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What Counts as Evidence for a Rehabilitation Device, and Who Pays to Find Out
Over many years of working in rehabilitation, I've heard two questions from clinicians more often than any others. What's the evidence that this works and is safe? And what's the cost?
They're the right questions. A therapist who asks them is protecting a patient from misplaced hope and a budget from wasted money. What I've come to doubt is whether we all mean the same thing by the first one. "What's the evidence?" is usually asked as if evidence were a single ladder, with a large, blinded randomised trial at the top. If a device has no trial at the top, the conversation can end there.
For a rehabilitation device, that evidence ladder often doesn't fit, and the reasons are practical rather than philosophical. I've set them out at length in a new whitepaper, and this article is the short version: how device evidence gets graded, why so much of it lands at "low certainty", what that verdict does and does not mean, and how the money decides how much evidence ever gets produced.