sirimlink, issue #2, 2012 - sirim-qas.com.my · pdf filesirimlink laboratory conundrum ......

Supporting Malaysia’s burgeoning medical technology industry

Driving innovation through technology and quality

116-MG-125-08-2012:GN PP 10002/05/2010(024916)

INSIDE

Vol. 2, 2012

•Metrologyandmedicaldevices

•Chitosaninwoundmanagement

•MedicalimplantswithMicro-MetalInjectionMoulding

SIRIMLink

LABORATORY CONUNDRUMImprovingdiagnosticsthroughmetrology

THE TRANsfORMERDrZainalAbidinisthenewbossatSIRIM

THE CHiTOpRACTORsChitosaninadvancedwoundmanagement

A DOsE Of sTANDARDsNewstandardsandregulationsformedicaldevices

ADVisORDr. Zainal Abidin Mohd Yusof

CHAiRpERsONTn. Hj. Nor Rashid Ismail

MEMBERsNoraini KassimRaja Yahya Raja AriffinAbdul Aziz LongDr. Abd Rahim SaadPn. Futom Shikh JaafarDr. Neelam ShahabDr. Kartini NoorsalMohd Ghazali Mohd YunosAzman HassanSalmah Mohd NordinZanariyah AliInderjeet Singh a/l Sohan Singh

Abd Halim YacobRuhil Amani Zainal AbidinNurazlina Ismail

published and printed by:SIRIM Berhad1, Persiaran Dato’ MenteriSection 2, P.O. Box 703540700 Shah Alam, Selangor.Toll Free: 1300 88 7035 Tel: 603 5544 6000Fax: 603 5510 8095

Writing, design and concept:Marcus Gomez & Partners Sdn BhdNo. 27, Jalan SS2/2,47300 Petaling Jaya, Selangor,MALAYSIA.www.marcusgomez.com

SIRIMLink is an official publication of SIRIM Berhad. The bulletin is distributed free to our clients, associates, business and research establishments. Copyright © SIRIM Berhad. Some images and artwork from iStockphoto, BigStockPhoto and other independent artists.

For further information on the articles featured in this magazine, please contact:

Corporate Communications section Group Corporate Affairs DepartmentSIRIM Berhad1, Persiaran Dato’ Menteri Section 2, P.O. Box 703540700 Shah Alam, Selangor Tel: 603 5544 6770Fax: 603 5544 6745Or email to: [email protected]

SIRIMLink

1siRiMLink 02/2012

Doctors can sometimes get a bad name for the wrong reasons.

Much of the medical profession today relies on highly-sophisticated diagnostic tools and devices in order to pronounce diagnoses. Some of these devices test for chemicals, such as pregnancy tests and glucose tests, while others offer a glimpse into the inner workings of the human body, such as x-ray machines and Magnetic Resonance Imaging (MRI) devices. If these devices do not perform as expected, there is a much greater chance of misdiagnosis.

There is obviously a lot is at stake in the field of medical technology, which is what makes the introduction of the Medical Devices Act 2012 (Act 757) so timely. The new law is aligned to international regulations and aims to raise the standards of medical devices provision and maintenance throughout the supply chain, and in doing so, reduce the risk of patients, hospitals and medical practitioners from untoward misdiagnoses.

Meeting the demanding requirements of the new law and its related regulations will be a challenge to local medical devices manufacturers and traders. As always, however, SIRIM has been working behind the scenes to help businesses improve their products and standards ahead of the enforcement deadline. This issue highlights these efforts as well as some of SIRIM’s own research breakthroughs in medical technology.

We hope you enjoy the issue.

THE RIGHT MEDICINE

Nor Rashid Ismail Vice President Corporate Division

EDiTOR’s NOTE

http://www.marcusgomez.com

NEWS & EVENTS ...04AstrategicalliancewithAgensiInovasiMalaysiatobringinnovationstomarket;ahaulof fivegoldandfoursilverawardsatthethe23rdInternationalInvention,Innovation&TechnologyExhibition(ITEX2012);electricityinaLubokAntulonghouse;anMoUwiththeShahAlamCityCouncilforimplementingaTQMprogramme.

INSIGHT ...10Dr Zainal Abidin Mohd Yusof,thenewPresidentandChief Executiveof SIRIMBerhad,intendstotransformthecompanyintoatotalsolutionsproviderinresearchanddevelopment,testingandcertification.

