The onslaught of devastating hurricanes, wildfires, floods, and other natural disasters the world suffered in 2018 have accentuated the need for business continuity planning (BCP) in medical device manufacturing. Although many companies develop plans for potential crisis situations, it’s important to ensure primary packaging providers are equally prepared because their products are critical in the medical device lifecycle.

After an emergency, it is essential that medical device manufacturing plants get back online to supply healthcare providers and ultimately serve patients. Device manufacturers rely heavily on their suppliers to keep business running smoothly and in compliance. However, companies can be significantly stymied when key packaging providers are unable to provide necessary products during an emergency or natural disaster.

Brace for the Worst
Some manufacturers may audit suppliers on business continuity aspects, but most are inadequately informed about their packager’s ability to recover quickly enough from a catastrophe to circumvent a supply chain disruption.

Medical device manufacturers increasingly are asking packaging providers to share their BCP (also known as a disaster recovery plan). A well-prepared packaging supplier is key to shipping medical products on time to satisfy customer demand. Consequently, an interruption in packaging can cause manufacturers to stop lines, delay deliveries to healthcare providers, and potentially lose market share.

Business Continuity Planning
A packaging supplier with a thorough BCP will recover quickly from a disaster and help device manufacturers supply quality product to meet patient needs.  Thus, companies should ask suppliers to detail their BCP so they can determine whether the packager is a reliable partner or a liability.

Although business continuity applies to any event that could endanger business operations, there are several top risk areas that must be addressed before corporate life can return to normal after a disaster. These include:

Communication: It’s important to communicate with employees, worldwide company operations, suppliers, and customers throughout a disaster. Determine the message(s) to send each of those audiences, the kind of communication to use, who should issue the communication, the frequency of communication, and contact people for each audience. Have backup methods of communication such as satellite phones and internet in case of a power failure.

When a storm is forecast, issue a message of precaution and/or prevention to employees. Explain the known risk, how communication will be shared, and how the company can support its staff. Use email, phone messages, texting, digital display boards, and team meetings to explain the situation and possible next steps after the storm passes. Share real-time updates on the storm’s evolution from local radio, television, or internet reports.

Give these same messages to teams at other company locations worldwide. Use one point of contact at headquarters and have that individual disseminate information to appropriate people at other facilities. This prevents inconsistent messaging and confusion. A BCP should include direction for other facilities to take over production or help with recovery after a disaster.

Business Continuity Plan Helps Thermoformer Minimize Production Disruption After Hurricane Maria In September 2017, Hurricane Maria made landfall on Puerto Rico, ravaging most of the island. By implementing a robust BCP, Prent Thermoforming’s Puerto Rican plant was the first facility of its kind on the island to resume operations. The plan helped the company minimize production interruption and achieve a 100 percent delivery rate to all medical device customers based on newly established priority orders. Before the storm, Prent communicated with employees, headquarters, and customers to establish a course of action. Employees were asked to report to work the following week if conditions permitted (this gave everyone a clear understanding of the company’s expectations). Prent’s facility—built to withstand winds up to 150 mph—sustained minimal damage, thus allowing the company to focus on supporting its workers and the community, and to quickly resume operations. With matched thermoform equipment designed and built by Prent positioned globally, Prent’s headquarters in Janesville, Wis., was preparing to leverage open capacity in Wisconsin, Arizona, and Costa Rica to assist customers in Puerto Rico.  Instead, shortly after the hurricane, Prent headquarters sent three airplanes of food, generators, and other supplies to all 47 employees in Puerto Rico—a gesture that gave employees and their families peace of mind during the recovery process. Surprisingly, many workers showed up a day early to prepare the facility for production. These workers understood the importance of getting the plant back online quickly as well as the significant role of medical device packaging on ultimate patient care. Prent team members immediately reached out to all Puerto Rico-based customers by physically visiting their sites because phone and internet were not available. Customers modified forecasts and dates so Prent could identify immediate packaging needs and ensure on-time delivery of high-priority orders. There was enough raw material in inventory to meet customer orders, as Prent has contracts with customers to maintain a certain level of stock for fluctuating order sizes. That in-house inventory was vital because additional raw materials came in slowly for weeks while the ports in San Juan and Jacksonville, Fl., were tied up with critical shipments from FEMA. When the facility returned to full operation, there were some lessons learned that were incorporated into an updated BCP: the need for backup communication (satellite phone, satellite internet, and voice over IP) and a significant amount of available cash to pay for local services, and support employees. — WM

