Early Life Science Development and the Dangers of Going Out of Order
STEP 01: Define and prove the assay/test with automation in mind.
STEP 02: Design a consumable based on assay & cost requirements.
STEP 03: Test the instrument to function seamlessly with the consumable and assay.
When developing a Life Science, IVD, or Complex Med device product taking shortcuts can actually lead to expensive delays in the program. It is critical that the assay, consumable, and/or reagents work well together. Following a proven order of operations reduces development risk.
STEP 01
It is crucial to ensure the assay/test or process is clearly defined and can work in an automated application. Although it can be tempting to skip ahead in the development phase, key elements of the assay need to be considered. Examples include…
Long Term Storage Capability
Consumable Friendly Volumes
Potential Thermal Control Needs and Tolerances
Added or Revised Wash Steps
Optical Detection Sensitivity
Incubation Timeframes
Etc...
STEP 02
Examples of early stage consumable design.
Design the consumable for the automation-friendly assay/test. Make sure the business margins make sense by having the consumable and reagents meet cost targets. Consumable prototypes are often built at the module level first to allow simplified testing and proof of feasibility before being put together as a complete start-to-finish consumable. This is commonly done with machined, 3D printed, or low-cost/fast-turn molded parts. Inexpensive & simple test module hardware is ideal for quickly confirming the feasibility of each major piece. Starting the design of the instrument before the consumable and assay are locked down could lead to the following:
Added features or scrapped parts/designs
More or different interfaces
Fluidics changes
Optics changes
Thermal control changes
Etc...
STEP 03
Above image shows machined and fast-turn molded prototypes.
Now that the assay and consumable are clearly defined, it is time to confirm full system capabilities. Prototyping is essential in this phase in order to make any final adjustments before investing in production tooling. A prototype instrument is typically joined with a fast-turn prototype full-function consumable for system testing and final optimization before production consumable tooling investments are made. Typical components used for this step are:
Prototype instruments (often without skins) using OTS modules or laptops for flexibility
Prototype full-function consumables with actual chemistry and reagents but built with fast-turn prototype manufacturing processes
Revisions often occur and should be expected during this effort