Thursday, 15 March 2012

A black & white regulatory world

I've just come home from MedTec Europe. The Human Factors stream was very interesting, with some great talks. However, the discussion focused largely on safety, error and legislation. This focus is important, but if it becomes the sole focus then all innovation is stifled. All everyone will do is to satisfy the requirements and avoid taking risks.

While it is a widespread and widely agreed aim of all medical interventions to “do no harm”, any intervention carries some small risk of harm, and medical progress requires that we accept those risks. So “no harm” has to be balanced by “where possible, do good” (where “good” is difficult to measure, though concepts such as Quality Life Years, or QaLYs, try to capture this idea). Without risk, we would have no interventions – no medical profession, no drugs, no treatments. That is unimaginable. So we need to have mature debate about acceptable risk. The world is not black-and-white… but every new piece of regulation reduces the shades of grey that are acceptable.

Imagine that universities changed their assessment to a simple pass or fail. What information does this give the future employers of our students about which are likely to perform well? Of course, academic excellence isn't the only assessment criterion, but if it's not a criterion at all then why do we assess it? More to the point, if it became a simple pass-fail, what motivation would there be for students to excel? The canny student would do the minimum to pass, and enjoy themselves (even) more. The pass-fail shows whether work basically conforms to requirements or not. The more detailed grading gives an indication of how well the work performs: work that was awarded a mark of 91% has been assessed as being of substantially higher quality than work that was awarded 51% even though both have passed. Even this is a fairly blunt instrument, and I am certainly not suggesting that medical devices be graded on a scale of 1 to 100. Quite apart from anything else, the best inhaler on the market for a young boy suffering from asthma is unlikely to also be the most appropriate for an elderly lady suffering from COPD.

Regulation is a very blunt instrument, and needs to be used with care. We also need to find ways to talk about the more complex (positive) qualities of next-generation products: risks are important, but so are benefits.

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