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.

IVD product development - IVD product development process - Future Diagnostics

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. After approval of all technical documentation, the phase or project is closed by signing off the Formal Review Report. This is how it works.

0. Contract & Definition

Based on your requirements and technical input from our experts the project will be defined. We will create a contract that includes an indicative time schedule for developing the test and a detailed cost overview for phase 1 – Proof of Concept.

Erlenmeyer lab flask measuring cilinder

1. Proof of Concept & Feasibility

To obtain a Proof of Concept (PoC), suitable raw materials, such as antibodies and antigens are screened. Subsequently, feasibility studies are conducted to explore the quality of the selected raw materials, the assay feasibility and intended platform based on key critical assay parameters.

2. Design & Verification

Next we will further optimise the assay 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.

During verification the the assay design is verified to complete design freeze. 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

We transfer the assay from R&D to Future Diagnostics’ FDA registered manufacturing facility or to another manufacturing location of your choice. At the manufacturing site, lots will be produced and QC released. Finally, we will perform an analytical validation and (accelerated) stability studies of the assay according to CLSI guidelines, which will be documented in appropriate reports complying with ISO 13485.

4. Closure

To close the project, we will transfer all signed technical documentation of the Design History file to you. 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!

Contact us