When entrepreneurs eyeing the mobile healthcare technology space start planning their new venture, they probably don’t have “regulatory strategy” on their task list. They forget that they’re entering one of the most heavily regulated industries, and how they manage that can have a significant impact on whether they're successful.
Ryan Minarovich, co-founder and CEO of the Tenzing Group, will address that gap at the HIMSS Media mHealth Summit. On Monday, December 9, he will give an overview of what they should know about FDA regulations in the mHealth space. His company specializes in educating mHealth app developers and start-ups on FDA regulatory procedures and requirements, and he says not enough mHealth entrepreneurs are remembering to factor regulations into their business plans.
According to Minarovich, the impetus for his consulting business came in part from the two summers he spent working for HIMSS while in law school. One of his tasks was to conduct a legislative analysis of potential impacts of the Affordable Care Act on IT firms. While conducting his research, he said he realized many startups haven’t given much thought to the potential impact of FDA regulation.
[See also: Venture+ Forum at the mHealth Summit.]
In his presentation, Minarovich says he’ll look at different business strategies for grappling with the world of regulation, using case studies that focus on start-ups.
He pointed to three critical steps all mHealth start-ups should take.
- “Think about your regulatory strategy right alongside your business strategy.” In other words, recognize the connection between a business strategy and the potential impact of regulations, and begin to plan how you will go about managing or mitigating those impacts.
- “Start trying to understand the costs.” Regulation costs money, and Minarovich said the way to approach thinking about regulatory costs – in particular the cost of going through any FDA approval processes – is to “think of it as an investment in your future. You put funds away as you would for any other investment, so if you need them they’re available.”
- “From the beginning, start determining if you want to be regulated.” Not all mHealth businesses need FDA approval, but while there are obviously costs to FDA approval there are also benefits to elevating a product’s profile in the marketplace. Determining in advance how you intend to position your enterprise, as well as whether your development plans will ultimately move you into a regulated category, will help you calculate potential costs.
“There’s a lot of confusion among start-ups about regulations,” Minarovich concluded, “but that’s not surprising. By nature, entrepreneurs are focused on how to get businesses started,” not on the future impact of what seem to be far-off regulations.
For more information, visit the mHealth Summit website.