Translate
State which anatomical, immune, flow, imaging and procedural differences remain.
Scope boundary · 19
Preclinical is not clinical
Keep in-vitro models, ex-vivo tissue, small animals, large animals, feasibility studies and authorised clinical use as distinct evidence layers.
Evidence statusResearch-frontier evidence framework · stage, material, control and retrieval validation requiredLast reviewed: 16 August 2026
19
FUURAA thesis
Biomedical promise should expand only as intended-use evidence expands.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Evaluate
Separate technical success from biological effect, safety and comparative clinical benefit.
Authorise
Identify product classification, intended use, configuration and jurisdiction without implying approval.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Which evidence layer directly supports each sentence?
- 02
Were outcomes technical, biological or patient-relevant?
- 03
What comparator and follow-up would clinical use require?
- 04
Has any specific product and intended use been authorised?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Evidence-stage and intended-use matrix
- 02
Evidence package 2
Technical, biological and clinical endpoint separation
- 03
Evidence package 3
Regulatory-status verification by jurisdiction
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Animal or in-vitro results cannot be represented as human safety, effectiveness, authorisation or availability.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
ETH Zurich · Published 2025-11-13 · verified 2026-08-16
↗02Magnetically guided microrobots for targeted drug delivery
Integrates a soluble capsule, magnetic navigation, X-ray visibility, catheter release and drug delivery, with testing in vascular models and large animals.
Harbin Institute of Technology · Published 2025-10-31 · verified 2026-08-16
↗03Microscale fish-like robot swarms for drug-delivery research
Reports magnetic coordination, three-dimensional motion, aggregation and shape-adaptive attachment, including ultrasound-guided control in in-vitro models.
U.S. Food and Drug Administration · Final guidance 2014-06 · verified 2026-08-16
↗Considering whether an FDA-regulated product involves nanotechnology
Explains that dimension-dependent properties may require particular, product-specific attention to safety, effectiveness, quality and regulatory status.