Shaping device evidence to meet market access demands and demonstrate real-world value

The medical technology (MedTech) sector faces unique challenges in demonstrating value. Unlike pharmaceuticals, devices can be iterative, and their value is often linked with user training. To secure adoption of the technology, a thorough evidence base is required.

At YHEC, we help MedTech developers to build and validate the evidence needed for market entry and reimbursement. Our position, which spans both industry and healthcare systems, enables us to provide strategic advice that anticipates and responds to payer expectations. We help you explore your evidence landscape and prepare for scrutiny, ensuring your value case is technically sound and aligns with health system priorities. We also offer training courses to help build your team’s internal health economic expertise.

How can YHEC help the MedTech sector?

We partner with you at every stage of the product life-cycle:

During early development phases, we help you to:

  • Conduct early reviews to identify unmet clinical needs and define your target patient/user populations.
  • Develop early economic models to explore value propositions and assess cost effectiveness.
  • Embed considerations of sustainability and equity into your evidence development plans to align with evolving health system priorities.
  • Structure your clinical evidence plans to anticipate future HTA and payer requirements.
  • Navigate uncertainty with clear, structured and forward-looking evidence strategies tailored to your technology’s specific context, incorporating methods like structured expert elicitation.

YHEC provides support to:

  • Conduct gap analysis projects, which involve reviewing the value proposition for a technology and mapping existing evidence against key value messages to inform future evidence generation.
  • Build a transparent evidence base for decision-makers, even in data-limited environments or with pragmatic evidence. Where evidence may be limited, incomplete or uncertain, we can use methods like structured expert elicitation.
  • Integrate patient- and clinician-reported outcomes, along with broader perspectives on health equity, to capture the full value of your technology in real-world settings.
  • Address evidentiary challenges through expert data synthesis and rigorous statistical analysis.
  • Conduct care pathway analysis to identify the best positioning for your technology within the existing clinical pathway and potential barriers/facilitators to adoption.
  • Synthesise your evidence and value story through literature reviews, economic models and statistical analysis.
  • Create compelling value communications that are easy to interpret and resonate with stakeholders.

For successful market access, your HTA and reimbursement submissions must be thorough and compelling. We provide support to:

  • Anticipate payer expectations for economic models and evidence submissions, considering how to maintain a consistent value narrative through multiple versions of the device.
  • Develop compelling, aligned and defensible HTA dossiers that are tailored to the requirements of specific national and regional bodies.
  • Adapt your global evidence to local HTA requirements, ensuring your submission is relevant and persuasive.
  • Prepare for HTA consultations, scientific advice meetings, and other payer engagements.

After launch, continuous monitoring and evidence generation is important for long-term success. We help you to:

  • Strengthen your value proposition with real-world data that reflects the lived experiences of patients and clinicians.
  • Use real-world data from earlier product versions to inform and support the evidence base for new device iterations.
  • Analyse patient registries and health databases to collect real-world data supporting your device.
  • Prepare for evolving healthcare expectations by embedding considerations of sustainability and equity into your continuous evidence plans.
It has been an absolute privilege to be a part of this team. I have learned so much from each of you and have been inspired by your dedication, expertise, and passion.
Health Economics Research Specialist, Top 5 Global MedTech Company

Talk to our expert

For information about our work with the MedTech sector, talk to our expert – Matthew Taylor

A head and shoulders photo of Matthew Taylor sitting in front of a bookcase in his office.