Front end innovation: the path to successful device development

What is front end innovation?

Front end innovation (FEI), sometimes referred to as the ‘fuzzy front end’, is the process of research, opportunity exploration, strategic planning and concept development that takes place before the start of a formal product development. During this process, you will build an understanding of your customers’ needs, motivations and behaviours, and understand your team’s commercial aspirations. You will research where your product fits in the competitive landscape, what enablers and constraints are introduced by your technology and, more importantly, how you will navigate the regulatory landscape. There are several key tools within FEI, including workshop facilitation, customer insights research, market analysis, technology landscaping and rapid ideation.

Using these tools, FEI allows you to set off on the right path for your development with a shared vision of what you want to achieve. Before exploring FEI in more detail, it is worth considering what exactly makes a medical product successful.

What makes a successful medical product?

In order for a product to be successful, it should have a strong market opportunity. Your product needs to solve real problems, provide real commercial value and ideally differentiate from the competition. Alongside these qualities, the technology incorporated needs to be feasible, robust and reliable. Your product should also provide an engaging user experience both in usability and desirability – there is no use having a functioning product if people do not want to use it!

The drivers for innovation vary based on commercial, technical and user goals. A successful innovation relies on finding a sweet spot between all three of these. When these goals become unbalanced or are not considered in relation to each other, complications can occur and this can often mean the difference between a successful product and a failed one. A good example of this is Clive Sinclair’s new vision for a vehicle, released in Britain in 1985. Clive thought it would revolutionise personal transportation, solve urban congestion and be a cheap alternative to owning a car. In reality his product failed. What went wrong? The developers did a beautiful technical execution of the wrong product. There was no protection from rain, no reverse gear, it was difficult to turn around in confined spaces, hills were too much for the C5 battery to handle and most importantly, no one felt safe in such a small and open vehicle. It would be fair to speculate that had Sinclair spent more time balancing those technical, user and commercial issues early on, the outcome would be very different.

One way to achieve this balance is through clear communication and strategic direction setting during the opportunity discovery phase of front end innovation.

The opportunity discovery phase

Creating a shared strategic vision

There are often many stakeholders involved in a product development, each with different skills, objectives and aspirations. Holding a strategic workshop early on in your project with key stakeholders (e.g. representatives from development, clinical, commercial, regulatory and programme management to name a few) is an important way to align the whole team and reach a mutual consensus on various decisions. This includes agreeing on a vision, the goals, objectives and scope of the program. When partaking in these workshops, it can be useful to create visual stimuli to help articulate thoughts. These visuals may vary from a simple image of an emotion you are trying to convey from your users, or an annotated sketch of what you are trying to achieve with the product.

There are many tools for aiding communication between a diverse range of stakeholders, who often have different views on what they want to achieve. A shining example is Lego Serious Play, a strategic planning and facilitation method established by the Lego Group. Here, Lego is used to empower each participant to take ownership of tangible models to represent their ideas. Everyone is encouraged to build and describe their own models and have their say, using the same medium.

Another great tool is the ‘Hopes and Fears’ activity. This is effective for understanding the individual objectives and concerns of each stakeholder. Participants are encouraged to share their hopes which could be, for example, ‘what do we hope to achieve with the new product’, as well as their fears, which could be ‘what are the barriers against us achieving what we’re hoping to do’?

From these workshops, discussions open up for groups to identify what they know, as well as any gaps in their knowledge which may need to be filled.

Competitor landscaping and market intelligence

Some of the knowledge gaps identified in your workshops may be in your understanding of the market and perhaps who your competitors are and what they might be doing. By undertaking competitor landscaping and market intelligence, you can examine similar products already on the market, or in development, and understand the potential size of the opportunity for your new product. This information is key to understand the value proposition of your new product and in frame how it will sit within the commercial landscape and differentiate from the competition.

Technology scouting, landscaping and assessment

It may become clear early on that there are gaps in the understanding of the technology available to meet the key technical requirements of your product. In some instances, it may be a commercial decision to develop your own technology, but in other cases it may be more desirable to acquire or license external technologies if something suitable already exists and is available.

To explore the possible options, teams should partake in an exercise to first determine and prioritise the key requirements of the product and agree the key selection criteria upon which a suitable technology will be assessed (e.g. technology maturity, performance, accuracy, usability, availability to license etc.). Once these are agreed, exploration of the potential landscape of technical solutions can be undertaken, using a variety of sources such as research articles, databases, company websites, patents and conference proceedings to identify both new and existing technologies.

