FDA Regulations Knowledge Required For mHealth Developers
By Christine Kern, contributing writer
mHealth startups offered hand up
MedCity News, writing about DreamIt Ventures, notes the venture capital firm specializing in incubation and seed investments is calling for applications for DreamIt Health Philadelphia in an environment where more and more applicants are developing smartphone diagnostic tools. “This trend in mHealth devices is prompting a shift in how DreamIt characterizes the accelerator to include not just health IT to health tech. It also wants startups to be more aware of regulatory requirements.”
Elliot Menschik, managing partner for healthcare with DreamIt Health, told MedCity News that DreamIt needs to educate its class members specifically about FDA guidelines and regulatory requirements concerning mobile health settings. “More and more, we will see companies that need to [know how to] navigate the FDA in an mHealth setting,” he said. “We ask them, ‘Have you thought about how the FDA will treat this?’ It’s a big, eye-opening experience for them. But we’re in a much better position to help those companies than ever.”
According to its website, DreamIt Health is an initiative “to jump start nascent healthtech companies developing innovative solutions to real world health care problems. Designed to help promising health care startups rapidly accelerate new products while identifying high impact business models, the accelerator provides up to $50,000 in seed capital, access to top-tier resources, guidance from experienced healthcare entrepreneurs, office space, and more to the companies selected for a four-month boot camp.”
DreamIt matches successful applicants with appropriate mentors who can offer the most relevant experience.
Another program open to applicants is the Digital Health Accelerator, based at the University City Science Center. Some former DreamIt Health participants have been encouraged to apply, which Menschik says is great for these early-stage companies because it lengthens their runway. This program, funded by the state of Pennsylvania’s economic development arm, provides successful applicants to the program with up to $50,000 to invest in their businesses.