Make+ taps all resources to accelerate medical devices
By Sohail Kamal, West Coast CorrespondentElectronics Medical accredited certified development Editor Pick Electronics medical R&D research
BCIT resident seeks to make Canada a world leader in medical product development
MAKE+ is served by a group of 15 multidisciplinary research team focused on product and process development, evaluation, applied research projects, and education. This contract research and development organization is the only academic product development group in Canada with a sub-group registered to IS0 13485 (Medical Devices) Quality Management Systems.
Tasked with a mandate to support private industry, hospitals, government, and both internal and external educational clients, they bolster projects for both new and medium sized technology firms. Half of their revenue comes from private industry. Since the COVID-19 pandemic has shaken the economy, Make+ is extending help to Canadian companies to redouble their efforts in the post COVID-19 landscape.
Understand the problem they are trying to solve
West Tech Report recently had the opportunity to speak with Nancy Paris, director of Make+, to find out more about its mandate, what entrepreneurs can expect from them, and how the group differs from other options.
“Our team takes pride in working with our clients by first really getting an understanding of the problem they are trying to solve before jumping into designing prototypes,” explains Paris. “Everyone is eager to see products however the best products are designed by getting a full understanding of the problem and requirements that the product must solve and meet.”
A prime example is Awni Ayoubi and the various medical device companies he has built over the years with Make+. His company first worried with Make+ on the initial development of the GlideScope, which was commercialized through his company Saturn Biomedical. The technology was eventually acquired by Verathon for $10-Million, but the GlideScopes are still manufactured in Burnaby, BC and are exported to more than 46 countries globally. The success and value of that relationship is still paying dividends as they continue to work together.
“We are now working with him again in another medical device company he founded called Rostrum Medical Innovation. They are developing a VQm Pulmonary Health Monitor, a non-invasive monitoring device providing clinicians with physiological insights into the effects of changes in lung health,” says Paris.
Make+ also introduces companies to government funding sources including National Sciences and Engineering Research Council of Canada (NSERC), NRC – Industrial Research Assistance Program (NRC- IRAP), and Make+ works with teams to write proposals to access funds. “By working with us companies can also increase their credibility with the investment community and are also much more likely to get their SR&ED tax credits on applied research projects due to the documentation we provide,” Paris remarks. “By partnering with an educational institution, you can also access special funding that isn’t available to the private sector.”
Access to breadth of skill-sets
MAKE+ resides inside the British Columbia Institute of Technology (BCIT), which is the 2nd largest post-secondary organization in BC. The impetus for starting MAKE+ in its initial form in 1990 was to help growing BC’s knowledge-based companies and make BC and Canada a world leader in medical device development. What effectively differentiates Make+ is the way no private design firm will have access to the breadth of skill-sets that they can provide, especially with regard to medical technologies.
They can work with companies that want to test their products with a simulated work environment, such as with nurses directly in BCIT’s nursing program.
“Although we are a contract R&D organization we differentiate ourselves from private contract R&D organizations through our deep expertise in how medical devices interface with the people that use them. We also tap into other BCIT faculty and labs,” Paris adds. The group deals with its share of challenges as well.
Gaining product approval for use and sale
“One of the biggest challenges we had to overcome was how to work effectively with companies in the highly regulated medical device industry. Our approach was to operate under the same quality system as medical device companies,” says Paris. “Many start-ups or companies new to this industry can take some time before they understand the complex regulatory system that they must operate under if they want to be in the medical device industry. My advice for them is to ensure they don’t fight it!”
It can be easy for entrepreneurs and investors to become hyper-focused on building devices that will underestimate the need to operate under the appropriate regulatory framework. Make+ and other experienced firms can help companies avoid this scenario that will slow the speed of gaining product approval for use and sale.
To learn more, go to https://www.bcit.ca/applied-research/makeplus-product-development
Sohail Kamal is EP&T’s West Coast correspondent.