Medical device design usually involves the use of computer-aided design and computer-aided manufacturing, or CAD/CAM environments. The process is long and iterative.
Now, two professors at the University of Minnesota have come up with a 3-D visualization device that aims to revolutionize how medical devices are designed and tested, thereby shortening R&D cycles and the costs associated.
The U’s Office for Technology Commercialization recently showcased the device in the hopes of finding a commercial partner, said Karen Kaehler, technology strategy manager at the OTC, in an interview with MedCity News.
Currently, a medical device company that uses a CAD/CAM-type environment does some development on the computer, but then manufactures multiple prototypes in order to finalize a design.
“That can be a very long iterative process. You make a change. You test it. You make a change. You test it,” Kaehler said.
But using the U’s 3-D immersive visualization and design environment, all the changes, small and big, can be tested without actually manufacturing a prototype. The system is the brainchild of Art Erdman, director of the U’s Medical Devices Center, and Daniel Keefe, a professor in the department of computer science.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The idea here is that all of the testing could be done in a virtual environment,” Kaehler said.
Product-specific data can be loaded onto the system along with other types of data such as those from a tissue registry database or a blood flow database. That allows the system to generate the visuals necessary to see how the device is functioning. For instance, in testing a new stent, researchers will actually be able to see how blood is flowing into a coronary artery.
“If companies could use an environment like this and cut out time and testing, both, then surely this would be an advantage then to the industry,” Kaehler said, but she could not say how much cost savings the new system can provide. ”
A “good-sized medical device company” is going to test the system, she said, declining to name the company or where it is based. The beta test is set to commence later this month. The goal is to answer several questions including whether people using this tool require any training.
“Ideally, we would want it to require minimal training so that it would work like a video game, like plug and play,” Kaehler said.
She hopes that ultimately the system can actually reduce even clinical testing of new medical devices. That would of course require the blessing of the U.S. Food and Drug Administration.
“The FDA has seen this environment and they reasonably would like to see more information about this.” she said. “But they are very supportive and think this would be something they would want the medical device industry to go with as well.”
But don’t expect any changes to occur overnight because the system requires fine-tuning.
[Photo Credit: Andria Peters]
