How to Customize Marketing for FDA Regulated TechnologiesHow to Customize Marketing for FDA Regulated Technologies
The pathway to acceptance for new medical devices and diagnostic tests is highly variable, depending as it does on class of device, physician specialty, clinical utility, reimbursement, and many other factors. Yet, new technologies tend to face similar sets of adoption barriers, both pre- and post-approval, no matter the variables. For example, a diagnostic test based on a unique platform technology is likely to require medical practitioners to learn a new vocabulary and change their practice patterns—regardless of the disease state.
November 22, 2010
Sandy Bodner |
The same can be said of a device that has received FDA market approval before society-based guidelines exist to identify the most appropriate candidates for treatment. The adoption hurdles confronting devices that require patient treatment to move from one medical discipline to another may be even more daunting, but they’re altogether similar because each innovation represents a break with accepted wisdom.
For marketers, virtually the same issues arise every time a new technology seeks to raise the standard of care. By and large, groundbreaking new instruments require physicians to modify their medical practice and, eventually, medical societies to rewrite their patient care guidelines. In these circumstances, developing a successful, bottom-up clinical marketing strategy turns on three factors that commonly apply to nearly every category of medical science. Simply stated, those factors are 1) situation, 2) challenge, and 3) solution. They can be characterized as follows:
Strict FDA rules and regulations guide the marketing of medical devices and diagnostic tests.
Marketers need to adapt marketing practices to meet regulatory guidelines.
Customer research needs to bridge the gaps between numbers one and two.
Depending on the nature of the products, which are discussed in the examples that follow, the situation and the challenge will be more difficult to handle in some cases than others will. Still, the defining element in the problem-solving equation is always customer research. Customer research provides a unique way to navigate the pathway to acceptance—or more specifically, develop a marketing plan, strategy, and programs that effectively incorporate best practices while complying with FDA regulations.
Key Inflection Points
This article takes a closer look at these variables and the potential benefits customer research can provide at key inflection points in an integrated market planning process. We begin by exploring each factor in order.
1.Strict FDA rules and regulations guide the marketing of medical devices and diagnostic tests. The marketing regulations covering analyte specific reagents (ASRs) offer an extreme case in point. ASRs, widely referred to as “home brews” in the laboratory testing industry are roughly—but not legally—the equivalent of a laboratory’s components of a diagnostic test. What makes the rules challenging to follow is that laboratories are not allowed to market ASRs as tests; nor are they allowed to target specific disease states. What does that mean in terms of what can—and cannot—be done?
Dave Condon, a very smart industry veteran, once described the ASR restrictions using an unlikely comparison standard—pizza ingredients. This was his rationale:
Manufacturers produce dough, sauce, and toppings (i.e., reagents.)
Manufacturers are not allowed to promote or label the finished product as pizza (i.e., a test for a specific disease state.)
Manufacturers are not allowed to sell the recipe (i.e., formula) which must be created and sold by a third party.
“The key point,” Condon emphasizes “is that the users decide how to put the ingredients together, what temperature to cook them at, and for how long. The manufacturer can't tell them how to do all that; they can only provide the necessary components.”
This example underscores the complexity of some of the regulatory boundaries. Companies need lawyers to interpret the letter and spirit of these rules and marketers to fully appreciate their intent before they can develop a plan.
2.Marketers need to adapt marketing practices to meet regulatory guidelines. Device company executives understand well that marketing programs for new applications must meet regulatory guidelines. What is often less well understood is the clinical utility associated with the application of a highly sophisticated new technology. For example, a viral load assay for an infectious disease may be able to quantitate subtypes that no other test is able to identify, and it may be able to legally substantiate that claim. But the clinical value of this application may still be unclear—and irrelevant. A life sciences company badly needing income may engage in nonstrategic sales to translational researchers (i.e., bench-to-bedside clinician/researchers) and spend an inordinate amount of time servicing a diffuse set of customers who may not be able to confirm the technology’s usefulness. A new technology requires a targeted customer base that will benefit the most from the application. Without this well-defined match of customer and device application, it is tough if not impossible for a new technology to carve out a market.
In a practical sense, advances in evidence-based medicine occur relatively slowly. This pace gives clinicians, researchers, and laboratory scientists sufficient time to evaluate the risks and benefits of changing established treatments. These transition periods also give clinical marketing professionals an opportunity to work on a parallel path—conducting interviews with prospective customers about the epidemiology of the disease, about competing viewpoints on current treatments, and about the leading indicators of change. These are the core questions:
Where are the gaps in the standard of care in this disease state?
What are the advantages and disadvantages of the current tools?
What would clinicians want to accomplish if a better tool were available?
Certainly, the tactical goals are to develop a marketing plan that conforms to FDA regulations, to clearly define the capabilities of a new technology, and to explain the benefits the application provides. However, the ultimate strategic goal is to identify who will benefit from the application of a new technology and to pinpoint the specific clinical segments that will drive the target customers to use the application.
3.Customer research needs to bridge the gaps between conventional marketing practices and regulatory requirements. Any device manufacturer will naturally solicit input from physicians and specialists. However, a true random sampling of opinions is not likely to occur at a very early stage and certainly not in a qualitative research project, where the number of interviews may fall between 10 and 20. This situation is where a manufacturer needs to be wary of the interview bias that occurs when seeking insights from relatively few professionals about the treatment challenges of complex disease states.
