Wouldn’t it be cool if…

You don’t have to be from Northeast Ohio to recognize the names Parker Hannifin Corporation and Cleveland Clinic. Chances are you have used some, if not many, of the products offered by Parker – considering the company’s portfolio ranges from hydraulics to automation, filtration, fluid connectors, instrumentation, and engineered materials. Often in the news for cutting-edge medical advancements, Cleveland Clinic is a world-leading hospital system in research, education, and health information.

However, what you might not readily recognize is the work these two establishments are doing with medical device development.

“Cleveland Clinic Innovations (CCI), a business development arm of the hospital system, works to support the development of new medical devices – often inspired from a challenge the surgeon might face during a procedure that sparks an idea for a better approach,” explains Dr. Joseph Foss, director of clinical research for general anesthesiology, Cleveland Clinic. “While this arm of the Clinic has vast abilities to fabricate devices, there are times where we have run into limitations when developing a product. This is where the partnership with Parker takes devices to a new level.”
 

Project collaboration

The collaboration works well because Parker has the Intellectual Property (IP), knowledge and patent portfolio in some spaces while the Clinic has the same in other areas. Bringing these two together allows the companies to innovate in the white space between knowledge domains, says Dale Ashby, vice president of technology and innovation, Engineered Materials Group, Parker Hannifin.

“Innovation occurs at the intersection of knowledge domains,” Ashby explains. “As we look at it, the doctors are most knowledgeable about how to improve on a device, but when Parker comes into the equation, we can offer the steps on how to take that to the next level so it can be mass-produced and commercialized. One great example is the work on the Cardioscope, developed in conjunction with Parker’s Fluid Connectors Group and the Clinic.”

Explaining the device, Foss says surgeons use catheters when they replace heart valves, but once placed, they have to rely on ultrasounds to see if the valve is correctly seated. Clinicians were asking why a device couldn’t provide a view of the valve from inside the beating heart. So, development of a prototype scope and flush system began at CCI, and animal testing showed the idea was on track. Quickly, the scope of the project turned to surgeons wanting to be able to manipulate and position the device better in order to get the necessary images.

After CCI’s work had taken the idea part of the way toward development, the next step would require Parker engineers for integration of video, light source, and the fluid control.

Once the project moved into collaboration with Parker, Ashby says their engineers looked at everything from components to connections. Work in extrusion, thermoplastic elastomers, fittings design, and electrical systems protection all played into determining the construction materials for all the components. Engineers also debated whether to ultrasonically weld or use an FDA-solvent for adhering tubing to the luer locks for the access ports, and worked on miniaturization of cameras, light sources, and components to facilitate access that minimizes patient risk and discomfort.

With Parker engineers contributing expertise in engineering, materials, and fluid and motion control for life sciences, the Cardioscope developed into a device offering visibility into the heart through a light-transmitting polymer, miniature high-definition camera, and a flow-control device delivering a steady stream of fluid to wash blood away for a clear field of view.
 

Opening doors

Although doctors can often identify problems they are facing, the ideas and tools on how to solve them are not always at their disposal.

“CCI has a very sophisticated facility featuring rapid prototyping machines, CNC machines, 3D printing systems, etc., for in-house work, but we know we have limitations because many of the materials we use are off-the-shelf and work simply for the proof of concept of the design,” Foss says. “So, once there’s a design started, there may be a part missing.”

Having Parker open its doors to Clinic physicians allows them to see the whole scope of capabilities. Something often sparks the answer.

“A surgeon might look at Parker’s use of a 500 lb valve on an oil rig and it clicks that miniaturization of that technology would be the perfect fit for the final component in the latest CCI device idea,” Foss says.

Ashby is enthusiastic when talking about transforming a component from use in an industry, such as aerospace, and having it work in a medical device.

“This is what makes it exciting and rewarding. We get a proof of concept idea from the Clinic – often it’s a great proof, sometimes it’s very basic – so many times if you look at this proof and compare it to the final product, they look nothing alike,” Ashby says. “It is after getting the proof that our engineers run with it, seeking input from Parker facilities across multiple groups to see how we need to transform it to become that robust medical device the surgeon envisioned.”

Parker leverages knowledge across all of its divisions to get the complete device, jointly files IP, 510k, and other steps to achieve FDA approval, and prepares the concept for manufacturing, Ashby explains.

 

Reproducing innovatively

Another example that can take a vision and really push the engineering field is CCI and Parker’s work on a side-entry torque system. Surgeons envisioned a device that would allow them to maneuver inside the body without having the residual hysteresis associated with trying to get to a specific point in the body.

“Interventionists were struggling with an unwieldy torque device that took a long time to get on and off the wires they were using. Because of this frustration, prototype development of a side-entry device began,” Foss says. “We then approached Parker to refine it and make it into something that could be mass-produced.”

The result was the Navis Torquer, which attaches to a catheter system, introduced via side-entry into the body. It directs guidewires through the body, something that is the opposite of the typical proximal end of a system.

“The ability to collaborate with Parker has enhanced our abilities to take something our staff has thought up and deliver it to a broader audience,” Foss states.

As Ashby frequently reiterates, medical device development all goes back to innovation occurring at the intersection of knowledge domains.

“Nascent ideas fascinate, and with just a widget combined with our open dialogue, our line of sight is good for what the next step is to get these medical devices to market. Parker’s manufacturing and engineering expertise together with the Clinic’s innovators keeps us on the path of medical innovation,” Ashby concludes.

Parker Hannifin Corporation
www.parker.com

Cleveland Clinic Innovations
http://innovations.clevelandclinic.org

About the author: Elizabeth Engler Modic is the editor of TMD and can be reached at 330.523.5344 or emodic@gie.net.