Ask pretty much any contract manufacturer what their medical device OEM customers can do to make their lives easier, and they will say something along the lines of “involve us as early as possible in the product development process.” Regardless of how often that point is talked about, it still doesn’t happen as often as it should, says Bob Lathrop, owner of Lathrop Engineering (San Jose, CA). “In many cases, contract manufacturers are not involved until the design is set,” Lathrop says.
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| Lathrop Engineering specializes in product develop for instrument and product development. The device above is an example of their handiwork. |
One example of this, in particular, sticks out Lathrop’s mind. “I was at a meeting once with [an OEM] to develop a particular device and everybody and their brother was there sitting at a really long conference table,” he recounts. “They had a guy from manufacturing and they had all of the people that made it look right. But the manufacturing guy was just sitting there; he wasn’t really engaged. Later, when it came time to start placing the tooling, he decided he didn’t like flex circuits,” Lathrop says. “It was a little late to decide that, when the design was all done and the design had been shown to work!”
Another piece of advice Lathrop offers is to avoid letting the contract manufacturer do early work for you for without paying them for it. “If you think you can just call up and get a quote for free and that is it, you are going to get what you pay for,” Lathrop explains.
Ideally, the contract manufacturer’s purchasing department should carefully look at your bill of materials and put their own estimates together with as much backup data as they can get. Although the numbers they come up with are clearly not set in stone, as the design matures and parts are firmly selected, the estimates become increasingly accurate. “But if you don’t pay them to do that, you are likely to get something of a thumbnail sketch—and you can’t afford that,” Lathrop says. “It is worth telling them: ‘I am going to pay you; give me value.’”
The same principle should apply to your dealings with a manufacturing engineer, Lathrop says. “You have to actually pay that person to lay out how they are going to do the assembly and ensure that there is a quality product coming out.”
Quality is also a vital consideration for prototypes. “If a prototype doesn’t reek of quality, people don’t want to give it a second thought—no matter what the design is,” Lathrop says.
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—Brian Buntz