Assemble Your Crisis Management Kit Now Before You Need It

As a small business owner, I know first hand that unexpected events can turn your business upside down in a moment. Over the past 18 years, we have had several unexpected events that could have endangered the quality of service to our clients or even the continued existence of Empirical.

Whether it was the electricity on the city block being taken out by a driver crashing into a utility pole housing the transformer, or navigating through a series of calamities that led me back to work three days after giving birth to my oldest son, running a group of companies has meant unpredictable events lurk around every corner.

Your business, however, not only can survive but potentially grow from these crises if you’re properly prepared. Not that we can brace for every possible outcome, but it is possible to minimize damage with the right management tools. I turned to our in-house expert on crisis management for some tips on what any business can do to keep stable during tough times.

Meredith May, MS, RAC, CQA, is vice-president of Empirical Consulting, part of the family of Empirical companies. She recently authored a chapter on crisis management for the guide “Fundamentals of U.S. Regulatory Affairs—Ninth Edition,” published by the Regulatory Affairs Professionals Society. She’s not just my top regulatory expert—she developed the crisis management strategy for all three of our companies (Empirical Testing Corp., Empirical Consulting, and Empirical Machine).

May is a devout believer in the five Ps: Prior planning prevents poor performance. We like to ask her to say this as quickly as possible five times in a row.

“When you’ve prepped and organized, people can step into their roles and start dealing with the crisis without the initial panic phase, during which the crisis typically deepens,” she said. “If you have a plan, if you know what to do, you move into action, not panic.”

She recommends putting together what she calls a crisis management kit with the help of relevant team members, preferably employees with a broad range of experience. It’s a group effort based on a lot of brainstorming and research. Quiz your team members about the worst crises they’ve dealt with over the course of their careers and how they handled them. Research potential issues based on your company’s services or products as well as your specific industry so you have an idea of what could go wrong and how to react, or even what not to do.

“You need to know where all the weak points are for your business and also for your industry,” May said. “You’re really coming at it from two different perspectives: internal and external. Do some soul- searching and be honest about where your liabilities are.”

For example, if your company produces metal hip implants, you want to know not just the failure points of your specific device, but also the ins and outs of metal-on-metal wear and how that issue has affected that particular market segment. If your company focuses on regulatory issues, read up on what’s triggering recalls, warning letters, and other potential blocks to market.

An example of an internal crisis would be equipment breakdown or other disaster that affects production. An external crisis could be the loss of a manufacturer that’s critical to your product.
Both can have immediate, catastrophic effects on your ability to conduct your business. Determining what those potential pitfalls are and how to address them brings you back to your brainstorming session with key players.

“In general, you want to bring in your senior leadership, your managers, and your vice presidents to do the planning,” May said. “Pull in people preferably that have multiple experiences at different companies.”

The results of those brainstorming sessions will translate into clear plans of action for the rest of your company. Regardless of your specific line of business, May recommends three general areas of crisis planning for members of the medical device industry: patient harm, financial, and legal/regulatory. Consider worst-case scenarios for each type of crisis and form your crisis management kit for the top-tier disasters first.

“Once you have come up with your list of all things that can go wrong, you’re going to prioritize them based on first, ‘Do you have a weakness in your company that makes this risk or crisis almost inevitable?’” May continued.

You may want to bring in a consultant to ensure your focus is broad enough and your crisis management kit is a solid foundation for recovery. Consultants will have seen a wide range of crises at a variety of companies; they’ll have a depth of experience to draw from that’s likely greater than what your team can bring to the table because those consultants work outside of your company. They also don’t have hidden biases or a personal connection to your work, so their thinking is often more objective. Spending the time and money with the right consultant for pre-planning will likely save you money and stress over the long term.

“You’re better off hiring them up front for a two-day brainstorming session than hiring them to deal with a crisis for six months,” May added.

The hire should be someone who can help come up with the specific tools needed to address the potential crises identified. This includes a step-by-step action plan with a checklist for each type of crisis and delineation of responsibilities (i.e., who does what).

May and I both swear by checklists. When you have a list to run down, it’s another way to decrease stress and panic. You don’t have to come up with what to do in the moment because you have it laid out in a simple format (Recommended read: “The Checklist Manifesto: How to Get Things Right”). Have digital and hard copies easily accessible to the people who will need them.

“You cannot rely on someone to remain clear-headed and make good decision at a time of crisis,” May said. “That’s why it’s so important to have it formatted so someone can read down the checklist. It gives people confidence and turns potentially panicked employees into heroes.”

You’ll also want internal and external communication templates ready to go as part of your kit. This could include emails to distributors, clients, regulatory bodies, and press releases addressing issues stemming from potential crises you’ve identified. Pinpoint who the appropriate contact for your stakeholders is (e.g., public relations director for the media, your regulatory expert for the U.S. Food and Drug Administration, etc.). If you produce a specific device, you might want to have a series of communications that address product failure or recall. If you’re a manufacturer, you may choose to prep a package of emails/letters that deal with production shutdown for various reasons. Writing out all of these communications ahead of time when you’re not in crisis mode will ensure you include all the relevant information to all the right players.

The best way to prevent disasters is to avoid them altogether, which is what we manage to do most days. That’s why taking the time on those good days to prep for the bad will build a solid foundation for taking appropriate action in the tough times with calmness, confidence, and clarity.

May often cites the “Miracle on the Hudson” as the ultimate example of an effective crisis management kit. In 2009, Capt. Chelsey Sullenberger safely landed an airbus 320 filled with passengers on the Hudson River with no loss of life.

Sullenberger credits that particular diversion of a potential catastrophe to training, preparedness, and checklists.

“Your crisis management kit will stabilize the ride,” May said. “It will enable you to land your plane on the Hudson River and someone else can get it out.” 

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Dawn Lissy is a biomedical engineer, an entrepreneur, and an innovator. Since 1998, the Empirical family of companies has operated under Lissy’s direction. She has been responsible for all Empirical operations, including designing test fixtures and protocols, running test protocols, and writing complete reports. She holds an inventor patent for the Stackable Cage System for Corpectomy and Vertebrectomy. She is a member of the Biomedical Engineering Society, Society of Women Engineers, the American Society of Biomechanics, and the ASTM. She holds an M.S. in biomedical engineering from The University of Akron, Ohio. She can be contacted at [email protected].