Amid headlines complaining of a slumping economy, and Canada’s lack of competitive advantage compared to other developed nations, it’s nice to know companies are choosing Canada to produce some of tomorrow’s health technologies.

A case in point: Koven Technology Canada Inc. Manitoba-born inventor Paul Koven relocated to St. Louis, Missouri, where he opened Koven Technology, Inc. in 1981; however, he and daughter Heather Bell—now company Managing Director—cofounded a Canadian operation, based in Winnipeg, shortly before Koven’s death in 2004. The company aimed to create a new and improved valvulotome for valvulotomies, where a surgeon removes valves in a vein before grafting that vein onto an artery in lower-extremity bypass operations to treat conditions such as atherosclerosis.

The patent on the company’s BSAVED valvulotome is co-held by Koven Technology Canada Inc. and Dr. Dale Buchbinder, a vascular surgeon working in Baltimore, Maryland. “BSAVED” is short for “Buchbinder Surgeon-Adjustable Valve Exciser Device.”

Buchbinder, who was not satisfied with the valvulotomes on the market had wanted to design a new one for some time, approached Koven; the pair had previously worked together on another project. Together, they studied the market potential for their device, and did a preliminary design, which eventually required substantial revision. The final BSAVED design offers several improvements over conventional valvulotomes, including precision control of the blades’ diameter, and retractable blades, leading to clean, precise one handed cuts.

The company set up an R&D team in the National Research Council’s Institute for Biodiagnostics building in Winnipeg, Koven’s old hometown, with Ian Maclean as Project Manager and Don Brooks as Technologist. The facility offered the new company dry lab space, and a grant from the National Research Council’s Industrial Research Assistance Program allowed them to bring the valvulotome to market faster and with fewer complications than if it would have been bootstrapped it in the US, according to Ms. Bell. Part of the motivation was to generate jobs and eventual wealth for Canadians. “For Paul, it was his way of giving back to his community,” says Bell.

Other motivations influenced the father-daughter team’s decision to set up in Canada. Says Bell:

“I think Canadians generally care about the health and well being of their fellow companies and citizens. Innovation within Canada is not new, but I think companies feel more appreciated. My experience in the US is that funding is limited, although regulatory climates are typically similar. Although with the BSAVED, the device class is lower, so Health Canada approved it in two weeks. It was amazing.... In the US, the FDA has become increasingly difficult. We are hoping to have our FDA 510(k) release to market soon.”

Chief among problems with the FDA has been the device name: “They don’t like it,” says a bemused Bell.

In the four years from patenting and company formation to the current commercial sales in Canada and Europe, the company faced some obstacles. These included problems arising from finalizing the design, from risk analysis, and cost projections.

Other typical problems arose, but were not insurmountable:

“We overcame the design obstacles by being tenacious,” says Bell. “Cost was contained by having one person dedicated to sourcing parts and outsourcing the assembly.”

The manufacturing is carried out in Richmond, British Columbia, a suburb of Vancouver. “We would have manufactured in Winnipeg if we could have, but with the lack of Class 10,000 clean rooms for medical devices, B.C. was our only choice,” Bell explains.

“Recruiting staff is difficult no matter where you are. Qualified people who have a passion for their work are sought by everyone, in the US or Canada. Koven Technology Canada’s staff is very dedicated. They work independently and are high-quality individuals. This is truly a team effort, and I appreciate everyone on the team.”

For more information on the BSAVED, visit the Koven website at http://www.koven.ca/, or contact:

Heather Bell
Managing Director
Koven Technology Canada Inc.
hbell@koven.com
(800) 521-8342 x19

You can also read about this technology in the Fall 2008 issue of NRC Newslink.