Ontario, Canada: Taking Medical Device Manufacturing to a Higher Level

Last week, I conducted an interview with Tofy Mussivand, director and CEO of the Medical Devices Innovation Institute (MDI²) at the University of Ottawa. The purpose of the conversation was to inform my Regional Focus article on Ontario scheduled for the May issue of Medical Product Manufacturing News (MPMN). However, readers may enjoy a sneak preview of Mussivand's candid portrayal of the problems facing Canada's medical device industry and his prescriptions for putting it on the path of progress. --Bob Michaels

MPMN: What is the role of the Medical Devices Innovation Institute at the University Ottawa? What do you do?

Mussivand: The Medical Devices Innovation Institute brings together many institutes, hospitals, and universities--including those in Ottawa and those across Ontario and Canada. It also brings industry, researchers, government, and those interested in medical devices together to focus on medical device discoveries, development, manufacturing, marketing, commercialization, and utilization in patient care. That's the main purpose of MDI². Of course, to do that, you have to train experts in medical devices. That's one area that we focus on, not only at one hospital or one university, but we share it with industry and many other institutes.

MPMN: Does that mean training experts in the use of medical devices or in the development and manufacture of medical devices?

Mussivand: We focus on all aspects of the medical device industry, including manufacturing, discovery, use, regulatory approval, development, commercialization, testing, and so on. The other area that we are interested in is to help the medical device industry with its needs. For example, if companies need medical device approval, we help them with Health Canada, FDA, European, Japanese, Chinese, Indian, or other national approval organizations. We have experts not only in Canada but also in other parts of the world that collaborate with us.

MPMN: On what types of devices are the members of the institute working? What is their focus?

Mussivand: At this time, the Institute is working on approximately 20 technologies, an example of which is a portable DNA detector device. This device makes life easier for healthcare providers to detect and diagnose disease and to determine DNA use for development of potential treatment methods for disease. In addition, this technology has forensic applications for use by the police. Another application is to sequence the DNA of individuals. We have been working on that, and there is a lot of excitement about this application.

Another project we're working on is an artificial heart that we have developed. We are also working on related technologies that have been sold and are being used the world over. Other agencies that are working on various technologies collaborate with us. At this time, there are more than 150 technologies that we are aware of and collaborating on. Such technologies include medical devices related to many different areas, including cardiovascular devices such as stents, artificial hearts, and pacemakers. But we're also working on infection or bacterial treatment technologies and high-throughput sequencing for stem cell development.

Basically, we define medical devices as any tool, instrument, or equipment being used in healthcare that is either used for detection, diagnosis, treatment, rehabilitation, collection, and analysis acquired through monitoring applications. Without medical devices, we believe that healthcare, as we know it, would be impossible. The thermometer is a good example of a medical device. Monitoring devices such as blood pressure monitors and imaging equipment are also examples. And of course, we're also involved with developing devices for orthopedic applications, such as hip and finger joints. Robots and surgical tools--these are also various technologies that we are involved with.

MPMN: Could you describe how you interact with medical device companies in Ontario and beyond and say a few words about your approach to training medical device experts?

Mussivand: We are working together with universities, hospitals, and industry to train not only students, fellows, doctors, and nurses but also industry people and experts. For example, this is the third year in which we are organizing the Medical Devices Summit, which brings people together from across Canada from various disciplines. One of the major areas in which we are working is training industry people in regulatory requirements and issues. If you are a medical device manufacturer, you have to get approval from Health Canada, FDA, or European standards organizations. We try to help companies to learn what to do, where to go, how to apply for getting approval, how to perform clinical trials, how to conduct in vitro and in vivo testing, and so on.

MPMN: What is an example of a successful project in which your institute has helped to develop and manufacture a device that has found its way to the market or will soon be marketed?

Mussivand: Several years ago, we developed a method for sending power from outside of the body to inside the body without making an incision. This technology is needed for devices that require power inside the body, such as artificial hearts. Right now, many artificial hearts around the world are using the technology that was developed at the University of Ottawa Heart Institute and its associated hospital partners. This technology was eventually sold. Now industry is using it, and patients all over the world are benefiting from it.

A technology that we believe is on the verge of being commercialized is a method for screening patients that enter the hospital based on the smell of their breath or saliva. Another example of the type of work coming out of our institute, this method could be used to triage patients prior to performing many other more-expensive tests. The many technologies we are involved with are in various stages of development.

MPMN: Have these projects been joint collaborations with companies?

Mussivand: Our devices are the products of work internal to our institute and of collaborations with companies in Ontario, Canada, and beyond. The technology we developed for sending power into the body involved a collaborative effort among eight partners and companies from the United States, Canada, Europe, and Japan.

MPMN: How do you view the state of the medical device sector in Ontario? How has it gotten to where it is today, and where do you think it's headed in the context of the global medical device industry?

Mussivand: Unfortunately, I must say that medical device development and manufacturing in Canada is not what it could be. For various reasons, our medical device industry is not working at capacity in terms of development, commercialization, and marketing. In fact, among industrialized nations, our medical device development and export activities are nearly in last place, just before Norway.

MPMN: Why do you think that is, and how do you think this situation can be improved?

Mussivand: There are several reasons for this state of affairs: lack of medical device experts, lack of incentives, lack of a national strategy, lack of international focus, and lack of sufficient investment in medical devices. Countries in many regions throughout the world, including the United States, Europe, Japan, and China, have placed a high strategic priority on developing medical devices. Canada does not have this, and we have been pushing to establish that priority and get politicians and decision makers here to think about this.

For example, no company is going to produce medical devices just for Canadians. Our population is small, and the market is not large enough to sustain a medical technology sector strictly for domestic use. However, that should not be the reason that we are not a medical device leader. Switzerland, which has been the first country to develop a variety of medical device technologies, is smaller than Canada. Thus, the small size of the population should not stop us from advancing to a higher level.

In terms of funding and investment opportunities, my experience shows that when you want to develop technologies and you need funding, you mainly have to go outside of Canada to bring capital in from outside. I think that this needs to be changed.

MPMN: Do you see any movement to rectify this state of affairs?

Mussivand: Yes. An example is the annual summits that we have held. The first of these Invitation-only events that I organized were held in 2010 and 2011. While we expected between 100 and 140 people, more than 500 attendance requests flooded in, and many people had to be turned away. Thus, there is much interest from all sectors--not only from hospitals and universities but also from industry and government. There is a positive movement afoot. Nearly the entire medical device industry supports our initiatives and has been working with us not only to advance these technologies but also to set medical device development and manufacturing as a strategic priority for Canada.