TYNGSBORO, Mass: The time and effort required to get a new medical device through the FDA’s application process has driven many companies out of the industry, but not Northeast Biomedical.
“We focus on early-end research and development,” says founder and CEO Tim Looney. “We invent new ideas and new products for the industry!.
It’s an industry he knows well after having spent many years as an engineer and executive in it, working for (among others) Irish company Creganna, setting up and closing a worldwide development center in Marlboro, Mass. in the late 2000s in just twelve months.
Biomedical boutique
Looney says that his knowledge of the biomedical marketplace made starting his own boutique firm a natural fit. Other industries, like consumer electronics, “are very tough to get into.”
“We’re trying to do good, and we are not necessarily involved with the final distribution or testing regimens”, he says.
When Looney founded the company in 2011 at the tail end of the Great Recession, a lot of the big medical device companies had reorganized and moved manufacturing abroad. Many smaller firms had left the biomedical space entirely. Looney had been an executive at several companies including Cornova, a startup in Burlington, Mass., and knew firsthand how tough the market was.
Cornova had developed a coronary stent that replaced a cobalt-chromium coating with platinum to improve biocompatibility. Cornova achieved CE registration, a manufacturing and testing approval allowing the device to be sold in Europe, for a related product but stopped development. “The cost [for clinical studies and US approval] is high, and investors didn’t want to pay,” Looney says.
He says working as a contract designer means “we still get to do the fun research and figure out the harder problems,” but leave the marketing to the big company that hired them. “There are significant advances in medical devices, where in many other industries it’s just a ‘me too’ product,” he says.
Laboratory Weight Drop System
One of Northeast Biomedical’s most engaging projects was an in-house device with a deliberately anodyne name, the “Laboratory Weight Drop System.” It’s a device used by Traumatic Brain Injury (TBI) and Chronic Traumatic Encephalopathy (CTE) researchers to measure the results of controlled, repeatable cranial impacts on lab animals. In house, they call it the “brain basher.” They have sold several different versions of it to hospitals around the world, including in their backyard in Boston.
“We [recently] did a model for a company that makes stereotactic surgical frames,” Looney says, giving them a total of four different models. It should start showing up in peer-reviewed research papers soon. “It’s one of those passive things that we don’t spend a lot of time marketing, but at the beginning of every semester, we start getting requests for quotes.”
Looney says that having a series of small instruments like the weight drop system that Northeast could sell directly would be “ideal.”
“That would cover the basic costs of overhead,” he says. “That would be fantastic,” and would give them the freedom to dream about projects that go “above and beyond.”
