Finding the Right Contract Manufacturer

Early, clear communication with a potential contract manufacturer is crucial for a successful end result, said Krystal Santiago, VP of quality assurance and regulatory affairs at Planet Innovation. She will be speaking at IME West 2024 on how to best leverage the right contract manufacturer for a company’s specific needs. 

“We want people to come away with how to work with a contract manufacturer and how to select the right one particularly for your company,” Santiago said, of her upcoming presentation, “Future Proofing Your Manufacturing Strategy for Regulated Medical Devices.” When Design News recently spoke with her, she said she hopes to have a good panel discussion regarding what issues are most important to consider when choosing and working with a contract manufacturer. 

Informa Markets Engineering (IME) West will be held February 6-8, 2024, at the Anaheim Convention Center and feature Medical Design & Manufacturing (MD&M) West, Design & Manufacturing West, ATX West, WestPack, and Plastec West.

Some of the biggest challenges facing the medtech industry currently, she said, are with supply chains, especially electronics, and also changing regulations, both in Europe and with FDA. Working with the right partner can help companies navigate through these issues.

For example, contract manufacturers can act as sort of an intermediary when dealing with FDA, she said. “If you wait until the very end of your design to have conversations with FDA, you're going to lose all time that you could have been having conversations along the way,” Santiago said. “We'll do negotiations on clinical studies, or we will do negotiations on what has to be filed for product approval,” she said. “FDA is really amenable to some of these conversations, and it makes it really quite good for the company as well.” 

As for supply chain issues, some risks include components, especially electronics, coming in and out of service. “We keep up to date with what the PCBA [printed circuit board assembly] manufacturers and the rest of the industry are doing,” Santiago said. 

Santiago noted that companies usually follow one of two paths in selecting a contract manufacturer. “I've seen people go completely by their gut and walk in and just look for the connection that they have with the folks. That is one way to go,” she explained. “The other way to go is completely in the other end where you set up a few matrices—you say ‘here are the things I'm going to force rank, all of the ones that I interview on, and I’m going to be very analytical about it.’ And sometimes [when doing this] you actually miss the other side.”

The answer lies somewhere in the middle, Santiago said, noting that a company needs to define what is best for its needs, such as flexibility or supplier base. “If you don’t set priorities ahead of time, you’re more apt to fall into ‘the last one was the best one,’ because it’s the freshest in your mind and it’s a long process. But you also shouldn’t overlook the skills and capability of the staff at the contract manufacturer.” 

When asked who she would like to see at her session, Santiago said both engineers and program managers on the technical side would benefit from it, and it would also be good for supply chain professionals. 

“The earlier you can integrate a full-service contract manufacturer into the process, the better off it is for everybody,” she stressed. “And it’s good for both the technical side and the business leaders to understand what that looks like.”

Santiago said she hopes that people come away from her presentation with an understanding that there are ways to safely negotiate with FDA, and that there is a right place and time to do it. “We also want people to come away with the idea of making sure that you're designing products optimized for transfer, because once you actually get them transferred into a contract manufacturer, dealing with changes after the fact is a little bit harder and costly than trying to figure out how to do it ahead of time,” she concluded.

“Future Proofing Your Manufacturing Strategy for Regulated Medical Devices,” will be held Thursday, February 8, from 2:30 to 3:15 p.m. on Center Stage.