Contradictory demands of medical markets and regulators. How do AI companies deal with them?

More and more artificial intelligence applications are entering the medical market. The market increasingly demands AI companies to develop comprehensive applications that are able to deal with multiple tasks, systems and cases. This demand, however, conflicts with the requirements posed by regulating institutions such as the U.S. Food and Drug Administration (FDA). To convince regulators of effectiveness and patient safety, companies have to prove that the capabilities of their applications have clear boundaries. As such, these regulations implicitly force companies to show the ‘narrowness’ of their application, while the market demands companies to develop applications that move beyond this ‘narrowness’. How do AI companies deal with these contradictory demands?

In his master thesis, Mr. Thomas Schut, one of our DBI students (Read more about education at KIN Center for Digital Innovation) examined the strategies that AI companies employ to receive both approval from the FDA and sell their product to the medical market. He analyzed 40 FDA cleared applications by 33 companies and 48 marketing materials (e.g. websites, brochures and white papers) showcased by AI companies. Based on this analysis, he identified 6 strategies employed by companies to showcase narrowness towards the FDA and 6 strategies to overcome narrowness towards the market. For more details about his thesis, click here.

Table 1. Strategies used by AI companies to navigate demands of FDA and medical market.

Originally published at https://www.linkedin.com.