BioMatters - Special Medical Devices Edition

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PACK AGING COMPLIANCE L ABS

TAKING ENGINEERING TO HEART BY CASSIE PETERSON, MARKETING, MANAGER, PACKAGING COMPLIANCE LABS

Packaging Compliance Labs has been through four major expansions in its history including, adding a lab, doubling its office space, and creating a mock surgical facility. Co-founders Matt Lapham and Ryan Erickson recognize the significance — and the seriousness — of their upward trajectory. Lapham noted, “We never want to lose sight of the people who need the medical products we work with.”

Seeing the heart lay on ice while the ECMO (Extracorporeal membrane oxygenation) machine sustained the patient’s life and the surgeon implanted the valve was sobering. Yet, it helped Erickson prepare for upcoming projects engineering packaging for emerging technology in prosthetic cardiac devices.

The medical device packaging engineering, validation lab, and contract manufacturing firm works hard to protect its small-business, customer-centric mindset from the pitfalls of big business. Lapham stated, “We are fortunate to work with global leaders and major corporations, but we also work with small startups and OEMs. Every one of those clients is in the business of bringing life-improving or life-saving products to people and families. We honor that reality with our clients. Internally, we have a continuous improvement culture that keeps us mindful.”

Back in Michigan, Erickson reported that it had been meaningful to reflect on the young patient’s new hope for the future and how her family must have felt. He went on to tell his team that the experience had driven home the weight and significance of their work. After hearing the story, it was easy for the team to agree that every strict quality assurance measure they follow is worth the effort.

Taking Quality to Heart When Ryan Erickson, Vice President of Engineering, attended an open-heart surgery at a northeast Ohio hospital, he had the opportunity to experience the full journey of a life-saving device, like those for which he designs packaging systems every day. Scrubbed and gowned, Erickson had listened intently as the cardiovascular surgeon explained that the open-heart surgery would repair a congenital heart condition that had not only severely affected the patient’s quality of life but had also been a looming threat to her life altogether. The surgeon explained that the procedure would replace a defective aortic valve with a prosthetic valve.

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MICHBIO | michbio.org

Within hours, the young patient, with a fully functioning heart, was wheeled to recovery with a new chance at a healthier, more active life.

Additionally, Erickson’s experience observing that procedure cemented the importance of understanding real surgery situations, patient needs, provider expectations and more. Since that visit, PCL (Packaging Compliance Labs) has launched a new Usability Evaluation service and mock surgical facility to ensure its packaging and manufactured products meet the highest quality standards and maintain a patient- or end-user focus.


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