How a Structured Development Process Can Make Design Thinking Better


"Process doesn't have to kill creativity; it can actually make it better." - George Sidis

Have you ever been asked whether you are ‘right’ or ‘left-brain’ inclined? What did you say? If you said ‘right-brain’ you might consider yourself more creative and intuitive. If you said ‘left-brain’ you might consider yourself more structured and analytical. However, did you know that this entire theory is a myth?

The reason why this matters is because it exposes our natural tendency to make sense of the world through a series of comparisons and judgements, relative to what we know. It also highlights our preference to categorise ‘creativity’ and ‘structure’ as polar opposites, where each is working against the greater good of the other. For professionals working in creative industries, structure and process is often seen as a strait jacket to creativity. But what if this isn't actually the case?     

What is Design Thinking? 

Design Thinking is a concept that has gained almost hyperbolic interest over the past 5-10 years, supported by the idea that creativity and structure work in isolation. Made popular by the Stanford School of Design, the approach has travelled like wildfire across organisations looking for a more creative and less restricted way of doing things.
Its strength lies in its approachability through total stakeholder involvement, emphasis on non-prescriptive language and loyalty to prototyping, testing and iterations. Design Thinking can help rigid structures feel less like a cage and more like a flexible net.  But what happens when processes and structures are in place to measure the difference between success and failure, or even life and death?

Why We Need Structured Development Processes CFR820 & ISO13485

For product developers working across highly regulated environments such as the medical device industry, following and meeting Quality Management Systems and regulatory requirements are crucial to successfully getting a product to market. Structured Development Processes CFR820 and ISO13485 guide the product development process through a series of checks and balances that make sure all elements of the product and its design meet strict sets of stakeholder requirements. In many instances, giving creativity the freedom to run wild without checks along the way could result in a failed product or even worse, a failed business.

ide is the only design firm in Sydney certified to ISO13485 standard, so we understand the potential conflict designers face when trying to merge process control with creative freedom. However our experience shows that process doesn't have to kill creativity; it can actually make it better. By answering the right questions at the right time and having well timed checks and balances in place, we keep on track so we can deliver a product that delights customers and provides them with a Design History File that satisfies regulatory requirements.

When we take a look at the Design Thinking process alongside the process of CFR820 & ISO13485, they’re both aiming for the same goal. Instead of looking at these two approaches as at war with one another, we see them as complimentary and compatible, where the weaknesses of one process are reinforced by the strengths of the other. When both Design Thinking and Design Controls are used together and done well, we've found that we produce much better results. Instead of limiting our creative freedom, following Design Controls is the well weathered rope that helps keep us on track. 

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Erin Evanochko