Designing an innovative solution to a medieval problem
Hubly Surgical is on a mission to transform bedside neurosurgery. We partnered with them to design a proof-of-concept, advanced intracranial drill with unique technology that could save thousands of lives each year in the US alone.
Hubly founder and CEO, Casey Grage sought our expertise to help drastically reduce the risks of complications and death when performing the burr hole procedure in which a perforation is made in the skull. We applied a unique, iterative approach to create an innovative solution that modernises an archaic approach to neurosurgery. Our method is designed for safer and more efficient procedures, which could save patient lives and ease the burden on surgeons.
Prioritising safety and patient outcomes
A ventriculostomy is the potentially life-saving process of drilling burr holes into the skull followed by the insertion of a catheter into the brain. It is the most common neurosurgical procedure worldwide. Yet it’s a highly dangerous one. Roughly 20 percent of ventriculostomies performed result in irrevocable brain damage or death. When a patient needs a ventriculostomy, each minute is crucial and so procedures are performed outside of the operating room — or “at the bedside”— by default as there is not always time to book and prepare an operating room—which can take hours.
Each year in the US, medical professionals perform 60,000 ventriculostomies at the bedside. It’s a procedure that requires precision and control. Burr holes are used to help relieve pressure on the brain when cerebrospinal fluid builds up and starts to compress brain tissue, which can result from traumatic brain injury or haemorrhage. The margin for error is very fine and the consequences of getting it wrong can be devastating.
Although the statistics are shocking, they’re unsurprising given that the standard of care is a hand crank drill at the bedside - an antiquated, almost medieval solution for such a delicate task. No product exists that would stop the surgeon from over drilling and accidentally entering the brain– it’s down to the individuals’ skill alone.
CEO Casey Grange knew there had to be a better way. And so, she reached out to our team with a clear ask: partner with us to design a new surgical tool – one that is safer than anything that’s ever been invented. It was a big ask. And one we were confident we could solve. We leapt at the opportunity.
A new approach to an old challenge
Many had tried but failed in the space before. The issues were many, and Grage could see that a combination of our team’s expertise in design and engineering allied to our strong track record of creating innovative medical devices could be the solution. To solve the challenge of stabilizing the drill for precision movement, we had to rethink the methodology that prevents motion.
The two clear frontrunners from this matrix were then breadboarded to prove their feasibility, and it was decided the lever-lock system was most successful.
Surgical safety for all, anywhere
The outcome was a complete reinvention of the mechanism, with the innovative lever lock system that prevents motion. It enables the drill to retract the moment it breaks through the skull. The ability to create a highly precise auto-stop (to within 0.2mm in benchtop testing) effectively eliminates over drilling. It also features a collar unit to keep the drill perpendicular to the surface and limiting the drill advancement speed.
This in turn could mean real results for patient care, such as significantly reducing incidence of brain trauma, stroke, haemorrhage, infection, and death for patients. And, to reduce operation room dependence and enable safe bedside cranial surgery, the drill is cordlessly powered. “I have to say, the teams’ creation of the lever lock system works incredibly well,” said Grage.
The features are designed for three primary benefits – better outcomes for patients when time is critical, a faster and more intuitive tool for healthcare professionals to use, and significant cost savings for hospitals by not using operating rooms.
Following Food and Drug Administration (FDA) Clearance, appetite for the drill is already strong with 100 hospitals exploring the option to purchase the drill. Hubly is now positioned to fulfil its mission to improve patient outcomes by transforming surgical procedures, across standard and underserved settings. Ventriculostomies are just the start.