Once you have completed your scoping, ideation and feasibility stages of the product design process it is time to test the concept or prototype with patients and healthcare professionals. Following user-centred design principles this should be an iterative process early on, with changes and improvements made to the product or service as you test and co-design with users.
So how do I do it?
Accessing your user community and test bed:
Your local AHSN will be able to help signpost you to patient groups and charities, as well as supporting you to broker introductions to healthcare professionals. This support is crucial. Having a ‘clinical champion’ to support and drive the development of your product or service forward, is increasingly essential at the later stages of the development cycle.
For studies focusing on proof-of-concept and prototyping, the sample sizes are generally small, for example between 20 and 60 participants. The focus of these studies is usually to measure training effectiveness and ease-of-use (also referred to as human factors and ergonomic testing). This helps to highlight product issues before moving further into user trials or clinical trials to define safety and effectiveness.
Practice user-centred design:
Build, test, iterate and repeat. Continue to engage with your users and build up a trusted user community who can help test and co-create your product or service. User-centred design is the process by which you understand all the different needs of the user, and create products or services to address them. The International Standards for ‘Human-centred design for interactive systems’ defines six key principles to judge whether design work is genuinely user-centred:
- The design is based upon an explicit understanding of users, tasks and environments.
- Users are involved throughout design and development.
- The design is driven and refined by user-centred evaluation.
- The process is iterative.
- The design addresses the whole user experience.
- The design team includes multidisciplinary skills and perspectives.
Consider regulatory standards early on:
In an ever-changing landscape, this is now a key consideration at an early stage. You should use the following resources and guides for MedTech and digital products to build a regulatory roadmap early on.
Consider your commercial strategy early on:
Although it may not seem a priority at the early stages of your product or service design, scoping out your commercial strategy early can reap rewards later on in the product development pathway and you should use this period to test and tweak your route to market and value proposition with key customers:
Who are your key customers, do you understand their needs (both emotional and practical) and how does your product or service meet their needs? You may need to conduct research with your key customers to tease out their needs and then work collaboratively with them to understand how your product or service concept could meet these needs.
Once you have established your customers needs and your value proposition, you need to consider how you will position your product or service in the context of current products or services. For example, where will it fit in the existing treatment pathway, will it replace, complement or augment existing products or services, what are the benefits or added value compared to current or future competitive products.
Route to market:
It is also important to test and work-up your route to market in the conceptual stage of development. For example you should consider and discuss the following questions with your key customers and user groups to begin to map out your route to market: How will your customers get access to your product or service? Will it be reimbursed by NHS organisations and providers or will you make it available as a direct-to-consumer product? What is your business model and pricing? What is an acceptable price point for your customers?