Santa Clara, CA -- (SBWIRE) -- 05/23/2013 -- New FDA consulting firm, The Tenzing Group, has launched an in-depth regulatory coaching service for Mobile Medical Application (MMA) startups to ensure success while understanding the costs and requirements of FDA regulation.
“For unprepared startups, FDA regulations on mobile medical applications could result in a critical obstacle or worse yet, the end to a company,” said The Tenzing Group CEO, Ryan Minarovich. “Having a mobile medical application labeled as a medical device, which is under evaluation by the FDA now, could have a significant impact on revenues and product development. Companies need to start their research early to understand the current policy landscape and how it may effect their business model as well as market strategies.”
The Tenzing Group is focused on providing clarity on FDA regulations while the industry waits for final guidance. The FDA published draft guidance mid-2011, which many agree has been too long and is causing confusion among many startup companies.
"We are pleased to be working with the Tenzing Group and we are impressed with the knowledge and background the company has to help guide us through FDA classification understanding," said Dr. Scott Jenkins, CEO of m-Health Technologies Inc. "Having a specialized practice on the challenges of both mobile and healthcare, makes the Tenzing Group unique in this field."
The Tenzing Group announcement comes at a pivotal time in the industry as the House Subcommittee on Communications and Technology held recent hearings on possible FDA regulation of MMAs and consideration that they could be classified as medical devices.
“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-like attachment.”
The Tenzing Group has been reviewing FDA regulations when the initial draft guidance was announced in 2011 and last summer. The goal of the firm is to decrease the amount of companies that may fail due to regulatory costs and help the mHealth market thrive.
Come See Us At VentureBeat’s HealthBeat Conference Ryan Minarovich, CEO of the Tenzing Group can be heard at VentureBeat’s inaugural health IT conference on May 20, 2012 in San Francisco moderating a panel entitled: When is a Mobile Phone a Medical Device? Washington Wants to Know, at the HealthBeat 2013. To schedule a meeting with Ryan Minarovich, see contact information below.
About The Tenzing Group
The Tenzing Group’s goal is to guide new Mobile Medical Application (MMA) companies through the complex FDA landscape by offering education and insight into the best possible path that will provide the easiest and most cost effective process through regulatory procedures. The Tenzing Group does not complete the FDA approval application so the company can remain unbiased in its approach to help deliver the best knowledge and options for least amount of cost. To learn more about The Tenzing Group visit www.tenzinggroup.com