From CIC to FDA Approval: Heejin Lee’s Invention Story

For over 35 years, the Collegiate Inventors Competition® (CIC), a program of the National Inventors Hall of Fame®, has recognized the research, discoveries and innovations achieved by college and university students. Competing for cash prizes and patent acceleration, CIC Finalists present their work to a panel of Judges including Inductees of the Hall of Fame, special guest judges and experts from the United States Patent and Trademark Office. It’s an invaluable experience on an inventor’s path to success.

2008 CIC Finalist Heejin Lee, now a senior principal scientist at GSK and a Massachusetts Institute of Technology (MIT) alum, first developed a small device platform to administer drugs noninvasively to patients experiencing painful bladder conditions and other bladder diseases. Nearly two decades after presenting the device at CIC, the invention was developed and commercialized. A fusion of engineering innovation and advancement in medical treatment, Lee’s pretzel-shaped invention has become the FDA-approved INLEXZO™ product and is transforming approaches to bladder cancer treatment.

The invention’s journey from concept to market demonstrates the power of persistence and the motivation to help others.

Early Inspiration For Invention

From science magazines to sci-fi movies and animations, Lee noticed that the figures he admired most as a child demonstrated remarkable intellectual ability. Hoping to adopt the attributes of engineers and scientists, like curiosity, persistence and intellectual brilliance, Lee recalled disassembling household gadgets (though often failing to reassemble them), reading science magazines and enjoying altruistic, superhero-themed cartoons that sought to solve the world’s problems.

“[As a child,] I loved sci-fi animation,” he explained. “I loved all the superhero robots, [and] I was always intrigued by the scientist or engineer cartoon character who developed [them]. There are several famous Korean and Japanese sci-fi cartoons where there’s always a doctor who created superhero robots. I used to think, ‘That guy is so cool — he can invent something and actually save the world.’”

Lee’s lifelong drive to help others led him to develop a technology worthy of presenting at CIC.

Competing at CIC

Reflecting on his CIC experience in an interview with the National Inventors Hall of Fame, Lee said his greatest challenge involved crafting an elevator pitch and presenting his work to his largest audience yet. Eager for feedback, he said the Judges’ questions reframed the way he viewed the potential of his invention through a fresh lens as they discussed scaling, manufacturing and commercializing his technology.

“I recall that I had made fewer than 100 prototypes, including the failed ones, before CIC in 2008. I had never thought about making 1,000, 10,000, or even a million. The eye-opening questions [at CIC] really motivated me.”

Lee’s invention was a pretzel-shaped device made of silicone elastomer and a special superelastic alloy that allowed it to be safely retained in a patient’s bladder after insertion, where it could slowly deliver medication directly to the bladder lining.

“The idea was to create a device that could safely remain in the bladder for an extended period of time and slowly release medication locally,” he explained. “What I developed was a small device with a high drug-loading capacity. It looks simple, but I put a lot [of thought and effort] into it.”

Speaking about whether he would encourage other student inventors to enter CIC, Lee said, “If you think you have an invention, or if you’re looking for new experiences, then just try it. Once you decide to enter CIC, you’re already halfway there. My recommendation is simply to try. You never know. It’s not about winning or losing; it’s about trying and experiencing.”

Describing the CIC experience, he shared, “I think you can gain valuable experience by meeting renowned inventors and fellow student inventors. I really enjoyed the whole experience. It motivated me to keep pushing and follow this track. I think that [CIC] was a very eye-opening experience for me — the whole process.”

Overcoming Challenges at MIT

The invention was the outcome of his MIT doctoral thesis. Facing limited resources, Lee overcame numerous challenges as a doctoral student. From managing a steep learning curve to navigating in vitro and in vivo testing and ensuring the robustness of his device design, his motivation was simple: to solve a critical problem and address unmet patient needs.

“It started with one problem statement: how to deliver the drug directly, slowly and safely to the bladder. I studied many previous failed attempts. As a graduate student at the time, I also read many patient stories about living with bladder diseases.”

“You have to get to the bottom of a problem or its essence and then try to list all the constraints. I think that’s an important starting point in the invention process,” Lee explained. “You need to understand what can be changed, what cannot be changed, and what you can control or design.”

Navigating the Prototyping Process

To bring his idea to life, Lee evaluated the properties of materials he could use to construct his prototype. He determined that nitinol, a superelastic material with a spring-like effect that allows it to return to its original shape, and silicone elastomer would be key materials in the construction of his invention.

“In this particular invention, I used superelastic nitinol,” he explained. “Some durable and flexible eyeglass frames are made from nitinol. It is biocompatible as well and, depending on the heat treatment process, it can exhibit either shape memory or superelastic properties.”

Lee believes that prototyping is part of “a continuous learning process.” As Lee developed and refined his concept and design, his dedication to learning was central to the iterative process of advancing his invention through different phases of development.

“Prototyping is all about learning,” he said. “Certain things you can only learn through failure and iteration. It’s very rare to create a perfect design on the first try. It’s all about trial and error, incremental learning and incremental improvement. Prototyping really helps that kind of process.”

Bringing His Invention to Market

Lee’s journey as an inventor did not end at CIC; instead, it evolved into the development of a breakthrough product. After earning his doctorate from MIT, he joined a startup focused on commercializing the device platform described in his doctoral thesis and contributed to more than thirty issued U.S. patents. These experiences helped him more fully understand the importance of securing intellectual property rights when bringing an invention to market.

He explained, “With intellectual property, sometimes it’s not about the idea; it’s about the claims. Sometimes an idea is very novel but may not be useful or may be obvious. We refer to these requirements as novelty, nonobviousness, and usefulness. It’s not just about novelty; you have to understand what already exists — prior art — and how you are adding value.”

Giving an example of how patented inventions can create a foundation for future innovations, Lee said, “Today, everyone uses the Global Positioning System (GPS). When I was an undergraduate student, it was still considered novel. Now, the technology is used every day and almost everywhere. It has enabled entire markets, such as ride-sharing services like Uber and Lyft. Innovation is not just about inventing a technology or tool; it is also about how it is used. These days, whenever I encounter a new technology, I am more interested in how it can be applied effectively to advance society and improve human life.”

Now that his invention has become an FDA-approved product under the trademark INLEXZO™ and is making a positive impact, Lee aspires to help even more people. “As a scientist and engineer, I want to contribute by bringing something new and useful to people so that families, friends and loved ones can live better lives.”

Lee’s story of invention, engineering, science and perseverance is a testament to the inspiring paths that continue from CIC. He recommends that more student inventors enter CIC to make unforgettable memories, join unique opportunities to connect with legendary inventors, gain expert feedback and advice, and earn national recognition for their work. For all aspiring creators and innovators, Lee has one more piece of advice: “Always remain curious.”

Learn More about CIC

Every year, CIC brings young innovators together to network with world-class inventors, advance their inventions and strengthen their pathways to patents. Are you a student inventor with an innovative idea you want to share? Learn more about the upcoming CIC event and start your application today!