In just 20 months, we completed the full development, regulatory and early prototype manufacturing of a 30 second 12-lead ECG system. In a 1000-patient clinical trial in a multisite primary care study our prototype systems out-performed traditional 12-lead ECG systems.
Starting with an idea from a clinician in NHS England, we explored and developed the product offering and the capability of a 30 second 12-lead ECG system. The system comprises of a portable ECG handset and display, connected multi-system charging base station and additional bespoke ECG Smartphone App, which secured patents and design protection.
Following a number of specialist Cardiac hospital-based trials and collaboration with some of the world’s leading academic and clinical ECG experts, we delivered the full development, regulatory and early prototype manufacturing from scratch in 20 months.
Upon completion of the design and prototype development process, the product design history file and quality management system was fully transferred to the client. We obtained full ISO13485 accreditation for the start-up business and secured approximately £2.8m in prestigious SBRI and NIHR i4i awards and fundraised a further £500,000 in EIS equity investment.
