By the time you get to the FDA, do you forget to tell the whole story?
Reaching an underserved population. Extra evaluations on patient subsets to evaluate effects on different patient profiles. Designing authentication and authorization schema to require 50% less clicking for clinicians. Guaranteed uptime even in the face of a ransomware attack, via a failover cellular connection. Monte Carlo simulations to predict better (scientifically sound) likelihood and impact of identified risks. Real-world evidence that is three orders of magnitude larger than a standard clinical trial. And, of course, the solution to an unmet medical need that inspired the innovation in the first place.
These are just some of the benefits and features I've noticed are forgotten when they could serve as key points of evidence in a technology decision.
When you are steeped in device development and preparing for regulatory review and commercialization, it is easy to forget some of the small elements and features that make up the total benefit-risk story of your device. I was leading a threat modeling session with a cross-functional team of engineers who had been working on a surgical system for a long time. During the session, we listed the benefits of their device before diving into the cybersecurity threats. The group's dynamic shifted. The fresh reminder of all that was good about the device, all that it would do for the users and patients, was a necessary reminder to motivate the rest of the session.
On a different team, I participated in a postmarket risk discussion. The cybersecurity risks were raised as a potential barrier to ever using the device again, and potentially having it recalled. Cybersecurity risk can be a valid reason for recall. However, in the case of this device, many patients would lose access to care in a recall. The cybersecurity risk seemed large until we re-contextualized it in terms of benefit.
Humans are pretty bad at estimating risk. We're even worse when we estimate risk without maintaining awareness, focus, and consideration of the full benefit story. This goes for R&D teams, regulatory teams, regulators, postmarket actions, and consumers. Keep telling the whole benefits story, over and over, in many contexts, with everyone who has a stake in the tech. Consider marketing the benefits internally well before external marketing campaigns are launched and into full gear.
Keep showing off the beautiful forest despite living in the trees.
~Shannon, the Optimistic Optimizer
