How can an agile approach benefit medical device development?
There’s a common assumption that agile working just means speeding things up. And as medical device development is a lengthy and compliance-heavy process, agile might not seem like an obvious fit.
But it’s a misconception that agile practices and medical device development are incompatible. In fact, the first similarity is that they’re both about the continuous delivery of valuable solutions to satisfy the customer.
The salient point about agile is that it’s not about working quicker and doing more; it’s about adding value from delivering less work sooner – in response to customer need. So what exactly is agile, and how can medical device development leverage its potential?
What is agile?
Agile takes an iterative approach to software development and project management, so that the product is delivered incrementally in stages, rather than at a single endpoint. Of course with a physical product, there is still a point at which the complete product is delivered, but the difference is the approach to getting there.
These days, agile working has left the confines of software development and is rolling out across a wide range of organizations looking to leverage value for their customers at every opportunity. So what’s different about it, and how can you make the change?
How do you implement agile in medical device development?
It starts at the top, and it begins with organizational change. The first step is to move from a control-oriented approach to a value-driven structure. This means embedding mindset changes and re-thinking resource allocation and organizational structure.
With the aim of high quality output and increased velocity, dedicated teams and resources are required to have frequent communication and work collaboratively. They also need to have clear priorities and objectives. And here’s the key thing: they need to decide on what work NOT to do. This work is done later when the resources become available.
In terms of organizational structure, rather than taking a siloed approach, where work moves along a chain of teams working by themselves (such as engineering, testing, or operations) with agile cross-functional teams work together to build, test, deploy and deliver an increment of the final solution in a shorter timescale or ‘sprint’ (typically 2 to 4 weeks).
You can get a more detailed overview of agile by reading our in-depth three blogs.
Why take an agile approach to medical device development?
Our survey of medical device development professionals revealed that only 8% were not familiar with it. Not only that, but 64% of respondents actually thought agile could be successfully implemented in every aspect of medical device development including software, hardware, and compliance.
One of the guiding principles of agile is to iterate until the product is ready to meet customer expectations. And whilst this approach lends itself to the development of software, it has clear application for hardware as well.
Traditionally, in medical device development, there’s an extended wait for the product to be market-ready due to compliance and time it takes. This has cost implications, and it also means that if you’re waiting for a year, you get the product you needed a year ago.
With agile, you get shorter iterations which can promise on delivery. And then the next iteration is agreed and the team commit and so on. This approach means that development can take account of any changes in priorities as they happen, making it much more adaptive and competitively advantageous in terms of development.
How can medical device developers leverage the benefits of agile?
As we know, unlike other industries, medical device development is constrained by compliance to regulatory standards in terms of Design History Files (DHF) and Quality Management System (QMS), which can massively impact the time to market.
With twenty years experience in software and systems engineering, Synergio has extensive expertise in the application and benefits of agile practices. After all, we’ve been around the same length of time as the Agile Manifesto.
Agile is embedded as part of our wider day-to-day practices, and from our experience in software development, we can see real potential and viability for medical device development.
If you’re a medical device manufacturer, and you’re looking to make your processes as agile as possible, Synergio can help you transform your product development, with services, and training that enable you to deliver business value as your priorities change.
Interested to find out how? Get in touch.