Periodic Reporting for period 1 - Dignum (Innovative toilet assistive device enabling people with reduced mobility to become independent)
Reporting period: 2019-06-01 to 2019-11-30
with reduced mobility to use bathroom and perform bowel care and multiple hygienic tasks on their own, such as insertion of enema, cleaning, wiping and inspection for pressure ulcers. This will save home care costs and increase the sense of achievement for the users. Dignum can be safely used by people with reduce or none sensation in the lower body since the device has an integrated module for visual inspection (screen, camera, and lights) which minimizes risks of injuries to the perineum and anal region. The SME Phase 1 project will be crucial for the maturation of the business plan, including the analysis of reimbursement schemes and regulatory work and the development of a business model compatible with geographical market expansion and growth, with focus on the Nordic, German and the UK market.
The need for an assistive device to inspect skin and prevent pressure ulcers is much bigger than the need for an assistive device for enemas. An assistive device for skin inspection, wounds and pressure ulcers is a medical device class 1, which means we can self certify as long as we follow the medical device regulations. Therefore we decided to pursue pressure ulcers rather than enemas.