Adoption Depends on Meeting Clinical Needs

JON HOLMES, MICHELSON DIAGNOSTICS LTD.

Every year, I am amazed and impressed by the number and variety of presentations at conferences in the field of biophotonics. We are blessed by the seemingly endless ways to manipulate and measure light, relatively inexpensively, in our pursuit of powerful new ways to understand, diagnose and treat disease. Much human ingenuity has been applied to overcoming difficult technical problems and pushing back the bounds of our knowledge.

But then I usually pause for reflection: How much of this advanced technology and research ends up in practical, routine use by clinicians caring for their patients? Of course, there are some big successes. In my own field of optical coherence tomography (OCT), imaging the eye is the poster child success of biophotonics, with thousands of OCT devices installed and an annual market size measured in the hundreds of millions of dollars. Then there’s the humble optical endoscope, which is relied upon by surgeons in many medical fields, as well as several other successful products of biomedical optics in clinical use. But many interesting and exciting biophotonic inventions have never made it to the patient’s bedside or the surgeon’s operating theater. Why is this?

To answer this question, it helps to think about the process of adopting a new technology from the point of view of the clinician. The clinician’s focus is always on the patient, not on the instrument. This means that a device must be easy to handle and the results easy to understand. If the technology is too fiddly to use, or if the results are too complex to be grasped by a nonphysics graduate, then the clinician’s focus shifts from the patient to grappling with the instrument. This is not a good thing. Unless these shortcomings are fixed, clinical adoption will be very slow or will stop altogether.

In my experience, the best way to address this challenge is to develop long-term, deep relationships with highly motivated clinicians and to collaborate with them in optimizing the core idea and developing it into something practically useful. When starting out on a new project, a biomedical engineer has no inkling of the complex nature of a disease, the variety of ways that it presents, or the wide variation in patients and their treatment options. This is the domain of the clinician. But by collaborating closely and persistently over a number of years, shared knowledge develops between clinician and biomedical engineer. This enables problems to be overcome, one by one, until there emerges a practical, useful instrument for clinicians.

The story does not end there. The community of clinicians (and the health care system payers behind them) set very high standards for quality of evidence. They will not support the adoption of a new device without being very sure that it works. It is sobering to find out the level of evidence sufficient to enable general adoption into clinical practice. For example, the Oxford Centre for Evidence-based Medicine typically considers a single published observational study to be only level 2a evidence¹, which is inadequate. The ideal level 1a evidence comprises systematic review of multiple randomized controlled trials (RCTs) from which diagnostic performance can be calculated.

Importantly, the best RCTs for diagnostic technologies are interventional and involve follow-up. Interventional means that the device-based diagnosis is actually used in making a treatment decision, whereas observational trials are at risk of bias because the user is still relying on a separate standard diagnostic. Follow-up means that patients typically are checked after 12 to 18 months to make sure that that there have not been unforeseen complications and that the patients have fared better than the control group. Clinicians also like to see studies that measure intraobserver agreement and observer variability, so they can understand how much the use of technology depends upon the skill of the user and their training and how consistent the results are by any one user.

Developing, running and reviewing a body of RCTs is a lot of work, takes a long time and uses up many resources and funds. But the potential of better health care for patients is huge. My message is this: Don’t stop and move on after one successful feasibility study of a new device. Be ready to find an open-minded, motivated clinician to collaborate with over a sustained period. Use this partnership to develop a practical, useful device and prove its benefits in a program of clinical trials. Then you can reap the rewards and see your idea in the hands of doctors helping patients.

Reference

1. Oxford Centre for Evidence-Based Medicine, www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009.

Meet the author

Jon Holmes is the lead founder, acting CEO and CTO of Michelson Diagnostics in Kent, England. Trained as a physicist at the University of Cambridge, England, he has 30 years’ experience in applying laser scanning and imaging to real-world problems; email: jon.holmes@vivosight.com.

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