Historically, the nature and function of clinical affairs within the orthopaedic device industry have been understood from a perspective of premarket need. Ask a device firm’s leadership why a clinical affairs team is part of the company infrastructure, and the response will likely make reference to securing key product approvals. This perspective is understandable. The long, arduous road of conducting clinical trials as part of the Investigational Device Exemption (IDE), Premarket Approval (PMA) regulatory pathway is of no small consequence, at times determining whether a firm will sink or swim. It is not surprising then that “clinical” has become virtually synonymous with IDE. Yet, in much the same way as individual cells work together to make an organism what it is, clinical affairs should be viewed as one of many multi-related, multi-obligated teams that collectively define the organization’s life.
At first glance, use of the organism analogy may seem like Organizational Management 101. Assemble cross-functional teams—check. Make sure clinical affairs has signed off on the design control documentation—check. Regroup as needed to determine what, if anything, is necessary from clinical to secure approval or keep a product on the market—check. Such checklists are good and necessary. However, if the last five years (and counting) of tectonic shifts in the orthopaedic industry have taught anything, it is that gaining crystal clarity regarding the nature and function of roles is a healthy thing to do prior to executing within those respective roles.
In light of this background, the following perspective seeks to be a starting point for discussion on the nature and function of clinical affairs. The goal is to gain a more expansive view than the traditional IDE paradigm allows so that substantially greater benefit is realized in the overall life of a medical device firm.
1. Science is the nature of clinical affairs
Consider these terms: hypothesis, randomization, minimization of bias, statistical analysis plan, equipoise. Clinical affairs is heavily laden with such language because its nature is scientific. If product development can be said to “encode” the intended behavior of a device into its design, clinical affairs can be seen as the “decoder” of how it actually behaves in patients. The extent of overlap between the encoded intended behavior and decoded observed behavior can be measured in terms of efficacy (controlled trial) or effectiveness (observed, real-world use). Many implications emerge from this perspective, three of which can be briefly described here.
First, because this scientific nature involves quantifying the extent of desired overlap, as well as the methods used to measure that quantity, the framework for a clinical study actually begins to take shape during device conception. Put this way, it is immediately apparent that clinical affairs should be integrated in the nascent stages of product development regardless of the regulatory pathway to approval. While the eventual decision may well be that the device does not require a full-fledged clinical trial, final design review is much too late in the game for sufficient consideration.
One of the hallmarks of sound science is the selection of variables that can be accurately measured. A second implication of having a scientific nature, therefore, is the need for clear, consistent communication across the organization as to what a particular study is and is not measuring. Clinical affairs professionals, this author included, should strive to promote ubiquitous inter-departmental understanding of the main features of specific trial protocols. In doing so, the entire organization will anticipate the same deliverable which, when derived from the data, will be on target with the pre-defined questions the trial is attempting to answer.