In the realm of healthcare, where the primary oath is to “first, do no harm,” the stakes are undeniably high. Every decision made in clinical trials must be meticulously considered, aiming not only to improve but also to avoid any detrimental effects.
Design thinking can help as it is a process for solving problems by prioritizing the needs of the consumer above all else. In a presentation at YPrime’s annual Innovation Network Gathering, Professor Stefanos Zenios of the Stanford Graduate School of Business shed light on how design thinking can revolutionize human-centric clinical trials. Stefanos’ insights draw from his experience teaching two distinct but interconnected classes: Biodesign Innovation and Startup Garage. Both these courses emphasize an unwavering focus on the consumer/end-user—whether it’s patients, physicians, or any stakeholders in any industry. They instill a culture of understanding customer needs deeply and iteratively, a core principle of design thinking.
Two standout examples from Stefanos’ classes are the creation of DoorDash as well as Zio by iRhythm, a patient-friendly patch ECG monitor that has transformed cardiac monitoring for hundreds of thousands of patients. The Zio success story underscores the power of design thinking in healthcare innovation—understanding the user’s needs, ideating solutions, prototyping, and iterating until a viable solution is achieved.
In the context of clinical trials, the application of design thinking principles is critical. Stefanos highlights four key elements that any successful innovation in healthcare must achieve: usability, feasibility, viability, and approvability (regulatory approval). These factors pose unique challenges, requiring a thoughtful and systematic approach.
Design thinking offers a framework to navigate these challenges effectively. By casting a wide net and involving all stakeholders—from patients to regulators—early in the design process, trial protocols can be tailored to meet the diverse needs of everyone involved. By slowly prototyping and testing early on, we allow for the identification and resolution of potential friction points, ensuring smoother and quicker execution in the long run.
“…because at the end of the day, this is all about getting life-saving care into the hands of patients—into the bodies of patients—as early as possible.”
– Professor Stefanos Zenios
Stefanos emphasizes the importance of taking a bias for action approach in clinical trial design. Engaging with patient advocacy groups, conducting workshops with actors, and involving regulators from the onset are all strategies to anticipate and address issues before they become obstacles.
The goal is simple: to accelerate the delivery of life-saving care to patients while minimizing risks and inefficiencies. Design thinking—with its emphasis on empathy, iteration, and collaboration—offers a powerful toolset to achieve this objective. By moving slowly and deliberately from the onset, we can incorporate these principles into the fabric of clinical trial design and navigate the complexities of healthcare innovation with confidence.
Innovation and quality are at the core of everything we do as an industry to improve clinical trials. That’s why every year, we host the Innovation Network Gathering—a forum for brilliant minds from various backgrounds to come together to engage in thought-provoking discourse that sparks new opportunities for growth and change.