Multiple supply chain risks accelerate resupply

Where there is surgery, there is blood. Every day, surgeons use electrocautery pens in countless surgical procedures to open incisions and dissect tissue. But cutting the organ inevitably causes blood to pool in the wound, obstructing the surgeon’s vision and causing the operation to be delayed while the blood is drawn away.

Alex Yang, SB ’17, tries to simplify this process with a new device that’s an electrosurgical pen and suction tube. He founded ClearCut Surgical earlier this year to produce the device, and his company has secured seed funding from several investors.

“Our ultimate goal is to try to put this device in the hands of every surgeon around the world, because this device is going to be used in every surgery,” says Yang, who is about to start his final year in his MD/MBA program. In association with Harvard Business School (HBS) and Harvard Medical School (HMS).

Yang first created the ClearCut as an undergraduate studying bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. He spent the summer after his first year working in the Innovation Digital Health Accelerator at Boston Children’s Hospital, where he met Hong Bae Kim, professor of surgery at HMS and Weitzman Family’s chair of surgical innovation at Boston Children’s Hospital. Kim and Yang started chatting, and the challenges of blood accumulation during surgery finally emerged.

“This is not a new problem,” Yang says. Many surgeons have dealt with this problem for decades. Over the years, Kim has tried to fiddle with a solution, but our chance meeting finally gave us incentives to sit down and think about creating a new device.”

From these conversations, ClearCut was born. The portable device uses buttons to switch between the electric ironing pen and the suction tube. The injection-molded plastic device does not require additional electrical power, switching functions with a pneumatic piston that connects to the vacuum suction in the operating room wall. These innovations keep the cost low, which could help make the device more accessible to hospitals in under-resourced regions of the world.

“This device has probably gone through more than a hundred iterations and 3D-printed designs,” Yang says. “Surgeons are understandably picky, and you really only have one right to get it right. If the button placement is a little off, or fails once out of a hundred, or if you feel the device is too heavy, you lose the surgeon there. For a while, it ranged The ratio is between 80% and 90%, but we wanted to make sure it was 100%.”

Yang has spent the past six years slowly developing the device while pursuing his MBA/MBA degree, and soliciting the opinions of multiple surgeons at Boston Children’s Hospital. He founded his company in March, and soon after won $30,000 both runner-up and crowd favorites at the HBS New Venture Challenge. Recently, ClearCut Surgical was selected as one of 50 startups in the MedTech Innovator and Accelerator Challenge, whose awards will be announced in October.

“It’s the largest medical technology accelerator in the world,” Yang notes. “It is very difficult to find a group that is focused and has so many resources. It is great access to capital, manufacturing partners, industry partners, all in one place.”

The design of the device is nothing new to Yang. His first project, a lower limb prosthesis for children, won the 2017 Dean’s Award for Best Engineering Project.

“My father is an architectural modeler and he has spent his life building miniature buildings,” Yang says. “Since I was 5 or 6 years old. I have been playing in his workshop with instruments, and he was definitely an inspiration.”

ClearCut has yet to be approved by the U.S. Food and Drug Administration, a process that Yang said will likely take at least another year. He’s looking forward to early 2025 for the company’s first commercial offering.

Once ClearCut becomes available, Yang believes that its low cost and ability to solve such a common surgical challenge will make it a huge success for surgeons around the world.

“One option was to take the idea, file a patent, and license or sell it to a large medical device company,” Yang says. “But given my SEAS experience and my engineering knowledge, I thought it would be a better use of my time and money to do it myself and take it as much as I can.”

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