Home-use Urology Monitor and Device
Medtechtomarket developed a urine collection and monitoring system for adults using indwelling catheters. Our system offered a range of design features and accessories to help manage continence at home and has had a transformative effect on the lives of catheter users.
We completed the full design, development, manufacturing, CE marking, FDA Registration and USA launch of a sterile self-aid urology system in 18 months. Securing regional and major national distribution contracts, key opinion leadership (KOL) sponsorships and adoption at a leading rehabilitation hospital.
Taking an existing product idea, we used our expertise to redesign the product, manage the full verification, validation, usability assessments and safety accreditation of an electronic monitor and wearable device.
Following the set up of the clean-room manufacturing in Asia, we gained HCPCS Reimbursement coding and managed the full product launch and supply chain. Obtaining ISO13485:2003 and ISO13485:2012 accreditation, CE Marking and FDA Registration on behalf of our client.
During an unannounced CE audit of Medtechtomarket, the technical design history and quality management files were audited as part of the CE marking process during customer due diligence and passed a 4-day FDA inspection.
The product was launched in the USA and was a finalist in the 2015 Home Medical Equipment Retail Product awards and has featured in several high-profile trade and disability user publications.
The company signed a number of national and regional distributors, wholesalers and sales representatives and the technology was adopted by the top rehabilitation hospitals throughout the USA. The product was well received and supported by high profile KOL endorsements including a former Gold Medal Paralympian athlete, along with user and industry experts.
CASE STUDIES
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…
Rapid ECG
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 TECHNOLOGIES
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.
Immunochemistry
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.
Microfluidics
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.
Lateral Flow Technologies
YOUR IDEAL PARTNER FOR LATERAL FLOW DEVELOPMENT & MANUFACTURE. We can develop quantitative, semi-quantitative and qualitative assays as well as multiplex assays and multi-strip assays; complying with the highest quality and regulatory standards. We can accommodate most sample matrices, applications, or budgets.
ELISA
PRECISION ASSAY DEVELOPMENT FOR ENZYME-BASED DIAGNOSTICS. We help transform your assay into a reliable diagnostic tool.
Molecular Assays
MOLECULAR ASSAY DEVELOPMENT FOR CURRENT & NEXT-GEN DIAGNOSTICS. Hands on experience with qPCR, LAMP, ddPCR, CRISPR, and NGS. From feasibility through to validated diagnostic assays.
Software as a Medical Device (SAMD)
TRANSFORMING ALGORITHMS INTO REGULATED MEDICAL SOFTWARE. Support across diagnostic algorithms, image analysis, digital biomarkers, and cloud-based health platforms.
Point of Care (POC) System Development
FROM CARTRIDGE TO CONSOLE – COMPLETE POC SYSTEM DEVELOPMENT. Full development support for point-of-care (POC) diagnostic systems, including disposable cartridges, calibrators, printers, accessories & instrumentation. Our experience spans assay integration, microfluidic design, and system-level development involving optical, haemostasis & electrochemical detection.
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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.