Determining Technology Trends of Emerging Microfluidic Medical Devices
- Authors:
- Center:
-
Contributing OfficeCenter for Devices and Radiological Health
Abstract
The field of microfluidics has advanced dramatically over the last decade. Microfluidic medical devices require only small fluid volumes and offer the potential of shorter analysis times with better sensitivity. They can be rapidly prototyped and adapted to simulate the complex structures of tissues and organs, or to perform a wide variety of diagnostic tests. Recent increases in investment, research and development in the emerging area of microfluidics are expected to lead to an influx of novel microfluidic-based device submissions to the FDA. To prepare for evaluating these novel technologies, CDRH’s Office of Engineering Laboratories (OSEL) has created a new Microfluidics Program. This poster describes a datamining project of internal databases and publicly accessible information to elucidate key commonalities and trends in the >150 microfluidic medical device submissions over the past five years. Ongoing keyword searches of these databases have included commonly used terms such as ‘microfluidics’, ‘capillary flow’, ‘lab on a chip’, and ‘microchannel’. Through datamining and data analysis using Excel and MATLAB, the project team has identified current trends in microfluidic device application areas and technologies. The majority of microfluidic-based devices to date have been used for diagnostics, with an emphasis on pathogen detection, hematology parameters, and biomarkers. Additionally, real world evidence gathered through surveys suggests that flow-related issues such as leakage, the presence of bubbles, clogging, and sample contamination are sometimes associated with microfluidic systems. Despite the increasing use of microfluidic technology in medical devices, there are no FDA-recognized standards or regulatory tools specific to microfluidics. Our datamining efforts will help us to: i) identify commonalities, trends and knowledge gaps among microfluidic medical devices; ii) determine which types of flow-related device performance tests will have the broadest impact for FDA; iii) understand how microfluidic-based medical devices are functionally different than traditional devices that have similar indications for use; and iv) determine what are the key safety and performance questions related to the technology. The results from this datamining and forecasting study will inform OSEL about which flow-related areas (e.g. fluid leakage, cell sorting, pumping mechanism) to focus on for test method development to support the regulatory review of microfluidic medical devices.