..AND use this as the opportunity to shout out the
vital work of the community in medical device regulation.
It can sound a bit dull, but the work of these people
might just save your life. The CE MarkI started in 'regulation' back in 2016. After a friend got in touch.
We went on to review 65 medical devices together.
Me reviewing
clinical data..Him, and other experts, taking care of the
technical side
. Checking that the implants and medical devices
(that we put inside ourselves)
..do what they say on the tin.That they are
safe and perform.That's the
CE Mark. That work was part of a bigger puzzle..
Later, as
Vice Chair of an Expert panel at the European Commission I worked with people crafting, implementing and enforcing good regulation continent wide.
Ensuring that implants are
safe and perform AT SCALE. More and more I began to see the work as an important part of securing good
clinical outcomes for people and patients.
For ALL of us. Take my specialty, hip and knee replacement…
We’ve touched on what it takes to get a good result..
- A good patient.
- A good hospital system.
- And, sometimes, a good implant or device.
Take each of those one by one..
Patient => I can champion the importance of good patient factors
- In my everyday clinic one patient at a time.
- And to a wider audience in this
newsletter and
on my
YouTube channel.
Hospital => And for over 25 years, I've got to play my (small) part in the best hospital system in the world. (
I’m biased.. the NHS is pretty amazing)
Implant => In medical device regulation I could help with the implant bit.
Clinical practice can help perhaps
several 1000 people over a career.
Arguably work in regulation can impact people on a
much BIGGER scale.You only have to look at the
breast implant, vaginal mesh, or, in my field, the
metal-on-metal hip scandals to see what happens when regulation goes wrong.
Over the last 20 years I've seen metal-on-metal hips go from the next best thing to pariah status. And I've published work on the
up and the
down of that.
These extreme examples should not have happened.
It came down to good versus bad regulation*
*changes are coming to the CE Mark that will helpWhat I came to realise is that
good regulation really matters, not just for these BIG examples, but in
everyday healthcare.. So what is UKCA?In 2021 I joined a company called DEKRA as their
UK Head of Clinical.
One of the biggest companies I’d never heard of..
DEKRA grosses around €4 billion revenue every year.
DEKRA started in vehicle inspection of the first German cars.
99 years on- and as a HUGE global company-
DEKRA tests, inspects and certifies just about anything.Our small group was tasked with setting up a UK branch to offer UKCA marking.
UKCA being the post-Brexit equivalent of the CE mark.
Brexit was supposed to get rid of
'red tape' right?
Well, for medical devices, it just
doubled.
(but, I'm writing here as a fan of 'red tape'..Good 'red tape' that is..Good 'red tape' that keeps us safe..
Good 'red tape' that gives us better outcomes)DEKRA could offer manufacturers both
Conformite European (CE) and
UK Conformity Assessment (UKCA).
Over 3 years DEKRA Certification UK secured and maintained UKAS & MHRA designation. Institutions that check on us as the checkers.
It's a robust process.And now, with DEKRA UK in a good place,
I’m handing on the UK role to focus back on the clinical day job. I now want to play a bigger (small) part in tackling the
huge backlog and waiting list...
