Boulder iQ Helps Hubly Surgical Assemble, Package and Sterilize Advanced Cranial Drill
January 29, 2023
Cranial drilling, a widely used technique in neurosurgery, calls for precision of the highest degree in both the process and the equipment. Hubly Surgical, based in Lisle, Illinois, is the developer and manufacturer of the first and only single-use cranial drill with advanced features for efficiency, safety and use in any medical setting.
Read on to see how Boulder iQ is helping Hubly strive toward its goals of making the procedure more efficient and safe for neurosurgeons throughout the country.
Hubly needed help in assembling, packaging and sterilizing its drill, along with validation on the packaged product. As a small start-up company founded in 2019, facing the rigors of testing en route to FDA clearance, Hubly required a partner with expertise and experience, yet was flexible enough to handle unpredictability, variance in batch sizes, and special requests.
“Because we’re early-stage, we were doing small batches for FDA testing requirements, which meant quick turnarounds and the ability to be flexible with the unpredictable nature of the FDA clearance process,” says Casey Grage, co-founder and CEO of Hubly. “We needed a group that was OK with small and large product batches, quick turnaround times, and understanding that there would be months where we needed them, and other months when we would be working on our own doing testing.”
Working with a strong recommendation from an industry referral, Hubly contacted Boulder iQ in early 2022. Key factors in the medical device firm’s assessment of Boulder iQ included:
• Extensive experience with small companies and start-ups: Boulder iQ had worked with products in the same space and was very familiar with product requirements and the FDA process.
• Flexibility: “Boulder iQ had, by far, the most flexibility” of any company Hubly considered, says Grage. She saw that Boulder iQ was used to working with early-stage device companies, and had the agility to deal with variable product batch sizes and inconsistent manufacturing schedules.
• Speed: Boulder iQ could provide a quick turnaround to work within Hubly’s schedule.
Members of Hubly’s team visited Boulder iQ’s facility in Boulder, Colorado. That trip established critical trust and confirmed that Boulder iQ would be the right fit. “Everyone on our team got an excellent feeling that the people at Boulder iQ were people we could trust, who knew what they were doing, who had done this before, and who would be open and communicative,” says Grage.
Results have been positive overall. The packaging, in particular, was everything needed – and then some. The Boulder iQ team suggested that Hubly package the tray containing the drill in a pouch. This critical piece allowed for the sterilization of the pouched product and eliminated the need for separate validation of the trays – a process that can be time-intensive and challenging for a start-up company. Hubly took the suggestion and has garnered positive feedback. Neurosurgeons have specifically complimented the packing, offering comments including, “That’s a really nice fit.”
Boulder iQ has also proven its ability to handle the myriad of special requests that arise. One example was a request to facilitate special testing. “We needed to manufacture some drills the standard way and others where the drill bit wasn’t fully molded to the drill,” Grage explains. “Boulder iQ handled it with no problem – and quickly.”
In addition, Hubly values the ability to develop relationships with the individuals at Boulder iQ. “We know everyone involved on our project,” says Grage.
The partnership is working. Hubly has completed the required 510(k) testing and is on track for FDA clearance. “Once we get that clearance, we can say Boulder iQ played a big part in getting us there.”