RISK · DECISIONS · EVIDENCE
How does risk shape the work?
Risk is not paperwork added after design. It determines what must be learned, controlled, and proven.
Risk is tricky.
In modern medical-device product development, we constantly hear that risk must be integrated into the design. Yet, how do you actually do that?
For PDSL, every design decision must go beyond whether the proposed solution works.
“We are deciding that this is the best way to approach an issue. However, that decision comes with trade-offs. Are we willing to accept them? And again, why?”
When we say that risk shapes the work, we mean that risk influences what the team investigates, controls, and proves throughout development. Through each iteration, the team must decide which risks are acceptable, which are not, and why.
These decisions should align the effort and investment with the potential consequences of failure.
Still, risk is natural to every product, not only to medical devices. A product development system should enable the team to ask, “What can go wrong with the product?”, provide the appropriate forums to discuss it, and assign the people responsible for addressing the potential issues.