RESEARCH & DEVELOPMENT ...14LABORATORY CONUNDRUM

Diagnostictestresultsconductedbyautomatedinstrumentsfrequentlydifferdependingonthedevicemanufacturerorprocedureused,leadingtounderdiagnosis,overdiagnosisandevenmisdiagnosis.Regulators,doctorsandmetrologistsareworkingtogethertoresolvethispredicament.

THE CHiTOpRACTORs

ResearchersatSIRIMhavedevelopedaskinregenerationsystembasedonthewonderpolysaccharidechitosanthatallowswoundstohealinsideout.

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CONTeNTSDR. siRiM: sUppORTiNg MALAYsiA’s BURgEONiNg MEDiCAL TECHNOLOgY iNDUsTRY

VOL. 2, 2012

STANDARDS & QUALITY ...26A DOsE Of sTANDARDs

Malaysiaissettobecomearegionalhubformedicaldevicesandequipmentby2020,atwhichtimetheindustrywillberakinginRM17billioninrevenueannuallywhilecreating86,000employmentopportunities.SIRIMisworkinghardatdevelopingthenecessarystandardstosupporttheregulatoryframeworkthatwillhelpthecountryachievethisgoal.

INNOVATION HIGHLIGHTS ...24MAN Of sTEEL

SIRIMisamongthefirstcompaniesintheworldtopioneertheusemetalinjectionmouldingformanufacturingstainlesssteelsurgicalimplants.

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Thanks to advances in metal injection moulding (MIM) technology, it is now possible to make very small medical implants with extremely intricate details. See page 24

A S pARt of ItS strategy to implement the national innovation agenda, SIRIM and 26 other universities,

research institutions and businesses joined together with Agensi Inovasi Malaysia (AIM) in signing a strategic alliance agreement to set up the National technology Commercialisation office (NtCo).

The signing, which took place at the official launch ceremony for the Innovating Malaysia Expo on 27 June 2012, was witnessed by prime Minister Datuk Seri Mohd Najib Razak. SIRIM Berhad was represented by Dr Zainal Abidin Mohd Yusof, its president and Chief Executive. The agreement is intended to strengthen the collaboration between academia, industry, the government and the public in the areas of innovation and invention. The other participating universities and research institutes were Universiti Malaya, AIMSt University, Construction Research Institute of Malaysia and Halal Development Corporation.

Agensi Inovasi Malaysia is a statutory body set up by the Government via AIM Act 2010, with the primary purpose of being the driving force behind Malaysia’s push towards establishing an “innovation economy” and the

country’s aspirations of achieving a high-income nation status. AIM’s role in the national innovation agenda has been to help Malaysian innovators to find commercial applications for their inventions by connecting them with businesses and entrepreneurs.

traditionally, the drivers of economic growth and wealth creation lay in the domain of land, labour and capital. Malaysia began as a factor-driven economy entrenched in agriculture and mining and then moved on to an investment-driven economy focusing on manufacturing, banking and real estate. today, the focus has shifted to an innovation and knowledge-driven economy to ensure that the country remains ahead of the competition.

The NtCo will assist universities and public research

institutes in commercialising their innovations, while also serving as a central collection point for innovations with commercial potential. Investors can make use of the NtCo’s consolidated library of innovations to find the right innovative solution to bring to the market. The NtCo represents a new, more structured and uniform approach to the commercialisation of intellectual property in Malaysia. This will enable innovators and entrepreneurs alike to commercialise technologies more efficiently in a supportive ecosystem.

The objectives and mandate of Agensi Inovasi Malaysia are closely aligned to those of SIRIM, which has always been a champion of innovation and quality. With this agreement, businesses will be able to more easily tap into SIRIM’s knowledgebase and expertise.

SIRIMentersstrategicalliancewithAgensiInovasiMalaysia(AIM)StrategicAllianceAgreementontheNationalTechnologyCommercialisationOffice(NTCO)willbringinnovationstomarket

Dr Zainal Abidin, President and Chief Executive of SIRIM Berhad along with other representatives signing the agreement at the Innovating Malaysia Expo.

