Medtechtomarket Consulting Ltd
Contract development and manufacturing organisation (CDMO) focused on in vitro diagnostics (IVD) and point-of-care systems. Offers end-to-end services from feasibility and assay development through regulatory filing, clinical validation and pilot-to-commercial manufacturing from ISO 13485:2016–accredited laboratories and manufacturing facilities.
Industries
Nr. of Employees
small (1-50)
Medtechtomarket Consulting Ltd
Magazine House, 6 Magazine Point, Riverbank Rd, Bromborough, CH62 3JP, United Kingdom
Products
Point-of-care viscoelastic coagulation testing system
Portable viscoelastic analyzer with single-use cartridges and controls for near-patient measurement of coagulation in whole blood, used in surgery, trauma and obstetrics.
Home-use urine collection and monitoring system
Redesigned urine collection and electronic monitoring system for adults with indwelling catheters, including wearable monitor and accessories suitable for home continence management.
Rapid 30-second 12-lead ECG system
Wireless portable 12-lead ECG handset with charging base and companion smartphone application for quick cardiac rhythm and morphology assessment in primary and acute care.
Microfluidic multi-assay sepsis diagnostic
Portable microfluidic multi-assay system designed for early detection and therapy monitoring of sepsis, with automated reagent dispensing and demonstrated correlation to laboratory markers.
Prostate cancer multi-biomarker blood test (Glycan biomarker assay)
Laboratory-developed blood test detecting a combination of glycans to identify clinically significant prostate cancer; product development, manufacture and clinical trial management facilitated.
Point-of-care viscoelastic coagulation testing system
Portable viscoelastic analyzer with single-use cartridges and controls for near-patient measurement of coagulation in whole blood, used in surgery, trauma and obstetrics.
Home-use urine collection and monitoring system
Redesigned urine collection and electronic monitoring system for adults with indwelling catheters, including wearable monitor and accessories suitable for home continence management.
Rapid 30-second 12-lead ECG system
Wireless portable 12-lead ECG handset with charging base and companion smartphone application for quick cardiac rhythm and morphology assessment in primary and acute care.
Microfluidic multi-assay sepsis diagnostic
Portable microfluidic multi-assay system designed for early detection and therapy monitoring of sepsis, with automated reagent dispensing and demonstrated correlation to laboratory markers.
Prostate cancer multi-biomarker blood test (Glycan biomarker assay)
Laboratory-developed blood test detecting a combination of glycans to identify clinically significant prostate cancer; product development, manufacture and clinical trial management facilitated.
Services
End-to-end outsourced services from feasibility and assay development through regulatory filing, clinical validation and commercial manufacturing.
Feasibility studies, assay design (immunochemistry, molecular, photometric/fluorescence), prototyping and analytical validation.
Regulatory planning and preparation of documentation for CE/UKCA and FDA submissions, including supporting audits and inspections.
Operational setup and management of clinical evaluations, multisite trials, method comparison and human factors studies.
Pilot production, scale-up, validated manufacturing procedures, packaging and supply chain management for diagnostic products.
Development of regulatory-compliant medical device software and mobile applications integrated with diagnostic hardware.
End-to-end outsourced services from feasibility and assay development through regulatory filing, clinical validation and commercial manufacturing.
Feasibility studies, assay design (immunochemistry, molecular, photometric/fluorescence), prototyping and analytical validation.
Regulatory planning and preparation of documentation for CE/UKCA and FDA submissions, including supporting audits and inspections.
Operational setup and management of clinical evaluations, multisite trials, method comparison and human factors studies.
Pilot production, scale-up, validated manufacturing procedures, packaging and supply chain management for diagnostic products.
Development of regulatory-compliant medical device software and mobile applications integrated with diagnostic hardware.
Expertise Areas
- In vitro diagnostic (IVD) product development
- Assay development (lateral flow, ELISA, molecular)
- Microfluidic device engineering
- Point-of-care instrument development
Key Technologies
- Lateral flow immunoassays
- ELISA
- PCR / qPCR
- Microfluidics
News & Updates
Exhibitor and speaker presence planned at events including MEDICA 2025, BSI Congress 2025, Biomarkers & Precision Medicine UK and regional diagnostics conferences.
Announcement of continued ISO 13485:2016 certification covering design, development and manufacture of IVDs and related services.
Report on Breakthrough Device designation for a viscoelastic coagulation monitor; development involvement and performance evaluation referenced.
Announcement that a multi-biomarker prostate cancer blood test has entered clinical trials; clinical trial setup managed by the company.
Report that a histopathological prognostic melanoma biomarker test manufactured by the company has been awarded UKCA marking.
Maintained ISO 13485:2016 certification covering design, development and manufacture of IVD medical devices.
Exhibitor and speaker presence planned at events including MEDICA 2025, BSI Congress 2025, Biomarkers & Precision Medicine UK and regional diagnostics conferences.
Announcement of continued ISO 13485:2016 certification covering design, development and manufacture of IVDs and related services.
Report on Breakthrough Device designation for a viscoelastic coagulation monitor; development involvement and performance evaluation referenced.
Announcement that a multi-biomarker prostate cancer blood test has entered clinical trials; clinical trial setup managed by the company.
Report that a histopathological prognostic melanoma biomarker test manufactured by the company has been awarded UKCA marking.
Maintained ISO 13485:2016 certification covering design, development and manufacture of IVD medical devices.