CDRH is at the receiving end of a seemingly constant barrage of criticism from the medical device industry and patient advocacy groups alike. So, it was rather surprising in February when the center decreed from its permanent address between a rock and a hard place that one of its three 2014–2015 strategic priorities was to provide excellent customer service.
Apparently, CDRH is shooting for the stars: The center aims to achieve at least 70% customer satisfaction by the end of the year and 90% customer satisfaction by the end of 2015. While CDRH should be commended for its attempt to address the complex love-hate relationship it has with stakeholders, is this lofty goal laughable or actually feasible?
In recent months, some regulatory affairs professionals have acknowledged CDRH’s perceived willingness to better collaborate with industry. But these efforts—while appreciated—do not always translate to a more predictable and consistent regulatory pathway, says John DeLucia, vice president of regulatory affairs, clinical affairs, and quality assurance at iCAD Inc., a provider of advanced image analysis and workflow solutions, and a member of MD+DI’s editorial advisory board.
Therein lies the problem. Communication, collaboration, and playing nice is all well and good, but customer satisfaction levels—from the industry side, at least—won’t truly climb until CDRH becomes more predictable and consistent.
Of course, the other intriguing part of this strategic priority is how CDRH defines and measures customer satisfaction. “Excellent customer service means understanding and addressing, as appropriate, stakeholders’ and colleagues’ needs through active listening, problem solving, seeking out the ideas of others, explaining the rationale for our decisions and requests for information, learning from our mistakes, and doing our best,” according to CDRH’s Web site. “Providing excellent customer service improves our interactions with stakeholders and colleagues and supports better regulatory outcomes, thereby improving patient health.”
While measuring customer satisfaction is by no means a science, this description is particularly vague and subjective—especially the part about “doing our best.”
“I would not even agree these are goals,” DeLucia says. “Goals, in my mind, are specific, which means: What is the target for improvement and measurable; that is, how do you quantify the improvement? Goals can never be goals unless the way you are going to measure them are stated. So, largely, I do not see these as realistic because there is no impact to their so-called customers (i.e., industry). Maybe they will have an impact internally for the agency.”
Mark DuVal, president of DuVal & Associates, a law firm dedicated to counseling medical device companies on regulatory issues, shares this sentiment. “These kinds of customer satisfaction levels exceed reality for any regulatory institution. While I applaud FDA for thinking along these lines, I assure you they will be defining the customer satisfaction goals and administering it themselves,” he says. “I challenge them to hand this task over to industry, work with industry to define the questions that will be asked, and [ask] industry’s definition of ‘customer satisfaction,’ and then let the chips fall where they may. FDA will come nowhere close to what they are seeking to attain, especially with start-up, small, and midtier companies.”
Basically, the agency is setting itself up for failure in regard to this particular strategic priority. Or its vague success metrics will allow it to easily meet its goal. To its credit, CDRH has made some strides toward improvement since announcing its strategic priorities and appears to be serious about nurturing its relationship with stakeholders. Its optimism is certainly encouraging.
But a 90% customer satisfaction rate is frankly setting the bar too high for a center whose stakeholders—particularly industry and patient advocacy groups—have viewpoints on policy that are often at odds with one another, despite both groups’ commitment to patients.
If anyone can appreciate the saying, “you can’t please everyone,” you’d think it would be CDRH. Too bad the center doesn’t offer a money-back satisfaction guarantee.
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