By Emily Stevenson
When young adults contemplate a career in science, the first thing that springs to mind is often becoming a doctor. Maybe a nurse, or perhaps a researcher or teacher. Becoming a business professional who helps inventors push new medical devices through the FDA’s rigorous process probably doesn’t cross many students’ minds.
It didn’t cross Kathryn Becker’s mind, either – at least initially.
“I was interested in science, but academia and research wasn’t for me,” Becker says. “Big industry wasn’t for me, either, but I wanted to be in the business side of science.”
Becker is principal and owner of Translational Science Solutions, LLC, a Charleston-based firm. She creates business-minded strategies to help get medical devices to patients, including creating what they’ll say about their products when they market them, what sort of testing will need to be done, and what kind of information they’ll need to submit to the FDA.
Medical devices encompass a broad range of products, from a simple tongue depressor all the way up to a stent inserted into the body.
“What I love is that I get to work with people who are really smart individuals with great ideas, and I get to apply my knowledge of FDA’s regulatory framework to what they’re developing and figure out how to frame their product and present it to the FDA,” Becker says.
While Becker says she loves her career now, finding it was a bit of a challenge. She grew up in Charleston and attended the Academic Magnet High School in North Charleston. She served as a summer intern for a graduate student at MUSC doing neuroscience research in high school, and continued doing lab-based research during her time at Davidson College, but she didn’t love being in the lab all the time.
During her senior year of college, Becker was introduced through a family friend to the founder of a consulting firm called Becker and Associates, although there was no relation. This was during the middle of the recession, and she was uncertain whether the firm would be hiring, but eventually Becker was offered a job as an entry-level research associate. She moved to Washington, D.C., to begin her career in life sciences consulting.
For five years, Becker worked in the nation’s capitol, but when her husband was offered a job in Charleston, she jumped.
“I wasn’t going to pass up the opportunity to move where I’m from,” she says. “You just can’t beat Charleston in terms of quality of life.”
Becker was concerned, however, about the quality of the life sciences in the state.
“I assumed I was going to have to come up with some kind of alternative career path,” she says.
Initially, she worked as a subcontractor for her D.C. employer, while at the same time putting out feelers to decide what to do next. One of the individuals she was put in touch with was the president of SCBIO, an organization dedicated to promoting life sciences in the state. The group’s annual conference was coming up, and she was invited to sit on the panel. The experience was a revelation for Becker.
“I was shocked because there were hundreds of people in biology and life sciences in South Carolina,” she says. “As it turned out, there’s been a great opportunity here to help, especially some of these emerging companies.”
It didn’t take long before she decided to hang out her own shingle. Her first client was a startup out of Clemson University, and she was able to help them get their product through the FDA and cleared for marketing. She hasn’t looked back since then.
“I’ve been able to work with companies not just in South Carolina but also throughout the Southeast and across the country, and internationally as well,” she says.
But despite having clients in far-off locales such as the Netherlands and Japan, Becker says the innovation in the life sciences sector in South Carolina is impressive – and continuing to grow.
“The market in South Carolina is evolving, and it’s at a critical point where a lot of companies are starting to come of age, and they need this help,” she says. “What I see is a huge emphasis on growth of knowledge-based economy in South Carolina, and a lot of the academic institutions are trying to spin out technologies. We’re seeing more investments in the life sciences in South Carolina than in the past.”
Becker says that the rise in angel investing and research university initiatives has contributed to the growth of the medical device market. She hopes that the increased activity will lead to more therapeutic products and medical devices being delivered to patients.
The route a medical device takes to market is wildly different from that of a drug or pharmaceutical product. In general, the time to market is much shorter for medical devices. Because the products can vary so greatly, it’s a less defined pathway and it’s different for each device, whereas the process is uniform for all drugs.
Becker takes a look at each device she’s presented with and helps determine the best route.
“Somebody has an idea, and we take a look at it and how it could be used and how those different uses would affect how the FDA would view the technology and regulate it,” Becker says. “You could have the same technology and use it for different applications. You can select, for example, what the application would be to get through to the market with the fewest number of hurdles and expand from there.”
Though it might seem overwhelming, Becker thrives off the challenge.
“It’s the business side and the science side and that’s what I like,” Becker says. “It’s like a puzzle to get through the regulations. There’s never just one way to do it.”
As the health care system as a whole evolves, jobs like Becker’s will become more prominent, showing youngsters interested in science that they don’t have to be a doctor in order to utilize their talents.
“I think that the traditional sciences as we know them are changing,” she says. “There are a lot of different facets of life sciences that you can explore other than just traditional research or medicine or pharma.”
She encourages students interested in a career in science to talk to industry veterans about career options.
“The biggest thing is to talk to people, talk about their experiences,” she says. “You can do all the job research you want on the side, but you really don’t know until you’ve spoken to somebody who’s experienced the day-to-day and has been there. There are all kinds of careers popping up now.”
Best of all, though, those careers are popping up in the Lowcountry, offering opportunities not just for Becker’s growing business but also for the area as a whole.
“I’m just really excited about the direction the life sciences industry is headed in the state and in Charleston,” she says. “It’s really linking the whole community together.”