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A hands-free remote monitoring solution for continuous and accurate medical grade assessment of heart health

Periodic Reporting for period 1 - wellwatch (A hands-free remote monitoring solution for continuous and accurate medical grade assessment of heart health)

Reporting period: 2017-02-01 to 2017-04-30

Cardiovascular Disease (CVD) in Europe causes 3.9m deaths and over 1.8m deaths in the EU. The European Society for Cardiology (ESC) estimates the EU cost to be over €196 billion per year. Currently CVD monitoring includes a hospital attendance, cardio measurement by a 12 lead ‘wet’ (ECG) and follow-up with a doctor. This process is time-consuming, costly to health systems and at best provides a snapshot of a patient’s heart health. If the results are an inconclusive ECG, a doctor may prescribe a Holter (24-48hrs), Event (1-2 months) or longer term mobile cardiac telemetry (MCT) monitors. However, current monitoring has a number of negative factors associated with usage eg.discomfort inhibit sleep and limit patient activities all adversely impacting uptake, reliability and, critically, accuracy of results. Additional problems associated with the elderly and infirm, i.e. dementia, delicate skin, sleep problems and difficulties in attending clinics, creates acceptance problems. With further R&D following this feasibility study, SmartLife’s’ objective is to prove the viability of its Wellwatch device and develop the solution to be the first certified medical wearable garment monitoring a patient’s condition in real-time, in the comfort of their own home, complying with their lifestyles whilst having no extraneous tech wires, fluids or straps.
Work performed included:
• Multiuser audience surveys determining form factors, the prototype specification, preferred materials identification plus, an environmental assessment to identify the C2C certification requirements.
• A cost benefit analysis produced manufacturing methods and a selection of manufacturing partners based on cost effectiveness, manufacturing methods, ability to scale and environmental impact
• Through analysis of market reports, a report with SWOT analysis was produced validating entry geographies, ranking, with identification of the top 3 countries for market entry.
• Input from clinical expert opinion created a clinical and regulatory strategy alongside a rigorous plan for Wellwatch certification.
• Voice of customer interviews collected from KOLs established and validate the business model proposed, and develop the preferred care pathway and reimbursement models.
• A data ownership plan addressing data pathways, usage rights, liability and security for all potential end users resulted with a choice of data implementation partners.
• Following outcomes of this action, the Business Plan focused on the commercial model as well as EU-wide dissemination to produce an updated market analysis. IP strategy was expert assessed, and strategic partners identified to assist with dissemination and commercialisation.
Results obtained confirmed the “gap in the market”, a need for the Wellwatch device and a future requirement to integrate additional biometric functions within the garment. Wellwatch offers a simple to use cost-effective solution to problems associated with current heart monitoring methods. Wellwatch is disruptive by providing a comfortable undergarment offering real-time, continuous monitoring as the wearers live their lives.
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Wellwatch Garment