Future Diagnostics Solutions: Certified IVD Assay Development
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Mike Klinkenberg, Managing Director The In-Vitro Diagnostics (IVD) market is highly competitive and fragmented with several large and small players vying for supremacy. In this marketplace, the success of developing, validating and marketing diagnostics depends considerably on the ability of manufacturers to navigate the specific, complex, and interrelated development requirements. However, IVD companies are struggling to navigate through an increasingly complex development process fraught with uncertainty. Supply chain globalisation, increasing pressure on costs, time to market intervals, and ever-higher quality expectations by customers are some of the critical challenges faced by IVD companies. To stay ahead in this IVD medical device market, one might need a specialised partner that challenges the status quo of the industry.
The Netherlands based Future Diagnostics, since 1997, has been working with start-up companies, mid-sized biotech, and IVD multinationals within the global IVD medical device market, standing tall as an extension of a client’s R&D. Future Diagnostics collaborates with innovative companies that require assay development support and manufacturing services to bring new IVD products to the market. With more than 22 years of experience and over 70 skilful employees, the company is dedicated to make successful developments and accelerate product launches for clients. This profound expertise makes Future Diagnostics a trusted partner for the development of many different types of immunoassays, with different technologies, either manually or automated.
Future Diagnostics develops full high-quality IVD immunoassays on demand, also offering support in (pre-) feasibility, design optimisation, verification and validation (analytical performance) projects.
We have the guts to make deals for certain projects where clients do not need to pay if we fail to deliver
The firm assists companies in materialising their concept assay to an IVD product that is ready for the European (CE-IVD) or US (21CFR809) market. “We believe in taking up challenges based on our experience; We have the guts to make deals for certain projects where clients do not need to pay if we fail to deliver,” asserts Mike Klinkenberg, Managing Director of Future Diagnostics.
When developing an immunoassay, Future Diagnostics utilises its proven four-phase New Product Development Process (NPDP), compliant with ISO13485. Based on clients’ requirements and technical input from its experts, Future Diagnostics draws up a contract and starts with the selection and screening of critical raw materials (e.g., antibodies), followed by pre-feasibility studies to explore the quality of selected materials. After demonstrating the feasibility of the assay(s) and optimising the design to meet the pre-defined product requirements, thorough assay verification is executed. Future Diagnostics then transfers the assay from R&D to either its registered manufacturing facility or another manufacturing location of the clients’ choice. Subsequently, analytical performance studies are executed, according to CLSI guidelines, which will be documented in appropriate reports complying with NEN-EN13612. The clients can monitor the progress of their project in real-time in the SharePoint environment. To close the project, Future Diagnostics transfers all mutually approved technical documentation to its clients as part of the Design History File.
During the entire development, the progress of the project is constantly monitored using key parameters such as deliverables, quality, budget, and timelines to adjust projects quickly if necessary. “We are not afraid to try something new, and we like to innovate and discover things that lead to progress,” concludes Klinkenberg.
Apart from developing complete IVD immunoassays, Future Diagnostics also offers analytical performance services, pre-feasibility studies, antibody/antigen conjugation, and micro-array spotting. The analytical performance studies are part of the clinical evidence requirements to ensure a smooth transition from the IVDD (In-Vitro Diagnostics Directive) to the new IVDR (In-Vitro Diagnostics Regulation), as the products currently classified as IVDD will require IVDR compliance. The company reviews current technical documentation and determines studies that have already been reported, all the while assessing their quality. Based on this, the company provides tailored advice and decides on the additional studies that are critical to demonstrate compliance.
Leading biotech and IVD companies collaborate with Future Diagnostics owing to its proven, transparent approach to assay development. The organisation has developed more than 150 products as per IVD requirements and regulations. Moreover, Future Diagnostics has already planned its implementation strategies according to the European Commission’s new IVDR 2017/746 and is focused on providing clients with a complete package from product development to writing part of the technical file you need for IVD registration of the assay, in compliance with Medical Device regulations in the country of interest.
Description Future Diagnostics Solutions offers IVD (immuno) Assay Development and Contract Manufacturing Services to IVD multinationals, mid-sized biotech and small startup companies within the global in vitro diagnostic medical device market. With more than 21 years of experience and over 70 enthusiastic and highly skilled professionals, the company is dedicated to accelerating healthcare innovation, providing high-quality assay development and manufacturing services. The firm is ISO 13485 certified and has its own FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities
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