"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products

Several years ago, while in Sweden conducting usability testing of a critical care device, I learned the expression (translated into English) to “rush slowly.” Whether the oxymoronic idiom originated in Sweden, I cannot say for sure. It might actually have come from India. I can say that it resonates with me now during this time of COVID-19 when critical care devices are being rushed to market to boost the healthcare system’s capacity to treat critically ill patients.

The expression warns about rushing to accomplish a goal and, in the process, creating other problems. So, what bearing does this have on the rush to get products such as masks, respirators, ventilators, and dialysis machines to the front lines of patient care? I believe it has direct bearing because fast-tracked products still must perform as intended in the hands of the healthcare providers and protect against harmful use errors (i.e., mistakes).

Accordingly, desperately needed products such as ventilators should still benefit from good human factors engineering. I believe this to be true even when a development effort is moving at warp speed amid calls for technical improvisation. After all, human factors specialists can work quickly just like mechanical engineers, electrical engineers, and programmers. Even while moving at warp speed, there is time to do the basics, including:

• Establish and follow user interface specifications that reflect good human factors principles.
• Define use scenarios, identify potential use errors, and implement the necessary design mitigations.
• Conduct “quick and dirty” usability tests to see if people can use a prototype correctly, or not.
• Conduct a human factors validation test to confirm that a device is serving the users’ needs and, most importantly, not inducing dangerous use errors.

Sequenced properly, these core activities will go a long way toward ensuring that the final product serves its critical purpose. Moreover, a presumably better user interface will make it easier for users to learn how the device works, and avoid making mistakes. This positive outcome is particularly important when people who are inexperienced using a given product are called upon to use it in fast-paced critical care environments.

It remains to be seen whether manufacturers that do not apply human factors to critical care products will be denied market access. In the US, these manufacturers may gain access if they have sought an Emergency Use Authorization (EUA), but FDA is known to look at these applications on a case-by-case basis. Yet, manufacturers should be mindful that EUAs call for products to be taken off the market when the emergency abates, and then to go through the normal FDA regulatory approval process in order to maintain US market access. Therefore, it makes sense to do the human factors work upfront, when it can have the greatest positive effect.

Michael Wiklund, CHFP, P.E., is General Manager of Human Factors Research & Design at Emergo by UL.