Abstract

Medical Device-on-a-Chip: The Future of Performance and Safety Testing?

K. Scott Phillips, Biofilms Research Group Leader, US FDA Center for Devices and Radiological Health

The use of medical devices is growing rapidly, with the US market expected to reach $133 billion in 2016. Performance and safety testing are an essential part of the total product life cycle (TPLC) for medical devices. The earliest testing done in the TPLC is normally part of the research (concept) phase. One of the most important goals for testing during this stage is throughput. A high-throughput platform increases the ability to screen a large number of potential materials, designs or chemistries, thereby reducing the all-important “time-to-market”.  Testing at later stages is often related to regulatory requirements and can require animal or clinical studies which are expensive, time consuming, and make it difficult to elucidate the role of individual variables in performance and safety.

Organ-on-a-chip models combine lab-on-a-chip technology with tissue culture techniques to more accurately mimic human physiology. In the field of pharmaceuticals, organ-on-a-chip in vitro models have seen rapid development. Although medical devices and pharmaceuticals have a number of similar testing needs, there has been no recognition of the potential for lab-on-a-chip models to transform performance and/or safety testing of medical devices. In this talk, we will describe the potential advantages of medical-device-on-a-chip (MDOC) technology to help increase the speed of performance and safety testing for medical devices, while decreasing the overall burden required to bring new technologies to market. We will discuss efforts in our laboratory to miniaturize current test methods, and  solutions that were developed to overcome unique challenges associated with combining macroscale device materials and microscale fluidics.