Source: Medical Plastics News.
On April 22 I visited implantable PEEK manufacturer Invibio Biomaterials near Blackpool, UK. I was immensely impressed with their attitude to manufacturing, a refreshing alternative to many companies I've spoken to which see regulation as a burden. Invibio, by contrast, clearly go the extra mile with policies which go much further than that which is required by law.
Regulation and manufacturing is a bit like oil and vinegar in a salad dressing. They will never become one but when mixed together they taste great.
Regulation is a key issue in Europe at the moment, as Eucomed are heartily lobbying the European parliament, and encouraging us to do the same with our local members of European Parliament (MEPs) to back their fight against the scrutiny procedure, proposed as part of the new regulations for the medical device industry.
The scrutiny procedure, a procedure for approving new high risk devices for sale in Europe, has been sharply criticised for being over cautious and likely to kill Europe's innovative market and vastly slowing down time to market for device makers. Experts have suggested that European patients will lose what is described as a three-to-five-year advantage over other countries where devices are available for use by clinicians three to five years sooner than elsewhere in the world.
The scrutiny procedure has been described to me as an over-reaction to the PIP breast implant scandal last year where non-medical grade silicone was used to make breast implants which were in turn implanted into unknowing patients.
Cosmetic practices are once again under the media spotlight in the UK as interest groups are shouting for more stringent regulation of "salons" which provide facial collagen and botox injections, with one observer saying "it's a disaster waiting to happen".
At the time of writing, cosmetic injections like this can be administered by a beautician who has taken a short training course, without any medical training.
Like in the case of the PIP scandal, if anything does start to go wrong with this treatment it will be the UK government who will be left to pick up the bill via operations to rectify unexpected outcomes.