Clinical trials - oh, how to describe them.
Patient advocates would say they are absolutely mandatory to ensure safety of devices. Device industry would likely argue that they are necessary mainly for many complex devices.
But no matter what vested interest you may have, there is one undeniable reality that defines clinical trials. They are notoriously expensive and difficult to enroll. In fact recruitment challenges often hobble or delay many a novel technology.
The Mechanical Engineering and Computer Sciende departments of the University of Minnesota have built a virtual prototyping device that can reduce the clinical trial burden that companies have. Only three such devices exist. One is at the University of Minnesota's Medical Devices Center. The other at Boston Scientific under a joint development program the company has with the Center. And the third is at the University's Computer Science department, said Art Erdman, the director of the Medical Devices Center, in an email.
What can it do? See the video below for a better answer, but in short it can cut down the number of recruits a company needs to have because by virtually prototyping the device and doing virtual implants, companies can get human data and refine the device they are trying to build. Saurav Paul, Director of the Medical Devices Center's Innovation Fellows Program, said that FDA officials including CDRH Director Jeffrey Shuren have seen the device and are aware of it.
"He has been at our labs twice and fully understands the power of the system for visualization of complex 3D anatomical data as well as the implications for improved medical device design," Erdman said of Shuren. "He is very much encouraging us to move quickly and to continue our addition of new features to the system."
The goal of course, is for such a device to be ultimately approved such that device approvals won't need so much clinical trial data in the future and that data from such devices would count toward FDA submissions.
In the video below taken during an informal tour of the new Medical Devices Center last week, the demonstration is being provided by Christopher Rolfes, an Innovation Fellow. Rolfes, along with Chinmay Manohar, also an Innovation Fellow who appears in the video, is developing a therapy to treat sleep disorders.
By Arundhati Parmar, Senior Editor, MD+DI