Peter Rizzo, Business Development Specialist, Cogmedix

M2D2I had the pleasure of visiting the Massachusetts Medical Device Development Center (M2D2) at the new 110 Canal Street building in Lowell for a talk on “Medical Device Start-Up Pitfalls” led by Christine Santagate, client solutions advisor with Regulatory and Quality Solutions, LLC. Christine broke down the journey of bringing an innovative medical device from concept to market, taking into consideration hidden fees, budgetary considerations, business development strategy, and a 101-type crash course in medical device definition and classifications.  Another important consideration if you are starting your own company or launching a new product that wasn’t discussed in this particular session is that of manufacturing. It’s very important to think of outsourcing your medical device manufacturing so that you can focus your investments on innovation and marketing while managing your cash flow as efficiently as possible.

Perhaps the most fascinating part of the guided discussion was Christine’s example of two different devices with the same exact function and ergonomics but different device definitions. Most of us know what a Fitbit is (a wrist-worn step- and pulse-counting device), and that there are several other competitors making similar devices (Misfit, Jawbone, Nike+ Fuelband). Neither Fitbit nor the other devices are classified as a medical device, but another, the BodyMedia Core 2—with the same exact functionality—is classified as a Class II medical device. Why? According to Santagate, it’s all in how you market the device for use.

BodyMedia developed their product to share biometric information through a web portal with each consumer’s physician, reinforcing diagnostic and prognostic efforts. By looking at the FDA’s medical device definition: “an instrument, apparatus, implement, machine, contrivance, implant, [ . . . ] which is [ . . . ] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease [ . . . ],” one can certainly see how their product description and use tips the scales in favor of medical device classification and distinction among competitors. Be sure to understand your market, intended use, and product classification early on.

M2D2 and its Innovation Hub are connected with a UMass Lowell-Worcester partnership and located in the Hamilton Canal District that invites start-ups to share space in state-of-the-art lab facilities and private rooms to develop innovative, scientific solutions to issues ranging from wildlife conservation to cancer research. Christine Santagate can be contacted by email at