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Asia gears up for its own medtech boom

The global market for medical devices reached a value of $215 billion in 2010, estimates consultant Frost & Sullivan (Mountain View, CA), but despite Asia accounting for more than half the world’s population, it only accounts for less than 24% of device usage.

February 10, 2011

5 Min Read
Asia gears up for its own medtech boom


Moving forward, however, rising living and healthcare standards are expected to boost demand for medical devices by more than 10% annually in the region. Long reliant on imports from Europe, the U.S., and Japan, developing Asia has signaled its intent to play a greater role in medical device manufacture, with companies in countries including China, Singapore, and Malaysia enjoying strong government support in their efforts to make their marks on the medical device map.

In 2009, Malaysia saw total investment of around $210 million in medical device manufacturing projects, with domestic investment increasing by 45% and foreign investment by 55%, according to Hitendra Joshi, board member and secretary of the Assn. of Malaysian Medical Industries (AMMI). “But what we’ve seen in the first seven months of 2010 is investment skyrocket to $445 million, which represents 8.4% of overall investment in Malaysia’s manufacturing sector,” he said. Joshi was speaking at the December Medtec Southeast Asia conference organized by PlasticsToday.com’s parent company UBM Canon.

Malaysia is currently home to 180 small- to large-scale medical device players with estimated export revenue of $2.8 billion. What’s noteworthy, however, is that a high proportion of total output, and of that revenue, is accounted for by latex gloves. Malaysia’s challenge now is to move into the manufacture of higher added-value devices, the kind that also tend to employ plastics extensively.

Recent entries into local manufacture in Malaysia include St. Jude Medical (pacemakers) and Jabil Green Point (continuous monitoring devices). Device clusters are forming in the Penang-South Kedah-North Perak region and the Klang Valley. The island of Penang was formerly known as Malaysia’s Silicon Island but much of this electronics production has since shifted to China. Local processors are retooling, however, to take advantage of the medical boom.

Singapore’s device hub
The companies in neighboring Singapore, meanwhile, continue to increase their output of medical and diagnostic devices. In the past decade, Singapore’s medtech manufacturing output has doubled from around $1.15 billion to more than $2.3 billion. “Leading manufacturers in Singapore now produce more than 50% of the world’s microarrays, half of the world’s thermal cyclers, and 10% of the world’s contact lenses,” said Beh Kian Teik, director, Biomedical Sciences Group, at Singapore’s Economic Development Board (EDB). Thermal cyclers are laboratory apparatus otherwise known as DNA amplifiers. In the microarray segment, meanwhile, processors are actively promoting the use of resins such as PP, PC, and cyclic olefin copolymer (COC) to replace glass.

In medical manufacturing, Singapore has also launched the Partnerships for Capability Transformation (PACT) program and the MedTech Manufacturing Consortium to facilitate partnerships between OEMs and suppliers, many of which are plastics processors.
Global medical device majors are also becoming more amenable to sourcing components from Asia. For example, heart valve manufacturer Edwards Lifesciences has boosted annual sourcing from Asia from just $50,000 in 2008 to $11 million in 2010.

Speaking at Medtec Southeast Asia regarding its supplier selection criteria, Au Yong Leong Kiat, Edwards’ Asia procurement office manager, said, “While ISO 13485 [medical device] certification certainly helps, we are still willing to explore using noncertified companies if they are willing to upgrade their quality control.” Edwards Lifesciences also allows a single supplier to source up to 20% of its overall sales from the company, but no more than this. “We also prefer to involve our suppliers in the front end of development to a large extent,” added Au Yong.

At the Medtec Southeast Asia conference, Jackelyn Rodriguez, president of consulting and training firm Monarch Quality Systems Solutions (Marlton, NJ), cited the importance of supplier audits in ensuring that medical devices perform as they are intended. “Supplier audits need to be conducted thoroughly and efficiently and proper documentation kept because if problems arise, the FDA will target the device OEM and not its suppliers,” she noted.

The FDA has found in inspectional observations that standard operating procedures at some device manufacturers do not include criteria for determining the level of supplier qualification required, procedures for ensuring that appropriate suppliers are placed on the Approved Supplier List, and procedures for disqualifying suppliers from the Approved Supplier List.

The FDA has also sometimes found that supplier lists do not indicate that any supplier audits have been conducted and that no documentation was presented to represent any audits were performed. Recent adverse events and failed products, and even deaths, in many cases have been linked to inappropriate change controls, qualification of materials, and validation programs in the supplier chain.

Fabrication focus
Medtec Southeast Asia also focused heavily on processing technologies for fabricating medical devices, such as precision machining employed to manufacture precision spinal cages for fusing vertebrae. Tornos SA (Moutier, Switzerland) manufactures high-precision CNC sliding headstock automatic lathes specifically designed for machining PEEK resin.

“Machining must be carried out dry [neither oil or emulsion] with the coolant replaced with chilled compressed air directed at the different cutting areas,” said Darren Way, applications manager at Tornos’ Thailand representative office. “Lubricants for the lathe must be vegetable-based.” A PEEK spinal cage typically can be machined in 5-10 minutes, including automatic insertion of tantalum pins and marker beads for X-ray visibility.

Laser sintering, meanwhile, is being employed by Hettich Zentrifugen in the washing rotor of an automatic cell-washing system for serological testing. The device maker fabricates the rotor from a laser-sinterable polyamide grade using an Eosint P 380 machine from Electro Optical Systems (EOS; Krailling, Germany). The PA 2200 grade has also been employed for fabricating customized prostheses. Furthermore, EOS is participating in the EU’s FP6 (Framework-Program 6) project called Custom-IMD, where one of the objectives is to develop customized implants fabricated from PEEK resin.

In the materials sector, the fallout over BPA is having some influence on the use of polycarbonate in medical devices, according to Thomas Wiles, head of industry management, healthcare and diagnostics, in the Styrenics Europe business of BASF (Ludwigshafen, Germany). “We have seen some medical device manufacturers move away from polycarbonate and look towards MABS as an alternative,” he noted. The company’s Terlux 2812 HD MABS (methyl methacrylate-acrylonitrile-butadiene-styrene copolymer) is a transparent ABS that it says has superior processability and resistance to chemicals and environmental stress cracking. MABS can also be electron-beam-sterilized. —Stephen Moore

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