045

SUMMER 2012 | THE MARKET

GERMANY: MEDICAL TECHNOLOGY
T
here`s an offenquofed sound Life
aLouf fhe Irish medical fechnology
secfor. If descriLes how, per capifa,
Ireland is fhe secondlargesf exporfer
of medical devices in Europe. And who`s fhe
largesf` Germany.
Buf Germany also imporfs: if is fhe largesf
medical device marlef in wesfern Europe and
one of fhe largesf in fhe world. So are fhere
opporfunifies for Irish companies fo esfaLlish a
presence in fhaf marlef, and if so, whaf do fhey
need fo lnow`
Germany, Leing home fo some of fhe
world`s leading medical device manufacfurers,
is nof only Europe`s mosf desiraLle exporf
marlef, Luf ifs sfrong economy and close
proximify fo Ireland male if an ideal exporf
locafion for Irish companies," says Dusseldorf
Lased }ane Greene, Life Sciences Marlef Advisor
wifh Enferprise Ireland for Germany, Ausfria
and Swifzerland. Local indusfry fends fo Le
geared up fo supply exporf marlefs fhe
majorify of goods manufacfured in Germany
are exporfed leaving fhe greafer parf of fhe
domesfic marlef fo Le supplied Ly imporfed
producfs, she nofes.
However, companies fhaf are looling fo
fhe German marlef need fo Le aware of fhe
ferrain: Ifs healfhcare sysfem can Le quife
complex, and requires a level of lnowledge
in ifs policies and regulafions, specifically
regarding ifs reimLursemenf sysfem," says
Greene.
LEARNING FROM DOING
One person wifh plenfy of experience of doing
Lusiness in fhe German healfhcare sysfem is
Cafhal O`Donnell. He was previously MD of
Irish company BMR/Neurofech in Germany,
sfarfing fhere in fhe lafe 1os. Ve grew
fhe company in Germany from zero up fo a
company fhaf has jo per cenf marlef share in
fhis marlef for pain fherapy and rehaL devices,"
says O`Donnell.
Ve worled wifh ;j per cenf of all
privafe pracfice orfhopaedic surgeons and a
significanf percenfage of fhe gynaecologisfs
as well wifh up fo j fo 1oo per cenf of fhe
insurance companies. Ve were freafing
in excess of oo,ooo pafienfs in Germany
every year." Today, he has a Konsfanz
Lased consulfancy, Valdon Healfhcare, and
specialises in reimLursemenf for healfhcare
producfs.
Healfh is a huge Lusiness in Germany,"
says O`Donnell. One in seven people worl
in fhe healfh secfor in Germany, and fhere are
aLouf zoo,ooo people worling in fhe medfech
secfor here. ALouf 6o per cenf of fhe producf
would Le exporfed."
One of fhe leys fo Germany`s success is
fhaf if has a roLusf medical device marlef of
ifs own reimLursemenf is availaLle and fhe
populafion is ageing. The marlef is growing
here af fve per cenf across all secfors," says
O`Donnell. Unemploymenf is down fo Lelow
seven per cenf, fhe lowesf since reunifcafion,
Germany is one of the biggest market in the world for
medical technology. Claire OConnell looks at what Irish
companies need to know to establish a presence there.
SIZING UP GERMANY
FOR MEDTECH
046
THE MARKET | SUMMER 2012
GERMANY: MEDICAL TECHNOLOGY
and fhaf enaLles a lof of funds fo go info fhe
healfh insurance coffers fo pay for new and
innovafive producfs going fhrough. If we were
fo descriLe fhe German medical device secfor
af fhe momenf, if`s sfrong Lecause you have a
good marlef here and Lecause fhe insurance
companies are sfill paying for fhe producf."
Midsized companies rule fhe roosf" in
fhe medfech space in Germany, according fo
O`Donnell, and fhe secfor has held up well
during fhe recession. New legislafion has Leen
infroduced fo help move innovafive producfs
fasfer fhrough fhe sysfem and healfh reforms
are ongoing. Plus while fhere are around 1jo
healfh insurers in Germany foday, fhaf fgure
has come down from more fhan |oo in zooo.
However, German companies are
sfruggling wifh fhe frends of falling
reimLursemenf and rising volumes, nofes
O`Donnell. You have an increased demand for
care, increased demand of volume of fve per
cenf and fhe eroding prices you are running
harder fo sfand sfill from a proff poinf of view."
GETTING IN
Irish companies should Le aware fhaf fhere
are differenf suLsecfors in fhe marlef home
use producfs, hospifalLased producfs and
professional producfs for privafe pracfice and
each has a reasonaLly well defned pafh for
enfry, says O`Donnell.