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NEWs

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T HE SIRIM pRoJECt “Innovative Method for producing Biomedical Components” successfully captured both the Best Asia

Award and a gold award at the 23rd International Invention, Innovation & technology Exhibition (ItEX 2012). The two awards for the project were part of a remarkable series of wins for SIRIM at the event, which was held at the Kuala Lumpur Convention Centre from 17 to 19 May, 2012.

SIRIM has been a regular participant in ItEX ever since its inception. Several of its award-winning innovations have since been successfully commercialised by private entrepreneurs. This year, every one of SIRIM’s nine participating inventions received awards in recognition of their innovative achievements.

An outstAnding medAl tAlly

Altogether, SIRIM’s projects won five gold awards, four silver awards, Best Asia Award, IfIA Laureate Award for Excellence Invention as well as awards for Best Woman Invention, Best Green Invention and Best Invention. In addition, SIRIM’s attractive booth won the bronze award for Best Booth Design for the category of exhibition spaces of 54 sq metres and below.

Best Asia Award and gold award: “Innovative Method for Producing Biomedical Components”

The winning team of researchers led by Noorsyakirah Abdullah successfully invented an improved and cost-effective method for producing fracture fixation plates that are compatible with living bodies and possess excellent mechanical strength. The project has blazed a trail for the rapid manufacturing of biomedical components in Malaysia and may soon enter the pilot stage. Noorsyakirah Abdullah also won the WIpo Award for Best Woman Invention at ItEX 2012.

Best Green Invention, the IFIA Laureate Award for Excellence Invention, ITEX Best Invention and gold award: “Producing Maxillofacial Implants of Titanium Alloy (Ti6A14V) Through Metal Injection Molding Using Palm Oil Based Binder System”

Dr Rosdi Ibrahim led this project, w h i c h f o c u s e s on the use

of palm oil stearin as a binder system for titanium alloy powder in the Metal Injection Molding process (MIM) to produce maxillofacial implants. Because it enables the process to use palm oil stearin as a basis for the binder, it runs on a more sustainable resource base, making it an important green solution for the MIM process. ItEX recognised its green potential with the Best Green Invention Award.

Gold award: “A Green Technology Carbothermal Reduction (GTCRP) Process for Synthesizing Nanostructured Silicon Carbide using Structured Alteration Local Silica Sand”

This project was recognised for achieving an economical process for forming silicon carbide whiskers and particulates at 1650°C, compared to traditional

SIRIMstrikesgoldandwinsBestAsiaAwardatITEX2012Allnineparticipating inventions fromSIRIMrecognisedwithawardsatthepremierexhibitionforinnovation,whichincludefivegoldawardsandfoursilverawards

Ms. fiX-iT: Noorsyakirah Abdullah (right) and Nurazilah Mohd Zainon (left) showing off the invention which won the Best Asia Award as well as the WIPO Award for Best Woman Invention.

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NEWs

AND THE WiNNERs ARE: (From left) Noorsyakirah Abdullah, Mohd Bakri Mohd Hijazi, Mohd Zakuan Abdullah, Bakar Meh, Abdul Hakim Hashim, Dr. Mohd Afian Omar, Mohd Nizam Abdul Jalil, Ahmad Zahid Omar, Norlida Johari.

synthesis methods, which require a much higher process temperature of 2400°C for the reaction to be feasible. Silicon carbide whiskers and particulates are widely used in heavy-duty cutting machinery in the automotive and construction sectors.

Gold award: “SIRIM RoboKit – An Innovative Platform for Educational Learning and Teaching in Robotic Application”

ItEX recognised the SIRIM RoboKit project with a gold award for developing an educational toolkit that engages students and teaches them about electronics, robotics and computer programming. The RoboKit is an ideal tool for cultivating creative and innovative thinking along with an interest in science, mathematics and information and communication technology (ICt) in Malaysian students.

Gold award: “Design and Development of the 4-Axis, 3-Spindle Filament Winding Machine”

The technology of filament winding is used for applications in defence and aerospace manufacturing such as missile casings, nose cones and fuselage structures. The filament winding machines developed in this project are computer numerically controlled (CNC) devices that use automation and computer controlled components to create specific components composed of continuous strands of carbon fibre, which is widely used in high performance automotive and aerospace applications as well as pressure vessels. The invention provides Malaysia with a local source of filament winding machines so that local manufacturers can become less reliant on imported equipment.

