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.
