The proof is in the pudding. Unlike pharmaceuticals, devices don't have the burden (or benefit) of launching with three phases of clinical trials right
out of the gate, for the following reasons:
» It's difficult to conduct a double-blind study with a device.
» It's much more expensive to conduct a device trial than a drug trial. (Think of the training and intensive involvement from
» It's challenging to go head-to-head with competitors, since endpoint definitions may vary from device to device.
You might think this would make things easier for a device manufacturer than for a drug company. However, there are many pitfalls
for device manufacturers that muddy the water. For one, the regulatory path for approval is often a 510(k), which is based
on a predicate device in the market, so pre-market trials tend to be simpler in order to demonstrate safety. But approval
can be challenging for a completely new concept that requires a PMA (premarket approval).
The good news is that for innovative devices, there is a new fast-track pathway for getting a PMA. This year, the FDA's Center
for Devices and Radiological Health (CDRH) intends to improve the FDA's premarket approval process using the "Innovation Initiative."
But don't be fooled: It still requires significantly less burden of proof than for a drug at launch.
For marketers, then, the benefits of devices are diverse—but so are the challenges.
A few thoughts to keep in mind:
» Although clinical effectiveness is important, look beyond clinical effectiveness alone. Consider: Will it save or make money?
Is it easy to use? Will it enhance patient compliance?
» Use a variety of metrics for proof: retrospective data, meta-analyses, even bundles of case studies.
» Don't underestimate the power of trial and experience. With equipment especially, some surgeon specialists are more comfortable
than others in taking on some risk to "see for themselves" how a device works in their hands.
Different from pharma
It takes a deep understanding of the nuances of device marketing to get it right.
There's a science to creative, whether it's an ad or a program. And it's important to remember that the expectation of the
device customer is not the same as it is for a pharmaceutical product. Implants and equipment require different approaches,
but they afford some exciting opportunities to build brands in completely new ways. Be open to the possibilities that devices
present, and you can start to write your own rules—without stealing a single idea from your pharma friends.
Amy Smith is Account Director, at HCB Health. She can be reached at email@example.com