When Rob Gabourie started developing an adjustable prosthetic foot for amputees – one that's more flexible and durable than any others on the market – he estimated it would take 12 months to design it, test it, and get it on the market.
That was seven years ago.
"I stumbled regularly from lack of experience," said the owner of Niagara Prosthetics & Orthotics International Ltd., of Fonthill, Ont.
A lack of venture capital made the marathon a financial drain as well. "I was putting my own money into it; and in hindsight, it cost more than I could afford."
He said he believes it was only through serendipity, and finding partners more interested in innovation than remuneration, that he ended up getting his Rhythm Foot tested and on the market. It won the gold award for rehabilitation products from the international Medical Design Excellence Awards announced in Philadelphia on May 23.
"To get the dedicated people involved is essential. Queen's University, for instance, provided lab space and money to do research, not so much because of the potential market but because they looked at it as an intellectual and mechanical engineering challenge," Mr. Gabourie explained.
An engineer at Queen's suggested he apply to the National Research Council's Industrial Research Assistance Program and the Department of National Defence to do field testing. Getting the right materials and manufacturing required more partners: Hippo Design of Montebello, Que.; Précicad Inc. of Quebec City; DuPont Canada, which made the plastic; and Centennial Plastics of Toronto, which did the moulding practically gratis.
"Without the engineering backup from DuPont, we would have been doomed," Mr. Gabourie said. To get plastic with the right blend of flex and strength required running a series of prototypes through months of impact testing on a machine that simulates walking. Each test foot had to be run through two million impact cycles and inspected for wear and cracks and put back on the machine for another million cycles.
Even with a successful product, there's no guarantee there will be a huge market, he concedes. "While the worldwide number of amputees is over 20 million, the market is so fragmented that the number of individual potential customers is limited.
"There's another factor in marketing a medical device internationally: the NIH problem. That's not the 'National Institutes of Health,' it is 'not invented here.'"
Other countries would prefer to produce their own designs for medical devices rather than licence them from an overseas manufacturer. "We're not going to get rich on this product," which costs about $100 each, Mr. Gabourie conceded. "But we're proud of what we achieved. Even if it's copied elsewhere and it's done well, that's okay, because the initial goal of this product is that it helps people."