Product Managers: How to Deep-Six a Medical Device or Pharmaceutical

Posted by Digital Manager on Mon, Nov 12, 2012 @ 01:53 PM

Like most product managers or directors, you want your pharmaceutical brands and/or medical devices to thrive — perhaps even be market blockbusters. You devote hours to your strategy, forecasting, marketing, distribution, and other key functions that map your product’s success.

Still, there are 6 ways you may be threatening to deep-six your product’s existence without even realizing it.

1. Taking a wait-and-see approach toward the product recall process.

Crossing your fingers and hoping for the best might sound like a potential strategy once your pharmaceutical brand or medical device receives market approval. However, hundreds of medical devices are withdrawn from the market, affecting millions of units each QUARTER. Although fewer pharmaceuticals are recalled, these drug recalls also involve millions of units with each announcement and often make sensational headlines.

A recall plan will help you appropriately — and responsibly — handle a recall situation, should an unwelcome scenario occur.

product recall process

2. Being vague about roles and responsibilities in your recall plan.

A vague recall plan won’t save the day — or your product. Instead, outline a multiphase recall process that clearly defines roles and responsibilities for all individuals and departments that would be involved in a product recall.

Who would be the recall coordinator? Who would be in charge for each department? Who would be the designated backups? In what sequence must events occur?

Know which federal agency is responsible for the recall of your product and the most efficient and effective ways to communicate with them.

3. Waiting until you’re "sure" to report a product defect or danger.

Medical devices and pharmaceuticals can promote health, healing, and maintain lives. But by their very nature, they may also cause significant harm — especially if a recall response is delayed. The longer you wait, the more people’s health and well-being may be jeopardized.

If you suspect that your medical device or drug may be dangerous, tainted, or defective, immediately report the concern to the appropriate regulatory agency — even if you’re not 100% sure there’s a problem.

4. Ignoring recall plans of your business partners, suppliers, distributors, or vendors.

You’ll not only need copies of your business partners’ recall plans, but you’ll also want to be sure that your partners include recall drills. These drills will help you evaluate not only your partners’ preparedness, but also their procedures, ability to respond, and recall capacity.

5. Relying on a standard liability insurance policy for recall risk management.

Standard insurance policies may include recall endorsements, giving a fall sense of protection and security. These policies often fall short of covering the full range of recall services needed to protect consumers and your product.

Carefully consider the risks and benefits of your product before purchasing your liability insurance. Comprehensive policies can cover all phases of an integrated plan, including crisis communications, logistics, and other necessary expenses.

6. Winging it.

Once you have a multiphase plan, put your people, policies, and procedures to the test. A well thought-out recall will help you:

  • Locate recalled products
  • Remove them from the marketplace
  • Protect consumers
  • Correct the defect as necessary

A mock recall drill can help discover holes in your process.

With an effective plan in place, most products and companies can weather the storm of a recall.

SCHEDULE a free mock recall

Topics: Stericycle, Pharmaceutical Product Manager, Recall Readiness, Product Manager, Medical Device, Brand Manager, Recall Risk Management, Product Recall Process, Drug Recall Management, Medical Device Product Manager, Medical Device Brand Management, Pharmaceutical Brand Management, Medical Device Management

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