By Eric Gombrich
“Regulatory Affairs,” “Health Canada,” “Medical Device Regulations,” “the FDA;” in most cases, these terms either send shivers up the spine or mean nothing to those unfamiliar with regulatory initiatives in technology. But with the explosion of Apps, sensors, wearables, and other new technologies entering the landscape, regulatory agencies like Health Canada and the FDA are investing resources to establish appropriate regulatory frameworks for these technologies.
When speaking with entrepreneurs in the industry, the immediate response often moves to explain why their particular innovation falls outside the boundaries of such regulatory models. This is what happened in 2009 when in an effort to regulate software solutions Health Canada issued a notice indicating any software that was “Patient Management Software” required licensing. The ensuing efforts by many software organizations to ‘wiggle out of’ the definition of ‘Patient Management Software’ was nothing short of impressive.
Personally, I believe the FDA’s approach to regulate based less on what the product is by category, and more on what it does makes sense. It largely removes this subjective interpretive process from the equation, and gets down to the root intent, which is to enforce safety in the application of a product for health & wellness purposes.
With Health Canada, FDA, and all other regulatory bodies around the world investing in establishing the rules for these new technologies, the intent is clear; these Apps, sensors, etc. will eventually be regulated. When, how, for what application, etc. is all to be determined in time, for sure. But as a country of highly skilled technical entrepreneurs, it seems to me that if we pay more attention to the intent of what is happening and less on the specific linguistics used at any given moment, we can seize a market advantage.
As an entrepreneur myself, I certainly don’t recall conceiving an idea and believing it to have a narrowly defined use-case; just the opposite. I may initiate my commercial efforts, for example, by marketing my new wearable not really for ‘health’ but rather for ‘wellness,’ and thus, being outside regulatory definition (as it exists today). But why would I not have visions of every doctor or hospital prescribing my wearable in the context of providing care as well? And as many entrepreneurs can attest, what is initially conceived as the use-case will invariable evolve, and success may come from entirely new applications than I initially conceive.
In light of this, why wouldn’t we as an industry seek to help Health Canada efficiently (for them, and for us) regulate these devices in the broadest sense so that ‘Canadian technology’ is the best, safest, and most cost-effective in all use-cases? If we do this, and we embrace the regulatory considerations in our product design and marketing efforts from the outset rather than try to avoid having to contend with them, we can assume a unique value proposition and speed to market advantage, and accelerate revenues, both domestically and for export.
I think that if we stop trying to avoid the inevitable, stop diminishing the value of our companies by narrowing the use-case opportunities for our companies, we can assume a global leadership position with these technologies. That equates to shareholder value, tax revenues, and jobs creations. And I haven’t even touched upon the benefits to my company to the bottom line of developing, maintaining, and supporting these products in evidence-&-best quality-based processes.
While it might have a one-time upfront cost to consider these things, why wouldn’t Canadian health technology companies lead the world from a regulatory perspective?