Periodic Reporting for period 2 - MobilityPlus (Commercialisation of the Connected Enteral Feeding Healthcare System for Integrated & Co-ordinated Care (Mobility+))
Période du rapport: 2021-05-01 au 2022-10-31
The Mobility+ project designed, developed, tested and validated to TLR8 the first FDA cleared elastomeric feeding device, which eliminates the need for an external pumping means such as gravity or electricity. This allows for greater mobility for the user and changes the enteral feeding device market from one requiring a capital outlay, with associated operations and maintenance costs, to one of a supply consumable.
An additional functional accessory, developed and tested to TLR6, will electronically measure the volume of feed delivered to the user and transmit that information via a short range network to a mobile phone. The application can then be connected to a services based clinical application which allows for clinical data aggregation and analysis for assistance in patient care. Moreover, a suite of device carrying accessories was developed to allow users better mobility and to ‘feed-on-on-the-go.’
An additional functional accessory, developed and tested to TLR6, will electronically measure the volume of feed delivered to the user and transmit that information via a short range network to a mobile phone. The application can then be connected to a services based clinical application which allows for clinical data aggregation and analysis for assistance in patient care. Moreover, a suite of device carrying accessories was developed to allow users better mobility and to ‘feed-on-on-the-go.’
The work carried out during the reporting period in line with the Annex 1 to the Grant Agreement includes:
o Mobility+ Design and Development has almost completed the Design Transfer phase of the Design Control process in co-operation with the intended Sub-Contract Manufacturer and is ready to move into the Commercialisation Phase now that FDA clearance has been granted (commercialisation phase not funded by this action)
o In the area of Sensor technology, smart materials and data management capability, concept and prototype manufacture have progressed well with Concept Selection completed & prototypes available for presentation and assessment. The Concept Phase of the project has been completed & is now ready to move into the Development Phase
o Submission for FDA 510(k) clearance was completed in May ’21 but concerns raised by FDA during the review of the submission and their desire to meet high standards for worst case conditions in Biocompatibility Testing caused RMD to pause the application process while additional Biocompatibility testing was carried out
o Biocompatibility testing has been undertaken to satisfy FDA request for additional testing at higher extract temperature and with different extract media. This was a substantial body of work taking 16 weeks for the longest test. The updated file was re-submitted to FDA on 29th Aug 2022
o FDA 510(k) clearance for Mobility+ was notified to RMD on 20 Oct 2022
o Selection of Notified Body for EU regulatory approval has been completed and RMD is interacting with that body as required. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o Assessment was conducted on need for the clinical trial with review of MDR, risk management files and engagement with notified body to assess what clinical evidence may be required
o Ongoing development of full Quality System has proceeded with an electronic QMS System for procedures and records
o The website (rockfieldmd.com) social media channels, numerous outreach events in schools and third level institutions, conferences and workshops were undertaken for Communications, Dissemination & pre-commercial Exploitation
o Mobility+ Design and Development has almost completed the Design Transfer phase of the Design Control process in co-operation with the intended Sub-Contract Manufacturer and is ready to move into the Commercialisation Phase now that FDA clearance has been granted (commercialisation phase not funded by this action)
o In the area of Sensor technology, smart materials and data management capability, concept and prototype manufacture have progressed well with Concept Selection completed & prototypes available for presentation and assessment. The Concept Phase of the project has been completed & is now ready to move into the Development Phase
o Submission for FDA 510(k) clearance was completed in May ’21 but concerns raised by FDA during the review of the submission and their desire to meet high standards for worst case conditions in Biocompatibility Testing caused RMD to pause the application process while additional Biocompatibility testing was carried out
o Biocompatibility testing has been undertaken to satisfy FDA request for additional testing at higher extract temperature and with different extract media. This was a substantial body of work taking 16 weeks for the longest test. The updated file was re-submitted to FDA on 29th Aug 2022
o FDA 510(k) clearance for Mobility+ was notified to RMD on 20 Oct 2022
o Selection of Notified Body for EU regulatory approval has been completed and RMD is interacting with that body as required. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o Assessment was conducted on need for the clinical trial with review of MDR, risk management files and engagement with notified body to assess what clinical evidence may be required
o Ongoing development of full Quality System has proceeded with an electronic QMS System for procedures and records
o The website (rockfieldmd.com) social media channels, numerous outreach events in schools and third level institutions, conferences and workshops were undertaken for Communications, Dissemination & pre-commercial Exploitation
The result of this work now enables enteral feeders better mobility, quality of life, lifestyle and to ‘feed-on-on-the-go.’ Several high value direct employment jobs were created in the periphery of Europe in a predominantly rural West of Ireland location . In addition, internships and graduate opportunities have been created as a direct result of the project. This project has strengthened the early-stage life science company Rockfield Medical Devices enabling it to secure Regulatory approval in the USA (i.e. major milestone of FDA 510(k) clearance) and pursue it in Europe, placing Rockfield Medical Devices in a strong position to develop future products and services in the life science sector.