Device ad-vice: Best practices for handling a medical device recall

Amy Smith

HCB Health

(Continued frompart 1 of  the “Device ad-vice”: Device ad-vice: dating vs. commitment: pharma vs. Devices)

Product recalls are a major headache for pharma, but device manufacturers can feel the pain, too. In the U.S., the FDA’s 510(k) process for approval is under intense scrutiny1, with critics charging that it allows unsafe products to be marketed by requiring only that new entries demonstrate substantial equivalency to other approved products.

Even if device manufacturers seek European CE Mark approval to market a technology prior to seeking U.S. authorization, it doesn’t lessen the risk of a potential recall—the rates are just the same2. While regulatory action may help diminish the number of recalls, it can’t prevent them completely, no matter where the device launches.

A recalled device can create a time of crisis for its brand. When patient safety is at stake, a recall can topple sales, reduce share value, and erode market trust. It’s vital to mitigate the damage.

Let’s take a general look at what’s going on.

High-risk vs. low-risk recalls

Device recalls are not one-size-fits-all. There are voluntary recalls and safety alerts, which the FDA stays fairly hands-off about. One example is Smith &amp, Nephew’s BIRMINGHAM HIP Resurfacing System implant recall3 in 2007, which was due to a package labeling error.

In some cases, the regulatory bodies suggest companies conduct a voluntary recall, in which case government scrutiny may still be high.

When it comes to formal FDA mandated recalls, they range from low- risk CLASS III recalls, which don’t even require a press release from the FDA, to high-risk CLASS I recalls, which are the most serious. Cardiovascular devices were the largest recall category between 2005 and 20094, accounting for 31 percent of all high-risk recalls during that time.

On the bright side, AdvaMed, a global device manufacturer advocacy organization, recently stated that less than one percent of devices cleared since 1998 were involved in Class I recalls5. Our friends in pharma might just be envious of that statistic.

Despite this low rate, keep in mind that this is a global issue—no matter which market you choose to launch in first. A recent study shows that the number of recalls in Europe is identical to that in the U.S., and the therapeutic mix and types of recalls are also similar to those in the U.S.6

“…we aren’t exactly cut from the same cloth as pharma. With devices, it could be a problem with your suppliers—not you.”

What’s Behind the Recalls?

Even companies that put a great deal of time and energy into research, development, labeling, manufacturing and distribution experience issues from time to time, which can have devastating consequences. In 2010 alone, J&amp,J had a string of recalls that cost the company $900 million in sales7, including surgical sutures, hip implants, contact lenses, insulin pump cartridges and more.

What’s the root cause of these recalls? While pharma has shown us that the generic first-to-market rush can be an issue, as well as dose-related repackaging and relabeling8, we aren’t exactly cut from the same cloth as pharma. With devices, it could be a problem with your suppliers—not you.

If you look at Toyota and the struggles that company experienced recently, outsourcing was at the heart of their woes9. Device makers should always take a close look at the entire supply chain and quality control process, particularly at the parts and pieces that are not manufactured in-house.

As a marketer, what can you do?

When it comes to device recalls, marketers have two critical jobs to do:

1. Take action (within your realm of influence) to prevent a recall

2. Prepare and focus on your response if a recall happens

The FDA’s overarching position10 is not that it expects a company to be “recall free,” but that it expects a company’s recalls to be conducted properly. This sentiment is shared by governing bodies in Europe. Device marketers have to be on top of their game when responding because, let’s face it, recalls happen. A locked-and-loaded communication strategy is a must. You can’t always control the action, but you can control your reaction.

Depending on the class of the recall, you will have varying positions and responses. Here are some rules of thumb to get you over the hurdles.

“The worst thing you can do is be silent, which may be perceived as being cavalier or idle.”

Four-step recall response checklist

1. Plan ahead

Assemble a crisis communications plan in advance, as part of your annual strategic planning process. Consider various scenarios for potential recalls and appropriate actions (and point persons), in order to react as swiftly as possible.

