Patients – the missing voice

An important question, when answered about an assay – is the performance good enough, is usually answered by a standards group. An example is the ISO 15197 standard for glucose meters.

The usual input into standards groups are manufacturers, clinicians, regulators, and laboratorians. Within these groups, manufacturers tend to dominate. This was true for ISO 15197.

But one voice is often missing – that of patients. This is particularly important for glucose, where patients act as clinicians and laboratorians.

The FDA meeting last year did have a patient advocate and patients have commented on the FDA meeting, here and here.


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