Dealing with disruptive events

Don’t let a crisis become a disaster

The term “crisis” has become much too familiar in medical device companies. Whether it’s an FDA 483 or warning letter, plant audit, product recall, or other unplanned event, a crisis disrupts your operation and can pose a significant risk to your business. And the challenge doesn’t have to be large-scale to cause disruption. Compliance challenges require immediate attention and well-coordinated efforts, or you can face staff overload, lost focus, delayed product launches, and financial losses.

Plan for the unexpected—before it happens

Of course, the best way to handle a crisis is to prevent it. The next best way is to be prepared for how the organization will mobilize when a crisis arises.

Apply risk management. First, learn to “see the future.” This doesn’t require a crystal ball. It requires a concerted, ongoing effort to monitor the market, regulatory landscape, key business metrics, and economic, po…

Read more
  • 0