Earlier this year, CardioFocus wowed the market when it won pre-market approval from the FDA for its HeartLight system, an endoscopically guided light energy device for the treatment of…
The combined team had to adjust not only to changing specifications and pre-clinical testing results, but also with the evolving processes around testing and verification, including human factors and usability. “The way that we perform usability testing on this product now, and really how we conduct overall verification testing, is significantly more sophisticated than even 10 years ago, based largely on new regulatory standards and guidance documents,” Smith says.
What Makes a Good OEM?
Smith says that when Minnetronix started with CardioFocus, it was one of hundreds of startups around the country. “We had no idea of their probability of success.”
And yet, being able to provide long-term support is critical for Minnetronix as a CMO that works with some of the largest medical device companies in the world. As Reed says, “We do a lot of work with startups as well as operating companies. We hope those startups will eventually become a company like CardioFocus and our goal is to help them cross that finish line.”
Over time, says Smith, you develop a sense of what good startups bring to the table. Essentially, Smith says, OEMs that know what they need and when they need it are in a better position. CardioFocus is the same company it’s been for more than 16 years, he says, but what they need from a CMO has changed dramatically along the way. That’s very common, he says, particularly in the medical sector, where timelines and product lifecycles can span decades.
A good partner is one that looks beyond its immediate needs, as well as what fits at the moment. “It’s important to play chess, not checkers,” he notes. Smith advises companies to look at today’s needs as well as next year’s – and then 5 years down the road. “They’re almost for sure going to change over time.” It’s important for companies to think about that and pick partners who can accommodate them for their whole company life cycle, not just the particular problem they face in the moment.
What Makes a Good CMO?
Melsky says an outsourcing partner should have specific technical capabilities, but there’s more to it than that. “I get a call every day from somebody who’s seen our box, saying, ‘That looks like the kind of stuff we make.’ They say, ‘Hey, why don’t you consider us?’”
It was critical to Melsky to find a company that could cover development at a very early stage, from ideation for the new product all the way through to a manufactured product – and one that could actually do the manufacturing. “Over the years, we’ve talked to different folks about being a supplier for us, doing things similar to what Minnetronix was doing.”
Many of them, he said, had development capabilities and were willing to make a few units, but they weren’t able to do full manufacturing. Alternatively, others were highly capable in manufacturing but couldn’t cover the development side. “Having somebody that was going to take it all the way through from the concept state into full production, that was very important for us,” Melsky explains, noting that a lot of issues occur at the hand-off from development into production.
“Another big thing for us is their response to problems that come up,” he adds. “They’ve always been very responsive when we’ve had a new issue that we’ve discovered. They’ve always been very responsive in trying to help us sort through what the problems are and giving us rapid proposals for addressing problems.”
Reproduced from Medical Design & Outsourcing, July 2016, pages 57 – 61