Silver awards

The other four SIRIM inventions at ItEX 2012 were:

• Multimedia Self-Reliant toolkit System on Quality Management System”

• powder Metallurgy WC tool Insert for High performance and Dry Machining

• Intelligent file Retrieval System

• Solar Detoxification System (Solar Detox)

Although the gold medal winners were the highlights of the event, each of the above projects received a silver award in recognition of their contribution to innovation and invention. Congratulations to the winners!

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L oCAtED DEEp WItHIN the interior of Sarawak, 275km from Kuching, Kg Sri Stamang 2 is accessible only by boat,

and has had to rely on a diesel generator for electricity – until recently. on 8 June 2012, the community upgraded to a 24-hour free electricity supply, thanks to an 18.3kW micro-hydro system commissioned by SIRIM Berhad.

Datuk Hj fadillah Yusof, Deputy Minister of Science, technology and Innovation, was on hand at the longhouse for the handing-over of the micro-hydro project. The project, which costs about RM1 million, was funded by the Community Innovation fund under the Ministry of Science, technology and Innovation (MoStI).

“This project initially began in 2009, when the government identified that the community of Sunok Longhouse were still left behind in terms of enjoying all-day electricity supply, as other Malaysians do,” said Datuk Hj fadillah Yusof in his speech. He added: “SIRIM Berhad, an agency under MoStI, was given the responsibility in commissioning the 24-hour electricity power supply to replace the diesel generator.”

He praised SIRIM for overcoming all difficulties and

challenges in its work on the system, as Sunok Longhouse is quite remotely located. He further announced an additional budget of RM41K for electrical wiring in the long house.

Located about one kilometre west of Kg Sri Stamang 2 Longhouse, the micro-hydro project in Sungai Ubo was initiated by SIRIM Berhad with the assistance of its technology partner, Cihanjuang Inti technik from Indonesia. The project involved the provision of a micro-hydro system consisting of civil and structural works, electro-mechanical equipment and a low voltage transmission and distribution network.

According to SIRIM president and Chief Executive Dr Zainal Abidin Mohd Yusof, the project has achieved its target of supplying

electricity supply to Kg Sri Stamang 2. Now, this community of 40 households will be able to enjoy uninterrupted electricity to run its rice thresher equipment and a future rice hulling machine. A nearby clinic complex, including a clinic building, four residential quarters and two guest quarters, will also benefit from the electricity supplied by the micro-hydro system. The existing diesel engine generator set is now reconfigured as a standby system in case of supply interruption due to maintenance or unexpected breakdown.

Dr Zainal Abidin explained that the local community was involved in the project since the early stages of construction. Three villagers were trained in running the micro-hydro system and performing maintenance on the cross-flow t15 turbine and other related machinery.

LubokAntulonghousecommunitygetsfreeelectricitythankstoMOSTIandSIRIMMOSTI’sCommunityInnovationFundfundsamicro-hydropowersystemforKgSriStamang2households

The local community waits for the micro-hydro system to be powered up.

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NEWs

S IRIM Berhad, through its subsidiary SIRIM training Services Sdn Bhd, will implement a quality improvement

programme following the total Quality fast track Model (tQftM) for the Shah Alam City Council (MBSA), according to a Memorandum of Understanding (MoU) signed on 16 July 2012 in Shah Alam. The MoU specifies that SIRIM will provide training and guidance services to MBSA in order to help the council in achieving SIRIM total Quality Management (tQM) accreditation by November 2012.

SIRIM was represented at the signing by Dr Zainal Abidin Mohd Yusof, its president and Chief Executive. Dr Zainal also serves as Chairman of SIRIM training. Meanwhile, MBSA was represented by Dato’ Hj Mohd Jaafar bin Hj

Mohd Atan, the Mayor of Shah Alam.

The programme, which has been active since January, involves the following services from SIRIM:

• providing guidance on total Quality Management, concept and principle requirements for all parties involved in tasks pertaining to quality, including management, officers and staff of the organisation as well as the quality management committee.

• providing training and guidance in developing a tQM plan.

• Negotiating the implementation of programmes based on the tQM plan.

• providing training and guidance in modules suited to MBSA’s business processes, which include topics such as Strategic Management, Benchmarking, Innovative and Creative Groups and Customer Service Evaluation.

• providing guidance in fulfilling SIRIM tQM accreditation criteria and creating a culture of quality at MBSA.

