The process from A to Z
IVD product development is a delicate and complex procedure. Only by using the purest of products, highly skilled professionals and effective communication we reach the optimal product development process. Because we are proud of our in-house processes we like to give you a good look behind the doors of our facility and tell you everything about product development at Future Diagnostics: the process from A to Z.
Our step-by-step action plan
Every single one of our clients will agree: by working with our proven step-by-step action plan we control every single part of the product development process. There are 4 stages to reach the set goals:
– Design and verification
– Production and validation
These steps guide us and keep us focused. They enable us to adequately and efficiently run our processes without losing precious time and focus.
A project is always supervised by two of our experts. The expert responsible for the technical part of the IVD product development process is constantly observing and controlling the terms of agreement. Our second expert controls the set time frame and overviews the costs. During the development process we regularly report the progress of the project to our client. Also, our SharePoint environment enables our customer to have a real time view of the progress. It is vital to have transparent communication between us and our client to keep the development process efficient thereby saving time and costs.
Phase 0 and 1; contract and definition
When developing an IVD test the first thing to do is set up a contract between both parties: Phase 0. We determine the request based on the input from our technical experts. The contract consists of a preliminary schedule of the IVD product development process and an indication of the cost of Phase 1. As soon as all parties support the contents of the contract the Definition phase follows.
Phase 1 is about establishing the definition of the project. The questions we ask ourselves, often during a pre-feasibility study, are: ‘What critical raw materials are needed and which ones are of the best quality?’ and ‘Which antibodies guarantee maximum result?’ Also, we investigate the feasibility of the test within the set time frame and analyze the predetermined budget. The completion of this phase gives us the opportunity to present to our client an overview of the main raw materials and the techniques we will be using. By providing a realistic estimate of the costs to proceed the IVD product development process, we also present an insightful transparent plan in which we incorporate an overview of possible risks which will be mitigated during the subsequent development phases.
Phase 2; design and verification
Once both parties agree and give the ‘go-ahead’ for the next phase in the IVD product development, we start to continuously optimize the product design to ensure that the IVD test improves to meet the demands of the pre-determined product development plan. This is what we promise you. Our team of experts is committed to establish critical test parameters before finalizing the test design.
Upon finalizing the test design the product design is then verified by testing assay parameters according to the design demands at our R&D facility. Stability studies provide indicative shelf life data.
Phase 3; IVD production and validation
In this phase of the IVD product development process the product is handed over to an ISO13485 certified and/or FDA registered production facility. At Future Diagnostics we have this facility in-house. However, our client is always in control to decide on a production location of their own choosing. No matter how much we stand behind our own methods, it’s always the client’s decision.
In the determined production location the test is put into production and preparations are made for technical and clinical validation. Once the end product is available we conduct validation studies and (accelerated) stability tests. Technical validation is conducted at our facilities according to the latest CLSI guidelines. During this validation process everything is meticulously documented into reports, compliant to ISO 13485. Every step in the process is documented by us and always back-traceable. In Europe analytical performance is part of the validation phase.
Phase 4; Completion
Once we are able to deliver a high quality product the time has come to complete the process. We hand over all technical documents and applicable parts of the design history file to our client. This document is in accordance with the regulations for medical devices in the country of choice. All expenses are already included in the development costs. The end product is now in full legal ownership of the client and only the client’s name is mentioned.
IVD product development is an extensive process and can hardly be captured in one blog only. That’s the reason we give you an overview of IVD product development by Future Diagnostics. If you are interested in more information on our daily activities or perhaps looking for collaboration in the field of IVD product development, please contact us. We are passionate about our profession and like to share our expertise with you.
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