Design thinking aims to solution for complex challenges through a continuous iterative process with the end user in mind. We describe and recommend a means to apply design thinking to pharmacovigilance processes.
Method
1. The end user undergoes observation by ways of contextual analysis methodology
2. Teams align on the insights gained from observation, and envision the future state
3. Multiple prototypes of the future state are created and tested
4. Feedback is incorporated and the feedback loop begins
Results
By applying user-centered design approaches and methodologies within PV we were able to 1) Develop ‘as-is’ personas that outlined the background of the PV professionals, the decisions made, their daily workload, goals, pain points, and environments within the case management functions ranging from receipt to safety scientists. 2) Identify areas in which technology can be applied to augment the decision-making process for the PV professional 3) Create a practical and intuitive UI/UX for the intake process within ICSR case management that was designed by inputs from a variety of PV professionals, for PV professionals 4) Create new roles and structure for the aggregate reporting function, that redistributed workloads, grouped tasks and resulted in a more efficient and scalable group 6) Created a blueprint of future innovation, wherein data and technology driven initiatives were identified that ranged from data mining with semantic technologies to real time signal detection.
Conclusion
Within pharmacovigilance, there are a growing number of complex problems ranging from excessive manual work, growing case volumes, and under-serving technology. Design thinking is a methodology that can be implemented in pharmacovigilance and used as a framework to systematically deliver user-centric, pragmatic outcomes by looking at challenges holistically, challenging assumptions, and understanding the end-user. To date, exploring design thinking has resulted in positive outcomes by supporting innovation initiatives, addressing unmet user needs, and problem-solving in a way that diagnoses the underlying problem rather than its effect.
However, the practice of design thinking can be used in areas beyond these examples and can be integrated into functions to better support activities within pharmacovigilance such as addressing auditing inspection findings, enabling effective change management, or supporting business process and IT implementation efforts. By addressing and focusing on user needs in a more consistent and structured manner, business priorities can be better addressed within pharmacovigilance, and the work-lives of the users transformed.
