Medical Manufacturing Report: In Good Condition

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by Noelle Stapinsky

A national focus on growing Canada’s medical technology manufacturing industry could mean big opportunities for supply chain demand

The global aging population has kept the demand for medical product innovation steady. But given the fact that most baby boomers will be over the age of 60 within the next few years, there is an even bigger push for advancements in technology and a growing trend toward personalized medicine and self-directed care to ease patient reliance on the classic brick and mortar hospital. Canadian companies already playing in the medical field are seeing opportunities to supply such unmet demand. 

“People are living longer and there’s increasing incidents such as obesity, diabetes and blood clots,” says Scott Moffitt, executive director of BioNova, an association that represents medical manufacturing in Nova Scotia. “There’s going to be an increased need for hip implants, complex wheelchairs that can navigate stairs, crutches, knee braces—anything that can help people get around. As well, there’s an increased need for diagnostic devices to help manage neurological and metabolic disorders, cancers and other chronic diseases. Those are the major drivers that are going to drive the industry.” 

Orthopedics or implants and the advancements in such technology are big touch points for manufacturers interested in diversifying into the medical world. “Precision manufacturing of everything from next generation knee braces, which require a lot of machining, and other technologies for such things as shoulder and hip implants, for example, all require metal based manufacturing,” says Moffitt. “But obviously this means bringing in higher levels of quality control and material management, which all factor heavily with anything medical and the requirements needed.” 

Of course, when looking at the medical device technology industry, it’s important to note the different classes certain devices fall under. Assistive medical devices such as walkers, wheelchairs, prosthetics and orthotics, for example, fall under Class I. Classes II to IV are devices that are in contact with the patient, take samples from patients and include diagnostic imaging as well. “That’s a very important distinction because these are products that require Health Canada approval,” says Brian Lewis, president and CEO of Medtech Canada, a national association for medical devices and medical technology manufacturers.

From a national perspective, Lewis says the industry is growing. From 2013 to 2017, exports increased from $2.3 billion to $3.8 billion. “Exports are growing well particularly in the area of innovative medical devices. A lot of these products are high tech and involve solutions as well as devices,” he says. “And big areas for research and development and growth in Canada is in image guided therapies, medical imaging, in-vitro diagnostics for point-of-care testing, connected health technologies, and artificial intelligence.”

For Medtech Canada, 90 per cent of its manufacturing members are based in Ontario. To point out a few, Lewis says there is Profound Medical in Mississauga developing customizable, incision-free therapies. Baylis Medical, also in Mississauga, is manufacturing equipment such as cardiology medical devices. “They’ve actually expanded to a secondary manufacturing facility,” he says. “And then there’s Synaptive Medical in downtown Toronto that’s developing image guided therapy and MRI machines. They’re not a member, but we’re closely associated with them.”

Atlantic Canada is also an area of high growth opportunity. Moffitt uses two of BioNova’s members as an example. “Spring Loaded Technology is manufacturing assistive knee braces. And ABK Biomedical in Halifax is in the interventional radiology space. They’re essentially manufacturing glass beads that are used for blood flow blockage in arteries to stop tumors. From a high technology manufacturing perspective, they are interesting because it’s similar technology that could be used in metal machining manufacturing, but just highly specific.”

Canada’s medical technology manufacturers rely heavily on exporting, with major markets being the U.S. and Europe. With Canada’s public health care system, which is provincially regulated, it’s a more difficult market to sell to. Besides, as both Lewis and Moffitt point out, if you can get a product approved in the state of California, that’s the population of Canada. 

But that’s not to say Canada isn’t on the radar. “There are always regulatory changes that are evolving quite nicely,” says Moffitt. “Health Canada has made a lot of improvements in the way they are reviewing and approving products.”

One of Medtech Canada’s main focus now is changing the mindset towards adapting innovative technology in Canada. Increased “at home” commercialization will greatly improve exports to countries such as Russia and China, both of which look for clinical utilization and home country support of new technologies, according to Lewis. “It’s also about a shift in mindset from cost minimization to one of value. For a hospital, you can have a really innovative product come along; it might be more expensive for the operating room, but there’s money to be saved downstream because of the better technology.” 

Outlook-Medical Technology IndustryGetting in the game
Moffitt says there has been some activity for other industries to segue into the medical industry. For instance, if you’re in aerospace manufacturing airplane wings, the regulatory burden is quite similar, just different. “I think the jump can be made and the talent exists out there to handle that level of complexity around the regulations and manufacturing processes. It’s just about if you’re willing to give it a shot,” he says. “And as technology comes into play, increased access to data and things like 3D printing, there’s precision metal manufacturing that can feed into the manufacturing of medical devices. Even in the design and development and prototype development areas there is a big opportunity because that’s primarily what’s lacking in Canada.”

