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Lessons Learned in Transforming In Vivo Devices from Pioneering Research into Tools Used Routinely in Medical

Harold M Swartz¹, Ann Barry Flood², Wilson Schreiber³

¹Dept of Radiology, Geisel School of Medicine, Dartmouth College, Hanover NH 03755 (H.M.S., A.B.F.); Thayer School of Engineering, Dartmouth College, Hanover, NH 03755 (H.M.S.); Clin-EPR, LLC, Lyme, NH 03768 (H.M.S., A.B.F., W.S.).

Academic Radiology

|July 30, 2025

Summary

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This summary is machine-generated.

Translating in vivo diagnostic devices to clinical use requires understanding measurement-phenomena relationships and addressing design/regulatory challenges. Early consideration of these factors optimizes clinical care improvements.

Area of Science:

Biomedical Engineering
Medical Physics
Clinical Diagnostics

Background:

Transitioning laboratory diagnostic techniques to clinical practice presents unique hurdles.
Investigators must bridge the gap between research and widespread clinical application.

Purpose of the Study:

To identify and discuss critical scientific and technical challenges in translating in vivo diagnostic devices for clinical use.
To provide insights based on experiences with magnetic resonance imaging and electron paramagnetic resonance spectroscopy.

Main Methods:

Review of scientific principles governing in vivo measurements, focusing on spatial and temporal dynamics.
Analysis of technical, user-based design, and regulatory considerations for medical device development.

Keywords:

Clinical use EPR spectroscopy FDA regulations IRB approval Imaging Investigational Device Exemption Risk management in vivo

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Main Results:

Measurements may not fully capture the intended clinical phenomena, potentially limiting clinical care improvements.
Understanding the assessed volume and timeframe versus clinical dynamics is crucial.

Conclusions:

Addressing scientific and design challenges early in preclinical and clinical phases is essential for successful device development.
A systematic approach to device design, manufacturing, and regulatory processes enhances clinical utility.