Synopsis

Keywords: Image acquisition: Quantification, Transferable skills: Commercialisation, Transferable skills: Intellectual Property

This presentation focuses on strategies for promoting standardization and dissemination of quantitative MRI technology, spanning the pathway from invention to eventual adoption in patient care. The presentation draws on lessons that were learned in the development and dissemination of MR elastography, which is now a standard of clinical practice, deployed on thousands of MRI systems around the world. This presentation reviews strategies for addressing hurdles and opportunities, technical and regulatory challenges, and approaches for obtaining clinical buy-in for new quantitative MRI-based techniques.

MRI is inherently a quantitative technology. Over the last four decades, investigators have identified and developed methods for measuring many quantitative MRI-based biomarkers for detecting and staging disease and for assessing function. Thousands of publications have studied and documented the potential usefulness of many of these biomarkers. Yet, in clinical MRI practice, quantitative biomarkers are still not used to the extent that might be expected.

This presentation is intended for researchers and innovators who develop quantitative MRI technology and who wish to see it translated to clinical practice.

Limitations in many areas have hindered the use of quantitative methods in clinical MRI:

· Extent of standardization of protocols and measurement techniques
· Availability of analytic tools to facilitate measurement and reporting
· Existence of practice guidelines that mandate use of quantitative techniques
· Service recognition through available procedure coding

The primary way that new MRI technology is disseminated is through commercialization by the MRI manufacturers. Medical imaging devices are very highly regulated, and outside the research environment it is not generally possible for an entity other than the MRI manufacturer to install a new acquisition technique on an existing system for clinical practice.

Given the high cost of meeting regulatory requirements required to introduce new MRI techniques, MRI manufacturers must determine that subsequent demand for the product will justify the investment required to implement.

Using MR Elastography as a case study, this presentation describes lessons learned in the journey from invention to clinical practice. The presentation will highlight the following strategies and their rationale:

· Make sure that you are addressing a real problem
· Work with clinical colleagues to establish value
· Deploy and seek validation in clinical practice
· Freely share with collaborators elsewhere
· Engineer the diagnostic process from end-to-end
· Promote evidence-based standardization
· Engage available institutional tech transfer expertise
· Proactively manage conflicts of interest

Acknowledgements

No acknowledgement found.

References

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