Diagnostics for All, a medical device start-up, grown out of Harvard University, received funding from the Bill and Melinda Gates Foundation and is developing low-cost, innovative, practical diagnostic devices.

Description

SPEC began working with DFA as they moved from product development to pilot production for clinical trials.

Project

SPEC began by assessing and documenting the existing operation for manufacturing the medical diagnostic devices, including the equipment used, the step-by-step procedure, and the manpower required.  SPEC and DFA then went over each step with the intent to eliminate or reduce time and waste, which resulted in several significant improvements to the process allowed them to scale-up production for clinical trials.

Project Highlights

Key improvements:

1. An improved adhesive patterning process was developed which eliminated an expensive raw material and improved product alignment.
2. A more efficient continuous convection oven replaced the existing batch laboratory ovens which increased throughput without increasing labor.
3. Quality was also improved by better alignment of the various layers, by designing special jigs and application equipment to ultimately reduce defects.
4. SPEC designed an improved climate controlled space, and developed a layout that would allow DFA to increase production without adding manpower within the existing space.

This was presented in a phased approach that allowed DFA to increase production as demand increased.