Covering every aspect of product life cycle development from concept through to commercial launch.
Working with Universities, Industry and Investors to develop a robust, compliant and commercially viable product within our 12,000 sq. ft custom built biohazardous laboratories and manufacturing facility.
Our process begins with an evaluation of the business, product performance and clinical usability requirements of the product and technology evaluation. Throughout this stage of the process, we explore functional improvements that focus on optimising the product offering and maximising the return on the investment. Ownership of all newly created intellectual property developed by us is assigned to the client.
At the core of our process is the full development of a product, encompassing specifications, risk management, technology verification, product validation testing, manufacturing validation and clinical studies. We do everything in the technical file.
From the first prototypes to the full validated manufacture of your product, we work closely with our clients and drive the program through each stage of the innovation pathway. Through our trusted partners in the UK and our FDA accredited contract partners in Asia, we can support our clients with longer-term large-scale commercial manufacturing, or the transition of the production to their own facilities.
We deliver regulatory assessments and submissions, road-map planning, and complete the IVDD/IVDR CE marking and FDA 510(K) applications and ensure your product is compliant with all applicable global regulations to ensure each technology is ready for launch in the chosen market.
Through the delivery of a complete technical file, quality management system records and regulatory submission support documentation, we can ensure full traceability with a high level of efficiency.
Launching the product to market is the ultimate goal of our process and one which we have extensive experience in delivering for our clients. Our team supports our clients to create packaging and labelling, user manuals and launch support materials.
We work with our clients to both appoint and manage distributors in Europe and the USA. With a strong network of industry and healthcare contacts and partners, we help our clients achieve a commercial exit through sale or licensing.
Our highly qualified team combine their expertise across a range of technologies and disciplines along with their seamlessly integrated approach to develop medical diagnostics products at our accredited facilities.
From ECG technologies, viscosity measurements, microscopic vision systems and mechanical techniques, Medtechtomarket has developed a number of products that deliver diagnosis with a direct measurement of the patient or on the sample itself.
At Medtechtomarket, we have wide-ranging experience in developing technical optical test cartridge formats and instrumentation to deliver highly sensitive colormetric, turbidity or fluorescence assay detection systems for measuring single biomarkers, enzyme assays and panels.
From state-of-the-art microfluidic immunofluorescence to traditional lateral flow technologies, we employ a range of immunological techniques to determine markers for clinical chemistry and haematology point of care diagnostic applications.
Utilising passive and active continuous-flow microfluidic approaches to channel blood and reagent samples into micro-cuvettes, flow channels, reaction chambers, electrochemistry and MEMS sensors we are able to measure a wide range of biochemical markers in a number of clinical applications.
The MedtechtoMarket team has worked together directly for over 25 years developing, producing and launching products in over 50 countries worldwide.