The programme is expected to raise the quality of service and performance from MBSA employees in line with the expectations of the organisation’s customers, the residents of Shah Alam.

The SIRIM tQM Certification based on tQftM was launched in 2010. It starts with the “5S” Japanese Housekeeping improvement model of Seiri (organisation), Seiton (orderliness), Seiso (Cleanliness)Seiketsu (Standardisation) and Shitsuke (Sustenance) before moving to standards-based management and continuous quality improvement. It is aimed at helping organisations to implement quality programmes that can help boost their competitiveness within their industries.

SIRIMsignsMoUwithShahAlamCityCouncilforimplementingTQMprogrammeNovember2012setas target foraccreditationaccordingtotheTotalQualityFastTrackModel(TQ

FTM)

Dr Zainal Abidin, President and Chief Executive of SIRIM Berhad signing the MoU with Dato’ Hj Mohd Jaafar bin Hj Mohd Atan, Mayor of Shah Alam.

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NEWs

THE TR ANSFORMER

The new President and Chief Executive of SIRIM Berhad Dr Zainal Abidin Mohd Yusof intends to transform the company into a total solutions

provider in research and development, testing and certification.

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DESpItE BEING one of the country’s most c e l e b r a t e d microbiologists,

Dr Zainal Abidin is a humble man. But as the new president and Chief Executive of SIRIM Berhad, his plans are anything but modest. In fact, he intends to transform SIRIM into a premier R&D institution that provides total solutions to its stakeholders, from government agencies to businesses to end-users.

the challenge, as always, will be with changing mind-sets. the archetypal scientist traditionally specialises on a single, narrow field of research which he or she studies to its depths. for Dr Zainal Abidin, that field has always been industrial biotechnology. But Dr Zainal Abidin has seen the business of research and development evolve over the past couple of decades, and he believes that scientists today must be prepared to take off their blinders and to participate in activities outside their area of specialisation.

“Gone are the days when researchers could concentrate on their own narrow disciplines and ignore everyone else,” says Dr Zainal Abidin. “R&D today is a lot more multi-disciplinary. Mechanical engineers, chemical engineers and product designers have to work side-by-side to innovate total solutions that are ready to be commercialised right off the shelf.”

Having been actively involved in research and development for over 30 years, Dr Zainal Abidin knows what he is talking about. the usual laboratory innovation

is understandable only to a select few – a new way to process environmental data, for example, or a new system for creating stronger materials. But such innovations have to be translated into tangible products or services before investors are able to get excited about their potential. turning a successful lab experiment into a viable business opportunity invariably calls for other specialist knowledge in building machinery, designing production processes and organising supply chains.

the traditional model for commercialising innovations has always been licensing: if a company likes a technology and what it can do, it can license it from the R&D institute for a fee. the R&D institute does not get involved in the actual business itself or how the company sells the product or uses the technology. Most automobiles and electronic gadgets are built by brands that licence one or more different technologies from other organisations. the simplest example in recent times would be proton’s licensing of Mitsubishi and Renault engines.

that is what SIRIM intends to do with its innovations: turn them into ready-to-licence products.

Dr Zainal Abidin points to the many niche innovations that SIRIM itself has produced over the years but which have failed to attract commercial interest because they are still only understandable to a handful of researchers and staff. these innovations are like single jigsaw pieces that belong in much larger jigsaw puzzles, and many more jigsaw pieces need to be built before the final result may be seen. turning these innovations into real products will therefore require deeper and more meaningful cooperation among researchers across several disciplines.

self-sustAining pArtner

Nowhere is this truer than at SIRIM, which was founded to drive industrial R&D. The company is vital for assisting technological innovation towards supporting national economic growth, and is generally more accessible to businesses than other R&D centres such as those at universities. This is especially true for small and medium enterprises that require total solutions encompassing R&D, testing and certification.

“SIRIM has the equipment and knowledge that SMEs need to develop new products,” explains Dr Zainal Abidin. “SMEs generally cannot afford to purchase such equipment or expertise themselves.”

Clients that engage SIRIM as technical partners can also leverage SIRIM’s expertise in developing standards. In fact, many industry players want SIRIM to go beyond harmonising standards and to play a more consultative role

“gone are the days when researchers could concentrate

on their own narrow disciplines

and ignore everyone else.”