Pre-event planning communications may not be possible during unforseeable events, so establishing an emergency response with headquarters is especially important. Suppliers with operations in multiple locations are best positioned to get immediate assistance and minimize production interruption.

Sales persons can help notify affected customers of an impending weather event and the potential for order disruption; they can also lend a hand creating a backup plan that prioritizes clients’ packaging needs. 

BCPs should involve logistics partners that can help deliver raw materials or ship finished packaging to customers, even when transportation is limited. Have multiple transportation sources to fulfill all clients’ needs. Establish payment arrangements ahead of time.

Human factor: Taking care of people must be a top priority after a disaster strikes. Assistance begets peace of mind, reassures employees that their families are safe, and helps them feel comfortable enough to return to work and resume a (relatively) normal life.

Depending on aid availability, the employer may be solely responsible for providing help and essential resources to its workers. This may include paying salaries in cash (as credit card machines and ATMs may be out of order), providing access to power and water at the facility, and helping nearby residents or businesses in the community. It is unlikely all employees can report to work immediately after a disaster. Include cross training to ensure there’s always a person available to run essential functions.

Facility protection: Sufficiently protecting the facility will best prevent operational disruption. This includes the ability to withstand storm surges and high winds, shutters and other methods to cover vulnerable areas like windows, bringing outdoor equipment inside, and battening down loose elements that could become dangerous projectiles. Perform routine inspections plant-wide to ensure all areas are always covered in the BCP.

Following a disaster, it will be especially important to guarantee security for the facility so workers and property remain safe against criminal activity. Security systems (like keycard entry and cameras) should be considered critical and tied into backup power service.

Utilities: When utilities are destroyed, a continuous power generator can effortlessly run production equipment. A continuous generator is only helpful with sufficient fuel supply; make fuel reserve plans with providers in advance to secure the needed supply. Conduct regular preventive maintenance on backup generators and related equipment so they are reliable and ready to use.

An onsite water tank can be very valuable if the public water system is contaminated. Water may be an urgent necessity for employees and area residents as well, so be ready to give them access to the water supply in dire situations.

Data/information access: A disaster will likely disable the internet for a period of time, so offsite data backup and replication is key to getting production running again quickly. This means having all crucial information residing and duplicated on multiple servers at different locations.

A packaging producer with several facilities will benefit from a shared network. In that case, another company facility can provide all customer information necessary to get online again. If necessary, those other locations should be ready to seamlessly assume production until the impacted facility has returned to normal function. Having manual (non-internet reliant) processes in place also allows essential machines to run with just data from an internal server. 

Every medical device manufacturer must be ready for disaster with a BCP. But that plan should extend to the packaging supplier as well. As a crucial part of the supply chain, packaging providers must be ready to provide uninterrupted service in case a disaster occurs at their location. It’s dangerous to wait until disaster strikes to set a recovery plan in motion. The best course of action is to proactively contact the packaging partner and ask how it plans to protect its customers during natural calamities. 

---

Wilfredo Mercado is the VP of manufacturing operations for Latin America and former plant manager for the Prent facility in Puerto Rico, where he has lived most of his life. He draws knowledge of business continuity planning from working 10 years in medical device operations. Mercado was instrumental in designing and implementing the company’s BCP after Hurricanes Maria and Irma devastated Puerto Rico in 2017.