Point of Care Haemostasis
Working with a client based in the USA, we developed, manufactured, and launched the world’s first portable viscoelastic test system for Point of Care Haemostasis. An innovative near-patient, semi-quantitative, viscoelastic measurement of coagulation in whole blood for use in major surgery, trauma, and obstetrics.
The system, comprising a portable instrument, separate incubator system, two levels of single-use Plasma Controls, system check cartridge, and test assay cartridges was quickly outperforming the competitor laboratory systems in precision, accuracy, cost, workflow and assay time.
Achieving 50% better precision, lower-cost benefits of over £30,000 per instrument, and allowed near-patient tests to be run within 20 seconds of blood draw, reducing time to results by around 15-20 minutes, and all within 3.5 years.
Guiding our client through every stage of the process, we delivered the full development, manufacturing, and commercial launch, ensured regulatory compliance was achieved and clinical trials were successful and completed around 40,000 validation and verification tests.
These included a number of clinical and human factor studies, a pilot clinical study, a method comparison study against market-leading predicate, normal reference interval studies, and precision studies in the UK and USA.
Medtechtomarket facilitated meetings and audits with multinational distributors obtained key opinion leader endorsement and evaluation and launched the product with hospital placements throughout the UK, Europe, and the USA.
Pilot manufacturing and manufacturing capacity improvements allowed for a full European launch initially, followed by a roll out into the USA and Asia, with a full technical file, design history, labeling, and validated manufacturing procedures, compliant to IVDD 98/79/EC, IVDR 2017/746 and 21CFR809 standards.
Working in close partnership with our clients, we develop robust, compliant and commercially viable products ready for launch in the chosen market.
Point of Care Haemostasis
Working with a client based in the USA, we developed, manufactured and launched the world’s first…
Home-use Urology Monitor and Device
Medtechtomarket developed a urine collection and monitoring system for adults using indwelling catheters. Our system offered…
Medtechtomarket developed a wireless ECG device for use by professionals in primary, acute and hyper-acute care…
Rapid Near-Patient Sepsis Diagnosis
There are approximately 123,000 cases and around 46,000 associated deaths from sepsis reported in England each…
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.
Mechanical and Solid State Systems
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.
Photometric and Fluorescence-Based Assays
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.
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The MedtechtoMarket team has worked together directly for over 25 years developing, producing and launching products in over 50 countries worldwide.