Once the potential landscape of technologies is identified, they can be assessed against the selection criteria to identify a shortlist for further exploration. This exercise enables the team to highlight any risks and determine any impact that the technical element of the development may have on the overall product development.

User experience (UX) research

When developing a new medical device product, another important aspect of the early innovation process is to consider the experiences of your target users and the context and environments of use for your device. Through UX research, we can immerse ourselves in the lives of our target users and build a detailed picture about how the new product is going to be used in practice, who by and what for. It’s important to not only think about the physical task of using the new product, but also to consider what other products it may be used alongside, who the key stakeholders are that will interact with it and what they might compare it to. We also want to build an understanding of where and in what scenarios and environments your product will be used, as well as the physical and emotional needs, behaviours and motivations of all your target users, in order to develop a product that addresses a real need, adds value and is desirable.

Meeting user expectations

The importance of user experience has seen increasing focus in the last five years in the MedTech and medical device industry, especially for digital products. It is inevitable that the user interface (UI) of your device will be compared by users to well known consumer products, particularly concerning app design and digital interfaces. While patients do not have the same vast choice of products to choose from in the medical world, they are still able to choose which product to use based on user experience and performance. Today, we are seeing more and more forums on the internet where people are sharing their experiences of different devices, from online videos to review sites and more. It is therefore essential to incorporate learnings from successful consumer products, to give your end product the best chance of commercial success.

Conducting UX research

UX research is a method of early stage user research which allows us to immerse ourselves in the world of our target users. There are many ways of doing this, both in person and remotely. Prior to the pandemic, UX research was predominantly conducted face to face, involving flying around the world to visit people in their homes and workplaces to observe them in context. Since the pandemic, more online platforms have emerged and contextual observations can now be collected remotely. A great example of this is Recollective, a platform which allows us to collect rich insights remotely over a period of a few days or weeks. Through this platform we can ask users to share their experiences through a variety of formats such as uploading videos and images of their environment and the products they use, completing daily diaries or describing things that are important to them. We can stimulate discussions between participants and ask them to complete daily tasks to bring out rich emotional insights. In addition, we can ask users to give feedback on uploaded content such as product concept images or videos.

While this is not quite the same as going out to see a user in person, it does have the benefit of providing a wider view of a user’s experiences rather than a single moment in time. Remote platforms also enable participants to engage with the tasks at a time convenient to them, meaning scheduling is easier and participant engagement is likely to be higher.

User personas

Having conducted extensive UX research, as part of the analysis and to convey the experiences of your users to members of your team – it can be useful to create user personas. These personas are archetypical users whose goals and characteristics represent the needs, views, behaviours and experiences of some of the people interviewed during the research. The aim of these personas is to bring your target users to life for those stakeholders involved in the development who were not involved in the research. Creating personas puts the user at the heart of the product development and ensures that it is designed inclusively and to address the behaviours of the target user groups. This can be a valuable way of keeping the user in mind as you progress through a development.

User experience mapping

In addition to personas, another tool that can be used to organise and bring your research findings to life is to create what we refer to as a user experience map. This is also referred to as a customer experience map or workflow map.

A user experience map is a very in-depth and detailed process that explores a user’s journey and the touchpoints and interactions they have along the way, for example from first symptoms, through initial diagnosis, treatment, therapy and follow up – or from receipt of a product, through storage, preparation, onboarding, use and disposal. Exploration of these stages can form the basis of the research conversations and when mapping out the findings, the user journey maps can be brought to life with imagery and quotations.

This process also seeks to identify pain points and opportunities for innovation you probably are not aware of, as well as the creation of a visual journey that allows you to put a spotlight on the pain points that have been identified. These pain points can then be used to highlight where there may opportunities to improve the user experience with a new product or service.

The end result is a visual and holistic view of what you need to know and think about with your medical device product, from all angles and from the viewpoint of different stakeholders.

Design challenges

In order to drive the creative process and to allow us to think more freely about potential solutions, the findings from the research are expressed as solution-agnostic problem statements called ‘design challenges’. These could be user-related challenges, technical challenges, or commercial challenges and are expressed as a series of “how might we?” statements. For example, you could ask: “how might we engage someone better with their therapy?” or “how might we tie different parts of the system together?”. By keeping these questions solution independent, they open the floor up for creative ideation to solve them.

