Medicines and Healthcare products Regulatory Agency (MHRA) approached Red Badger to create a bespoke Agile Delivery Framework in line with the Government Digital Service Technology Code of Practice to enable faster and better decision making and delivery of patient focused products to provide value to the public.
The MHRA is the government agency responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
All their work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.
As a regulator, naturally MHRA are a research-driven, fact and evidence-based organisation. They have a core vision of keeping the public safe with thorough risk assessments, rigorous critique of methods and evidence-based decision making; all great skills for implementing experiment-driven, agile service and product design.
Over the last decade, they have introduced a robust IT division built on this regulatory stance. However, in recent years this has come at a cost - it lacked the agility of modern day organisations and has impacted their ability to efficiently deliver value to the public.
“We have recognised that in designing services around our customers and staff, it is best delivered in a holistic way, where we combine digital and technology change, delivery, business process and cultural change together. ”
With years of defined processes and governance to unravel it was clear we needed to start by walking in the Agency’s shoes and decided to take a two-pronged approach:
As we set out to deliver our first digital product for MHRA, products.mhra.gov.uk, it soon became apparent we were attempting to deliver using a product-centric approach within a project culture.
The detailed business case, budget constraints and governance stages to get the software into the hands of customers were all very explicit but no longer supported the agility and speed of MHRA’s vision.
We had a clear understanding of the “what”, the “how” and the “when” but what we found hard to answer was the “why”.
It was also clear that the processes in place to deliver projects had taken time to create over the years as a method to help form structure and resilience, and the output of these projects had brought positive change.
Therefore it was important for us to cast empathy over the process, its uses and most importantly the people following the process.
The project culture isn’t anything new or revolutionary. It has been a methodology in place for decades, having been adopted by many large corporations because it has worked in the past.
Project thinking is focused around the delivery of something with a set end date, and by doing so it casts a focus on measurements such as timelines, scope and budgets.
Success is largely defined as delivering on the specifications handed to the team within a defined period of time. But one of the key issues with a project culture is the focus.
The focus tends to be and measured on the output - a successful delivery within a timeframe, budget and scope instead of a focus on the outcomes - the delivery of value to the end user and the Agency.
Maps have been a trusted tool for decades. When accurate they are reliable, safe and familiar. It means we can rely on predefined routes created for us by someone else, usually many many years ago.
But these predefined routes also mean they are the only pre-discovered routes and therefore we are limited to where and how we can get to a destination. So what happens if the route is blocked or the roads have changed but the map has not been updated?
More often than not, you will find yourself overwhelmed, knee-deep in problems and stressed, leading to fire fighting your way out of trouble, and getting yourself as close to dry and familiar territory as possible.
By drawing a comparison between a map and a project, we can see that if we prescribe the direction and requirements to a team or create something within isolation with the expectation of reaching a specific date, it can run the risk of a team heading in the wrong direction and heading in the wrong direction for a long time before realising it.
It lacks the agility and flexibility of what is required for modern software delivery; these ‘maps’ made up of predefined directions that worked in the past, are now outdated leading to poor decision making, insufficient clarity, and lack of direction.
By delivering a digital product within a project governance framework we were able to understand that this was MHRA’s core problem restricting them from efficiently, quickly and safely delivering value to the public.
The map that worked well in the past had not been updated and was therefore no longer an accurate depiction of how to deliver efficiently or effectively. They knew they needed to transform their delivery but were unsure of how to do so.
In order for us to help MHRA, we used our learnings from product delivery to develop a clear strategy to transform the overall delivery.
We learned from our 2 pronged approach that we needed to enable a shift from the project mindset, and introduce a Framework built on the foundations of Product thinking, focused on the customer value outcomes instead of the project output led approach.
So why a Product based approach? A product is more than a piece of software, platform or application; it is the lifecycle of something that evolves, adapts and changes to the conditions, needs and evolution of its users.
A product approach keeps the focus on the outcomes, empowering the teams to apply creative methods to meet their vision. A vision is hugely important, it is there to inspire and articulate the future state of where you want to get to and helps teams understand how they can contribute to making the vision a reality.
If we look at the product lifecycle as a compass. A compass helps navigate us in the right direction even when moving through tough and unknown terrain.
We still have a clear direction and we understand where we need to get to regardless of the journey we may end up taking.
A compass lets us adapt our movements to changing and unpredictable surroundings while staying on course. It empowers the users to adopt innovative techniques and enables them to reach the best decision regarding how to get where they had envisioned.
So our strategy to transform Delivery within MHRA was simple, it was to enable Product thinking to create the Delivery Framework and in turn provide MHRA with their very own compass (Delivery Framework).
A compass that will enable MHRA to adapt, evolve and empower teams to make the best decisions for their users and lead them to their Framework vision:
“To adopt collaborative & data-driven delivery excellence, which provides value to our customers and patients and empowers our staff.”
In creating the MHRA’s ‘compass’, we used methods and tools we would recommend as part of the Agile Framework.
This was an important aspect; with lots of different services, projects and products inflight we found it important to create and recommend simplified, easily adapted approaches with big impact.
We found the best mechanism to enable this was to show by doing - by applying and demonstrating Product based thinking and methodology while developing the Delivery Framework. Below is an outline of the key methods we used.
These methods enabled us to co-create a bespoke for MHRA Agile Delivery Framework adopting design thinking, and agile best practices, with tailored Principles and purpose for MHRA.
The Framework has been developed with evolution in mind and has the mechanisms and tools in place to enable MHRA to iteratively adapt to changes, and achieve their business goals while delivering value to the public.
Co-creating a Framework with MHRA ensured we were intentionally delivering value at all phases and showcasing through a hands on method, the true value of adopting a product and design thinking mindset.