Empower product development by leveraging design thinking for design controls
Commonly viewed as separate stages within the product development cycle, design thinking and design controls have a significant overlap, which means that key design thinking tools can feed into, and take feedback from, design control methods.
What is design thinking?
Design-thinking is a creative problem-solving process which gives priority to the needs of the end-user above all else. Rather than predicting how someone will engage with a particular product or service, it takes a more human-centred approach to innovation, by observing how something is actually used. This knowledge then informs a continuous and iterative design process responding to the user experience.
During the early stages of life science products, design thinking includes a variety of powerful innovation tools, methods, activities and exercises which catalyse creative problem-solving. Aligned with your organization’s creative vision, design thinking can help you determine the viability and priority of ideas and solutions. Not only does it highlight future design issues, it also provides a structured approach to the ‘fuzzy front end’ (FFE) of early-stage product development.
What are design controls?
Design controls refer to the formal methodology applied to the development of a product, which is often compulsory in regulated industries like medical devices. This means that problems can be uncovered and fixed at an early stage, reducing potential risk.
Controls provide a series of steps to ensure design and testing is systematically planned, executed and documented against user needs and requirements. For that reason, when design controls are implemented too early in the development process, they are liable to restrict innovation and limit a fully comprehensive evaluation of the issues.
What happens when these two processes collide?
If it is well-managed, the transition between design thinking and design controls can enhance your overall product development. Of course, innovation doesn’t stop once the rigour of design controls begins, but the initial transition can be made much clearer through the early adoption of the right design thinking tools and methodologies.
In many cases, the transition between design thinking and design controls is nonlinear, so it’s important to understand how different tools overlap and complement each other. The crossover between design thinking and design controls provides an excellent opportunity to create a cleaner transition, and feedback loops give your product design the agility to change and pivot during the early phase of development. Once embedded into your organization, the structures that hold up innovation and design controls can fully integrate, empowering your product development in significant and constructive ways.
Of course, this relies on having the right design thinking tools and methodologies in place. There are a number of different design thinking tools which intersect well with design controls. The tools which are the best fit for your organization are dependent on your team’s skill set, restrictions, and experience. Some tools at your disposal are:
- Journey Mapping And Storyboarding
- Stakeholder Mapping
- Rapid Prototyping
- Business Model Canvas
Typically, in medical device development the Use Specification and Use Error Analysis products would qualify as design thinking tools!
You can find out more about these invaluable design thinking tools by reading Compass’s white paper ‘Design Thinking “Collides” With Design Controls’.