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Tenzing Group New Firm Provides Strategic Advice to Mobile Medical Application StartUps on Proposed FDA Regulation
Date:5/16/2013

“There is a strong need to balance the role of the FDA to oversee patient safety while at the same time promoting innovation,” Minarovich said. “What we are seeing is that the lack of clarity is already causing many companies to slow down their launch to market. Also, many startups are not getting funding from cautious investors who are concerned how potential regulations could play a role in the company’s product development.”

The Tenzing Group offers an in-depth customized report to customers who are seeking FDA regulatory coaching, called the TNZ Report ™. The components of the report include:

  • Interviews with key company leaders to understand the company’s objectives, past and present business practices, development strategy and marketing.
  • Extensive research on how the FDA has or will review the company’s product.
  • A customized summary that details the FDA’s current medical device classifications, subsequent requirements and how this matches with the company’s long term goals.
  • Recommendations on how the company may want to alter or change direction for development and marketing based on the initial findings.

Venture Capitalists, individual Angel investors and startup accelerators specializing in digital and mHealth can use the Tenzing Group research to more fully understand the potential impact FDA guidelines may have on a particular startup product.

“The whole industry has been following the hearings in Washington D.C.,” said Missy Krasner, founding member of Google Health and Executive in Residence, (EIR) at Morgenthaler Ventures. “It’s a strong sign to investors when startups are getting early counsel from groups like Tenzing and other industry specialists on these types of policy discussions in D.C. especially if they are an mhealth solution with a device-lik
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