Periodic Reporting for period 2 - Mobility (Development and Commercialisation of the ‘Next Generation’ patient-centric wearable Tube Feeding System)
Okres sprawozdawczy: 2021-12-01 do 2022-11-30
More than a million children and adults in Europe and the United States rely on feeding tubes, and the number is expected to increase. There are hundreds of conditions that require daily tube (enteral) feeding, from cancer to multiple sclerosis and cystic fibrosis. There is also a growing demand from patients to simplify this method of feeding and make it more discreet. This is the aim of the EU-funded Mobility project. It will replace existing cumbersome, complicated, expensive solutions utilising electricity-driven pumps and aims to disrupt current business models of how enteral feed is sold and distributed. Overall, the project’s innovative technology will transform and improve care for patients requiring tube feeding. The consortium's mission is to radically improve the lives of people dependant on the use of tube (enteral) feeding. This is an under-served segment that experiences low patient satisfaction and high patient distress. Patients and clinicians alike agree that enteral feed patients’ needs are not being adequately met by current options.
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.
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.
• The work carried out during the reporting period in line with the Annex 1 to the Grant Agreement includes:
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.
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.
Progress is being made to deliver the innovative feed delivery systems that will transform the mobility and quality of life of those on tube feeding.