New Product Development Process
How we work
The development of all assays at Future Diagnostics is performed according to our New Product Development Process (NPDP).
The NPDP describes the assay development, including all the phases and phase reviews, at Future Diagnostics. The NPDP consists of 4 phases. These phases (1 – 3) are closed with a formal review and the outcome of the phase review will be documented and signed off in a Formal Review Report. During the entire project, technical meetings will be held on a regular basis with the customer.
PHASE 0 - Contract
We set up a contract for phase 1, based on the needs and wishes from the customer and technical input from our experts. An indicative time schedule to develop the test will be given with a detailed overview of costs for phase 1.
PHASE 1 - Definition
The purpose of the definition phase is to define the project, to perform antibody/antigen selection, antibody/antigen screening and conduct pre-feasibility studies to explore the quality of the raw materials and assay feasibility.
Within pre-feasibility studies, a first indication of key raw materials or assay/technology performance is given. We identify (technical) risks, and include a reasonable accurate budget estimation for further development.
PHASE 2 - Design & Verification
Phase 2 of the project consists of two main work packages; design and verification.
In the design work package, feasibility of the assays will be shown and the assays will be optimized to meet the design requirements described in a product development plan. Our R&D will produce a bench lot to confirm critical assay parameters before design freeze.
The goal during verification is to verify the assay designs and complete design freeze (the assay can now be sold for Research Use Only).
During the verification work package, verification lots will be produced at R&D using R&D documentation and benchmarked against the design requirements. Accelerated stability studies will also be initiated for indicative shelf life data.
PHASE 3 Production & Validation
Phase 3 also consists of two main work packages: Production and Validation.
In the production work package, the assay is transferred from Future Diagnostics’ R&D to either Future Diagnostics’ manufacturing or another manufacturing location.
Time needed for transfer is depending on the location and type of manufacturer to be transferred to.
In the validation work package, technical validation and (accelerated) stability studies of the assay are performed. Lots are produced at the manufacturing location and QC released. These lots shall be labelled for Investigational Use Only (IUO) and can be used for technical and clinical validation. Technical validation will be performed during the validation work package according to the CLSI guidelines at Future Diagnostics and documented in appropriate reports complying to the ISO13485 standards.
PHASE 4 Closure
Closure consist of transferring all signed technical documentation of the Design History File to the customer.
For IVD registration of a product a technical file needs to be set up in compliance with the Medical Device regulation from a specific country. Future Diagnostics will write a part of the technical file that is needed for the legal registration. This is included in the total development costs.
The customer will be the legal owner and legal manufacturer of the product. The product will only show the name of customer.
We use several tools to make communication easy and frequent:
The customer will be involved during the project and will have calls with our experts on a regular basis for being updated on technical status, timelines and to provide feedback if needed. In addition, the customer can follow the progress of the project in real time on our SharePoint database. They can log in onto SharePoint to review all the data that has been produced.