Collaboration Between Design and Regulatory

Collaboration Between Design and Regulatory to The Benefit of Clients and Patients Alike in the Medical Industry

Aidan Petrie, IDSA, Co-Founder/Chief Innovation Officer, Ximedica; Sharon A. Mulligan, PMP, Program Manager, Ximedica

Abstract

The modern healthcare industry, with all of its complexities and challenges, traces its roots back two and a half thousand years ago, to a humbler time when the earliest practitioners developed their craft and established baseline principles centered around improving the quality of life for human kind. In more recent history, modern industrial design practices emerged from the intersection of art and commerce in the industrial age. And while the practice of medicine and design differ in many ways, at their origins they share the same fundamental intent of producing beneficial outcomes for society. Just as doctors pledge to uphold the ethical standards of their profession, we, as design professionals have an obligation to create products and experiences that are intuitive to use, delightful to behold, and—each in its own way -- uplifting to the soul.

However, these shared altruistic goals often collide with stark differences in methodology and approach when it comes to the practical side of product innovation and development in the medical field. Two of the major tenets of medicine are “evidence-based” and “patient safety”. Following strict scientific principles, evidence-based practices dictate that a particular innovation must follow progressive steps of proof that it not only makes a measurable improvement to outcomes, but also that tradeoffs are fully considered in the process. Patient safety is an obvious concept, but specifically in this context relates to the process by which drugs, devices, environments, and services are developed posing no risk to anyone involved in their use. This extends beyond physical risk to include physiological risk and privacy as well. In all cases, the potential benefits of innovation are formally and objectively quantified and weighed against possible risk in all its forms.

By contrast, the world in which most industrial designers are accustomed to working is a less rigid one, a freer form of art, industry, and its relationship to the people and the things they use. It is a culture where ideas are often born from pure intuition and creative thinking, then refined and ultimately commercialized with increasingly formalized methods and metrics. Many designers take pride in their unique abilities to navigate between creativity, industry and human empathy and intuition. And while many industries have embraced and integrated our profession—and consequently, benefited from it—the medical industry, for obvious reasons, imposes limitations to its application and unique challenges for wide-scale integration. If the practice of industrial design is to be fully embraced by the medical community, it is incumbent on design practitioners, as individual ambassadors of the profession at large, to understand and respect the culture and methods of the field, and to integrate without being assimilated.

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