Medical Manufacturing Sector Report

The shop uses its 3-D printers for 30 to 40 builds per month, creating forms that cannot be achieved by conventional manufacturing.

The Advanced Machine Shop at Toronto’s Sunnybrook Health Sciences Centre exemplifies two trends in medical manufacturing: a move toward additive manufacturing and the merging of machine shops and hospitals.

Staffed by five personnel, the machine shop at Sunnybrook designs, manufactures, and tests medical devices, including medical instruments used in the treatment, mitigation, diagnosis, and prevention of a disease or abnormal physical condition.

The Advanced Machine Shop relies heavily on two 3-D printers, a Viper SLA® from 3D Systems and a Fortus 400 rapid prototyper from Stratasys.

Shop Manager Michael Pozzobon offered an example of 3-D printing in action at the shop during the creation of a femoral antegrade starting tool (FAST) intended to treat fractured femurs.

“A technician had a tool that needed to be made for a meeting with a surgeon in two days,” explained Pozzobon. “We printed the first design that night. The next day we made changes and printed the second version. We had no time to make the complete part any other way. The meeting went so well [we were] asked for a working version to be brought into the OR.”

As always time was an issue so the main body of the part was cut on a waterjet to save time while the remainder was manually made.

“I believe it will only be a matter of time before metal printers will be replacing machine tools for certain, but not all, jobs,” said Pozzobon. “Technology is changing in this field so quickly. It may not happen in five to 10 years, but it will happen. We manufacture a number of parts for work inside the bore of an MRI machine and around it with our 3-D printers.”

The Sunnybrook shop uses its 3-D printers for 30 to 40 builds per month.

A femoral antegrade starting tool (FAST) intended to treat fractured femurs is created using a combination of processes, including waterjet cutting and 3-D printing. All images courtesy of Sunnybrook Hospital.

As the sector grows, it’s likely more machine shops will team up with medical facilities.

“There are doctors getting involved with manufacturing groups. There are machine shops in a lot of hospitals, which is kind of surprising to people, but many hospitals have either a partnership or some type of relationship internally with a machine shop,” said Sean Smith, GF Machining Solutions product manager at Machine Tool Systems, Mississauga, Ont.

The hospital/machine shop connection also can be an incubator for growth.

“We have about two dozen startup companies that have originated at Sunnybrook that are businesses working in the medical field. These can be located at Sunnybrook, renting space and finding their feet, or fully off-site with little contact with us,” said Pozzobon.

At Concordia Hospital, Winnipeg, the Orthopaedic Innovation Centre (OIC) was established in 2010 to design and test medical devices. In January 2014, the OIC launched a Precision Labs division, which does metrology work on medical devices with coordinate measuring machines. Then, in 2015, it set up an Advanced Digital Manufacturing Hub (ADMH). Out of the ADMH emerged a for-profit company called Precision ADM, which makes medical parts.

New Technology

Like Pozzobon, Smith is an advocate for using additive manufacturing to make medical products.

The ability to customize medical parts is a huge advantage of this technology.

“Before, in medical components like hips and knees, they made certain products size one, size two, size three. They would look at each person and decide if they were a one, two, or three. None of [the components] fit that person 100 per cent,” said Smith. “They made them as generic as possible—small, medium, and large. Now they can detail the specific part or component using the [additive] machine to that specific person. This results in a better fit and definitely increases longevity of the part being replaced, whether a hip, knee, or heel.”

Smith doesn’t think, however, that additive manufacturing systems are going to replace traditional medical manufacturing equipment anytime soon.

“You can’t replace them,” said Smith, of mills, electrical discharge machines (EDMs), lathes, and other equipment. “You still need a way of doing the subtractive work.”

Indeed, Sunnybrook’s Advanced Machine Shop also utilizes a waterjet, CNC mill, CNC lathe, three manual lathes, and three manual vertical milling machines. The shop, which will be installing a 5-axis Microlution 5100-S CNC mill this fall, also uses the latest cutting tools from Sandvik and Horn.

