Module 1: The Strategic Case for Evidence Planning

Many medical device, diagnostics and digital health companies routinely reach the point of seeking reimbursement or the approval of a health technology assessment (HTA) body without a coherent evidence strategy behind them. Our first module makes the case for early, structured evidence planning and explains why reactive, piecemeal approaches to evidence generation lead to weaker submissions, wasted budgets and avoidable delays.

• why evidence planning matters — the cost of arriving at an HTA submission or procurement decision without a strategic evidence base behind the product
• how pharmaceutical companies approach evidence planning through clinical development and why medical device and diagnostics companies typically do not
• what a good evidence generation plan looks like at a high level — scope, structure, timeline and the relationship between clinical, economic and humanistic evidence
• the changing regulatory and HTA landscape for medical devices — how MDR, NICE and international HTA expansion are raising the evidence bar

Module 2: Understanding the Decision Landscape

Before any evidence can be planned, the first question is: evidence for whom? This module maps the decision-makers and frameworks that determine whether a product achieves reimbursement, formulary listing or procurement and identifies what each requires in terms of evidence type, quality and format.

• HTA frameworks in practice — NICE, G-BA, HAS, CADTH and the emerging international picture, with a focus on what each expects to see and where requirements diverge
• NHS procurement and the MEAT criteria — how clinical evaluation reports, value-based procurement and tender scoring frameworks create specific evidence demands
• mapping the decision pathway for a specific product — identifying every point at which evidence will be evaluated and by whom
• how requirements differ across the product lifecycle — what is needed at launch versus what is needed for re-evaluation, line extension or new market entry

Module 3: Early HTA Engagement and Scientific Advice

One of the most underused tools in evidence planning is the opportunity to ask decision-makers directly what they want to see. This module covers the formal scientific advice and early dialogue processes offered by HTA bodies and regulatory agencies and explains how to use them to shape an evidence strategy before committing resources.

• NICE Scientific Advice, EUnetHTA early dialogues and other formal routes to pre-submission guidance — what each process involves, what it costs and what it typically delivers
• regulatory scientific advice — FDA pre-submission meetings, MHRA Innovation Office engagement and how to align HTA and regulatory evidence requirements in parallel
• preparing for a scientific advice meeting — how to frame the questions, present the evidence plan and maximise the value of the interaction
• translating advice into action — how to interpret and incorporate feedback from HTA bodies into the evidence generation plan, including managing conflicting advice across jurisdictions

Module 4: Evidence Landscape Assessment and Gap Analysis

With the decision landscape and any early HTA feedback in hand, the next step is to survey what evidence already exists and measure it against what is required. This module covers how to conduct a structured landscape assessment, catalogue available evidence and systematically identify and prioritise the gaps that the evidence generation plan must address.

• conducting a rapid evidence landscape assessment — a structured approach to identifying and cataloguing published and unpublished evidence across clinical, economic and patient-reported outcomes
• assessing the strength and relevance of available evidence — distinguishing between evidence that will withstand HTA scrutiny and evidence that exists but will not support the claims being made
• structuring the gap analysis — comparing available evidence against the specific requirements of each target decision-maker, framework and market, and prioritising gaps by their impact on reimbursement, timeline and commercial outcomes
• AI-assisted landscaping tools — how emerging platforms accelerate the identification and mapping of relevant literature and where human judgement remains essential

Module 5: Clinical Study Design and Real-World Evidence

With gaps prioritised, the question becomes how to fill them. This module covers the full spectrum of available study designs — from randomised controlled trials through prospective registries to retrospective database studies — and provides a practical framework for selecting the right design based on what payers and HTA bodies will accept.

• matching study design to evidence need — when an RCT is genuinely required, when a prospective registry is sufficient and when retrospective real-world evidence will serve
• comparator selection and its downstream consequences — how the choice of comparator determines whether results can support an economic model and whether an HTA body will consider the comparison relevant
• designing credible real-world evidence studies — the HARPER protocol template, target trial emulation and the practical challenges of accessing hospital episode data, national registries and disease-specific databases
• practical constraints specific to devices — operator learning curves, iterative product design, inability to blind and the particular challenges of recruitment and randomisation in surgical and diagnostic settings

Module 6: Endpoints, Study Quality and Designing for Synthesis

The endpoints a study measures and the rigour with which it is conducted determine whether its results will survive HTA scrutiny — and whether they can be combined with other studies in a future systematic review or meta-analysis. This module covers the design decisions that are easy to get wrong at protocol stage and impossible to fix afterwards.

• endpoint selection for market access — why the endpoints clinicians find most interesting often differ from what payers need to see, and how to select clinical, economic and patient-reported endpoints that serve downstream submissions
• study quality from the payer’s perspective — how HTA bodies assess risk of bias using tools such as ROBINS-I, RoB 2 and GRADE, and how decisions made at protocol stage about registration, follow-up and loss-to-follow-up determine the quality rating a study will receive
• designing for future evidence synthesis — standardising endpoint definitions, measurement timepoints and reporting formats across studies so that results can be pooled in a systematic review or network meta-analysis
• institutional evidence standards — developing internal guidance that ensures consistency across company-sponsored and investigator-initiated studies, building an evidence base that strengthens with each new study

Module 7: Planning Economic and Outcomes Evidence Generation

Clinical evidence alone rarely secures reimbursement. This module covers when and how to plan for economic evaluations, health-related quality of life data collection and other outcomes evidence that HTA bodies and payers expect — and how to sequence these activities around the product lifecycle.

• when to commission economic evidence — deciding between budget impact analysis, cost-effectiveness analysis, cost-minimisation analysis and other approaches based on what each decision-maker requires
• planning for utility and quality of life data — why EQ-5D and other preference-based measures need to be built into clinical study designs early, and what to do when they were not
• real-world evidence and database studies — how these complement trial-based evidence and when they are credible substitutes in the eyes of HTA bodies
• sequencing economic evidence around lifecycle milestones — launch, re-evaluation, geographic expansion and the iterative relationship between early models and later, data-rich submissions

Module 8: Publication Strategy and the Evidence Roadmap

Evidence that has not been published cannot be cited in a submission, and an evidence plan without governance will not be delivered. This final module brings together publication strategy and operational planning into a single, actionable evidence roadmap — sequenced, costed and managed.

• designing a publication plan that aligns with market access goals — mapping each planned publication to the evidence gap it addresses and timing manuscripts to support submissions and launches
• targeting journals and congresses strategically — selecting outlets based on payer and HTA reviewer readership rather than impact factor alone
• constructing the evidence roadmap — integrating clinical, economic and publication plans into a unified timeline with milestones, dependencies, budget and resource allocation
• cross-functional governance — aligning medical affairs, regulatory, commercial and market access teams around a shared evidence strategy and maintaining the roadmap as studies complete and markets evolve