Periodic Reporting for period 1 - MobilityPlus (Commercialisation of the Connected Enteral Feeding Healthcare System for Integrated & Co-ordinated Care (Mobility+))
Reporting period: 2020-05-01 to 2021-04-30
This connectivity between Mobility+ sensors and devices will enable healthcare organizations to streamline their clinical operations and workflow management, and improve patient care, even from remote locations. It will disrupt existing business models of how enteral feed is sold and distributed. Due to elimination of hardware (external pump, batteries & other paraphernalia), simplicity of use, reduced maintenance and improved monitoring, Mobility+ will lower enteral feeding healthcare costs by up to 60%. It will provide significantly enhanced benefits to the user (patient) in terms of increased mobility and feeding efficiency - leading to radically improved quality of life.
It will be the first and only solution that will provide enhanced usage control options and e-connectivity: enabling effective self-monitoring, better quality of care and improved diagnosis of side-effects. Mobility+ has already gained traction with target customers, End-users and Key Influencers Foundation and Scientific Researchers.
o Project Plan and detailed Gantt Chart has been developed with the full team and submitted as deliverable
o Mobility+ Design and Development has proceeded with substantial progress though Design Freeze and successful Design Verification and Design Validation Testing including Biocompatibility testing
o Assessment of Sensor technology, smart materials and data management capability have continued which will enable selection for concept and prototype manufacture to begin in the next reporting period
o Submission preparation for FDA 510(k) is well underway with some sections completed and remaining in draft awaiting some report sign-off. Expect to submit 510(k) application to US FDA in May ‘21
o Selection of Notified Body for EU regulatory approval is well underway. This will apply to ISO13485 certification, MDR approval and CE marking as needed
o Assessment is ongoing of need for the clinical trial 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.