Madhuri Iyer and Amanda Céspedes are Untangling the Web of Regulations to Help Life-Saving Technology Reach the Market

Amanda Céspedes and Madhuri Iyer are familiar with the complex web of laws and timelines and documentation that comprise the federal regulatory landscape in the United States. Anyone creating a healthcare startup or building a new medical device needs to make their way through an astounding 18,000 requirements established by the Food and Drug Administration to determine which ones apply to their products.

These regulations are important—they help to ensure that drugs do what they’re supposed to do with as few side effects as possible, and set standards for clinical trial outcomes, medical device functionality, and more.

Take the EpiPen for example. The life-saving device contains a retractable needle that delivers a precise dose of epinephrine to block anaphylaxis in people who are having severe allergic reactions. Users are instructed to press the tube-like device against their outer thigh to administer the drug. The inventor of the EpiPen (a Northeastern University alumnus) would have had to prove to regulators that users wouldn’t accidentally hold the device the wrong way and stab their finger, instead.

“Governments put these rules in place to make sure products are safe and effective, and these are good laws,” Iyer says. “But their complexity can make them a barrier of entry between an amazing product and the market.” 

These federal regulations exist in a tangled mass that’s difficult to parse for even the most savvy entrepreneur. And it’s not just the U.S.—federal regulations in countries around the world are often complicated to follow.

Céspedes encountered this in Chile. She’d spent five years working at a medical device startup that ultimately failed because of regulatory challenges, she says.

“It was five years, gone,” Céspedes says.

And Iyer encountered the same challenge in Australia. For nine years, she worked at companies large and small and saw that in almost every instance, “it wasn’t clear what the quality and regulatory expectations were,” she says.

Frustrated with the murky regulatory environment, they each enrolled in a graduate level regulatory affairs program in the College of Professional Studies at Northeastern University. They met and started talking, astonished at how closely their experiences halfway around the world matched.

“We both realized how difficult it is to understand these requirements if you don’t have them set out in front of you from the start,” Iyer says. “We asked ourselves: What can we do to fix it? We’ve each faced the problem, what is the solution?”

There are regulatory consultants that entrepreneurs can hire to guide them through the process, but they can be prohibitively expensive, Iyer says. In that case, there are blogs and websites by other founders, but often they’re so laden with jargon that they can be impossible to parse.

“A lot of times, the novel medical device innovators are people who don’t know the regulatory space but just have a great idea and want to help people,” she says. “Unfortunately, the FDA isn’t something you bring in after the fact; you have to build it in before you even start conceptualizing a design.”

So, the pair combined their experiences and strengths, and created a solution: EZReg, an online platform that clearly defines the federal requirements that healthcare and medical device startups must meet in order to get their ideas to market. Céspedes and Iyer were each recognized with a 2022 Innovator Award in a competition hosted by Northeastern’s Women Who Empower.

Céspedes and Iyer are still building out the platform, which will eventually guide entrepreneurs through the regulatory landscapes in various countries, they say. It involves painstaking work, sorting through tens of thousands of laws and requirements, but it’s work that inspires them.

“A lot of the technology that comes out of research labs could be life-saving advances,” Iyer. “If companies are failing just because of regulatory challenges, for me that’s an unacceptable reason. I want to do everything I can to help these companies reach the market and have the most impact possible.”