With over 65 years combined experience, we have a long track record of delivering timely solutions for our clients.
We understand the complexities of the regulatory environment and the shifting expectations for health technology approval. We offer comprehensive HTA preparation services, guiding you from initial planning through full submission and post-assessment support, helping your MedTech or digital health innovation achieve market access and reimbursement.
Expertise and Experience
With over 15 years of specialised experience in health technology assessment, our team brings deep scientific, regulatory, and market access expertise across MedTech, IVDs, diagnostics, and digital health. We continually track evolving HTA methodologies, national guidelines, reimbursement frameworks, and regulatory updates to provide accurate, evidence-based guidance throughout the entire preparation and submission process.
Tailored, Evidence-Driven Solutions
No two technologies are alike — and successful HTA submissions require a custom scientific strategy, not a generic template. Whether you are preparing for regulatory review, seeking reimbursement, or demonstrating clinical and economic value, we build a tailored plan aligned with your:
Technology and data maturity
Target markets and HTA bodies
Regulatory and reimbursement pathways
Strategic commercial objectives
This approach maximises your likelihood of achieving a favourable HTA outcome.
Comprehensive Scientific & HTA Services
We support the full lifecycle of HTA preparation through a rigorous, end-to-end service model. Our capabilities include:
Literature and systematic reviews
Evidence gap analysis and study planning
Health-economic modelling (CEA, BIA, cost-consequence)
Clinical and economic value dossiers
Stakeholder and KOL engagement
Submission preparation and post-submission support
Each component is crafted to build a strong, defensible, and compelling case for your health technology.
Regulatory & Reimbursement Compliance
Navigating regulatory expectations is central to HTA success. Our team understands the requirements of major HTA bodies across the UK, EU, and global markets, including NICE, G-BA/IQWiG, HAS, AIFA, RedETS, ZIN, and others. We ensure full compliance with national methodologies, evidence standards, clinical coding requirements, and documentation rules — helping you mitigate risk and submit with confidence.
Strategic Market Access Insight
Beyond dossier creation, we help position your technology for long-term success in competitive healthcare systems. Our strategic services include:
Market landscape assessment
Competitor and comparator analysis
Reimbursement mapping across countries
Value-proposition and pricing strategy development
We help articulate the unique clinical, operational, and economic value of your technology to payers, clinicians, and decision makers — strengthening acceptance, adoption, and market traction.
Post-Market Surveillance and Reporting
Our services extend beyond the initial HTA submission to support Post-Market Surveillance (PMS) and ongoing regulatory reporting once your health technology enters the market. Continuous PMS is essential for demonstrating long-term safety, performance, and real-world effectiveness.
We can help you establish robust PMS systems, monitor and document adverse events, generate periodic safety reports, and maintain full compliance with post-market regulatory requirements. This ensures that your technology remains safe, effective, and aligned with HTA and regulatory expectations across its lifecycle.
Engagement with European HTA Decision-Makers
Odelle Technology has a strong track record of working directly with decision-makers across European HTA organisations, helping innovators articulate clinical and economic value with clarity and rigour. Our experience includes identifying and evidencing the benefits of new technologies, addressing uncertainties, and demonstrating real-world value to facilitate adoption, coverage, and reimbursement.
By bridging scientific evidence with payer expectations, we help accelerate market access and strengthen the likelihood of positive HTA outcomes across the UK and EU.
To find out more and discuss your project, please contact us.