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By Marc Egeth

Theory of Mind” refers to individuals’ cognitive ability to represent other individuals’ mental states. It is the sort of thing that is theorized to be somehow central to the human condition, underlying the ability to take into account other people as thinking, feeling individuals. Psychologists have examined the development of Theory of Mind as it emerges in toddlers and along with biologists have looked at the evolution of Theory of Mind by considering primates, dolphins, birds, and other seemingly smart animals’ ability to take others’ perspectives. A Theory of Mind deficit has been theorized to explain, or at least describe, the social interaction difficulties present in the autism and asperger’s neuro-atypical continuum personalities. A person with deficient Theory of Mind has a hard time understanding other people’s points of view. Some research has pointed to tradeoffs where the types of people who are employed to design and develop devices because of their intellectual prowess, potentially possess that prowess at the expense of Theory of Mind. There is even an weird external physical feature proposed to correlate with poor Theory of Mind skills and high engineering ability: a relatively short pointer finger.

A Theory of Mind deficit would imply that individuals who have the technical qualifications and are hired to engineer solutions to today’s healthcare problems have a hard time understanding the limitations and motivations of the users they develop products for. As a result, they may underestimate the degree to which their users may struggle and/or fail to use their designs. We see this with manufacturers who go from the invention stage to development and even clinical trials without testing their products with representative users. These devices have been developed, and instructions for them have been written, and the folks designing and developing the product can use the devices and maybe even teach others how to use them, but if you put the same device into the hands of new intended users (such as a patient with Parkinson’s Disease) they do not know what to do with it or are physically unable to use it in a reliable manner. There may be too many little mechanical parts that each need to be twisted and pressed in the right sequence, the instructions may be  ambiguous or overly technical and the users may be unable to use the product as intended. If the product is eventually tested with actual users, whether pre or post market launch, this inability of the users to use the product as intended comes as a surprise to the people who designed and developed them. Devastatingly, finding that the intended users of the product are unable to use the product safely and effectively later on in the product development lifecycle leads to costly redesign and delayed time to market or worse (e.g., serious harm to users if the issues aren’t mitigated prior to product release)

Human Factors Engineering has a process that helps to bridge gaps that exist between the people designing the product and the product’s intended users. The Food and Drug Administration has also developed a human factors engineering guidance to assist medical manufacturers to improve the design of their devices to minimize potential use errors and the resulting harm. Participating in human factors activities such as interviews and formative testing helps the medical device development process systematically take into account the perceptual and cognitive limitations and capabilities of end-users. The insights gained from human factors activities help drive modifications to the design of the products in an attempt to make these a better fit for the users.