Brief · Use case · Innovation
Technology Overview.
LiveOverviewUnderstand how a technology works, what evidence has been accepted so far and where it is still unproven, written for a reader who has not worked with it.
Technology Overview is a ready-made use case for Innovation. It ships under the Overview template.
For clinical development and innovation leads assessing a new technology. The overview explains the mechanism in plain words, separates what is established from what is assumed, defines the terms and names the developments that would shift the view. Evidence claims carry a source and a certainty label, or a gap.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
What are digital biomarkers, how does a measurement become a trial endpoint, what evidence have regulators accepted so far, and where is the technology still unproven?
What the overview covers
A technology overview explains the mechanism in plain words and then asks what has actually been accepted. The overview keeps the two apart.
| Part of the picture | What the overview explains | Where it looks |
|---|---|---|
| What a digital biomarker is | A measurable characteristic of a biological process or response, captured by a digital device. The overview places it within the established biomarker categories, so you know which question it answers.4 | The FDA-NIH BEST glossary of biomarker terms. |
| From measurement to endpoint | The three steps that make a measure fit for a purpose: verification of the sensor, analytical validation of the algorithm, and clinical validation that the measure is meaningful for the patients concerned.1,2 | The V3 framework (Goldsack and colleagues), and FDA’s guidance on digital health technologies for remote data acquisition in clinical investigations, issued in final in December 2023. |
| What regulators have accepted | The cases on record. In Europe, the EMA qualified a wearable-derived stride velocity measure as a secondary endpoint in ambulant Duchenne muscular dystrophy in 2019, and a later opinion, first published in July 2023, covers its use as a primary endpoint.3 | EMA qualification opinions. |
| Where it is unproven | The indications, devices and populations with no accepted case, and the evidence that would be needed.3 | The absence of an accepted opinion, stated as an absence and not as a finding. |
What the overview does
Fit for purpose, in three steps. Verification asks whether the sensor captures the signal correctly. Analytical validation asks whether the algorithm turns the signal into the measure correctly. Clinical validation asks whether the measure means something for the people it is used on. The overview uses these three questions to separate what has been shown from what has not.1
What FDA asks of a digital technology in a trial. FDA’s final guidance, issued by its drug, biologics, device and oncology centers in December 2023, concerns remote data acquisition with digital health technologies and focuses on whether a technology is fit for its purpose and adequately validated for the trial. The overview reports what the guidance asks and says it is not a statement about any particular technology.2
One accepted case, read carefully. The EMA’s qualification of stride velocity at the 95th centile is the case most often cited. The overview describes its context of use, which patients and which setting, and what it does not show about other measures. The age threshold differs between the 2019 and 2023 opinions as summarized, so the overview states it from the opinion itself.3
Terms defined once. At Comprehensive length a table defines the terms a newcomer needs: biomarker, endpoint, context of use, qualification, and the three validation steps.4
Recommended length
Comprehensive
A reader new to the technology needs the mechanism shown and the terms defined. Comprehensive adds the how-it-works section and the terms table.
You can pick another length on the form. The other two stay available.
Assumptions the overview checks
The overview says which assumptions its conclusions rest on and names the most fragile one in its first paragraph. Examples for this subject:
- The measure under discussion is a biomarker in the BEST sense, not a clinical outcome assessment.
- The accepted case applies to the reader’s indication, which the overview checks and does not assume.
- The FDA guidance and the EMA opinions cited are the current versions.
Standards, guidance and sources
Fitness for purpose
- Goldsack, J. C. et al., the V3 framework for verification, analytical validation and clinical validation of connected digital measures, npj Digital Medicine, 2020.1
Regulators
Terms
- The FDA-NIH BEST (Biomarkers, EndpointS, and other Tools) glossary.4
The decision practice behind the memo itself is on the template page.
What gets flagged
Any statement of regulatory acceptance that is not backed by a specific opinion or guidance, any claim about a device or population outside the context of use of the accepted case, and any figure that is a vendor’s own.
What arrives
- Bottom line
- Why it matters now
- What we know
- How it works
- What it means
- Terms and actors
- What would change this
What it will not do
It explains and does not recommend. If you need a recommendation on what to do next, the Decision Memo is the template for it.
It does not assess a particular device or say whether a regulator would accept one. It explains how the question is asked and what has been accepted so far.
It does not recommend an action. An overview explains; it does not decide. When you have a choice to make, a Decision Memo is the template for it.
It is one specialist’s reading of public sources. Check any figure you will act on against its primary source.
It does not replace reading the regulation, the filing or the guideline it cites.
References
- [1] Goldsack, J. C. et al. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). npj Digital Medicine, 2020;3:55. DOI 10.1038/s41746-020-0260-4. Read from the Digital Medicine Society’s page and search excerpts; the paper was not read in full.
- [2] U.S. Food and Drug Administration. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. Final guidance, issued 22 December 2023. Status and date as listed on FDA pages; the guidance text was not read in full.
- [3] European Medicines Agency. Qualification opinions for stride velocity 95th centile as a secondary endpoint (EMA/CHMP/SAWP/178058/2019) and as a primary endpoint (first published 31 July 2023) in ambulant Duchenne muscular dystrophy studies. Known from EMA listings and search excerpts; the opinions were not read in full, and the age threshold differs between the two as summarized.
- [4] FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource: glossary. The page could not be opened from our tools; the category list is from search excerpts.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
To edit a saved template, open New → Brief → From template, or the library rail on the service form.