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.
Drive to change service design and delivery
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.
Where we started
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:
- deliver a digital product meeting the needs of MHRA’s end users such as patients, medical professionals and the public by leveraging the existing processes and governance
- while simultaneously using digital product delivery as the vehicle to understand and analyse the depths of the existing delivery processes and methods so we can improve the delivery framework
Understanding MHRA’s delivery practices
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.
A good way to understand project thinking is to look at a project as a map.
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 unsure of how to do so.
Moving from project to product mindset
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 a 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, the 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.
Think of your product as the compass leading you in the right direction to your vision.
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.”
Here is how we created a bespoke Agile Delivery Framework
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.
- Design Thinking: A strong focus throughout developing the Framework was applying and coaching design thinking methods to help understand the user needs and key problem areas to help inform our recommendation. We formed this around the design thinking model, the Double Diamond by the British Design Council leveraging divergent and convergent thinking. The two diamonds illustrate the process of exploring a problem widely or deeply (divergent thinking) and then taking focused action (convergent thinking).
- Diverge - Discover: We jumped into understanding and empathising with the current users through research, interviews, the delivery of a product through the project process and mapping the idea to live.
- Converge - Define: We synthesised the discovery information into key problem statements to solve and formed these into “how might we’ questions to turn these challenges into opportunities to focus on.
- Diverge - Develop: We used experimentation to develop and test opportunities which were co-created with the MHRA working group with built in feedback loops.
- Converge - Deliver: Through experimentation best solutions emerged that provide MHRA with a bespoke and practical Agile Delivery Framework, easily adopted by teams at all levels of the business.
- Clear and consistent feedback loops : As part of the Delivery Framework we established a working group made up of champions from a variety of the disciplines across the organisations. This created a space for open and transparent conversations with those impacted by the Framework and ensured shared understanding and development of the recommendation. The working group are able to champion the Framework they co-created and begin to permeate the approach across the organisation.
- Clear vision and principles: Based on the discovery and research findings, it became apparent prescribing a strict set of guidelines would not be effective. Instead the approach to handling the variety in delivery across MHRA was to create a Framework led by a vision and key principles. These were established with the working group to collaboratively align on a vision and key principles for the Framework. More on the principles can be found in this blog.
- Making everything visual and measurable: To align with data-driven vision, we helped MHRA create a measurement framework to effectively measure and visualise progress and pull out meaningful and actionable insights. Along with the MHRA data team we built a visual metric dashboard to measure people, delivery and portfolio metrics. Metrics were aligned across multiple teams. We coached MHRA on adoption techniques to socialise the data so it can be used to make important, continual improvements to the delivery processes.
- Purpose driven Framework: We were intentional with creating a Framework that was explicitly purpose driven. Together with the working group, we established clear purposes at each phase of the delivery to help teams unify and focus on what is important, the ongoing journey of continual improvement and discovery. The purpose driven approach allows teams to deliver something that aligns with the principles and vision set out by the team.
These methods enabled us to co-create a bespoke for MHRA Agile Delivery Framework adopting design thinking, 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, 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.