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Innovative toilet assistive device enabling people with reduced mobility to become independent

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

People with reduced mobility often suffer from bowel problems. Spinal cord injury (SCI), multiple sclerosis (MS) and cerebral palsy (CP), are some of the illnesses that lead to the loss of the ability to control the bowel reflex. The loss of bowel control often means that the evacuation requires extensive amounts of time and the assistance of health care providers or attendants. Moreover, bowel dysfunction is one of the most devastating sequelae of these patients, because it not only affects morbidity, but it also can severely disrupt a person's quality of life. IndGear has developed an innovative assistive, multifunctional device – Dignum - which enables for the first time, people
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 initial period of the project was mainly used for identifying potential third parties to assist in the assessment of the reimbursement systems for Dignum in Germany and UK. We decided to abandon the idea of a multitool because we learned that such specific and individual problems requires specific and individual solutions.
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.
Based on the pressure ulcer detection function of Dignum we developed a skin inspection tool, called Spectum. So through this project the multitool Dignum has developed into two separate, specialized devices, one for enema insertion (Dignum) and one for skin inspection (Spectum). The following assessment of Dignums market fit in the German and UK market is based on the original Dignum multitool, so we learned a lot about the needs for both enema insertion and skin inspection, as well as the reimbursement policies for assistive devices. The business plan is based on Dignum and Spectum as separate products, and gives a more in depth view of the process that lead to this divide.
Dignum illustrated use situation