The Flourishing Medical Device Industry
Safety Assessment
Regina Kelder

The Flourishing Medical Device Industry

From the first electrocardiograph machine, invented in 1904, to the robotic surgeries of today, medical devices have advanced dramatically, and continue to evolve

In the US, the world’s largest medical device market, the industry was valued at US$173 billion last year—an increase of nearly 30 billion since 2016. Globally, the medical device (or medtech) industry) is projected to grow at a compound annual rate of 5.6% through 2024, reaching $595 billion, according to and new analysis from Evaluate Ltd.

With so many high-tech devices on the market – from orthopedic implants to pacemakers to the tools used to inject gene therapies—companies and regulators need to ensure that these products do not pose a health risk to the consumer. Like drugs, medical devices are held to certain regulatory standards before they can be marketed to hospitals and patients.

“What is more challenging is that each medical device has its own characteristics that often require different types of insertions, different types of delivery and different studies over time,” said Guy Leclerc, MD, who formed the contract research organization, AccelLAB (now part of Charles River), that specializes in medical device testing and is now its Senior Director. “For instance, stent studies differ from a cardiac valve or orthopedic implant study. You need different expertise to do this kind of research, and there are just a few labs equipped to do this.”

Leclerc’s interest in medical device testing began at the University of Montreal Health Center. Heart patients account for the use of a large percentage of the medical devices on the market and Leclerc, an interventional cardiologist was utilizing a lot of them in his practice. He created a biotech that developed a gene therapy strategy to treat end-stage coronary artery disease patients who were not eligible for bypass surgery or angioplasty. The treatment involved using an adeno-associated vector to deploy DNA that was designed to increase creation of small blood vessels in the heart. The company became known for its expertise in testing cardiac products in animal models.

Eventually Leclerc sold the biotech, but later formed AccelLAB, a preclinical CRO niched in the field of medical implants. The company quickly generated a global clientele.

Because every new drug-coated stent, every new valve needs regulatory approval, there has been no shortage of business for AccelLAB. Most of their work--about 60%—comes from cardiovascular medicine, with another 30% in orthopedics and 10% in other specialties such as neurology. “In the field of CV medicine, stents remain a large portion of our business,” said Leclerc. “But the new trend is to deliver drugs using drug-coated balloons that are inserted into peripheral vessels in the lower limbs.

The materials used in medical devices is also changing. The coronary stents that doctors employ to reopen arteries used to be made of stainless steel and chrome cobalt. About 20 years ago, the industry starting coating metallic stents with drugs and a topping of plastic, which allows the drug to be delivered locally. “Lately, there are efforts to manufacture biodegradable devices,” said Leclerc.

Like drugs, most medical devices are tested in animals, typically rabbits, pigs, sheep, small bovines, and other large research models. Healthy animals are used in the studies. To test the safety of a stent, for instance, researchers overstretch the devices in healthy animals to induce a local inflammatory reaction. If the stent delivers the drug efficiently, it will prevent an inflammatory reaction. In doing so, can draw observations about both the safety and efficacy of the device.

With the acquisition last year of Citoxlab (of which AcelLAB was a part), Charles River will be launching a medical device group next month that will also include the Matawan and Senneville sites. The group will offer a broad-based menu of medical device testing services that in addition to safety and efficacy studies will also include biocomparability and microbial studies offered at other sites from Charles River.

With people living longer and technology advancing at light speed, Leclerc sees an even greater reliance on medical devices in the future. “We are getting closer to the bionic man,” says Leclerc. “We might be saying goodbye to the stethoscope and eventually insert a device into your body