Tips and red flags to help you select a medtech contract manufacturer
A few years ago, Vivasure Medical faced an emergency that “nearly shut our company down,” co-founder Gerard Brett said.
“We picked a supplier in good faith — it looked like they had what it took to do the job for us,” he said. “We were working away at developing a part of our product, and we got a phone call with 24 hours’ notice to say the sheriff is going to put a lock on the door of that company.”
The supplier was about 4,500 miles from Vivasure’s Galway, Ireland headquarters where Brett serves as chief operating officer of the maker of advanced polymer implants and delivery systems.
“We literally put people on a plane, hired what looked like the CIA, we had black Suburbans, and we backed up to the back of that facility at 2 a.m. and took our stuff out: equipment and materials,” Brett said. “At 6 a.m., it was locked.”
Vivasure Medical co-founder and Chief Operating Officer Gerard Brett [Photo courtesy of Vivasure Medical]
They offered tips, advice and red flags for medical device developers seeking outsourcing partnerships with contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs).
Getting started
“Ask first of all: What do you want, why do you want it and can you afford it?” Brett said. “Depending on the state of your company’s finances, depending on the state of development of your technology, what you need in a vendor from concept through design through development could be considerably different than what you need for post-clinical and commercialization.”
