Casey Grage, CEO and founder of Hubly Surgical, has invented a whole new way to put a hole in your head. Literally.
Drilling an opening into the skull is a prerequisite for basically any neurosurgical procedure. Anytime you need to access the brain, you need to create a hole. This can be for several different kinds of emergencies—strokes, hemorrhages, ruptured aneurysms, or traumatic brain injury. There are some elective procedures as well. For example, inserting deep brain electrodes for epilepsy. There are certain therapies for Parkinson’s disease which require inserting either electrodes or drugs into the brain. You can deliver chemotherapy directly into the brain. Even minimally invasive laser interstitial thermal therapy for brain tumors requires a small incision and hole (about the size of a pencil). Just about any kind of neurosurgery most likely starts with drilling a hole in the skull.
What’s so revolutionary about the Hubly Drill?
“With the current standard of care for drilling a hole, there’s no method for guidance or stopping,” Grage explains. “There’s nothing to prevent the drill from plunging into the brain tissue or being drilled at the wrong angle. The current drill used is a two-handed model and is outdated for 2022.” Grage decided to create a more efficient tool. “We invented the Hubly drilling system to be not only battery-powered and to allow for a one-handed procedure, but it also stops automatically once it breaks through the skull. The Hubly drill is a significant upgrade in preventing accidental plunges into brain tissue when operating.”
How did Hubly Surgical start?
Hubly started as an idea when Grage was attending an MBA class at Northwestern. “In that course, I met a neurosurgeon, Dr. Amit Ayer. I had been aware of this procedure, and I’ve been aware of its antiquity in the field of neurosurgery. Amit was the one who brought a drill from the hospital and said that was what we needed to change first.” Today, Ayer is her co-founder.
The team came up with the idea in 2018. “After doing some big competitions, and filing our provisional patents, I went full-time in December 2019,” said Grage. “And it was right around that time, in the first couple of months, that Amit’s protege, another neurosurgeon, joined us. Then, I also hired my CTO, Tyler Panian, full-time. I met the whole team through the very small world which is Chicago-land medical device entrepreneurship.”
What’s the path to launching the product?
Even though Grage’s drill is a milestone in neurosurgical procedures, medical devices go through a rigorous process for approval by the Food and Drug Administration (FDA). This approval can take time. “We are a Class 2, 510(k) device, that’s our regulatory pathway.”
Class 2 medical devices are those devices that have a moderate to high risk to the patient and/or user. Around 43 percent of medical devices fall under this category. “This means that we have to submit a 510 K proposal, which we have already done,” explains Grage. The 510(k) is a complex application to the FDA, which demonstrates that a device is safe and effective by demonstrating that the device is equivalent to another device that is on the market. “When the FDA process is cleared, we’re good to market and sell and launch.”
In the meantime, Hubly has found its funding through grants, competitions, and angel investors. “We’ve had kind of small limited partners (LPs), angel groups and individual angels, too. In the last couple of years, we’ve raised about $1.3 million in dilutive capital, and we’ve raised an additional $300,000 to $400,000 in government grants and non-dilutive pitch competitions.”
What kind of advice do you have for other entrepreneurs?
Grage has two different but related pieces of advice for other entrepreneurs. The first part is advice useful for other first-time entrepreneurs: be aware of your areas of inexperience. “My greatest strength is basically knowing what I don’t know.” The second part is about bringing in others to cover those areas and trusting them. Grage points to her team, “And being able to find people that I really trust.”
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