Device Firms in Puerto Rico Look to Learn from Hurricane Maria’s Aftermath
With Hurricane Maria’s anniversary approaching, medical device firms in Puerto Rico are reflecting on lessons learned to mitigate the impact of any future natural disaster on supply and quality.The devastation that the hurricane wrought is reflected in Puerto Rico’s death toll, with the estimates reaching a total of 2,975 residents. But the experience of having to operate below capacity and on generator power presented some unique challenges that some firms see as opportunities to grow from.
Edward Lifesciences and Boston Scientific are two of the many international medical device manufacturers with facilities on the island. Others include Abbott, Medtronic and Baxter, which was particularly affected by the hurricane’s aftermath.
The impact on Baxter’s production prompted the US Food and Drug Administration (FDA) to step in (because of an already short supply of saline products) and allow temporary exportation from overseas facilities. In March, Commissioner Scott Gottlieb indicated FDA intends to explore new ways to address “the root cause of more of these shortage situations.”
In preparation for any natural disasters that may come this season or those to come, the quality manager at Edwards’ manufacturing facility in Añasco, PR, and the head of sales at Boston Scientific’s plant in Dorado, PR, shared some of their main takeaways to improve crisis management strategies.
Retracing steps and revising processes
Edwards is revisiting at least two contingency plans to strengthen its processes for shipping products and to support greater use of renewable energy, Richard Rodriguez, quality manager at Añasco, told Focus. “The most important carriers, such as FedEx and UPS, did not provide logistics for product shipments on the West side,” which is where Añasco is located, he said.
Another lesson learned among Edwards personnel relates to FDA site inspections. The agency has conducted more than one visit to the Añasco facility since the hurricanes stuck, Rodriguez said. “The agency’s observations call for more aggressive contingency plans to avoid impacting the quality of the products manufactured at the facility and safeguard controls already in place.”
Boston Scientific, meanwhile, learned how to take a more team-based approach to their sales operations while staying within the parameters of previously established processes, sales supervisor Javier Perez Zayas told Focus.
Boston Scientific is also looking at how to expand on the steps it took last year, including designating a team to manage special product orders and sending teams to other areas outside PR that may be easier to reach in the event of a natural disaster, Perez added.