This planning may include, for example, having a digital resource ready to launch a recall website. Check out various types of recall sites, such as Medtronic,11 McNeil,12 or the very robust one for Toyota.13

2. Respond quickly

Communicate, communicate, communicate! Aside from regulatory mandates, be proactive in your outreach. The worst thing you can do is be silent, which may be perceived as being cavalier or idle. And ensure that your response is appropriate for your brand.

Consider your position. What you say — and how you say it — can help mitigate negative perceptions. Are you apologetic? Steadfast? Partnering? Make sure your position and tone are woven through your communications at every turn.

Arm the infantry. Alert your field employees with crisis management instructions and expectations for relationship management. Face-time in the field is worth its weight in gold.

Keep tapping their shoulders. Aside from the mandatory letter, consider following up with emails to your customers.

Make it easy to get the scoop. Recall websites can be password protected if you want to keep customers informed while keeping competitors off your heels.

Put your CEO out in front. Share his / her statement with a letter and / or a video on your website.

Get personal. If possible, go dark with mass media by pulling your existing campaign for a brief period. Let your brand communication with customers be one-on-one and personal.

“It’s critical to handle a recall with integrity and open communication.”

3. Acknowledge it

It’s critical to handle a recall with integrity and open communication. More than anything, don’t try to sweep a recall under the rug. As a good corporate citizen, be up front with customers about the situation. Be sincere, authentic and honest. Try sugar-coating the situation and you’ll risk losing even more trust.

4. Turn the corner

A recall isn’t a moment in time, it’s a journey of weeks, months or sometimes even years. You have to work hard to rebuild trust and confidence in your brand. But the good news? Your work can reach beyond your customers to the entire market.

Consider planting a seed for the future with a “commitment” message. This could take the form of an interim campaign (after you pull your current advertising) to acknowledge your dedication to the future, to your customers and to your patients’ safety.

Responding to a competitor’s recall

What if you’re on the other side of the fence and a competitor experiences a recall? As I’ve said already, it’s important that you do what’s appropriate for your brand and market. It might be best to stay silent (lest you end up in their shoes), or it could be a golden opportunity.

Although not a device example, consider how Pfizer positioned Advil to take the lead among OTC pain relievers in the U.S. when McNeil recalled rival Tylenol in 2010. The company launched a response campaign14 offering “FREE ADVIL” and urging consumers to clean out their medicine cabinets and dispose of recalled drugs. The campaign website15 hit hard with strong, direct messaging: “Every day, thousands of people are switching to Advil. What are you waiting for?” and “Advil was not part of this year’s pain reliever recalls.”

Opportunistic? Perhaps. But marketing is about survival of the fittest — even during a recall.

What do YOU think?

When a drug or device is at stake, the pressure to respond and resolve the issue can seem immense. So think back to the recalls you’ve witnessed recently. No doubt you have an opinion on how they handled the bad press and added scrutiny. Consider Medtronic, Smith &amp, Nephew or J&amp,J DePuy. In your opinion, did they handle their recalls gracefully under pressure?

















Part 3 of this series: “Device ad-vice: Giving device reps the sales tools they needcan be viewed here

About the author:

Amy Smith is an account director at HCB Health in Austin, Texas, one of the top 25 independent healthcare communications agencies in the U.S. She leads the company’s professional/clinical account strategy team, with extensive experience in medical device, biotechnology and pharmaceutical marketing.

A graduate of the University of Texas, Amy joined HCB 10 years ago and built her department from the ground up, with a foundation of therapeutic and diagnostic healthcare experience spanning dozens of specialties and disease states.

HCB Health’s medical device credentials include work with numerous companies in the global healthcare space, including Alcon Labs (a Novartis company), Medtronic, Covidien and McKesson.

For more information, email Amy at

What are your top tips for handling medical device recalls?

Device ad-vice: Giving device reps the sales tools they need