In a small-scale research project that accounts for diverse geographies and practice settings, it can be extraordinarily helpful to speak with opinion leaders. The experts can include clinicians who have served on guidelines panels, on medical journals, or as officers of clinical societies, because they can speak from two perspectives: personal and professional. Manufacturers with a working hypothesis about the potential clinical utility of a new technology may reap multiple benefits by posing questions, such as those listed below with emphasis added, to a select group of very tough, expert customers:
Where will the technology fit in the continuum of care?
Who will use it?
Why is it needed?
What data will be required to support adoption?
How can it be reimbursed?
A research project that engages expert clinicians with opposing viewpoints may be more likely to generate findings that broadly reflect current concerns and trends across the field. Overall, manufacturers may benefit from the opportunity to test their own beliefs and assumptions, even as they explore potential drivers for and against change. Additional advantages reside in the conversations with expert researchers that can create an opportunity to extend invitations, if they seem interested, to join a clinical advisory board and possibly to serve as clinical investigators.
Figure 1. Seven integrated activities, each of which forms the core of its successor, compose the launch sequence for a new medical technology. This sequence suggests that combining activities (ABCD) can streamline practical, clinical, and regulatory investigation and provide a broader foundation for the next major step shown in Figure 2—developing an integrated marketing plan (E). |
Seven Integrated Activities
In the medical marketplace, the multiple uses of customer research shown in Figure 1 can inform the target audiences, give insights into clinical utility, identify candidates for a clinical advisory board, and refine the hypothesis for a validation study.
Case Study 1 (sidebar) offers an example of how to integrate customer research and market development and outlines the potential benefits this approach provides.
The Paradox of Planning
The paradox of planning is that acknowledging its importance doesn’t make it easier to accomplish. There are often situations where planning seems to be an inconceivable luxury. And yet, developing a capable marketing campaign is impossible without conducting research, establishing priorities, and devising a comprehensive launch strategy in a disciplined way. A disciplined approach to planning is meant to create strategies and tactics that leverage key opportunities, tackle major stumbling blocks, and meet measurable objectives. Case Study 2 (please see sidebar) shows how customer research findings can provide the structure for an integrated marketing plan (E).
Figure 2. A basic template for outlining a marketing plan. |
Input Affects Output
In a practical sense, a marketer’s ability to translate data about a new technology into meaningful insights rests on an in-depth understanding of the environment in which customers utilize a new tool and the benefits they derive from it. The diehard challenge, so to speak, is that the standard performance indicators are all-too-familiar. Sample requirements, turnaround time, reproducibility and precision—these are the habitual performance measurements in the diagnostic industry. To capture attention for a groundbreaking assay, a marketer needs to express routine measurements in way that makes them memorable and fresh and new again. Customer research can help marketers achieve that goal in extremely variable circumstances.
The following three concluding examples show how the process works and why it matters.
Example 1: Measurements
An expert user places "sample requirement” in a dramatic context.
Positive scenario: A laboratory scientist explains how the exceedingly small sample requirement of a new blood testing system is suited to a pediatric hospital environment and why nurses love him for it. “With our former blood testing system,” he observed, “the nurses in the NICU (Neonatal Intensive Care Unit) wanted to kill me every time I drew blood from newborns. With this new system, I can run a complete blood test from a tiny bullet tube of blood drawn from the foot of a newborn baby.”
Why it matters: Within a very specific context, a small sample size supports a humane approach to testing sickly newborns, speaks to a broad-based pediatric target audience (e.g., laboratory directors, nurses, NICU), and provides a true-to-life anecdote that bears repetition. For marketing, sales, advertising and public relations, a neat anecdote can provide an invaluable conversation piece.
Example 2: Sales Tools
A weighty promotional tool reveals a chasm between marketing and sales.
Negative scenario: The marketing manager for a diagnostics manufacturer explains that his company spent $100,000 assembling notebooks describing dozens of new assays, and the sales reps refused to carry the books. They were heavy and awkward to display in a presentation.
Why it matters: What the reps wanted was an 8- to 12-page brochure that covered the entire portfolio. A closer examination of the sales department’s needs would be more likely to yield a sales aid that meets a predefined set of expectations.
Example 3: Applications
Research clarifies the relative importance of application versus technology.
Negative scenario: A sales manager for a life science company summarizes a problem he is having with sales materials in this concise but less-than-elegant way: “Marketing spews technology all over the customers when all they want is to understand what the system can help them accomplish.”
Why it matters: When an overwhelming desire to honor technological achievements obscures the connection between a product’s capabilities and its real-life applications, market research has the potential to deliver a diplomatic, yet powerful, push-back. Data representing “the voice of the customer” ought to cast the deciding vote in a controversy over the substance or priority of key messages.
Leverage and Define
A marketer takes subtle concepts such as quality of data, scale of unmet need, and clinical utility and transforms them into concrete elements—a value proposition, key messages, packaging, promotion, pricing, and distribution, to name only a few examples. The sum of these elements helps define the worth, significance, or merit of a new tool. To arrange the tangible and intangibles in a way that helps a complex technology find its audience is no small feat.
In the medical community, a marketer needs to be vigilant about regulatory requirements, cautious about promoting clinical trials, and unfailingly attentive to patient safety. The devil is certainly in the details. More specifically, however, it is in the definitions—how a manufacturer leverages customer research to define a product’s target audiences, define a product’s utility, and define the marketing objective of a campaign.
Sandy Bodner is the principal of Strategic Communications LLC, (Medford, MA.) She may be reached at 617/549-8523 or at [email protected].
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