Out on Vancouver Island, Micro Precision Parts Manufacturing uses a set of three Haas office machines, a lathe, as well as a 3- and 4-axis mill, said Matthew Cotton, head machinist and programmer.

A little over half of the company’s work is medical-related. Past clients have included Johnson & Johnson and Procter & Gamble.

“We are currently working on medical surgical devices, some as simple as different types of scalpels and blade shapes, but also some more complex assembled rotary tools for cosmetic surgery as well,” said Cotton.

Medical part machining is different than other work the shop does, he added.

“Medical work seems to be about smaller, finer details, with tougher materials, and often higher tolerances. Harder stainless and GR5 titanium are commonplace, and to be working to within 0.0002 in. or tighter is not uncommon,” said Cotton.

For his part, Pozzobon said the Advanced Machine Shop regularly uses stainless steels, but not titanium.

“We work with a variety of materials, but hardly use titanium. As we are a prototyping shop mainly, medical parts made here are typically stainless for the initial designs until a final version is completed,” said Pozzobon.

The tiny sizes typical in medical work pose difficulties to machinists in the field, said Cotton.

Fixturing something that is obviously too small or delicate to apply any pressure to is a challenge.

“Next comes the inevitable: Will a thin feature of only a few thou thickness hold up to the tool pressure required to cut it?” asked Cotton. “Everything is possible. We just have to imagine the proper ways to do it in a timely fashion. Another challenge is measurement without removing things from the machines. And at the end of the day, automating the processes and ensuring they are 100 per cent repeatable and reliable [are additional challenges].”

According to Smith, the type of equipment needed for a small shop interested in getting into medical parts for the first time varies.

“It depends on the medical parts. If I was going to get into medical, I’d have a high-speed mill and a wire EDM. The issue with [additive machines] is, they’re very expensive machines. There are some companies out there that would do subcontracting work until you can afford that $750,000 machine,” said Smith.

Smith offered similar equipment recommendations for a larger shop, say with 50 workers, that wants to start doing medical manufacturing.

“Definitely a high-speed mill. High-speed milling is a big thing now. I used to work in a shop and at 8,000 to 10,000 RPM, you thought you were flying. But when you get into the 40,000- to 50,000-RPM range, what it allows you to do is use smaller corners or smaller tool diameters—and most of these medical components are very intricate, small, detailed parts,” said Smith. “That’s where high-speed milling definitely comes into play. EDM as well.”

Smith added that 5-axis machining is important because it allows manufacturers to get to five sides of a part.

“There’s less setup time, and your part becomes better because it’s done in one setup,” said Smith.

Medical Manufacturing Booms

According to Innovation, Science, and Economic Development (ISED) Canada, the Canadian medical device market generated $6.4 billion in revenue in 2012, up from $4.5 billion in 2006. The global medical device market in 2012 was valued at US$327.7 billion, with the U.S. accounting for more than a third of this total.

Medical device exports are rising too.

According to ISED, from 2007 to 2012 Canadian medical device exports increased from $1.7 billion to $1.8 billion, and the nation’s largest trading partner for medical devices is the U.S.

Leading medical device exports include composite diagnostic and laboratory reagents; medical, surgical, dental, and veterinary furniture; instruments and appliances; and computed tomography apparatus.

As for the future, industry experts predict continued growth, because of improvements in technology (especially additive manufacturing) and a growing number of seniors.

The latter point is spelled out in a report by MEDEC, the Toronto-based association representing Canadian medical technology companies. The paper, titled “MEDEC Policy Pillars,” reads, “MEDEC recognizes that medical device technology will be an instrumental tool in assisting governments as they address the imminent demographic challenges faced by Canada … MEDEC member input will be invaluable, and most probably crucial, in ensuring that patients and the system are able to best address the management of chronic disease and comorbidities as Canada’s aging population continues to grow.”

In other words, medical devices will be more in demand as the baby boomer population ages.

Medical manufacturing is “definitely a growing business in Canada,” said Smith. “It’s becoming one of those almost niche markets that are opening up to be more viable in Canada.”