Across the 18-month FitSleep action, we implemented the five planned activities and delivered the core outputs foreseen in Annex 1: (i) a miniaturized Stage I Clinical Device (SICD) for bilateral temporal-interference hypoglossal nerve stimulation, including the main electronics, user interface/enclosure, and clinical accessories (electrode patches and patient cables), supported by a fit-for-purpose QA/QMS set-up (SOPs, design history/technical file structure) and verification/validation testing appropriate for first clinical home use; (ii) bilingual clinician/participant information materials and step-by-step home-use guidance; and (iii) designed the multi-week take-home pilot with home baseline, in-lab titration, and at-home use, generating an integrated data package covering efficacy signals (AHI/oxygenation trends with expected inter-subject variability), safety/tolerability, and human-factors/usability feedback to lock down device performance specifications for the next design iteration. In parallel, we delivered the planned market-insights output (competitive landscape, target segments, willingness-to-adopt drivers and barriers), a consolidated IP/regulatory workstream (FTO/IP surveillance and filings strategy, initial regulatory pathway mapping and technical-documentation plan, and early interactions with a CE Notified Body), and a business strategy deliverable (commercialization options, development roadmap, and investor-ready summary/pitch materials) to position the innovation for follow-on funding and/or licensing.
Relative to the Description of the Action, implementation differences were limited and justified by de-risking priorities typical for PoC-to-TRL5 translation: the primary SICD and take-home clinical package proceeded as planned, while the “Series II” wireless device work (Task 1.5) was completed to a pre-engineering/design-freeze level (architecture, requirements, risk file, and supplier/manufacturing plan) but we did not progress to a fully integrated wireless 2.0 hardware build within this action, because the team prioritized incorporating take-home usability/comfort learnings and locking clinical specifications before committing to a costly redesign and additional pre-compliance testing; this shift strengthens, rather than weakens, the next step toward a commercial prototype. Pre-compliance/bench testing was used where full certification-grade testing would not be proportionate at this stage, with the standards roadmap captured in the technical documentation plan. No partial lump sum share is declared, as the action’s planned work packages were completed and all key deliverables for the PoC objectives were produced; the wireless build is treated as a planned follow-on activity beyond this action’s scope rather than an unfinished core task. Subcontracting was used only as foreseen (specialist suppliers and market analysis, and external patent/regulatory support including Notified Body interactions); no additional, unplanned subcontracting was required.
