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“Everything in life is dynamic, so if you think

about medical devices for bone repair, the

bottom line is if you have got a new

technology, it will never reach a patient unless

somebody can commercialise it. While some

people look at that in a critical way, it’s

important to remember we live in a free

market economy; you have got to be able to

commercialise in order to make money, and

thus help the patient.”

Drug or device?

Hatton then drew attention to the “profound”

regulatory difference between drugs and

devices and the diverging guidelines that must

be adhered to, dependent on what role the

medical treatment takes.

“Historically, placing a device into the body to

repair bone is literally called a ‘medical device’.

We have fairly groundbreaking medical device

regulations in Europe, a really good example of

how the European Single Market works well for

the benefit of European citizens.

“Yet if such devices have too much of a

biological effect, there are question marks

about whether or not they are indeed devices,

and this is something which is still a debate that

perplexes regulators and lawyers alike. If the

action taken by the ‘device’ is too profound, like

combatting infection, there are question marks

about whether this is a ‘device’ or is it starting

to work as a drug?”

Whilst defining medical treatments as either

a ‘device’ or ‘drug’ can be problematic, there

are also implications as to what rules must

be complied with, as well as a consideration

of cost.

“If you want to make a device that simply mends

the bone, then one set of particular regulations

must be complied with, and regulations cost

money – it’s a form of risk management.

L

eading scientists at the UK’s University of Sheffield have

discovered nanotechnology could hold the key to preventing

deep bone infections after developing a treatment that

prevents the growth of bacteria and other harmful micro-

organisms. The pioneering research showed that applying small

quantities of antibiotics to the surface of medical devices, from

small dental implants to hip replacements, could protect

patients from serious infection. Scientists used revolutionary

nanotechnology to work on small polymer layers inside implants,

which are only a few nanometres in thickness.

To find out more about the investigation, overcoming potential infections

and the benefits to patients, Portal spoke to the Professor Paul Hatton,

lead researcher of the ‘Nanostructured & Biomimetic Ceramic-Polymer

Composites for Bone Tissue Regeneration’, or NBC-ReGen4, project

which benefitted from around €200,000 of funding from the then Marie

Curie Actions (MCA) under the Seventh Framework Programme. The

MCA Intra-European Fellowship supported Italian researcher Dr

Piergiorgio Gentile, who developed the research ideas in Hatton’s group

as a research fellow. The project ran between 2012 and 2014, though

its results have just been released.

Hatton described deep bone infections, in particular those relating to

devices, as “an unmet clinical challenge”, and one where “there are not

many technologies” providing an adequate solution. Portal asked Hatton

to expand further on why relatively few solutions had been developed

so far.

I S S U E S E V E N

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

www.horizon2020projects.com

140

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

Bone breakthrough

Following a nanotechnology breakthrough using an antibiotic to minimise the

development of deep bone infection,

Portal

spoke to

Professor Paul Hatton

from the University of Sheffield, UK, about the MSCA-backed project

The EU-backed project

has made advances in

helping to prevent

deep bone infections

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