Proving One’s Metal

With the capability to produce ­complex features and accurate parts, an additive layer manufacturing centre looks to change the face of medical and dental devices

Photo: ADEISS Centre technical manager, Matthew Parkes, and CEO Paul Paolatto

A SEISMIC SHIFT in manufacturing is underway at the newly established Additive Design in Surgical Solutions (ADEISS) Centre. Now, medical parts and devices can be made-to-measure by advanced imaging, and then printed—not machined or moulded. Think of it as an intersection where personalized medicine meets the shop floor.

Located in the Western University Discovery Park, ADEISS is a partnership between British engineering and scientific technology firm Renishaw PLC and the London Medical Network, a city-wide enterprise that aims to commercialize medial research and discoveries into market-ready healthcare solutions.

Paul Paolatto, executive director of Western Research Parks and CEO at ADEISS, says the goal is to commercialize printed parts in additive layer manufacturing and leverage London’s competitive strengths in medical imaging. “We want to attract a broader, more substantive investment in medical devices to London, and now we are off to the races.”

Without doubt, the partnership with Renishaw—the first time the firm has partnered with an academic centre—has greatly accelerated the trajectory. With 4,000 employees and more than 70 offices in 35 countries, Renishaw supplies products and services used in applications as diverse as jet engine and wind turbine manufacturing through to dentistry and brain surgery. It is also a world leader in the field of additive layer manufacturing, also referred to as metal 3D printing, and is one of only a handful of firms globally that designs and makes industrial machines capable of printing parts from metal powder.

“Our goal is to make products save time in surgery. Even 10 or 15 minutes is a huge potential savings when surgery is $100
per minute”
— Dr. David Holdsworth

Combining London’s front-end expertise in imaging technology with Renishaw’s additive layer manufacturing platform, the centre will create innovative instruments and products that can be marketed to the dental, orthopedic and medical-device sectors throughout North America and around the world.

In the U.K., Renishaw’s entry into the medical-dental additive manufacturing market, barely five years ago, was for a more prosaic application. Mark Kirby, Renishaw’s additive manufacturing business manager in Canada, says the company’s engineers recognized that British citizens had false teeth that fit poorly and looked worse. “We started in 3D printing with dentures,” explains Kirby. “Removable partial dentures are a very difficult item to print. We knew if we could perfect this, then other applications would be easier. Now we are leaders in printing dentures.”

Unlike subtractive manufacturing, where you take a block of metal and cut away what you don’t need, additive layer manufacturing builds a 3D object of exactly what you want. The computer-aided design (CAD) technology can produce complex shapes that are not possible with traditional subtractive methods like moulding and machining.
It is called additive because the print manufacturing process involves building up thin, even layers of fine metal powder. Titanium, cobalt chromium, stainless steel and nickel alloys are commonly used metals. Renishaw’s process uses a high-powered laser to fuse, or melt, the metallic powder layers together.

The shop floor of additive layer manufacturing is the interior of a Renishaw’s space-age printer. The layers get added to a small baseplate, and you can print off different parts at the same time because each one is controlled by a separate CAD file. Scaling up the process simply means adding more printers. At the end of the manufacturing cycle, each part is broken off the base and polished. A cranium implant to repair skull fractures, for instance, might require over 1,000 layers of titanium powder to produce a strong, flexible metal wafer with a complex shape.

Needless to say, expertise in the front-end of additive layer manufacturing—imaging and design—is of critical importance. ADEISS scientific director, Dr. David Holdsworth, is a professor in the departments of surgery and medical biophysics at Western’s Schulich School of Medicine & Dentistry and a scientist with the Robarts Research Institute. He is also the Western’s Dr. Sandy Kirkley chair in musculoskeletal research. Holdsworth built his early career in vascular imaging systems in stroke diagnosis and therapy, but shifted to musculoskeletal disease research a decade ago. His R&D resulted in the development of Western’s Bone and Joint Institute, a powerful tribute to his former colleague, the late Sandy Kirkley.

“The Bone and Joint Institute has been recognized as a centre of excellence and we have a fantastic team in cell biology, biomedical, orthopedic surgery and engineering,” says Holdsworth. “Bone and joint problems aren’t often fatal so they did not have the same profile as other diseases. But with an aging population the time has come to recognize the burden and costs of arthritis and musculoskeletal issues.”

