MedTech Intelligence features Observing the Human Factor by StarFish Medical COO, John Walmsley in the October 4, 2016 Product Development online edition. John’s column reinforces his message as a panelist in the recent MedTech Product Development Conference Roundtable Discussion on User Needs.
“There is a long history of designers making assumptions and over-relying on a user’s capabilities and capacities. However, an inadequately designed device can hurt people” notes John in the column’s opening paragraph.
The article includes observations and insights on FDA Guidances, key opinion leaders (KOLs), and early prototyping. He discusses several examples and concludes with this thought: “A design based on a sound understanding of the human factors will be much more robust in subsequent testing and in launch. In addition to avoiding errors, your users may love your device.”