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“Whilst we have tackled many of the great challenges, infection is

becoming one of those growing concerns to clinicians. Consequently,

with a technological push and the development of science, overcoming

regulatory barriers is becoming more achievable and clinicians are asking

for more solutions, these are the combinations of a good news story;

antimicrobial therapies are looking a bit more commercially viable.”

However, with many positive changes, one caveat still remains.

“When industry makes a claim about a product, they have to be careful

about the wording they use for the claim, the evidence for which they

are resting on, and the way it will be received by the community. So if

we say, for example, ‘the technology developed here at the University of

Sheffield, developed in part with European funding, has been put it onto

a device that has the potential to inhibit microbial organisms and reduce

infection rates’, that might be ok.

“If, though, we imply that its ‘guaranteed’ to prevent and protect, and

then of course micro-organisms, which are versatile and so will get

around the technology, even if the product is effective in 99.9% of cases,

the 0.1% of litigation to the people who complain it did not work might

cost the profits that are made on the device.

“So it has become a very complex environment in which to operate,

balancing patient and commercial benefit, and of course science and

innovation, and its way to help people.”

Breaking the barrier

Turning to the project, Hatton described how the venture sought to take

advantage of the recent developments in regulation and science in order

to mitigate bone infection.

“Consequently, if you wanted to do something

more dramatic and combat or prevent infection

at the same time as repairing a bone, the

regulatory burden became more complicated

and costly. Historically, manufacturers were put

off by the challenge of antimicrobials because

it would cost a lot more money and the market

size was much smaller; the simple equation in

the financial director’s office was that it was

probably not worth the investment.”

New hope

Yet despite such divergence, there is change in

the air as new rules are implemented and

traditional differences are broken down.

“The regulatory difference between a

conventional device and an enhanced device

may arguably not be as great, but the

regulations have become tougher in response

to public opinion. Yet the actual gap between a

‘conventional’ device and an ‘enhanced’ device

is not so great because of the pressure on

manufacturers to comply with tougher

regulations for all devices. If you are now in

the financial director’s office, it does not

look quite so expensive to develop an

antimicrobial device.

H O R I Z O N 2 0 2 0 P R O J E C T S : P O R TA L



S O C I E TA L C H A L L E N G E S : H E A L T H & W E L L B E I N G

Hatton drew

attention to a more

friendler regulatory

environment which

could help bring

the breakthrough

to market