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A tale of the two-thousand MedTech regulations

By Chelsea McCullough / July 21, 2014


The tale of the two-thousand MedTech regulations

In the past few years, the persona of the entrepreneur has been given their rightful place in the universe and elevated from geek to God. We hear these amazing tales of courageous adventurers who start in their dorm rooms and end when the bell rings on Wall Street. They are a special breed who do what only entrepreneurs can do: find a problem, create a unique solution, get it in the hands of those who need and want it.

This is a risky endeavor akin to a classic fairytale; a hero/heroine accepts a challenge which unfolds into an adventure chocked full of thrilling rides and perilous treks that requires wisdom, courage, patience, fortitude, and the support of those you meet along the way, all in search of a precious prize; the exit. As if conceptualizing, creating and getting a product to market isn’t hard enough, entrepreneurs in the healthcare space have the added pressure of understanding the regulatory rules that could mean life or death for their product and the people they’re making it for. Sounds daunting, right? Well wait until you hear the story of the Med-Tech Entrepreneur and the Regulatory Fire Swamp.

A short time ago in a far-away land

In the recent past, tech entrepreneurs tinkered and experimented with circuits and devices, while the regulators lived and governed in their ivory towers in a far-off land called Washington DC. These two clans typically remained in their own territories, but whenever they were forced to come together, it usually resulted in a heated battle.

It’s no surprise that regulators–in charge of protecting the public against the great unknown–and entrepreneurs–known for breaking the rules and creating a reality that us common folk could only begin to imagine–had a hard time seeing eye to eye, especially in the furiously evolving industry of medtech. Even as recent as three years ago, there was great fear and trepidation amongst medtech entrepreneurs about what could be expected when a prototype was ready for regulatory review.

Regulators, in the same vein, were struggling to even wrap their heads around the entrepreneurs’ foreign concepts, much less put laws in place that supported and protected these innovations. Ideally there would be a dialog between these two entities, but how can they possibly talk with each other given the distance in ideology, purpose, and perspective?

A great big hope

Just before the tension between the two groups reached a fever pitch, a couple of heroes emerged from the west coast of America: Google and Apple. In recent months, both of these mammoth tech companies have entered the wearables and fitness arena. Google Fit and Apple HealthKit are person-centric products that could be a the greatest step towards health innovation since the X-ray machine.

Apple came out first with HealthKit–announced during this year’s WWDC conference. Google followed with Google Fit–announced during its Google I/O Developers Conference. Both will “provide a hub for users to keep track of fitness goals and health-related information” as stated in a recent Mashable article. And while most pundits in the opinionated tech community were just short of a yawn, these two products point towards a critical benchmark in medtech history–the start of mainstream adoption.

Instead of the Wild West of app development, there are now two “platforms that must be integrated” in order to be relevant for the end consumer. And when the consumer wins, everyone is happy. These new platforms will help users keep track of their fitness goals, health stats and relevant personal information as part of living a more holistic and integrated life, all at the hands of tech. If this all sounds familiar, it should. Remember the advent of the first smart phone? And just look at us now.

Slaying the Dragon

So with regard to regulatory affairs, this can only be a good thing. Instead of a thousand solo entrepreneurs trekking in foreign lands without a map penned on an ancient scroll, Apple and Google are the sage guides, informing and translating for those who continue to explore medtech innovation. Instead of chasing the whims of a local entrepreneur with a big idea, policy makers, hospital systems, insurance providers and patient-centered care givers can relax and operate knowing that Apple and Google are spending lots of time, capital, and energy creating a playing field that is easier to navigate and can potentially lessen ambiguity.

Mobile and Internet technology is finally ready to revolutionize healthcare. It acts as a magical amulet, using its scalable power to overcome challenges for both patients and providers: personalized communication, information management, timely access to research, etc.

But what are the responsibilities of entrepreneurs, providers and practitioners in this story? Enter the next character in our saga, the HIPAA Omnibus Rule, born in 2013–and joined by our friend, the FDA–creating a duo of federal regulatory agencies who keep standing in our heroes’ ways with a wide range of security stipulations from patient billing information to genome sequencing that involves an entire family’s genetic history. These specialized areas are on top of the current regulatory issues the tech community has to combat for the access and management of broadband Internet and wireless Spectrum.

In the midst of this confusion, as worlds collide, there are wise oracles who can provide guidance. One of these in the medtech space is Paul Sonnier, who has been named #9 on the list of 1,000 Wearable Tech Influencers. His Digital Health LinkedIn group and Story of Digital Health website are trusted network hubs for the global digital health ecosystem. This article is chock full of resources on all things healthtech. It’s encouraging to see so many experts come together in this space, like Health 2.0 with its national network of local healthtech chapters.

It is this kind of convergence and information exchange that will bridge the gap between kingdoms so that regulators and entrepreneurs, platforms and providers can find a common language. In our ideal world, regulations are fair and flexible, providing boundaries that allow and even encourage innovation to flourish without imposing antiquated laws that put our modern-day kingdom back into the dark ages. We will continue to voice concerns, encourage conversation and direct the dialog so that peace can reign across this uber-connected land where everyone lives in health and happiness forever and ever–or at least longer than usual.

The End.

Chelsea McCullough serves as Executive Director of Texans for Economic Progress, a statewide coalition that advocates greater access to tech education, entrepreneurship and infrastructure.