To further steer the subsequent innovation activities, it can be helpful to prioritise the design challenges to understand which are essential to be addressed with the new solution and would be showstoppers for the product if not addressed, and which are more of a ‘nice to have’. This helps to maintain a focus on what’s important.

Opportunity discovery stage – outcomes

By the end of the opportunity discovery stage of your development, your team will be armed with knowledge and confident that you understand your target users, what is happening in the market, what your competitors are doing and what technologies are best for your product. You will also have agreed on your strategic vision and the design challenges you need to focus on to set you off on the path to a successful product development.

The concept generation phase

Having completed the opportunity discovery phase of the development process, you will now understand the opportunities for innovation and have prioritised the design challenges to be addressed. So, where do you go from here? The next step is to ideate around each of the key design challenges and to start creating, prototyping and testing concepts.

Create – prototype – test

As mentioned earlier, the purpose of creating solution-agnostic design challenge statements is to ensure that ideators are open to think about ‘how might we’ solve the problem at hand and therefore explore many ways that it may be addressed. The aim is not to be pushed towards focusing on a particular solution due to the way the challenge statement is worded.

In addition to the ‘how might we’ statements, there are some useful tools for helping you to think about a problem differently and to start creating a wide range of ideas. Crazy eights, for example, is a method that encourages you to come up with eight different ideas in eight minutes. Another tool is analogous industries, which is an exercise that involves identifying similarities in other industries which you can draw on. A third example is SCAMPER, a methodology that encourages you to think about substituting, combining and replacing elements of your ideas.

Once your initial set of ideas have been established, it’s essential to make very basic prototypes early on so that they can be tested. As soon as you have developed some early ideas, it is incredibly helpful to start building these into “quick and dirty” prototypes that can be put into the hands of your technical team or end users. Even the most simple prototypes made from basic block models or some quick, breadboard circuitry can help you start to get an idea of how a product might work or perform.

For example, in the earliest stages of developing an organ transplant system for a MedTech start-up called OrganOx, our design team found a visit to the John Lewis kitchen department inspired a great idea based on a click-lock lunchbox and a collapsible silicon colander, as part of addressing our “how might we protect the liver during transport” statement. This simple product allowed the design team to quickly put together a basic prototype for the design, which could then be discussed with surgical specialists to get their initial thoughts.

Starting a dialogue in this way can be a great way to help visualise how your final product may look and function. You are not of course trying to test the final solution at this stage, however people tend to be much more able to articulate their thoughts and feelings if they have something tangible in front of them.

There will inevitably be a lot of failed ideas at this stage, with the core idea being if you’re going to fail, fail fast and fail early while there is still time to change the design. This is an important way of identifying what the challenges with the product solution are and how to overcome them. You will inevitably go through multiple iterations of create, prototype and test to help inform and refine the design of your new medical product. As your design progresses, you will however start to build increasingly sophisticated, high-fidelity prototypes, to the point that they look, feel and behave exactly like the real product.

Utilising Design Sprint in front end innovation

Design Sprint is a rapid innovation tool used by our innovation specialists at Team, which guides the design teams through a process from gaining an initial understanding of the problem on day one, through to testing a prototype with users within five days. The process is typically set out as follows:

• Day one – understanding the problem and the needs of end users
• Day two – exploring ideas to solve the problem
• Day three – reviewing ideas and deciding which to prototype and take forward
• Day four – the prototyping stage
• Day five – testing prototypes with users

Going through several one-week sprints helps to quickly refine ideas and provide you with the confidence that you are following the right path for your product development.

The path to a successful development

While all the steps discussed lead you on the right path for product development, you shouldn’t put all your faith in one concept. Two-to-three great ideas are optimal for progressing through this iterative concept generation process, as they can be filtered down to a final concept at a later date.

Ultimately, by spending time on setting the direction in the front end of your innovation, you’ll save costly changes later on down the line. An ideal medical product innovation is not only technically feasible, but also commercially viable and above all desirable by your end user. This involves a blend of user experience, technical performance and commercial success and isn’t an easy balance to achieve. However, creating a vision and aligning your team at the beginning of a development will put you in good stead for success, acting as an anchor to refer back to later on and ensure you are on track.

The FEI process provides thorough research and exploration of the potential opportunity space and gives you the confidence and evidence needed to determine strategic direction. When this is followed by an iterative cycle of create, prototype and test, you can be confident that you are on the path to a successful medical device development.