Earning the trust of foreign and local
medical institutions
TRUST is a big
word in the medical devices industry it has the power to make or break a
manufacturer's business anywhere.
A local
manufacturer who wants to break into the international market will have
standards to live up to in order to attract foreign buyers and there have been
some local success stories.
“Different markets
respond to different standards,” says Vigilenz Medical Devices Sdn Bhd
managing director Shudipta Choudhury,
quoting from experience.
“For medical
devices, the standards that are most significant comes from the United States
Pharmacopeia or the European Pharmacopeia,” he says.
“However, most
advanced markets will have their own entry barriers through product registration
requirements for sale in-country and through the regulatory bodies.”
The “barriers”
that Choudhury refers to include the US Food and Drug Administration (FDA), the
European Conformity (CE) marking, the Canadian Medical Devices Conformity
Assessment System, the Pharmaceutical Affairs Law in Japan and the Therapeutic
Goods Administration in Australia.
He told StarBiz
that while there are country and agency peculiarities on the required
in-country standards, there is a drive to harmonise the standards globally now
so that the standards will largely be the same, with exception for some local
requirements in some countries.
In Malaysia, the
Medical Device Bureau under the Health Ministry is the body that regulates
medical devices.
While companies
are looking beyond their local shores, the irony is that Malaysian players are
getting the sceptical squint from local buyers.
UWC Healthcare Sdn Bhd operating manager
Jason Ng says there is a lack of sufficient medical device
expertise in the Malaysian market, resulting in government hospitals preferring
to buy overseas brands instead of local products.
“This happens even
when the quality is the same and local products are cheaper,” he says.
“Nowadays, a lot of China and India medical devices are offered at a better
price but without guarantee on the quality. The brand or manufacturer could
disappear when some serious issues happen,” he adds.
Acknowledging the
effortsmade by the Economic Transformation Programme (ETP), Ng says that the
relevant authorities still need to look into the matter seriously and review
the tax structure to make local manufacturers competitive.
Ng says a number
of factors need to be addressed to accelerate industry growth. One factor that
affects the industry is the lack of medical devices innovation and support such
as pro-local product procurement policies in both the public and private
sectors.
“There is also no
sufficient incentives to attract and retain local players, as well as a lack of
harmonisation internally and externally with other jurisdictions, and no clear
national strategy for the sector,” he notes.
The ETP healthcare National Key Economic Area (NKEA) associate director
Fabian Bigar reveals that the problem of getting local buyers is
not new to the industry but he believes it is not insurmountable.
“We were told
that the biggest problem is the preference for foreign branded products over
locally-made quality products. I believe that over time this can be overcome,
as long as local manufacturers can demonstrate that their products meet quality
and safety standards and have access to the local markets.”
“It doesn't make
sense when local products are exported to Europe with CE marking and registered
with FDA, but cannot access local markets because users prefer foreign brands,”
he says.
Bigar adds that Pemandu (the Performance Management and Delivery Unit under the Prime Minister's
Department) has been working on incentivising the sector. It has organised an
NKEA lab specifically for medical devices last year, bringing together industry
players and government agencies.
He says one incentive
for local players to go global is via an “off-take agreement policy”. “(That
means) they can enter a procurement agreement with the Government for a
specific period and this can be extended should the players are able to prove
they can register the products abroad and export them,” he explains.
The Health
Ministry has agreed to the proposal and is now drafting the mechanism for
implementation.
Other than
governmental initiatives, Choudhury says that the sector itself should also
push matters. He notes that the Government has made efforts to develop this
industry, and for him, the most significant has been the formation of the
Medical Devices Authority (MDA).
“The task before
the MDA is quite daunting, but I am sure it has very capable people manning the
fort. The industry itself has largely been the preserve of the multinational
companies having their production bases here.”
He adds that the
only significant local medical devices players enjoying a global reputation are
the rubber glove makers.
“Today they still
are the most significant exporters of Malaysian medical products globally and
this certainly was not achieved in two years. There is already a group of
committed companies under the healthcare NKEA for medical devices charting a
growth path from here to 2020.”
Choudhury hopes
that the group will get the required support to succeed as the impact is
expected to be very significant for the industry. Besides that, there are also
many local institutions getting into research and development work in medical
devices.
“Of course we
need to do more. The Government can only do so much. We should see more big
private sector initiatives, even some governtment-link companies should ramp up
their involvement in this industry especially manufacturing initiatives.
“I wish also to
see more local practitioners coming out as inventor of devices and then have
local companies produce for global consumption. Let the cycle begin.”
Source : The
Star
Date : 25 July
2012
afternoon highlight
(26/07/12/132/606)
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