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Product qualification: a barrier to point-of-care microfluidic-based diagnostics?
Ratna Tantra1, Henne van Heeren
1National Physical Laboratory, Teddington, Middlesex, United Kingdom. ratna.tantra@npl.co.uk
Lab on a Chip
|May 9, 2013
Summary
Product qualification is a major hurdle for microfluidics-based point-of-care (POC) diagnostics. A collaborative community effort is needed to accelerate the product qualification process for these innovative medical devices.
Area of Science:
- Biomedical Engineering
- Medical Diagnostics
- Microfluidics Technology
Background:
- Microfluidics-based diagnostics show great promise for next-generation point-of-care (POC) devices.
- Despite numerous prototypes, commercialization of these advanced diagnostic tools remains limited.
Purpose of the Study:
- To identify and discuss the generic issues surrounding product qualification for microfluidics-based POC diagnostics.
- To propose potential solutions to overcome market entry barriers.
Main Methods:
- Literature review and analysis of existing challenges in the field.
- Discussion of generic product qualification issues specific to microfluidics.
Main Results:
- Product qualification is identified as a significant barrier to the commercial success of microfluidics-based POC diagnostics.
- Several generic issues impede the progression from prototype to market-ready products.
Conclusions:
- A unified, community-based approach is essential to expedite the product qualification process.
- Addressing these qualification challenges will accelerate the adoption of microfluidics in POC diagnostics.
