Switchback Medical, a Maple Grove, Minn.-based medical device contract design and manufacturing company, announces the expansion of services through the creation of a new division called Switchback BioSim Innovations. The new division offers functional dynamic biosimulator model development, cell culture services, and physician training. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to assess a valve repair device, perfused tissues to evaluate neurovascular catheter usability, or a neuron cell culture built on a biodegradable scaffolding.
 
As part of this new service, Switchback BioSim Innovations can develop preclinical models for device testing and training that currently do not exist. This will improve the safety and efficacy of the devices and significantly speed up the development cycle. The BioSim Innovations services will enable customers to have a single source to develop and test their device. This allows device customers to create efficiencies in their interactions with Switchback.
 
“We are extremely excited about this new venture. It allows our customer’s product development teams to get more clinically relevant and faster testing feedback. With the BioSim Innovations capability, we can now host development through physician training all here in one location,” said Brady Hatcher, principal of Switchback Medical.
 
Currently device test models provide anatomy information or physiology information, but not both. Historically most device testing was done using healthy specimens that often do not provide accurate human data heading into clinical trials. BioSim Innovations has the ability to create models that simulate pathological conditions that can be repaired by the devices being developed. The increased sophistication of medical devices being invented requires improved models and training solutions that current benchtop or animal models do not achieve.
 
“We are excited to help our customers design experiments that generate data demonstrating the efficacy, usability and risk analysis associated with their device, which will also allow us to offer a better physician training experience for complex devices. This new offering creates a sandbox approach for scientists, engineers and physicians to innovate together,” said Dr. Leanne Bakke, director of BioSim Innovations.