Team:Purdue/Implementation
Our microfluidic device is currently set up for rapid Covid-19 detection outside of lab conditions. Due to the unique ability of our diagnostic device to operate outside of lab conditions, our device is primarily intended to be used to rapidly screen individuals for Covid-19. The complex nature and the potential risks associated with working with the materials contained in the device means that the device will need to be operated by a trained professional. Using our device will likely require dedicated operators and is thus more suited for commercial or public health applications. This would include use in airports to prevent the spread of infectious diseases or in hospitals to protect vulnerable populations. The dominant safety concern related to our device is potential exposure to hazardous material. The spit/ swab samples that are collected are potential biohazards so samples should be collected and handled by trained medical professionals. There are also some buffer solutions inside the chip so it is important that nothing leaks since it could potentially be harmful. We initially planned on using the PDMS (Polydimethylsiloxane) but are exploring more environmentally friendly alternatives.
To distribute our final product, it must first be approved for sale by regulatory agencies such as the FDA. We talked to Frederick Gates who worked on regulatory affairs at Pfizer for 15 years and he gave us advice on our device. The FDA is one of the key players in regulating medical devices and diagnostics. Under standard FDA review, it would take about 12 months for a diagnostics device to enter the market. The FDA CFR Title 21, Section 820 outlines the requirements for medical devices. From this interview, we made sure to be more aware of FDA regulations and make sure our device follows them as well as introducing a control into the design of our chip and conducting validation assays. The summary of the requirements of a medical device according to FDA regulations can be found below:
https://www.nytimes.com/interactive/2020/03/17/us/coronavirus-testing-data.html Proposed Implementation
End Users of cArgo
cArgo Safety Concerns
cArgo Regulatory Considerations
References