Moving Beyond Improvisation. Solving a High Volume, High Value Unmet Clinical Need to Advance Patient Care

A “Catheter Gripping Tool” solving an unmet need as GCMI’s grows its roster of collaborative medtech innovations with the Children’s Mercy Kansas City Center for Pediatric Innovation.

 

Human beings are generally good at improvisation. Assembly calls for a 10mm socket? Try this handy crescent wrench right here and maybe it will do. What happened to the ratchet straps? Well, these bungee cords right here will work. Kind of. And there is always duct tape! Of course, we’re joking about a serious situation, but there’s never a shortage of ‘jerry-rigging’ something to improve a process in healthcare.

 

Working with one of the most vulnerable populations, pediatrics, Children’s Mercy Kansas City Center for Pediatric Innovation knew a better way might exist to solve a problem encountered daily.

 

It’s difficult to estimate the number of line connections among catheters, IVs, central lines and the like that hospitals and clinicians use, make, take apart and reassemble every single day. Suffice it to say that number is … high, possibly in the millions every day.

 

Yet no tool exists specifically for the purpose of removing line connections. Clinical staff ‘conveniently’ resort to using hemostats, gloves, towels or other random tools that act like pliers for the task. The unsolved problem has been, tubing expands and contracts with fluctuation in humidity and temperature causing connectors to bind. Breaking those connectors too frequently results in wasted time, unnecessary pain for the clinician and patient, and, in some cases, additional surgical procedures.

 

As just one point of evidence of their commitment to innovation in pediatrics, the Children’s Mercy Kansas City Center for Pediatric Innovation identified the need for a more effective, standardized “Catheter Gripping Tool.” The team envisioned a better solution and GCMI is proudly supporting its design and development.

 

David Keeler, Children’s Mercy Kansas City ICU Assistant Director of Nursing, identified the problem after being asked to help other nurses with less grip strength who had difficulty with with connectors that would get stuck.  In addition to the potential risk of damaging connectors when they are stuck, patient care can be delayed if the catheters can’t be accessed quickly by the nurse on duty.

 

The device includes a pair of distally hinged, elongated levers having some flexibility, and which include a separate gripping element which is more flexible than the lever material; this separate gripping element is designed to hold the connector hub without causing cracking or breakage. The exterior surface of the lever is textured to reduce slippage at the user’s grip point.

 

The device is designed to securely hold a catheter ‘hub’ element during disconnection of a relevant member, while reducing the risk of damage to the central line that can occur when trying to dislodge stuck components by other means. The intended users for the device include healthcare professionals who are trained to use and care for central lines and other catheters as part of routine patient care.

Process Matters: Identify the Regulatory Burden As Early As Possible

Armed with early-stage, yet detailed descriptions and renderings, 3D printed prototypes and very early test results produced in conjunction with Kansas State University, the Children’s Mercy Kansas City Innovation team  engaged GCMI to evaluate the regulatory implications of the device on the development pathway.

 

“The first questions we needed to answer on behalf of the team is how will regulatory bodies, the U.S. FDA in particular, view the device?” GCMI Design and Development Engineer John Tipton said. “What’s the hill to climb? Is it formally a medical device? Is it a commercial tool? If it will indeed be a medical device, what will be its classification? Will it be used in a surgical setting that requires sterilization? If so, the design, development, testing and regulatory requirements will be much more rigorous and resource intensive. We will provide well-informed answers to those questions, our interpretation of pathway options and what that means in terms of business strategy and the nuts-and-bolts of design and development work ahead.”

 

“Our proven, phase-gated medical technology design and development process allows for a disciplined medical device design and product development approach,” GCMI CEO Sherry Farrugia said. “We are eager to continue pushing towards a regulatory submission and de-risking this solution to a high volume, high value unmet clinical need with the Children’s Mercy Kansas City innovation team, along with two other projects in-flight and more anticipated in the pipeline.”

 

“If all goes well, we anticipate full design history file creation including specifications, inputs, user needs and risk analysis in preparation for an FDA pre-submission meeting as the next step in our process,” John said. “Formal design for manufacturing, component parts and assembly vendor identification, manufacturing and inspection protocols, testing as needed, formal regulatory submission, then transfer to manufacturing for product launch rounds it out. We anticipate the Children’s Mercy Kansas City clinical team will be the earliest adopters for user feedback and any functional design tweaks prior to manufacturing transfer and production scale up.

 

“If the team determines a non-sterile device is the best place to start to build familiarity and accelerate time to market, the team can take on the work needed for design, development and regulatory approval for a ‘second version,’ a version intended for use in the OR requiring sterilization, in parallel [a ‘first version’] transfer to production.”

 

We look forward to continuing our work with the Children’s Mercy Kansas City Innovation team and sharing spotlights on our other collaborations in progress soon.

 

Should you or a hospital you know want to focus on innovative medtech products, GCMI can help de-risk the process and clear the path for success. Thanks for reading!