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Technical performance is strong. How far can your clinical claim go?

A clinical evaluation or product-planning discussion is approaching. Material studies, animal experiments and comparator literature exist, but their evidence types are not clearly separated.

How does this scope address your concerns?

Treating similar products as equivalent, or translating bone-ingrowth performance into reduced revision rates, could send the evaluation in the wrong direction.

When this scope fits

For device teams with a defined product version, intended use and target market that need to evaluate the support provided by literature.

When the scope needs adjusting

This does not guarantee equivalence, registration or exemption from clinical trials. Animal experiments, human trials, testing and registration-agent fees are excluded.

REAL SOURCES · ILLUSTRATIVE REQUEST · DOWNLOADABLE SAMPLE

Porous-titanium implant: separate bone ingrowth from revision rates

Download sample packZIP

Claims versus evidence types

01Material performance

Describes bench-measured performance; does not directly establish human benefit

02Animal bone ingrowth

Mechanistic/nonclinical support with model limitations

03Human osseointegration

Check version, anatomical site, population and measurement

04Reduced revision rate

Needs relevant human outcomes and comparative evidence; no inference across types

The matrix uses MDCG 2020-5 equivalence dimensions; it establishes no proven benefit for an implant.

Check	Finding / sample content	Use
Product differences	Separate porosity, surface, contact materials, site and patients	Record potential clinical impact and required materials
Proposed claim	Illustrative materials do not establish “reduced revision rates”	Prioritise the relevant human-outcome evidence gap

SOURCES USED IN THIS EXAMPLE

MDCG 2020-5: Clinical evaluation — equivalence

Prepared 5 Oct 2026 · Selected references, not an exhaustive systematic search

Scope & acceptance

Work covered by the quote

Illustrative scope: 1 implant version, 1 target market, up to 2 comparator products, 1,000 records and 40 full texts, including agreed professional review.

Pilot reference: CNY 50,000–200,000 per module; comprehensive programmes CNY 200,000–800,000+. Fictional module budget: CNY 80,000—definition CNY 20,000; search and difference evaluation CNY 40,000; review and handover CNY 20,000. Milestones: CNY 24,000 at start, CNY 32,000 at draft and CNY 24,000 at delivery.

Acceptance criteria

Material performance and human outcomes are labelled separately. Product differences, extrapolation conditions and sources are recorded for the company's further professional review.

Checking the evidence

Allowances follow illustrative scopes in the current pilot proposal. Customer situations, walkthroughs and budgets are fictional examples, not actual orders, product findings or validated savings.
Authorised product-version and technical materials, intended use, market and comparator information; literature retains source and reading records.

Workflow and inputs

From inputs to delivery

Explore the workflow and deliverable structure. This preview does not run searches, read real records or produce medical findings.

01 / WORKFLOW PREVIEW

Define the task

Illustrative request: a porous-titanium implant team asks what evidence is needed for 'supports bone ingrowth' versus 'reduces revision rates'.

Methods, sources and professional responsibilities

THE BASIS FOR THIS SCOPE

Why this approach? Inspect the basis.

Check the match between product, population, use conditions and outcomes before defining a supported claim.

OFFICIAL GUIDANCE

FTC · Health Products

Federal Trade Commission · US

Does the research match the product claim?

Scientific support for health-product claims should match the product and claim, rather than merely a similar ingredient.

Scope & access conditions

This is US guidance. Other markets require separate assessment; it is not an approval or compliance conclusion.

Open official source

PUBLIC DATABASE

ClinicalTrials.gov

NLM / NIH

Check studies and reported results

Review study objectives, eligibility, locations, status and reported results, then identify questions for the clinical team.

Scope & access conditions

Sponsors or investigators submit the records. A listing is not government approval of safety or effectiveness, or a determination that you should participate.

Read the official description

Open official source

METHOD REFERENCE

GRADE · Cochrane Handbook

Cochrane · Chapter 14

Show effect size and confidence separately

Present important outcomes, relative and absolute effects, available data and certainty, with reasons for downgrading.

Scope & access conditions

GRADE evaluates a body of evidence for a particular outcome. Database inclusion or one study does not automatically establish high certainty.

Open official source

These references support problem definition and evidence appraisal. Your conclusions still require project-specific sources and professional review.

The value of this commissionEOS separates nonclinical, equivalence and human-outcome evidence by product version, purpose and comparator.

Device clinical evidence and gap packageCompare alternatives and value

An advanced material or design is promising. How much supports the clinical claim?

What to assess	ICON / EVERSANA	Evidence OS · Commissioned scope
Service focus	ICON supports endpoint selection and lifecycle evidence; EVERSANA offers device-value services.	EOS separates nonclinical, equivalence and human-outcome evidence by product version, purpose and comparator.
When to choose	Registration execution, clinical trials and full market support require appropriately qualified teams.	Example: one version and market, up to two comparators and 40 full texts, with agreed review.

What the fee pays for: Planning reference: CNY 50,000–200,000 per module or CNY 200,000–800,000+ per plan; execution is separate.
Value beyond this task: R&D, clinical and registration teams can reuse the version/claim/evidence/test matrix.
How to assess value: Track unmatched claims, reusable studies and duplicate preparation hours avoided; do not promise faster registration.

Verify market qualifications, product identity and equivalence assumptions; evidence work is not regulatory acceptance.

CHECK THE OFFICIAL SERVICE SCOPEEVERSANA · HEOR, Value & Evidence ICON · Health Economics and Outcomes Research

Reuse and updates after delivery

Development, clinical and registration teams can use the same evidence-difference table. For a new version or market, reusable materials are checked first rather than charging the full price again for identical work.

Agree reuse rights, retention and export periods, and future update fees when scoping.

Questions before commissioning

Does extensive comparator literature mean trials are unnecessary?

No. Product comparability, claim sufficiency and necessary trials require the company's and relevant professionals' assessment under applicable requirements.

Can we use the work in other countries or for a new version?

First assess the market, intended use and product differences. New markets, versions or populations are not automatically included in the original package.

Is this a registration report ready for immediate submission?

The page currently presents a literature-evaluation package and examples. Formal report requirements, reviewers, contracts and transfer arrangements must be confirmed first; registration responsibility has not been assessed by this page.

Define the delivery for your actual question.

Add your goal, available inputs and timing. Agree scope, review responsibilities and a quote before commissioning.

Request scope & quote

Explore other situations

Medical device clinical and regulatory teams

Your evaluation baseline is ready, but new evidence and product changes are not kept aligned.

Maintain evaluation materials quarterly, record evidence and product-difference changes, and explain their effect on existing claims and outstanding evidence needs.

CNY 200,000–1,000,000+ per yearSee the deliverable

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