Periodic Reporting for period 1 - Mobility (Development and Commercialisation of the ‘Next Generation’ patient-centric wearable Tube Feeding System)
Reporting period: 2020-12-01 to 2021-11-30
Over 1,000,000+ people in Europe and US are dependent on tube feeding every day, expected to increase by 8% over the next 3 years. Over 300 conditions require daily tube feeding, such as Cancer, MS, Cystic Fibrosis and Diabetes. Mobility+ will transform the tube (enteral) feeding market by introducing a game-changing user-centric feeding system.
Users in both home settings and hospitals demand simplicity, ability to feed discreetly when on the go, enhanced functionality and are looking for the tube feeding to be as normalised an experience as possible.
o Project Plan and detailed Gantt Chart has been developed with the full team and submitted as a deliverable
o Outside of the FTI project funding, the Mobility+ Design and Development has proceeded at Rockfield with substantial progress through Design Freeze and successful Design Verification and Design Validation Testing including Performance testing and Biocompatibility testing, this feeds directly into the FTI project.
o Development of hard tooling for plastic component parts is well underway at Menshen as is development of a pilot production spout assembly line there
o Validation of Mobility+ assembly process at SteriPack is progressing well with no issues so far
o FDA 510k application submitted in May ‘21.
o Selection of Notified Body for EU regulatory approval is now underway. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o Assessment of need for the clinical trial is planned with review of MDR, risk management files and engagement with notified body to assess level of clinical evidence required and we will plan work accordingly
o Ongoing development of full Quality System is proceeding with an electronic QMS System for procedures and records.