for the needs of software developers and do not support collaboration across teams and functions.

Most importantly, though, the classical top-down implementation strategy of software development platforms is in conflict with the mindset of software developers today – developers want to work on a platform that allows collaboration, integration with other systems to support rapid customer feedback to their development iterations.  Furthermore, the openness of Atlassian products makes them very attractive and has created a vast growing add-ons market which integrates seamlessly with the Atlassian products.

Another major differentiating feature of Atlassian is that they distribute and sell their products without the traditional sales infrastructure. Atlassian products are sold through an online marketplace without the need for sales or support/assistance. Similar distribution and sales model can also be adopted by the add-ons developers that are listed in the Marketplace.

Building Regulatory Compliance on Atlassian Tools

Similar to other systems today, the safety-critical systems are also growing in complexity and becoming more innovative, with software being the main source of both their complexity and their innovations. Medical devices used to be primarily electrical and mechanical systems with very little, if any, software. This has changed drastically as software systems are now essential components of medical device control functions. In fact, from 2007, medical devices could be solely made up of software if they satisfied the medical device definition and operated on a general purpose IT platforms intended to be placed on the market without a dedicated hardware. An example is an iPad application that advises doctors on the correct drug dosage amounts for a patient.

Like Atlassian has noted itself in their IPO Prospectus: “We also believe that the greatest lever teams have to advance humanity lies in the power of software innovation. Through software, contact lenses now monitor and report on the blood glucose levels of diabetes patients, allowing patient and doctor to better manage the disease…”

What Atlassian was referring to here was the innovation in medical devices where the majority is made through innovation in software. It is important to remember that innovative software systems, as all complex systems, can behave in unexpected ways under some conditions. Since there is the potential for harm, safety-critical devices must gain regulatory approval before being released for use.

Regulatory approval is a time-consuming and resource-demanding process ensuring, among other things, that the medical device manufacturer has analysed and mitigated all the foreseeable unacceptable software risks that can cause harm to the medical device users.

Regulatory compliance is a part of any safety-critical software development but it is rarely integrated to the software development technologies today.

We believe that software compliance in medical devices should be integrated into the software development toolset allowing easy collaboration between software developers and regulatory experts. Regulatory compliance is, in fact, a part of software development, ensuring that the software developers also adopt the mind-set of software safety, understanding the potential harm that the innovative yet complex system they are developing may cause to the users.

For that purpose, we have developed an Atlassian add-on for JIRA that automates medical device software risk management helping software developers quickly identify, analyse, mitigate and verify their software risks while linking them with software requirements and test cases – SoftComply Risk Manager.

In order to fast-track the regulatory compliance and allow innovative medical device software products to market faster, we have also developed an Atlassian add-on for Confluence for Quality Management System – SoftComply eQMS.

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