Barriers to developing new medical devices | Letters
I was interested to read about the life‑changing treatments being discarded because scientists run out of cash (The long read, 11 March). As Alexander Masters says, failure to move new medicines to commercial, and therefore clinical, use results in vast wastage of research resources and loss of valuable treatments because most never leave the lab. This also applies to implantable medical devices, which are in common use today.
New devices, particularly those that can significantly reduce complications such as infection, are potentially available, but, as with new drugs, often stay in the lab for want of commercial support to the next stages. Randomised clinical trials (RCTs) are often thought of as the “gold standard” next step, but many new drugs and devices fail at this stage. Those that pass the RCT, which as Masters says are not representative because of numerous restrictions on those taking part, can also fail when released into “real life” assessment on the general population. But these stages are essential to show safety and effectiveness.
Another big cliff at the other side of the “valley of death” is regulatory approval that, though essential, is out of date, too costly and not suited to modern innovations – another reason for the failure of new drugs and devices to advance to clinical application.
Roger Bayston
Prof emeritus of surgical infection, University of Nottingham
