Innovative ways of working can often seem at odds with achieving regulatory compliance. Despite the promise of an edge in an increasingly competitive market, some medical device developers are wary of trying Agile. Many still feel that the popular methodology often used to increase production speed and efficiency is wildly incompatible with highly regulated industries like medical technology. However, there are plenty of practices that you can use to adapt Agile to the needs of medical device development. Used in the right way, Agile can even accelerate your compliance efforts. Read on to learn more about some of these key practices and how to go about implementing them!
Why do some medical device developers still shy away from Agile practices? Well, popular Agile practices tend to focus a little bit more on functional aspects, i.e., how a system works. Regulatory compliance, on the other hand, emphasizes nonfunctional requirements (how the system performs) as well as various risk management procedures. When you combine this with the constantly changing requirements and decentralized development that characterize Agile development, it’s no wonder MedTech developers feel that Agile practices don’t fulfill the demands of their line of work.
Agile in MedTech: not as new as you might think
That being said, software in and as medical devices is becoming more and more important, presenting limitless new opportunities to developers while also highlighting key challenges in the MedTech sphere. Between stringent regulatory compliance requirements, the struggle of combined hardware/software development, and the increasingly important role of software, medical device developers have their work cut out for them. That’s why MedTech companies all around the world are reimagining medical device development; to keep up with growing customer demands and ever-shifting market conditions. But despite the common industry concerns outlined above, Agile is in fact a reliable and proven way to help with that.
Interested in unlocking the power of Agile in Medical Device Development? Check out our 3-part webinar & white paper series with Agile expert Dr. Birk:
The implementation of Agile practices in medical device development already dates back 20 years, with companies like Abbott Laboratories, GE Healthcare, Siemens Healtineers, and Philips already having explored the territory with successful results. So there are plenty of Agile practices which not only work for, but are extremely well-suited to highly regulated environments like MedTech development. Leveraging these practices can help organizations increase speed to market, efficiency, and productivity across the board. And getting it right actually optimizes compliance efforts – rather than hindering them. Let’s dive into a few of those key practices to get started.
Essential Agile best practices for MedTech development
Before your organization starts on its journey to Agile, it's important to get the fundamentals right. You'll need to carefully plan processes to align Agile with MedTech regulatory requirements. You might want to consider taking a hybrid approach to ease into Agile and control any risks related to this change. Finally, you'll also need to build an Agile QMS to ensure product quality in your new, high-velocity environment.
Let us help you take the first steps! Access fundamental insights about getting started with Agile in MedTech:
Once you have the basics figured out, the following best practices help make sure your Agile transition is successful:
1) Definition of Done
The Definition of Done, or DoD as it’s commonly referred to, refers to a set of criteria that need to be fulfilled for each work item in an Agile project. It is particularly characteristic of an Agile methodology known as Scrum. Think of it as a checklist with a set of boxes that need ticking before you can label a task as done. In order for a piece of work to be included in an iteration’s product release, it needs to meet those listed conditions.
Having a well-established DoD is also excellent for representing and ensuring the achievement of regulatory compliance requirements in Agile projects.
The Definition of Done typically covers three basic criteria:
- Individual nonfunctional requirements statements
- Groups of nonfunctional requirements
- Institutionalized processes and automated testing
How to go about setting it up? The Definition of Done needs to be an agreement between the product owner and developers, with buy-in from the whole team. In a situation with multiple teams, they must collaborate to establish the product’s Definition of Done to reflect organization-wide quality standards and make sure everyone’s on the same page. The DoD can be implemented and visualized using written lists, central online documentation, backlog checklists, or by using separate tasks in an interaction backlog.
To give you an idea of what to include, here are some of the criteria that are commonly used to establish the Definition of Done:
Criteria for Potentially Shippable and
Definition of Done(*) on Backlog Item Level:
- Code and tests checked in
- Unit tests complete and pass
- Code documentation complete
- Integration succeeds
- Integration tests complete and pass
- Static analyses complete and pass
- Packaging and staging succeed
- System tests complete and pass
- Acceptance tests complete and pass
Criteria for Potentially Shippable and
Definition of Done(*) on Iteration Level:
- Performance tests complete and pass
- Risk management complete and documented
- All defects closed or prioritized for later
- Installation packages available
- Operations documentation complete
- User documentation complete
- Marketing material complete
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2) Traceability between work items
Traceability across the chain of work items is a crucial requirement of being able to demonstrate that you have achieved regulatory compliance in a product. Instead of predefined work instructions, requirements tracing clearly connects the path between work products and results to demonstrate compliance. This is done by displaying the relationships between software artifacts and the overall product development lifecycle.
To give you an example, trace links can start with functional requirements to represent the demands of a legal regulation like EU regulation 2017/745, then connect to their implementations and test cases to document their status. This way it is easy to see how the product, or different parts of it, satisfy certain regulatory demands.
The most important thing to remember when tracing requirements using Agile is:
- Comprehensively planning how you will capture and implement requirements
- Using the right tool to track their development status and progress, something which covers the whole product lifecycle
- Leveraging an integrated infrastructure that combines development information and assets
3) Incremental compliance
Too many projects still address regulatory compliance late in the development lifecycle. It’s often the case that most, if not all compliance activities are undertaken after finishing product development. Leaving it all to the end can cause untimely delays, unnecessary rework of what is supposed to be a finished product, and inevitably hikes up those pesky project costs.
Agile development encourages incremental compliance, giving you the opportunity to check in on compliance management efforts throughout the development lifecycle, instead of just at the end. This has a huge effect on your team’s productivity. The more you integrate compliance, the faster and more efficient the team can go about their development activities.
So how exactly can Agile practices help you achieve incremental, and eventually, continuous compliance?
- Including compliance criteria in the Definition of Done to make sure that that compliance measures are undertaken for every backlog item or iteration
- Continuously reduce “undone” work to strengthen the Definition of Done
- Adding compliance-related functional and technical capabilities in the product backlog to be implemented just like any other product element
How to implement Agile best practices in MedTech development?
Now that we’ve explored some of the core Agile practices which lend themselves well to both MedTech development and regulatory compliance, you may be wondering how to go about implementing them in your organization. Collaborating with other Agile teams, targeting low-hanging fruit, and continuously improving as you go along by conducting retros for example are reliable ways to get started. You can also use hybrid development methods in order to leverage Agile benefits without fully divorcing the way your organization already works. There are a whole host of other Agile practices worth exploring to see how you can mix and match them to your advantage.
Learn more about how companies like GE Healthcare, Philips Healthcare, Siemens Healthineers, and others have implemented Agile:
All in all, Agile provides significant advantages in comparison to traditional and rigid plan-based development methodologies, while hybrid Agile (e.g. the combination of Waterfall and Agile) allows you to keep the best of both worlds. Established Agile practices not only comply with healthcare regulations but can actually help you optimize the process of complying with them for increased speed, efficiency, productivity, and stakeholder satisfaction across the board.
For step-by-step instructions on these practices and how to best implement them, check out our webinar with Agile expert Dr. Andreas Birk: