Starting with an idea from a clinician in NHS England, Medtechtomarket explored and developed the product offering and capability of a 30 second 12-lead ECG system.
Comprising a portable ECG handset and display, connected multi-system charging base station, and additional bespoke ECG Smartphone App – securing patents and design protection.
Medtechtomarket delivered the full development, regulatory and early prototype manufacturing from scratch in 20 months, following a number of specialist Cardiac hospital-based trials and collaboration with some of the world’s leading academic and clinical ECG experts. The system out-performed market leading traditional 12-lead systems in a 1000-patient clinical trial in a multisite primary care study.
Medtechtomarket obtained full ISO13485:2012 accreditation for the start-up business and secured approximately £2.8m in prestigious SBRI and I4I awards and fundraised a further £500,000 in EIS equity investment.
Medtechtomarket ensured that the product design history file and quality management system was fully transferred upon completion of the design and prototype development process.