Roadmap

Why it matters

Mitigation in place

The first-in-human investigation, study design, ethics approval, patient recruitment, and data quality, represents the most operationally complex workstream on the path to CE marking.

• The founding team includes a practising emergency physician.
• Clinical and regulatory advisors are already engaged.
• Pre-existing relationships with IRCCS-class institutions were developed through the structured clinical interview programme and the cadaver campaign.
• The expanded ex-vivo dataset reduces the required patient count.
• Documentation groundwork with the lead investigation site is already underway.

Notified Body capacity under MDR is constrained, and review timelines can add months to the certification calendar if the submission is not prepared and sequenced correctly.

• Preliminary discussions with the Notified Body have already begun.
• A regulatory advisor is engaged and guiding the strategy.
• Technical documentation is being structured progressively against MDR Annex II/III requirements in collaboration with the CDMO, so that the submission package is built continuously rather than reconstructed at the end.

A single failure in EMC, electrical safety, or biocompatibility can introduce a redesign loop measured in months.

• Pre-compliance pre-scans are planned in Q3 2026 ahead of formal testing to identify and address failure modes early.
• EMC and electrical safety risks have been specifically addressed during the hardware architecture review.
• Biocompatibility material selection was made on the basis of ISO 10993-1 evaluation.

Moving from prototype to manufactured device can surface unexpected yield and supply chain issues that delay first deliveries.

• Creanova engaged from the design transfer stage rather than after design freeze, ensuring manufacturability is built into the product rather than retrofitted
• Per-PCB specifications, BOM, and supplier audit already completed.
• First production batch sized to absorb both the clinical investigation and the first commercial year.

Large medtech players could accelerate their portability roadmap in response to Rilemo's market entry, reducing the time available to build a defensible market position.

• Rilemo's core advantage is not hardware alone but the combination of proprietary AI algorithms, training data, and image reconstruction software, assets that require years of focused R&D and proprietary training data to replicate.
• The IP portfolio creates a legal moat around the key innovations.
• A champions-first go-to-market strategy is designed to build switching costs and clinical loyalty before larger players can respond at scale.

Introducing a new imaging modality requires behavioural change across multiple specialties each with different workflows, decision criteria, and institutional dynamics. Adoption can be slow even when clinical evidence is strong.

• The go-to-market strategy deliberately targets clinical champions across neurology, neurosurgery, emergency medicine, and radiology as first adopters, leveraging peer influence to drive broader departmental adoption.
• Pre-existing relationships with IRCCS-class institutions provide credible reference sites that reduce perceived adoption risk for subsequent buyers.
• The device requires no patient preparation, no shielded room, and no specialised training minimising the behavioural change required at point of care.