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, political, and social trends. The more you can consider and anticipate, the better you’ll be at identifying potential risks and developing mitigation and contingency plans.
Risk management involves proactively identifying what-if scenarios (e.g., what if we can’t get a key raw material or there is a sudden demand spike? What if we lose a key customer?), evaluating the probability of occurrence and potential impact, and taking steps to eliminate or reduce the negative consequences. Scenario planning is a key tool in risk management, as it can help identify possible risks and solutions, and it encourages the team to look at potential situations from different angles. Keep in mind that risk can be associated with a positive outcome as well, such as an unexpected increase in demand. What if a drug was found to be an effective treatment for another disease?
Proactive risk management is not a one-time exercise. Monitoring and controlling risks are ongoing efforts that you should do at regular intervals, after any major milestone, changes to a key resource, or whenever a new risk is identified.
Plan a structured response. Develop a structured response plan as part of your overall business continuity plan. This high-level plan addresses how to react if any type of crisis occurs. In a nutshell, a plan will identify the person or position that will lead the response, as well as requirements such as cross-functional support, time, funding, and other resources required. It should also consider who will support the work of those who are pulled to focus on the crisis.
The more specific the plan, the better. It can serve as both a starting point and communication plan for internal and external stakeholders. Organizations can develop structured response plans for any potential crisis event from a hurricane to a global pandemic that stalls overseas imports.
Like the risk assessment, update the structured response plan regularly and incorporate any lessons learned from past crises.
Crisis management is an ongoing process
Despite all your prevention and risk mitigation efforts, a crisis will eventually occur. Integrated Project Management Company, Inc. (IPM) has a checklist that can help you triage the crisis and decrease its impact. Read our whitepaper, Don’t Let a Crisis Become a Disaster, to get a copy of the checklist and learn how advanced preparation, strong leadership, and disciplined execution can reduce the impact of any disruptive event and even become a competitive advantage.
Integrated Project Management Company, Inc. (IPM) can help you address compliance issues in a way that minimizes disruption to your business and culture, while driving long-term response improvement. An industry leader in life sciences consulting for more than 30 years, IPM has managed thousands of projects for more than 150 biotech, pharmaceutical, and medical technology companies. Contact us to discuss how we can help with your critical initiatives.
Sponsored content by Integrated Project Management Co.