Headquartered in Victoria, B.C., Starfish Medical is Canada’s largest device design, development and contract manufacturer. It works with everyone from doctors with an idea to large firm clients on end-to-end project and technology development. 

Gene Way, senior mechanical engineer for Starfish, says, “one of the best examples I have on a project that was centred around high performance metalworking is when we developed a spinal surgery system for injecting medication into the spinal cord. The unique constraint there was that the system was used in a sterile field in the operating room. The parts were patient contacting and they needed to be reusable.”

Such constraints meant that the device needed to be biocompatible. And there are a variety of ISO standards that Starfish complies with, one being ISO 10992, which covers biocompatibility. “Any material that touches human skin or other tissue—internal or otherwise—the nature of contact is classified and the material has to be demonstrated either through comparison to existing products or through testing to show that the material won’t react with the patient’s tissue or cause an adverse reaction,” says Way. “The other constraint we found was sterilization. In this case, the instrument would be used in a hospital and steam sterilized. So it had to withstand steam temperatures and repeated sterilization. We ended up using 416 stainless steel because it’s relatively easily machineable and the parts were very precise. You can see how the applications constraints—maybe on the surface clean and relatively straightforward—can get complex when you consider the use and reuse of the application.”

Another discovery Starfish found was that even though it used an amicably resistant and corrosion resistant grade of stainless steel, the machining process had embedded some carbon into the parts, which led to corrosion after a handful of uses. “That was quite surprising. We ended up electro-polishing all of the parts to help remove those surface impurities and improve the corrosion resistance and make the part smoother. That was an interesting learning experience that we’ve applied on additional products since.”

Regarding the main materials used in medical devices, Way says that stainless steel is used quite a bit. Grade five titanium is used for patient contact and for strength purposes. And aluminum is used for general purposes in a lot of devices, just not for patient contact. 

“You’ll hear about medical grade or surgical grade stainless, which do tend to be buzz words,” says Julian Grove, mechanical engineering team lead for Starfish. “But ultimately it comes down to the material you select and if it’s compatible with the type of patient contact and the application. Stainless steels are quite inert and would be fine for patient contact. Depending on how those parts are processed is what has a huge impact on whether the part would be biocompatible.”

If, for instance, during the heating process a lubricant is used, which could transfer to a patient’s skin, it’s considered not biocompatible. “Depending on the application, what we end up doing is working with the vendor to clean the part and set up risk procedures for when the part comes off the machine to make sure that it’s clean before they ship them to us,” says Grove. “It’s not sterile, but it’s clean and there isn’t any residual oils or lubricants. Once the assembly reaches its final destination, if it’s a sterile device, the medical manufacturer will have to develop a sterilization and cleaning procedure for the end users to follow.”

The crossover for other industries is in understanding the unique constraints of developing a product that will be in contact with a patient. “The constraint set is a little different,” says Grove, “But in terms of dimensions and tolerances we put on a drawing, there isn’t a huge difference.”

Wes Chamberlin, principal mechanical engineer for Starfish, adds that it’s also about conformance. “It’s a design specific on the precision required. It’s not because it’s medical, it’s because it’s design specific. We also need more traceability than others might need for their parts. So that ends up being—not limiting—but just an extra step for sourcing the appropriate material because we need to have traceability of what it’s actually made of.”

Health Canada and the Food and Drug Administration in the U.S. obviously heavily regulate the medical device industry, and there are different risk classifications depending on the use of the device and what level of harm it would cause a patient if it’s misused or malfunctions. “So that can have implications on the amount of traceability Wes was describing,” says Grove. “And also potentially the level of control that Starfish as a development company would need to have or impart on our vendors.”

Starfish has registration and certification with ISO 13485, an international standard governing quality management systems and the development of medical devices. “In some applications, we look to machine shops and mould vendors that have this registration because they would have a quality management system with a set of standard operating procedures. They have traceability of materials and know where their raw material vendors are supplying their materials from, and that helps with that level of control,” adds Grove.

In terms of what Starfish looks for in a vendor, certainly having ISO 13485 is attractive, but it’s also about time to market. “We rely on our vendors a lot,” says Chamberlin. “If we have a challenging technology that we need to develop and can’t create a whole new manufacturing process, having vendors and partners that can work through the designs with us to make those early decisions that matter on the manufacturing side is pretty important to us.”

For a small machining or fabrication shop to get into medical, Chamberlin says it’s about understanding the regulatory landscapes and documentation requirements. “For anyone looking to branch into medical, looking at ISO 13485 and what that path means would be a pretty important early step for a machine shop. So they need to look at that ISO certification and what that would mean to their business model.”

The medical device technology industry in Canada is quickly building momentum. And according to Lewis, there’s a lot of government support with SR&ED tax credits and the Strategic Innovation Fund, which has made a sizeable investment in image guided therapy research and development and will soon expand its investments into the manufacturing side. With such support and positive growth, future opportunities are undeniable. SMT

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