If you wanf fo Lring your producf info fhe
home use, you need fo go via a medical device
regisfer (Hilfsmiffelverzeichnis or HMV),"
he explains. And for home use, wifh fhe CE
marl and clinical dafa gafhered you are falling
Lefween fhree and six monfhs if you do if well."
If you are Lringing a new hospifalLased
producf fo fhe marlef, you need fo esfaLlish
where fhe producf ffs in among fhe 'diagnosis
relafed groupings` or DRGs, which cover in
pafienf services and devices. New freafmenfs
need fo Le assessed Lefore Leing emLedded in
a DRG and fhis can fale up fo fhree years in
some cases. Meanwhile, for privafe pracfices,
you need fo defermine how fhe producf ffs
info fhe EBM (or uniform value scale) code,
says O`Donnell, poinfing ouf fhaf fhe privafe
pracfice landscape in Germany is quife differenf
fo fhaf of Ireland.
There are more fhan 1oo,ooo privafe
pracfices here. A fown of fhe size of Afhlone in
Germany could have four or fve orfhopaedic
surgeons, one or fwo neurologisfs and mayLe 1o
privafe pracfice gynaecologisfs," he says. You
need fo fnd fhe end marlef and undersfand
why a professional docfor mighf pay co,ooo
for fhaf piece of equipmenf fhaf gives a
compefifive advanfage."
And across fhe secfor, innovafion is a
driver, he adds. If you are Lringing ouf purely
a generic producf you can`f expecf fo see a
large adopfion Lecause fhe pricing is already
very compefifive. You need fo Le looling af
innovafive and disrupfive fechnologies, if needs
fo have somefhing special."
047
SUMMER 2012 | THE MARKET
GERMANY: MEDICAL TECHNOLOGY
REIMBURSEMENT - FORTUNE FAVOURS
THE PREPARED
One of fhe ley piffalls awaifing fhe unprepared
is fhe area of reimLursemenf, according fo
O`Donnell. You can gef a CE marl fairly quiclly
once you have your QMS sysfems in place and
carried ouf your risl managemenf, Luf if you
don`f have a reimLursemenf sfrafegy in place,
you could Le siffing fwiddling your fhumLs for
anofher fwo or fhree years," he says.
If`s lile a second CE marl, and wifhouf
fhaf second CE marl you will nof Le aLle fo
sell effecfively info a lof of differenf counfries."
Vaifing fo cross fhaf Lridge when you come fo
if could incur delays fhaf spell fhe difference
Lefween leading fhe marlef and losing if, and
O`Donnell sfresses fhe need fo prepare for fhe
reimLursemenf sysfem early.
Vhen someone has a profofype of
fheir producf fhey should already have a
reimLursemenf sfrafegy wriffen," he says. And
if someone in fhe medfech secfor in Ireland is
developing a producf, fhen for me Enferprise
Ireland would Le an early porf of call."
More generally, he advises fhaf companies
should expecf year on year price erosion due
fo fhe normal marlef forces. Buf despife fhe
hurdles of regulafion and reimLursemenf,
O`Donnell argues fhaf if you do if righf, if`s
worfh doing. If`s a greaf marlef fo Le in, and if
you did nofhing else Luf creafe a clear roadway
in Germany, you would Le doing your company
a favour."
GETTING READY
Many Irish companies have already made
fhaf leap and anofher currenfly looling fo fhe
German marlef is MifaMed. The spinouf from
fhe Corl Cancer Research Cenfre is developing
a new device, currenfly in human frials, for
freafing colorecfal cancer. By encouraging
fumours fo fale up anficancer drugs more
readily, fhe aim is fo male freafmenf easier and
improve pafienf oufcome.
Ve are a sfarfup, and need supporf for
marlef access and reimLursemenf in fhe
German marlef," says company cofounder Dr
Declan Soden. And we are fnding fhe supporf
and experfise very useful as we prepare a
roadmap for enfering fhis marlef."
MifaMed`s device should Le assessed
fhrough a mechanism for innovafive producfs,
and Soden anficipafes fhaf if will fale around
four fo six monfhs Lefween applicafion and
approval for reimLursemenf.
For any ofher Irish medfech company
fhaf`s eyeing up fhe opporfunifies in Germany,
}ane Greene from Enferprise Ireland offers
fhese fips: Research your marlef, undersfand
who your compefifors are Lofh locally and
infernafionally, undersfand your USP [unique
selling posifion|, acquainf yourself wifh fhe
Medical Device ReimLursemenf sysfem and
plan accordingly."
For more informafion confacf }ane Greene af
}ane.Greene_enferpriseireland.com
Its a great market to be in, and if you did
nothing else but create a clear roadway in
Germany, you would be doing your company a
favour.