In 2012, the Robarts Research Institute, which houses Canada’s most robust and sophisticated imaging facilities, became interested in 3D metal printing and wrote grants to buy state-of-the-art equipment. “Certainly we were one of the first in North America to get into 3D metal printing,” says Holdsworth. “We credit the Canadian Foundation for Innovation and the Ontario Research Fund for pushing us forward.”

Renishaw took note of the Robarts imaging group as they became power users of their equipment. They found that London had the assets in place to build the additive layer manufacturing market. Robarts’ skill in imaging, at the nexus of where bone and soft tissue meet metal implants, is essential to the design process. The challenge is to make all of these parts work together in the body at the cellular level. And the ability to capture complex images and create detailed CAD files dictates the quality of the part printed, and of course, implanted. With $10 million of committed funding from the City of London to help develop the market for medical devices, ADEISS was born.

Matthew Parkes, a Renishaw employee and recent transplant from the U.K., is technical manager for ADEISS. He says the Robarts imaging group has solved many complicated problems for large-scale additive manufacturers. “At Robarts, you have dozens of scanners and can get every possible image. The scientists are experts in the use of the equipment and their shortcomings,” he says. “We can inspect the interior of engineered lattices—the finest printable medical structures—for their precise accuracy, even in metals. That is brilliant.”

Going forward, one of the biggest hurdles for additive layer manufacturers will be Health Canada and FDA approval for the parts to be implanted in humans. Dental and veterinary applications generally take less time to get approved and give valuable insight to the process for medical parts. For example, ADEISS is developing a front-end imaging interface for CT scans on dogs to be used at the University of Guelph’s Ontario Veterinary College.

“Down the line, we could be the Amazon.com of medical parts. They can be printed here and shipped anywhere” — Paul Paolatto

“Veterinary surgeons are finding it takes less time to do the surgery if the fit is predetermined to be perfect,” says Holdsworth. “You spend less time trying to manipulate the part for the space. The goal should be a better patient outcome.”

Holdsworth, however, cautions that the promise and innovation associated with medical 3D metal printing likely won’t be enough to change current conventions, and says the adoption of printed parts may take time.

“For most practicing surgeons, this whole trend to patient-specific devices will be a paradigm shift and new way of thinking,” he says. “Companies will need to show that their products are better and more cost effective. Our goal is to make products save time in surgery. Even 10 or 15 minutes is a huge potential savings when surgery is $100 per minute.”

Take a knee replacement. As a class-three medical device, a printed metal knee would take roughly six to nine months to get approval. Right now, knees come in multiple sizes, which are expensive to stock in inventory at hospitals. The day may not be far away when 3D images can be taken of your knees and a just-in-time printed metal version can be ready to implant only days later—customized to your anatomy.

“Demand for patient-matched devices should only increase,” says Parkes. “If a device is safer for patients and faster for surgeons, that is what we want. Usually, that also means less recovery time, less time in a hospital bed, less anesthesia, and this builds a case for making printed medical devices being cost effective.”

Noting that surgeons are often skilled metalsmiths, Parkes also believes the precision shape of 3D metal printed parts will also be coveted. “Surgeons bend metal plates to fit and they are very skilled using metal implants,” he says. “But sometimes, a person will have significant facial asymmetry after an emergency reconstruction, and if the orbital floor bone is broken, your eye loses support, impacting vision. And if you don’t look as expected post-reconstruction, that can add trauma. So, often a second reconstructive surgery will be done to fix these problems. That is when you have time to digitally plan the treatment and print metal parts to achieve a better outcome.”

Parkes says the ADEISS Canadian ISO 13485 application—organizational and management requirements for medical devices and related services— is on schedule and they expect to have a certified facility by the end of 2017. Renishaw already has this certification for Europe, where cranial and maxillofacial implants have been approved for use. “We are talking to the hospital team in London about these products,” he says. “The plan would be to license them through Health Canada and the FDA at the same time. But the first step is ISO 13485.”

As for Paolatto, he believes the sky’s the limit in terms of how big ADEISS might grow. “We could have a facility that will soon print parts for Fowler Kennedy [Sport Medicine Clinic] clients,” he says. “Down the line, we could be the Amazon.com of medical parts. They can be printed here and shipped anywhere.  Mary Ann Colihan