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Medical Device Recalls 101: My Device Was Recalled. Now What? (Part 2 of 2)

Posted by Amy Smith at 12:17 pm, April 7, 2011

Part Two of a two-part series

The FDA’s overarching position (PDF) is not that they expect a company to be “recall free,” but they expect a company’s recalls to be conducted properly. 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.

Bottom line: 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:

FOUR-STEP RECALL RESPONSE CHECKLIST

1. Plan Ahead

As a marketer, you should be heeding the Boy Scout motto, “be prepared,” by putting together your crisis communication plan in advance. Make it a 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 may include, for example, having a digital resource on the ready to launch a recall website. Check out various types of recall sites, such as Medtronic’s, McNeil’s or the very robust one for Toyota.

2. Respond Quickly

Communication, communication, communication! Aside from FDA mandates, be proactive in your approach. The worst thing you can do is be silent, which can be perceived as cavalier or idle. 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 follow up email responses 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 either with a letter 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.

3. Acknowledge It

It’s critical to handle a recall with integrity and open communication. More than anything, do not 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. Sugar coat 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 years. You have to work hard to rebuild trust and confidence in the overarching 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 when McNeil recalled Tylenol this year. They launched a response campaign offering “FREE ADVIL” and urging consumers to clean out their medicine cabinets and trash recalled drugs. The campaign website hits hard with 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 & Nephew or J&J DePuy. In your opinion, did they handle their recalls gracefully under pressure?

About the Author

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Amy Smith is an Account Director at HCB Health.

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