Last week we posted an article promoting the above-mentioned select committee’s meeting on Medical Device regulation, drooling as we were at the prospect of a bit of heated exchange between witnesses on the subject. The reality can be viewed here and is indeed an interesting watch.
The witness panel comprised representatives from various interested parties, the most vocal of whom were Dr Carl Heneghan and Prof Stephen Westaby, politely polarised in their expressed views. We’ll be editorialising in greater detail over the next few days, but for now figured you might like to watch the proceedings.
What’s clear in considering how to summarise the piece is that there are some shared objectives, but plenty of differences of view when it comes to turning the common goals of delivering medical technology advances into a beneficial patient experience.
One word kept cropping up though-transparency- and indeed the fact that the meeting is now in the public domain is itself a form of greater transparency in medical device regulation… well, it’s as good as it gets for now.
There was another word kept cropping up in my mind though, and I’m not really sure whether it should-pragmatism. Is there really a place for pragmatism in medical device regulation or should every aspect of every device be subject to absolutes rather than the reality that however much evidence is collected it will either never be conclusive, never be enough or never be deliverable quickly enough to bring benefits to patients at a cost that doesn’t prohibit it from ever happening. Carl Heneghan’s view is that tighter regs sort out the men from the boys and force the entry level quality requirement higher in a way that device developers will adapt to. Furthermore he reckons tighter regs will protect us against the “equivalent”, but implicitly inferior products that a demand for cheaper products will result in. Steve Westaby’s view is that MHRA does a good job and tighter regs will only delay access to new developments in a way that doesn’t benefit anyone.
More to come.
Source: UK Parliament; Science and Technology Select Committee inquiry on medical implants