The Cleveland Clinic is keeping research, development and manufacturing of medical devices in-house through its Medical Device Solutions unit.
Thirty-two MDS staff members work alongside physicians and clinic personnel to design, develop, create and test prototype devices to bring new medical innovations to life. Six specialty groups make up the MDS core: BioRobotics, Computational Biomodeling, Electronics, Engineering & Design, Mechanical Prototype and Polymers. The Nitinol Commercialization Center recently joined the unit as well.
Tony Shawan is manager of the prototype lab. He manages machinists, engineers, designers and fabricators in the MDS unit. The 13-year veteran of the Cleveland Clinic said the unit began about 25 years ago.
“We have an injection molder in the polymer lab,” Shawan said in a recent telephone interview. “We're hoping to make little medical parts for prototypes — nothing for human implant, but maybe we'll make a connector for a balloon catheter, or maybe a little bracket that would hold part of an injector.”
The unit's 900-square-foot polymer lab houses a main laboratory for polymer processing, a molding room with a canopy hood and hydraulic press for compression molding and dip or solution casting, as well as a Class 100 clean room and transitional gray room for bioprosthetic valve fabrication and biomaterials processing. Synthetic and natural polymeric materials like polyurethane, polyolefins, silicone, epoxies, PVC, gelatin and pericardial tissue are fabricated to create medical devices for use in the Cleveland Clinic.
Shawan said they especially use plastics that can be sterilized at temperatures above 275° F, such as Ultem polyetherimide, polycarbonate and nylon.
“Right now we're working on an artificial kidney for one of the doctors,” Shawan said. “It is cast with an epoxy resin now, but it's only for animal studies.”
The unit is looking to the future through the development of three-dimensional printing, where one solid model is made and sent into a machine that prints layer by layer. Shawan said they can get through many design models quickly with that method.
Dr. Brian Davis served as director of the Medical Device Solutions Unit from 2007-10. He said nearly all the work with polymers at the Cleveland Clinic was for cardiovascular devices, such as balloon designs for stent deployment, thanks to funding from the Global Cardiovascular Innovation Center. GCIC is a Cleveland-based product-development consortium that seeks to attract cardiovascular-related businesses to Ohio.
“Dr. Mike Manley was the chair of musculoskeletal research at the clinic,” Davis said. ”He was originally chair of biomedical engineering at the University of Cape Town in South Africa, where he believed very strongly in having core facilities in both mechanical prototyping and electronics. He set this up when he moved to the clinic in the late 1980s.”
From there, the musculoskeletal research unit merged with the artificial organs unit, Davis said, and they added a polymer core to the mechanical and electronic cores.
In 2005, the three cores, dubbed Medical Device Innovations at the time, were assimilated to the Department of Biomedical Engineering and continued serving the clinic through reparation and refurbishment of surgical and electronic instruments. After Davis joined as director in 2007, the group was renamed Medical Device Solutions and developed the Robotics and Mechanical Testing and Finite Element Modeling Core.
As current vice president of the Medical Device Development Center at the Austen BioInnovation Institute in Akron, Davis has expanded upon his work with polymers. The ABIA was founded by the University of Akron in Ohio, which boasts the highest concentration of polymer researchers in the world. ABIA's Medical Device Development Center focuses primarily on orthopedics and wound healing.
In December, the institute signed a contract with the Food and Drug Administration to collaborate on research and regulation of safe use of biomaterials in medical devices, a first for the FDA and ABIA. The goal of the partnership is to conduct the necessary research that will result in the standardization of safety protocols for the use of biomaterials in medical devices.