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Growing medical device market may be good for the health of your manufacturing business

by Tim Wilson

To get a handle on Canada's medical industry, it is important to know that Canada has four classes of medical devices.

The lowest, Class I, involves devices with limited contact with humans–and therefore the lowest risk–and requires no license. 

"The first level is for products like wheel chairs," says Lauralyn McDaniel, industry manager, medical device manufacturing, Society of Manufacturing Engineers (SME). "It then goes all the way to implants in the body."

Class II is self-regulated, with the manufacturer obliged to attest to device effectiveness and safety. Classes III and IV involve pumps, catheters and implants; in other words, technologies that either directly support human life or are resident in the body.

"These products have to be very innovative," says McDaniel. "Once the design is together the manufacturer gets involved, but trying any new process adds risk and can extend time to market. It is always a balancing act to embrace a new technology while minimizing the risk of the unknown."

McDaniel says machine shops might want to consider getting into the lower level to gain industry exposure without having to face regulatory hurdles. From there, they could find that the diversification helps with business planning and delivers more solid revenue to the bottom line.

"The medical device industry is far less susceptible to ups and downs in the overall economy," says McDaniel. "We are also seeing some growth in contract manufacturing in this area. It presents an opportunity to get into this market." If so, however, McDaniel says that manufacturers should consider certifications to be able to validate all of their manufacturing processes.

"I would say ISO 9001 is a good place to start. From there you can also go to ISO 13485, which is specific to medical devices."

This is true for DM Precision, an ISO 9001 certified company in Dunnville, ON, which specializes in machining exotic materials in complex configurations, often for small medical components with tight tolerances.

"We just got our certification two years ago. It was something new for us," says Chad Plath, who is the owner of DM Precision’s 14-person operation and the company’s shop floor manager. "ISO opens future opportunities. To gain new business in the medical industry we went forward with certification."

DM Precision, which machines entire medical components to its customers’ specifications, specializes in testing and calibration for ultrasounds and for the cutting edge Lucy Phantom machine, which coordinates radiation beams when treating brain cancer.

We were already 85 per cent there when it came to ISO," says Plath. "We had to shuffle some things around, and add some new procedures for data management and recording."

DM Precision does not machine Class IV materials that are inserted inside the human body; instead, it is sticking to its medical niche: manufacturing components for medical imaging machines.

"We see medical as a growth area," says Plath. "From last year to this year we are up 15 per cent in the sector."

DM Precision uses a range of equipment, from lathes, mills, and CNCs, to basic saws and grinders. It also has sophisticated EDM capabilities, such as the GF AgieCharmilles Cut 20P wire EDM System and the GF AgieCharmilles Form 20 die sinking EDM.

"Some of the machining technologies we are seeing being used more and more include EDM," says SME’s McDaniel. "It’s very popular because of its accuracy. You can go very small–I have seen repeatable processes at two microns."

McDaniel says lasers are also popular because in medical manufacturing, small sizes and increased accuracy are of utmost importance. 

"For machine shops, this market is challenging but doable," says McDaniel. "We have stories where former automotive machine shops have stayed alive and thrived because they have found a way into the world of medical device manufacturing."

Implants Bring a Smile
Dental and orthopedic implants represent a great opportunity for machine shops. However, these high value components come with their own challenges. They are small, they are made of exotic materials, and they are highly regulated.

"I have never heard a design engineer going into a meeting and saying," ‘how can we make this bigger,’" says Peter Reypa, president of Integral Machining Ltd., Oakville, ON.

Integral Machining is active in the dental and orthopedic space. It has developed capabilities in a wide range of difficult-to-machine materials, including stainless steels, titanium, and super alloys such as Kovar, Invar, and Inconel. The most interesting exotic metal the company deals with might be Nitinol.

"Nitinol is a highly malleable material," says Reypa, "It is essentially 50 per cent nickel and 50 per cent titanium. This stuff is special. It is malleable at room temperature. It can bend–not easily, but it has a lot of flex in it, a lot of strength."

Nitinol addresses challenges faced, for example, by pins that are put into ankle joints, which have a history of problems with stress fractures in the implants themselves.

"A lot of what we are doing, especially in micromachining, is working with start-up ventures," says Reypa. "A lot of surgeons, professors at universities, they get together and think up products. We help them with design optimization for production."

For example, the company has machined a dental implant intended to go directly into a jaw bone. Though Integral designed and manufactured the implant, the company had to keep a close eye on external requirements.

"There is a specific process we have to follow," says Reypa. "Everything within that process is regulated, from the type of tooling, to the type of material, even down to the lubrication that we are allowed to use in the machine."

And to get to the point where it could micromachine parts, Integral had to invest in quality control equipment so that it could measure down to the right tolerances. But it’s been worth it–and likely will be in the future, too.

"The market is a little more mature now," says Reypa. "We see terrific opportunity in terms of our micromachining. When things are in the body, you want to keep it as small as possible." SMT

Tim Wilson is a contributing editor based in Peterborough, ON.

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