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 trails 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, 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 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, labelling and validated manufacturing procedures, compliant to IVDD 78/79/EC, IVDR 2017/746 and 21CFR809 standards.