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by Tim Wilson

Only shops with rapid response to this sector's challenging demands will succeed

Medical device manufacturing is one of the most exciting industrial sectors in Canada, but also one of the most challenging–specifically given the complexity of the regulatory environment.

Materials and design requirements mean there has to be tight coordination between biomedical engineers and operators on the shop floor.

"In Canada there are shops which can respond rapidly to a prototype request, with about a third of these also able to switch over to large-scale manufacturing," says Geoffrey N. Maksym, an associate professor at the School of Biomedical Engineering at Dalhousie University in Halifax. "However, one often has to negotiate contracts with different manufacturers."

Dalhousie can do rapid prototyping via a 3D printer to assist innovators like Maksym, who is also a director at start-up Thorasys Thoracic Medical Systems, which makes a lung function device named tremoFlo. 

"Our early work was with our team of engineers," says Maksym. "From there, we collaborated with a tool and die shop in Burnside, near Dartmouth, Nova Scotia. The shop had great people for brainstorming and problem solving."

For a device as complex as the tremFlo, which is radical for its ability to measure lung function without patient effort, having a job shop that can engage in problem solving is a huge plus. However, Canadian medical device companies of all sizes will also source globally. For example, plastic parts that require thermal moulding can be sourced from China, as can electronic boards. 

"But at times there are functionality and quality issue," says Maksym. "We can't go with a cheap two layer electronic board, so for multi-layer capabilities we have gone with an electronics firm in Shelbourne, NS. People in China are incredibly responsive, but we have had issues with paints and coatings."

Maksym's experience argues for the benefit of a geographic "clustering" approach, in which research, engineering, and manufacturing capabilities are all close at hand, and in which the participants are familiar with the sector's regulatory requirements.

"If you're not down the street, it's still a phone call," he says. "We have a plastic mouth piece that has to reach the highest level of compliance, and we were considering an Australian supplier, but their plastic is not FDA approved. Now we will have to find someone else."

That said, Maksym points out that adherence to the ISO 13485 medical standard is not much more complicated than ISO 9000 or ISO 9001.

"There is some additional documentation around risk analysis," he says. "And the choices are fewer–you can't just pick a screw off a shelf."

For those job shops that are aware of the regulatory requirements–whether mould shops delivering quality plastics, or metal shops that work with the highest quality steels and alloys–the medical device sector offers significant opportunity. The market is growing, and enhanced device integration with electronic systems is about to take off.

"We will see a new round of blood sugar, cholesterol, skin colorimetric and galvanic devices become available," says Dr. Norman Yee, a Calgary-based physician who also works as a health technology consultant. "The wave of consumer level devices and their generated personal health data will become compelling."

Another observer from the medical field, Dr. Alan Brookstone, says the slow uptake in medical deviceintegration with electronic systems in Canada is about to change–but only thanks to leadership coming out of the US.

"Right now we are seeing pretty basic stuff around connecting vitals, blood pressure, with some glucometers being connected," he says. "This is fairly simple, but it is quite sophisticated in the US right now."

Connectivity issues are crucial because they extend the viability of a medical device. At present, most devices require a physician to log data manually. If the technology is integrated with electronic health records, the power and value of a device increases greatly. When that happens, the industry will see a new growth surge–and those shops with the right partners could benefit significantly. SMT

Tim Wilson is a contributing editor. This email address is being protected from spambots. You need JavaScript enabled to view it.

 
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