What You Absolutely Need in a Medtech Contract Manufacturer

Here's a hint: it involves less hand-holding, says Olympus' Nikhil Murdeshwar.

Chris Newmarker

As a principal research engineer at Olympus, Nikhil Murdeshwar's job involves helping to scout out new business opportunities for the Japanese multinational, and then getting to work on making them a reality. His initial design input work involves helping to forge some of the early contract manufacturer and supplier relationships for medical devices of the future.

So what is one of the biggest mistakes a contract manufacturer could make with Murdeshwar? "My pet peeve with suppliers is that they walk through the front door and tell me how great they are, but when they get into trouble they're incapable of managing their problems themselves," says Murdeshwar, who is based outside Minneapolis. (See Murdeshwar discuss reducing design validation challenges for safe and effective devices at MD&M Minneapolis, September 21-22, 2016.)

"When things don't go well, that's when I want these guys to use science and engineering, materials science, process engineering, whatever it takes," Murdeshwar says.

Murdeshwar's views actually seem to be part and parcel when it comes to medical device OEMs such as Olympus, Medtronic, and many others. Such OEMs are increasingly asking contract manufacturers to not just build parts to spec, but actually solve problems. Medtronic, for example, worked with a supplier to improve the refrigerant spraying technology inside a cardiac cryoablation catheter balloon, Qmed reported in late 2013.

Murdeshwar recalls how the automotive OEMs such as Ford and General Motors used to design everything in cars; now outside suppliers design everything from electronic sensors to car seats.

The same type of thing is happening with medical device companies when it comes to their suppliers. "They are now being asked to do more. It's not, 'Stamp something and give it to me.' It's, 'Stamp this and plate this and take responsibility for this product. If you don't do plating, go ahead and subcontract it out, but I'm going to hold you responsible,'" Murdeshwar says.

Olympus' supply selection process continues to evolve, and the company is electing to throw out contract manufacturers who fail to demonstrate competence.

With medical device OEMs asking suppliers to do more, contract manufacturers have been increasingly engaging in mergers and business partnerships to expand  their capabilities.

"I think it helps them because some of these industrial segments are more advanced in certain areas than in other areas. It helps transfer those knowledge base to the other customers," Murdeshwar says.

For example, automotive customers for years have used ceramic dielectrics, Murdeshwar says. Medical device companies have been afraid to use ceramic dielectrics because they could be costly or more expensive. But now there could be a desire to move to ceramic dielectrics to improve durability.

"That's when things get interesting," Murdeshwar says. A big supplier that can stamp a component and then put ceramic on it is attractive. "You get it from a one-stop shop."

Other attributes Murdeshwar looks for in a supplier include at least a basic understanding of what the FDA's regulatory process requires Olympus to do, and how clinical needs affect design choices.

Murdeshwar sees a whole range of abilities among contract manufacturers. "We have suppliers who are very, very capable. They're on one end of the spectrum. And we have suppliers on the other side of the spectrum. The capable ones will know exactly what I want before I want it, will offer us a price point we need. If there's something wrong, they take care of it right away. They ship us on a very timely fashion. These are our model suppliers. But on the other hand, you have these guys who are totally lost."

(See Murdeshwar discuss reducing design validation challenges for safe and effective devices at MD&M Minneapolis, September 21-22, 2016.)

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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