Periodic Reporting for period 3 - Mobility (Development and Commercialisation of the ‘Next Generation’ patient-centric wearable Tube Feeding System)
Reporting period: 2022-12-01 to 2023-11-30
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 Outside of the FTI project funding, the Mobility+ Design and Development has proceeded at Rockfield through the Commercialisation Phase leading to initial launch in US.
o Development of hard tooling for plastic component parts has been completed at Menshen
o The development of a pilot production spout assembly machine has been completed at Menshen with successful formal qualification
o Validation of Mobility+ assembly process at SteriPack has been completed
o FDA 510k application submitted in May ‘21. Following consultation with FDA it was agreed to execute additional Biocompatibility testing. The updated submission was sent to FDA in Aug ’22. RMD were notified of 510(k) clearance on 20 Oct 2022
o Selection of Notified Body for EU regulatory approval has now been completed. It is TUV Sud. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o A clinical study is taking place at the Mayo Clinic (US) with enrolment having started in Nov 2023. Ethical approval was received from IRB in Sep ‘23.
o Ongoing development of full Quality System is proceeding with an electronic QMS System for procedures and records. An ISO 13485 QMS is now in place and awaits Stage 1 and 2 audits by the Notified Body in 2024
o Outside of the FTI project funding, but helped by the successful award and execution of this grant, a Series A funding round was completed by Rockfield in Oct ‘23
o Outside of the FTI project funding, the Mobility+ Design and Development has proceeded at Rockfield through the Commercialisation Phase leading to initial launch in US.
o Development of hard tooling for plastic component parts has been completed at Menshen
o The development of a pilot production spout assembly machine has been completed at Menshen with successful formal qualification
o Validation of Mobility+ assembly process at SteriPack has been completed
o FDA 510k application submitted in May ‘21. Following consultation with FDA it was agreed to execute additional Biocompatibility testing. The updated submission was sent to FDA in Aug ’22. RMD were notified of 510(k) clearance on 20 Oct 2022
o Selection of Notified Body for EU regulatory approval has now been completed. It is TUV Sud. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o A clinical study is taking place at the Mayo Clinic (US) with enrolment having started in Nov 2023. Ethical approval was received from IRB in Sep ‘23.
o Ongoing development of full Quality System is proceeding with an electronic QMS System for procedures and records. An ISO 13485 QMS is now in place and awaits Stage 1 and 2 audits by the Notified Body in 2024
o Outside of the FTI project funding, but helped by the successful award and execution of this grant, a Series A funding round was completed by Rockfield in Oct ‘23
Mobility+ is now all set to be commercialized and deliver a solution that alleviates the burden on healthcare and addresses specific feeding needs of patients with Complex Chronic Conditions (CCCs). The Mobility+ system enables major advances in mobility and quality of life allowing the user more freedom while feeding on-the-go.