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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.
Finally, the scientific nature of clinical affairs necessitates taking a long-term view with respect to firmly characterizing product performance. Comparative Effectiveness Research (CER) grew out of the realization that short-term, controlled clinical trials have limitations in making real-world conclusions precisely because they are short-term and controlled. Device registries and other tools have surveillance capabilities to make real-world observations, but conclusions can take several thousands of patients over several years. Nevertheless, one of the tectonic shifts in the last five years was the European Union’s Medical Device Directive (MDD) essentially mandating a long-term view. Using the language of product “life cycle,” the MDD clarified that “clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use.”
2. Construction, execution and results dissemination of trials are the function of clinical affairs
Based on the view that science is the nature of clinical affairs, it is only a short distance to see its function—the construction, execution and results dissemination of clinical trials. The singular form of the word “function” is used to imply continuity and dependency, or put negatively, to communicate that dysfunction results when construction, execution and results dissemination are performed independently.
A helpful analogy for illustrating clinical affairs function is the design control process in product development as shown in Exhibit 1.
Exhibit 1: The Design Control Process in Product Development
| Product Development | Clinical Affairs | |
| Construction | Concept and Product Design | Concept and Protocol Design |
| Execution | Modeling and Testing | Data Collection and Analysis |
| Dissemination of Results | Final Review of Design History and Release to Production | Final Review of Trial History and Release of Clinical Study Report |
The point of this analogy is not to present clinical trials as necessarily the same in complexity or workflow scope as that required for device development. Rather, the analogy aims to make the function of clinical affairs clearer by relating it to the more tangible science of creating a medical device. In so doing, the engine of clinical function—investigators, coordinators and clinical affairs team—can continually assess improved ways for optimizing output, much the same as engineers, drafters and prototype makers evaluate better ways of optimizing device characteristics.
Although not nearly exhaustive, the above discussion attempts to show that an IDE-only paradigm is inadequate if a firm is to reap the full benefit of investing in a clinical affairs team. If the nature of clinical affairs is science and its function is construction, execution and results dissemination of clinical trials, a commensurately broad value proposition is in order. Clinical affairs leadership should establish such a proposition by thoroughly understanding the objectives of all other teams within the firm, and then defining as internal customers, those teams whose objectives will be served by clinical data. The value proposition should be formally written so that clinical team members perform in the context of obligation to internal customers, while the internal customers themselves gain progressively broader scope regarding the value they are being provided. This initial step of establishing a value proposition aims to culminate in firm-wide desire for maximizing the range of benefits derived from a clinical affairs team.
Joel Batts joined SANUWAVE in October 2011 to lead the dermaPACE clinical study. He previously served as Senior Director of Clinical Affairs at Wright Medical Technology where his focus was orthopaedic reconstructive products, foot and ankle products and wound therapy. He has a Bachelor of Science in Exercise Physiology from the University of Florida and is finishing a master’s in bioethics and health policy at Loyola University Chicago’s Stritch School of Medicine. Contact Joel at medsuppliers@yahoo.com.
