By Takara Small
News at Northeastern
TORONTO—Samyukta Rajkumar always knew she wanted to help people.
As a child, she dreamed of getting her nursing degree so she could save lives and support those who needed a helping hand. These days, the 27-year-old’s dreams have come true: She has a nursing degree and is helping people in need, except it’s not from the side of a hospital bed.
After tiring of her back-breaking hospital job, Ramjkumar decided to go back to school and earned a master’s degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University’s Toronto campus in 2017. Now, she saves lives not in an emergency room, but from her desk at a medical startup called Exact Imaging.
The company makes micro-ultrasound systems that can scan, inspect, and identify suspicious tissue in the body faster than traditional ultrasound machines. Rajkumar’s job is to ensure regulatory safety and quality control.
She’s tasked with combing through clinical research and medical data to make sure that the company’s devices meet safety rules and that research outcomes are accurate and up-to-date. It’s a big role that gives her a chance to think about how to help patients live healthier lives.
“The job is huge,” Rajkumar laughs. “I’ve been in a sector where I’d treat patients after they’re sick and I always thought we should be thinking a lot more about preventative care. Now I finally get to focus on that.”
Her work helps doctors diagnose people quicker, and more importantly, prevents the type of health complications that once pushed desperate people into her ER ward.
Take, for example, a fateful interaction with a coworker:
“When I started at Exact Imaging, we tested the devices and scanned all the men in our office and actually saw something kind of suspicious on one co-worker,” says Rajkumar. “He went to see a doctor, and it ended up being prostate cancer, but they were able to catch it really early. It’s hard to put into words what that felt like.”
Although, the best part about her “exciting” role is that every day is a little different, Rajkumar says.
“I work pretty normal nine-to-five hours, but it’s different from week to week,” she says. “Some days I’m in my office doing regulatory submissions to get our devices approved for sale—putting together educational packages, looking through all the data and review testing to support our devices. Then other times I’m meeting with health regulators from around the world who come to our office and want to review our products.”
Since Exact Imaging’s devices are in demand across Europe and South America (and may soon be available in China), regulators representing international markets will schedule “medical audits” to make sure products meet their country’s health standards.
Typical audits can last a week and take place in the company’s boardroom, during which Rajkumar will showcase devices, present the latest data, and go over clinical work—sometimes for 12 hours at a clip.
“The auditors go through our entire process, and it’s my job to sit with them and answer their questions,” she says. “They make sure that we’re building to this really high standard and have proper processes in place to test it.”
Despite the long hours, Rajkumar says she’ll never take her job for granted, especially since she’s seen first-hand how her work can impact the long-term health of others.
“I still get that feeling of joy, because it’s not just the U.S. and Canada where our devices are saving lives,” Rajkumar says. “We’re working on approval in China, Israel, and smaller countries where such new and innovative devices aren’t always available, and that’s big. Right now that’s, like, the most rewarding thing.”
(Reprinted with permission from News at Northeastern.)