Making Human Factors Affordable for Medical Device and Global Health Startups

Abstract

Including human factors during medical device development leads to better outcomes as recognized by the U.S. Food and Drug Administration (FDA) and the International Electrotechnical Commission (IEC). Startup companies have historically been a major source of medical device innovation. However, many startups are unaware of the field of human factors or do not know the value it can bring in creating safe and effective medical devices that are well-adopted in the market. In this paper, there are four ideas for including human factors during medical device development at startups: demonstrating the value of human factors to startups; collaborating on early funding proposals; delivering value on multiple levels simultaneously; and using resources creatively and judicially. These ideas are illustrated in 3 case studies.