Medtech POV Blog

Guided By Principles-Based Management in Times of Crisis & Uncertainty

  1. Christopher L. White General Counsel & Chief Policy Officer

When the history books look back at the 2020 coronavirus pandemic, it will unquestionably be viewed as a time of crisis and deep uncertainty. I continue, however, to be confidently optimistic that it will also be remembered as a time of human adaptability, resilience and ingenuity. Early projections of millions of American deaths by summertime have already proven wrong—not because COVID-19 is any less lethal than originally anticipated, but because those forecasts underestimated in large part the global medtech industry’s profound ability to remain nimble, adapt in real time, and innovate at record pace.

In particular, after more than six months of responding to an unprecedented public health emergency, and despite lingering uncertainty about when an effective COVID-19 vaccine will become widely available, medtech companies have begun to recognize several key lessons that will guide the way they steer business operations in the pandemic days and beyond.

In my role as AdvaMed’s COVID-19 Action Team Leader, one important takeaway that I have gleaned from conversations with my colleagues and our members is the immense value that can be offered by effective principles-based management in times of crisis, especially relative to rules- or process-based management. I have witnessed the benefits of principles-based management at AdvaMed firsthand: in the earliest days of the pandemic, AdvaMed’s Board of Directors swiftly approved five COVID-19 principles that have helped guide our organization’s COVID related vision and work during unpredictable and challenging times. That is not to say rules, policies, and procedures do not have their place (in fact, successful companies will inevitably have aspects of both). But a flexible decision-making framework founded upon guiding principles, like those adopted at AmazonGoogle, and AdvaMed, provides significant competitive advantages:

Some Rules-based models are holding us back. For the pitfalls of rigid rules anchored in time, we need look no further than to a topic that I have repeatedly and fervently discussed: HHS-OIG’s need to modernize and reform the Anti-Kickback Statute (AKS) regulations to protect all innovative value-based health care arrangements. Created in the era of fee-for-service medicine to prevent bad actors from acting in ways adverse to a patient’s interests in order to gain some sort of financial benefit, the current version of the AKS has become outdated. By failing to keep up with the pace of unforeseen technological advancements (and the benefits such advances make possible, including coordination of care and payment for value), these fraud and abuse safeguards are daunting legal barriers to the kind of working relationships that deliver optimal health outcomes. We must evolve.

As this Harvard Business Review article aptly explains, “decision principles” provide leaders with “an opportunity to let go without losing control” (emphasis added). 

Like I mentioned a prior blog post, the revised 2020 AdvaMed Code of Ethics serves as another outstanding illustrative example of this framework in action. Unlike the original version’s rules-focused document, the revised Code of Ethics’ “Cornerstone Values” empower medtech companies to achieve and maintain compliance in all company interactions with health care professionals in any given situation, including those not otherwise addressed in the Code. Such value and resiliency in the face of crisis is exactly why I strongly encourage all leaders—if you haven’t already—to “let go.”

These are unusual times and many of the usual rules no longer apply. Charting a course to success now requires that we understand and look to essential principles to empower effective and appropriate decision-making. I look forward to sharing with you other lessons AdvaMed has learned during the pandemic. In the meantime, please stay healthy and safe!

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