Smartlife Inc Ltd are a Manchester-based company that specialise in smart garment technology.  They have developed innovative, patented textile sensors, electronics and firmware that are capable of detecting the body’s biophysical signals, and delivering actionable insight to users via mobile apps. In order to move their technology into the healthcare sector, they secured EU funding through the H2020 scheme (SME Instrument, Open Innovation call, Phase 1) to undertake a feasibility study to develop a garment that can measure and record an electrocardiogram (ECG) trace, to appropriate clinical standards. Currently this information is captured by a Holter monitor but it can be difficult to fit and to use for some patients over a 24 or 48 hour period and an alternative wearable garment would be a more convenient and suitable solution. The new product will be considered a medical device and will therefore need to comply will the EU Medical Device Regulations.

The CHEATA Solution

The client engaged with CHEATA to undertake the following work

  • To undertake a review of the regulatory requirements of the garment and its manufacture
  • To scope out the Value Proposition for the proposed technology including
  • To conduct a clinical focus group with cardiology technicians to get feedback on the device and how it might be implemented in practice.

Outcome

CHEATA delivered several reports that contributed to the Phase 1 Delivery report as required by the EU.

  • We produced a regulatory report on the device including identifying the potential class of the device, the EU standards it will need to show compliance against and the need for a quality management system to be implemented by Smartlife Inc.
  • We also scoped out the Value Proposition and identified areas to be populated with further evidence on the clinical utility and the economic impact of implementing the device.
  • Finally, we organised a clinical focus group with a number of cardiac physiologists (the people who currently fit Holter devices and analyse the data), where Smartlife demonstrated their device and gathered essential feedback, opinion and information. CHEATA produced a report summarising the questionnaire answers from the group as well as the dialogue during the session.