Software applications play a crucial role in digital transformation, modernization, and improvement projects in the life sciences sector. This includes everything from bespoke applications to configured off-the-shelf solutions to customized vendor platforms. In all these situations, agile development processes offer a range of advantages.
Agile development has a long history in the software industry, but it is not widely used in life sciences. This is understandable as the Agile Manifesto favors working software over comprehensive documentation and individuals and interactions over processes and tools. In the highly regulated life sciences sector, documentation and processes cannot be ignored.
That said, the benefits of agile development also can’t be ignored as pharmaceutical and medical device organizations accelerate and widen their digital transformation and modernization strategies. Life sciences sector companies can benefit from digital solutions that are better aligned with business needs by adapting agile development methodologies and ways of working that are suitable for regulated industries.
What is Agile Development?
There are many different ways of developing a software solution, whether creating code from scratch or customizing a vendor’s platform. The approach that has been most commonly used in the life sciences sector is predictive development. This is the common waterfall model where the scope and specifications are set out at the beginning of the project with a big-bang delivery of the full solution at the end.
Agile development is a combination of two other approaches to software development – iterative and incremental.
Iterative is a prototyping-type model, where the exact scope and specification don’t need to be declared at the outset. Instead, developers listen to requirements and then create the code with an “is this what you are looking for” approach.
Incremental development accelerates value and ROI by creating, testing, and demonstrating code in small batch sizes known as sprints. Each sprint is designed to produce usable, valuable code that then becomes part of the final solution.
This iterative and incremental approach is more collaborative and ensures all stakeholders can see and use what is being developed throughout the project rather than only getting sight of the new code/solution at the end.
Benefits of Agile Development
Flexible and Adaptable
The traditional approach to software development required life sciences sector companies to understand and define what they wanted from the project at the outset. This can be incredibly challenging, especially on larger and more complex projects.
With an agile development approach, the scope and requirements can change throughout, so you don’t need to know everything you want or need at the outset.
Fixed Costs and Time
The traditional approach to software development in the life sciences sector involves variable costs and time. However, with an agile development approach, costs and time are fixed, helping with budgeting and planning.
- Traditional approach – the scope is fixed while time and cost are variable.
- Agile approach – the scope is variable while time and cost are fixed.
Competitiveness
Agile development methodologies are about quickly developing working and valuable code. This makes it possible for companies in the life sciences sector to pivot in order to remain competitive and/or meet or adapt to customer demand.
Faster Delivery of Value
You will see and use working code regularly throughout the process, ensuring continuous delivery of value during the project. In fact, it is even possible if required to push code live while the project is ongoing (subject, of course, to verification, UAT, and other testing processes).
End User Buy-In
One of the biggest challenges in new software projects is getting end-user buy-in. Agile development involves end users throughout the entire process so there are no surprises. End users also feel more ownership of the solution because of that involvement, plus they have hands-on familiarity with the application before it goes live.
Minimises Waste
In the traditional approach to software development, there are high levels of uncertainty as the scope, requirements, and specifications need to be outlined at the outset. Projects inevitably change over time, resulting in code being binned or reworked. This waste is largely eliminated with an agile development approach.
Agile Development in Life Sciences
At SL Controls, we have direct expertise in agile development processes in addition to extensive experience delivering solutions for life sciences sector companies, specifically medical device and pharmaceutical manufacturers. Understanding both – agile development methodologies and the essential compliance requirements and restrictions that exist in the life sciences sector – is crucial to project success.