How we work
Proven assay development approach
Many leading biotech and in vitro diagnostic (IVD) medical devices companies appreciate our proven, transparent approach to assay development, and are happy to work with us. Why? Because they know what to expect from us every step of the way, and rely on our expert experience – to identify risks at an early stage, and bring their concepts to market quickly and cost-effectively.
Four-phase New Product Development Process
It is applied to all assay development at Future Diagnostics, and it is the key to accelerating your innovation: our proven four-phase New Product Development Process (NPDP), compliant to ISO13485. Every phase is closed with a formal review – the outcome is documented and signed off in a Formal Review Report. This is how it works.
First, we will draw up a contract, based on your requirements and technical input from our experts. This will include an indicative time schedule for developing the test and a detailed cost overview for phase 1.
The purpose of this phase is to define the project. If needed, we will perform antibody/antigen selection and screening and conduct pre-feasibility studies to explore the quality of raw materials and feasibility of the assay. As part of this, we will give you a first indication of key raw material or assay/technology performance. Also, we will identify (technical) risks, and provide a realistic budget estimation for further development.
2. Design & Verification
Phase 2 consists of two main work packages: Design and Verification.
We will demonstrate the feasibility of the assays and optimise assays to meet the design requirements described in the product development plan. Our R&D team will produce a bench lot to confirm critical assay parameters before design freeze.
Aim is to verify the assay designs and complete design freeze – the assay can now be sold for Research Only Use. We will produce verification lots using R&D documentation and benchmark them against the design requirements. In addition, we will initiate accelerated stability studies for indicative shelf life data.
3. Production & Validation
This next phase also consists of two work packages: Production & Validation.
We transfer the assay from R&D to Future Diagnostics’ FDA registered manufacturing facility or to another manufacturing location of your choice. How much time is needed for this, depends on the location and type of manufacturer involved in the transfer.
We will perform an analytical validation and (accelerated) stability studies of the assay. At the manufacturing location, lots will be produced and QC released. They will be labelled for Investigational Use Only (IUO) – to be used for technical and clinical validation. At Future Diagnostics, we will perform a technical validation according to CLSI guidelines, which will be documented in appropriate reports complying with ISO 13485.
To close the project, we will transfer all signed technical documentation of the Design History file to you. Writing part of the technical file you need for IVD registration of the assay, in compliance with Medical Device regulations in your country, is included in the total development costs. You will be the legal owner and manufacturer of the product, and the product will only show your name.
We believe in transparency and clear communication. That is why we work with a dedicated core team of specialists for every assay development. They will involve you on a regular basis throughout the project, and you will also be able to monitor progress real-time – in our SharePoint environment.
Would you like to learn more about our assay development process or to discuss possibilities to accelerate you innovation?
We’d love to hear from you!