Three Wise Dames

Marketing in the Life Science Industry

Simply Described: FDA Review of Medical Devices March 13, 2013

FDA Logo BetterWhen I learned about the regulatory process that a medical device goes through to get to market, I learned about it on-the-job from experienced medical device communications colleagues, clients and their regulatory counsel.  Since then, I’ve looked for resources to pass on to other teammates or students to explain the process, which can be complex. I’ve found some really good descriptions of the process a drug or biologic undergoes (one of my favorites is by my colleague Mark Senak), but nothing that really works for medical devices.  (If you have a resource, please share it!)

So, here’s what I’ve developed and shared (with the caveat that I am not a regulatory expert.  I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective.)

Devices are can go through two different processes at the FDA: The 510(k) and the Premarket Approval (PMA). Every year the FDA reviews thousands of 510(k) submissions, which is about 10 times as many PMA applications.

510(k) Clearance

Approximately 90% of device applications that the FDA receives annually go through the 510(k) process. This is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective (substantially equivalent) as a device that is already being legally marketed. This process on average takes under five months, although it can range from three months to about a year. Because it usually requires no clinical trials or research it also requires less investment and presents less financial risk to investors.

However, changes are underway.  The FDA is now requiring some devices going through the 510(k) process to have supporting clinical data, requiring a trial. This is generally the case when there is a new technology or a request for a new indication for use. When a study is required, it is the same as an IDE study (explained below).

Premarket Approval

A PMA is an extensive application submitted to the FDA to request approval to market. Unlike a 510(k), a PMA is based on the FDA’s determination that “there is sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm)

This process generally takes at least five years, and often longer.  Here’s the process at a glance:

  • Feasibility studies are usually animal studies, and may include other kinds of economic and market research.
  • Investigational Device Exemption (IDE) approval is required from the FDA before in-human trials can begin.  An IDE trial can be a small, pilot or proof of concept study, or it could be a large pivotal trial.
  • In the medical device world, a pivotal trial is considered large when it includes several hundred patients, vs. the several thousand that may be included in a trial for a drug or biologic.
  • All PMAs for a first-of-its kind-device require an advisory committee review.  (I’ve never worked on a project going through the PMA process that didn’t have an advisory committee meeting.)
  • Of the three decisions the FDA can make, two are clear-cut: The device is approved or not approved. An approvable letter is a lot less clear-cut.  It means that the review is complete, but the FDA wants the company to address a few things, such as labeling, or setting up an inspection. When the issues are addressed to the FDA’s satisfaction, then the device may be approved.

Important Lingo

  • The FDA clears 510(k) submissions and products receive 510(k) clearance.
  • The FDA approves PMA applications and products receive FDA approval.

Other Good Resources

Mann Foundation

FDA PMA Overview

FDA 510(k) Overview

WSJ: Too Fast or Too Slow?

This information reflects my experience in working with FDA-regulated products.  Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!

©2013 All rights reserved. This article may be shared in part or whole with credit given to author and link to Merryman Communications

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Vanilla doesn’t sell unless it’s Ice Cream October 28, 2010

Vanilla ice cream has a rich taste and appealing aroma, making it the best selling ice cream flavor around. The Wikipedia page devoted to vanilla notes that it is the second most expensive spice after saffron, because of the labor required to grow the vanilla seed pods.Vanilla is used in foods, perfumes, aromatherapy, and apparently even as a bug repellant and a home remedy for minor burns. Clearly, it is very versatile.

Getting it right

However, when promoting a product, a ‘vanilla’ description is anything but appealing or versatile. Product descriptions are critical in product positioning.  Descriptions provide the basis for establishing a brand identity, a communication platform, a competitive edge, the value proposition and so much more. In the medical device space product descriptions are considered labeling. Significant effort and expense goes into securing medical device labeling.  Because medical device labeling is absolute and creative license is forbidden, getting it right is critical.

Connect the dots

To have the best possible chance at successful product adoption customers should readily recognize the value of the product through the labeling. Product descriptions should resonate intrinsically with the customer. Understanding customer needs is the core responsibility of marketing. Therefore, involvement by marketing in the product description is essential. It is senseless to disconnect the customer and patient advocate – marketing, from the customer and patient guardian – regulatory/clinical. 

Engagement at a higher level

Proactive interaction by marketing with the regulatory/clinical department early on in the clinical plan development provides the best possible outcome for labeling that will resonate with the physician customer.This is not about making it easy for marketing to promote a productNor is it about securing labeling that is loose, boastful or inaccurate in any way

Rather, this assertion that marketing participate in the discussion about the clinical plan and the desired outcome is because marketing should be leading the efforts to ensure that the product or service truly meets and exceeds customer expectations and is reflected clearly in product descriptions. The regulatory/ clinical expertise is most impactful by establishing strong and undisputed product labeling, that doesn’t need interpretation or lyrical descriptions for the product to be appreciated.

Untangle the tangle

Many marketers complain that they are hamstrung by the regulatory department when product promotion and communication plans and tactics are proposed. Many regulatory departments cringe at the creative approach marketers present to convey a product purpose, benefits and applications. 

It seems that the simplest and cleanest approach is to use the product labeling granted by the FDA,

based on evidence provided by the regulatory and clinical experts

that distinguishes the product precisely as it is intended to be used by customers,

through the distillation of customer needs by marketing. 

And while that seems a mouthful and a tall order, early collaboration between marketing and regulatory/clinical is the most likely path to labeling that is descriptive and telling. The kind of labeling where ‘creative marketing’ is about the many ways to communicate product availability and not about the many words required for product description. Product labeling typically happens only once. Getting it right so the right customer connects their needs with the value of the product will make the best use of all efforts to promote and protect.

(c) 2010 pH Consulting; all rights reserved.

 

 
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