If your assay protocols are working manually and need optimization, you are ready for semi-automated control with instrumentation support to further optimize and de-risk the assay workflow in an integrated fluidic cartridge.
In this stage over a 2- to 6-month period, we would provide:
- Definition of product specifications including cartridge functional requirements, material and surface requirements, consumable product target cost, and storage condition and instrument interface needs, evaluate target cost, strategy for assay protocol integration, material testing protocol and instrument interface needs
- Mechanical drawing of initial design and design review
- Conduct material evaluation and preliminary testing in close coordination with client
- Develop instrumentation support for semi-automated testing of devices along with an actuation protocol and training as needed to provide independent testing capability in the client’s facility
- Videography, weekly meetings, and meeting summaries as part of routine communication and program management
- Batches of 20 to 100 cartridges for assay optimization and data collection
- Further design revision to eliminate failure modes and to optimize assay performance
- Additional batches of 50 to 100 cartridges for further data collection and uncovering and correcting new failure modes
- Development of QC criteria done both in process and for 100% final QC inspection
- Pricing for higher volumes to support continued testing
- Some products may not need more than this to be transferred to higher volume production
- Provide quotes and cost models for scale up from 100s to 100,000 devices, and show you at what volumes, a transition to injection molding becomes cost effective.