The Development Process
On commencement of a project, a development team will be appointed to work closely with you through the product feasibility and development process. We are extremely collaborative and welcome as much or as little customer input as you wish. We provide regular reports during the process and welcome customer audits.
DCN’s product design strategy is compatible with US and international regulation in numerous industry segments. DCN is ISO 9000-2001 certified and operates its development program under Design Control procedures.
Design Input Phase
We work with you to generate the assay specifications and determine your exact needs from the process. A design input document is created and a workplan and proposal are created for the first phase, Feasibility and Prototyping. This proposal will include a resource evaluation for the project, the proposed workplan, timeline and cost.
Feasibility and Prototyping
This phase involves the development of working prototypes and the determination of the functional characteristics of the assay relative to the design inputs created in the Design Input Phase. The assay will be optimized and the performance of the reagents assessed in terms of analytical sensitivity, specificity, cross reactivity, and stability (accelerated). Limited clinical studies will be performed. At the end of this Phase, a set of prototypes will be generated and given to the client for assessment, along with a full report and a set of SOPs used for production of the prototypes. At the end of this phase, the client can choose to complete development themselves or move into the Development Phase with DCN.
In this phase, the prototype product will be optimized in the best industrial conditions, taking cost and manufacturability into consideration. Integration of other assay components will occur during this phase, including cassettes (novel or off the shelf), sample handling and delivery elements, and reader systems. We will work with our partner companies to provide any required assay system components and manage those aspects of the project so that our clients need only deal with a single source supplier for all elements – DCN. At the end of this phase, assay performance will be verified and the design will be frozen. A complete Device History File will be delivered along with devices for performance verification studies.
Validation, Scale Up and Manufacturing Transfer
In this phase, the assay will be scaled up, manufacturing processes defined and validated, and manufacturing transfer activities will begin. A full set of validated manufacturing SOPs will be produced and the assay will be transferred to production. At the end of this phase, the validation lots of product will be produced and all development documentation will be completed. Upon completion of validation, the assay will enter production.