by Tim wilson
Prescriptions for success in medical manufacturing
The Canadian manufacturing landscape is changing, and many metalworking shops are eyeing the growing medical market as a source of long-term opportunity. But this industry has unique requirements, and that can be daunting for a shop that has served industries with fewer regulations and shorter turnaround times. Shop Metalworking Technology reached out to the experts for advice on how to get into this market, and how to succeed.
Go ISO. It costs money to get ISO certification, but there is a close affinity between ISO 13485 and FDA requirements. “FDA manufacturing practices do not always require ISO certification,” says Jon Winer, CEO of Tollos, a Barrie, ON-based manufacturer of patient handling and care products. “However, testing labs for safety as well as some manufacturing have very similar practices.” Going ISO then gets you closer to FDA approval, and access to the lucrative supply chain into the US.
Look to America. Given the time and money required to get started in medical manufacturing, it only makes sense to set your sights on the US market. Obamacare has delivered some uncertainty, but that should clear in the next year. “We sell to the US market, which is suffering from the effects of Obamacare, as hospitals are worried they will get less reimbursement,” says Winer. “That said, 90% of our business is in the US – it represents a much larger market opportunity.”
Find transferable skills. If the medical industry is new to you, it makes sense to look internally for transferable skills. If you don’t have them, go out and get them. “We have two former Magna executives working for us,” says Winer. “The automotive sector was having difficulties, and we have now picked up expertise in plant management, mechanical skills like tool and die, as well as electronics.”
Learn the business. To succeed in the medical industry, you have to know how the business works. This, according to Rob Henderson, President and CEO of Biotalent, is one of the industry’s biggest challenges. “The problem is that people don’t know the business of science, the regulatory issues. Many people also lack the skills required when looking for industry specific financing.” Getting the qualified business development, financing, and leadership skills are a must if metalworking companies are to succeed in the medical sector.
Get some partners, and show value. To participate in the medical manufacturing market, you can’t go it alone. “In order to continue to build on successes, Canada’s device manufacturers need to continue to work with industry partners and government,” says Brian Lewis, President & CEO of MEDEC, which represents medical technology companies in Canada. Lewis says that those companies that partner to add value will have a better chance of succeeding. “It’s important to show that innovative medical devices can improve patient outcomes, while reducing costs to the overall health care system at the same time.”
And to do that, says Lewis, manufacturers had better be ready to show the value of their technology. SMT
Medical device market data
From 2007 to 2012, Canadian medical device exports increased from $1.7 billion to $1.8 billion. Canada’s largest trading partner for medical devices is the US. In 2012, Canada’s medical device exports to the US were $1.2 billion, or 64.7% of Canada’s total medical device exports. In 2012, Germany (4.5% of total), China (3.1%) and France (2.7%) constituted the next three leading destinations for Canada’s medical device exports. In 2012, China (7.0% of total), Germany (6.3%) and Mexico (4.7%) constituted the next three leading sources of Canada’s medical device imports after the US.
Tim Wilson is a contributing editor. [email protected]