Canada’s Emerging Medical Device Technology

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By Jacqueline Csonka-Peeren

Technological advancements that have the potential to lead to new medical devices are often referred to as emerging medical device technologies. These advancements can come from within a company or institution making improvements to current state-of-the-art devices, or from organizations developing alternatives to conventional health-care systems.
There exist many Canadian-grown emerging medical device technologies. This article looks at Canada’s inventive output in this area, concentrating on those device inventions that are retained by Canadians, and thus have the potential to be commercially exploited by Canadians.

What Are Emerging Medical Devices?
Emerging medical devices refers to a wide range of health- or medical-related instruments, apparatus and contrivances that have the potential to improve health-care delivery. It refers to any item for use in the improved treatment, mitigation, diagnosis or prevention of a disease, or of an abnormal physical condition.
Some emerging medical devices offer an improvement over current methods with relatively little change to clinical practice. Other devices embody novel technology that presents new paradigms to improved health-care delivery and outcomes. Because these require greater shifts in the way health care is delivered, they may take longer to adopt.
For example, the current method of determining Type 2 diabetes risk involves a brief fast, followed by a blood test. This method, while widely used in Canada, has the disadvantage of being invasive and relatively slow. An alternative patented technology, the Diatest™ from Isodiagnostika Inc. (Edmonton, AB), has already been developed into a commercial breath test.
Unlike the blood test, the breath test is non-invasive and provides rapid, accurate results. Although laboratory test equipment would need to change to accommodate the new testing method, clinical practice would not.
Other emerging medical devices involve a substantial shift in the way clinical care is delivered, and by whom. One example is a hand-carried ultrasound unit for point-of-care cardiac examinations, such as the SonoHeart® Elite by SonoSite Inc. (Bothell, WA) or the OptiGo™ from Philips Medical Systems (Andover, MA). According to current evidence, these devices are more accurate than physical examination, and widespread use during more routine cardiac assessment would likely offer advantages.
Extensive adoption of this technology, however, would require a substantial shift in current health-care practice. Currently, echocardiography is performed mainly by sonographers, cardiologists and cardiac anesthesiologists, upon referral. To have physicians and other health professionals apply and interpret tests using these portable devices would require training and integration into clinical operations. Because of this additional complexity, thoughtful and perhaps lengthy assessment of the operational impact would be required prior to any widespread attempt at adoption.

Patent Landscape
Many emerging technologies that find their way into devices are patented. While a medical device technology patent does not guarantee the commercial success of any medical device that is based on it, a patent does represent a form of technological strength in its subject area and has the potential to deliver commercial success in a related area of the emerging medical device market.
To get a sense of Canada’s areas of technological strength, a patent landscape of the U.S. medical technology patents owned by Canadians was performed. Since 80 per cent of Canadian medical devices are exported to the U.S.,1 patent protection south of the border would be expected to have a greater impact on the commercial success of any derivative medical device. Since patents typically expire 20 years after they are filed, analysis was restricted to those patents that have at least 12 years of commercially useful patent life remaining. The patented technologies considered related to devices, their method of use and their method of manufacture. This review did not include biotechnology unless it had a physical or material science component to its use. For instance, it did not include those inventions related to in vitro diagnostics, such as devices for clinical chemistry, microbiology, immunology and genetic tests. It did, however, include bioengineered implants.

Canada’s Inventive Output
Over 400 patents were classified, uncovering three main areas of recent invention for which Canadians own patents in the U.S. Approximately one-third of the patents owned by Canadians could be applied to these three areas together:

• Medical imaging


• respiratory


• implants

Close to 95 per cent of these U.S. patents owned by Canadian entities were invented by Canadians. However, this proportion only reflects approximately 50 per cent of the total number of U.S. patents invented by Canadians. In other words, Canada seems to have “exported” roughly half of its inventions that are patented in the U.S.
It is worth noting that data used for this research, including ownership information, was drawn from published patents. Ownership for some of these patents may have changed since publication or may have been withheld. Further, this analysis does not include the effect of any existing licences or other contracts on patent rights. It is not known at this time how this would affect the results.

Canadian Interest
Technology is not useful if it cannot be applied to medical devices that are of interest to health-care providers. The Canadian health-care system has indicated an interest in the types of medical devices that arise from these three areas of technological strength. During the time that these patents were filed, Canadian assessment organizations have produced dozens of reports relating to each of the areas of imaging and implants. Canadian assessment organizations include the Canadian Coordinating Office for Health Technology Assessment, Quebec’s Agence d'évaluation des technologies et de modes d'intervention en santé, the Ontario Health Technology Advisory Committee/Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat, and the Alberta Heritage Foundation for Medical Research.
A few assessment reports are also available relating to respiratory technology and its applications, such as inhaled insulin and steroids. Respiratory methods for drug delivery have great potential for use in so-called combination drug/device products, providing an effective way to refresh patent protection for drugs that have not previously been delivered via this method.
In performing these assessments, the Canadian health-care system is gaining a better understanding of the types of devices in which Canada specializes. If these were developed into new medical devices, this knowledge could aid in their timely uptake and integration.
Homegrown emerging medical device technology has the potential to improve Canadian health-care delivery. Canadians retain the rights to a relatively high number of inventions in the areas of medical imaging, respiratory and implants. These clusters of emerging technology might represent areas of technological strength for commercial medical devices that are, according to technology assessment activities, of current interest to the health-care system.

References
1.     Invest In Canada. Government of Canada. December 15, 2005.
<http://www.investincanada.gc.ca/
en/942/Markets.html>

Jacqueline Csonka-Peeren is a consultant with BioAlliance Consulting Inc. (Kingston, ON), a Canadian firm providing expertise to commercialize biomedical technology and analyze market opportunities. She has a dozen years of collective experience in product development, manufacturing, technology transfer, commercialization and global intellectual property co-ordination. Csonka-Peeren holds an MBA for Science and Technology from Queen’s University (Kingston, ON), an MASc in Biomedical Engineering and a BASc in Aerospace Engineering from the University of Toronto (Toronto, ON), and is an active member of the Healthcare Committee of the Licensing Executive Society. She is also a member of the Regulatory Affairs Professionals Society and the Professional Engineers Ontario.