Lab-on-a-Chip, September 27- 28th, booth 43E – Analytical Objective

San Diego, CA

In considering the development process, we help you ask the right questions to achieve the analytical objective of your microfluidic product. This involves identifying the product performance requirements through pre-analytical, analytical, and post-analytical phases. One helpful approach is to create a clinical needs assessment to ensure the technical feasibility, the user needs, and business sustainability objectives are well-aligned.

We support our clients in the development of a detailed design control table to identify risks and requirements, and then establish a development program that addresses the high risk areas first in a modular, stepwise fashion. At each step, the analytical performance of the intended assay is evaluated and optimized. As complexity is integrated, sources of variability and error can be identified, and the assay performance benchmarked with gold-standard methods.

Our approach is to start from the analytical science, and then engineer in robust performance with Design for Manufacture incorporated early in the program.

Make an appointment for a confidential discussion by contacting Leanna Levine, PhD, President, ALine, Inc. at llevine@alineinc.com or 877-707-8575.

Learn more about our expertise by attending Dr. Levine’s Technology Spotlight talk titled, “Using the Analytical Objective as the Organizing Principle for POC Development”