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

Moving laboratory-based techniques such as in vivo diagnostic devices into widespread clinical use is a common and laudable goal for investigators. Achieving this goal requires addressing two different types of challenges not commonly considered in research-oriented laboratories. The first is a scientific challenge to thoroughly understand the relationship between what the measurement from the device is actually assessing in relation to the underlying clinical phenomena of interest. In particular, it is important to understand the relationship between the critical clinical dynamics occurring over time and space, compared to what volume and timeframe is actually being assessed and reported. The second challenge is to address the technical and user-based design issues to minimize risk and optimize its usefulness and acceptability, while addressing regulatory concerns. Based on our experiences with magnetic resonance imaging and electron paramagnetic resonance spectroscopy for in vivo measurements, this paper discusses some potentially non-intuitive points that should be considered.

In terms of scientific aspects, what is actually being measured may not fully be taken into account, which may lessen its success in improving clinical care. This challenge is reviewed in the context of in vivo measurements of oxygen, but the same problems occur when making any in vivo measurement. Principles for designing and manufacturing the device during preclinical and clinical phases are discussed, using examples from our experience including progressing through the regulatory process for medical devices. Achieving well understood and useful measurements to improve clinical understanding and care can be a long and intricate journey, but it becomes more efficient when these challenges are addressed from the beginning.