TRANsfORMiNg siRiM

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in the application of local and international standards.

“SIRIM needs to focus and lead the industry,” says Dr Zainal Abidin. “We have a very wide breadth of services, but these services must also be able to provide the depth of expertise the market demands. We are expected to spearhead industry technological development.”

to this end, all of SIRIM’s activities will now be aligned to its three flagships: energy and the environment, medical technology and plant and machinery. the three flagships are all key focus areas under the government’s Economic transformation programme, and the company’s research, standards development and quality improvement services will all be geared towards addressing industry’s needs within each of these areas.

“We are the country’s primary centre of innovation,” explains Dr Zainal Abidin. “the private and public sector looks to us to come up with solutions that will address the country’s challenges in these areas.”

SIRIM is one of only a handful of corporatised government agencies that has consistently given stakeholders returns since its first year in operation. Nonetheless, Dr Zainal Abidin is adamant about the company becoming a self-sustaining entity, and he has proposed a six-strategy transformation plan that will enable SIRIM to compete with the best.

“We are going to change the way we undertake research and commercialise our technologies,”

6-sTRATEgY TRANsfORMATiON pLAN fOR iNNOVATiVE sUCCEssDr Zainal has established a clear direction for the road ahead for siRiM.

The company will transform itself into a self-sustaining R&D institution

capable of competing with the best by:

Delineating the company’s commercial and developmental

activities

Profitableactivitieswillbespun-off asindependentcommercialoperations,

eachwiththeirownsustainablebusinessdevelopmentmodels.

Ensuring the business sustainability of the SIRIM Group of

Companies

EffortsshallbemadetogrowSIRIM’ssubsidiariesandtoaligntheirproduct

andserviceofferingstomarketdemands.SIRIMstateofficesshallbeturned

intovibrant,resilientoperationcentres.

Enhance SIRIM human capital and work environment

SIRIMshallsignificantlyimproveitsoperatingpractices,processesandsystems

toenhanceproductivity.Staffingshallbeincreasedinordertoprovide

effectiveandefficientservicestocustomers,whileperformancemeasures

andrewardswillbebalancedandfairbasedonclearlydefinedrolesand

responsibilities.Toencouragegreateraccountability,themanagementshall

developintrapreneurshippoliciesforemployees,includingequityownership

byemployees.

Aboveallelse,thecompanywillestablishacultureof innovationandenhance

knowledgesharingandcommunicationamongemployeestoencouragemulti-

disciplinaryR&D,whichistobecomethehallmarkof SIRIM’stransformation.

Build a deep foundation and excellence in industrial research

SIRIMwilllaunchanintegratedprogramtobuilduponthecompany’sglobal

standinginindustrialresearch.Flagshipswillberepositionedtodeliver

integratedsolutionstocomplexproblemsandnationalneeds,leveragingon

SIRIM’ssynergyintechnologyandquality.

Strengthen and enhance connections and collaborations

SIRIMwillenhanceitsstrategicpartnershipwithindustryandthegovernment

inareasalignedtotheirneeds.Itsapproachtoreachingoutandengaging

keystakeholderswillbecomemoresystematic,anditwillbuildstrategic

partnershipinconformityassessmentandmetrology.

Developing the “SIRIM” brand

Themanagementwilldevelopandimplementanintegratedcommunications

andbrandingprogrammeforthe“SIRIM”brand.

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says Dr Zainal Abidin. “We have conducted technology foresight studies with the participation of industry and academia, and these reports will specify our areas of focus and the direction of our research projects.”

Beginning with 2012, SIRIM has begun developing product roadmaps so that each of its products has a generational succession plan. the company is also incorporating market studies into its research projects to ensure that it only undertakes projects that are in line with the demands and needs of the market.

“our chief concerns are the needs of industry,” explains Dr Zainal Abidin. “We want to know what their problems are and provide them with the right solutions. that’s why we’re enhancing our efforts to interact with industry players on our research projects. We want to contribute to their success.”

spindle success

SIRIM is also moving towards a two-pronged approach to technology development, with multi-disciplinary project delivery teams to undertake product development and technology core teams to focus on capability development. The multi-disciplinary project delivery teams are drawn from the technology core teams, thus ensuring that only the best people are used to deliver projects. Researchers will thus be able to see their innovations come to life, step by step, from lab bench to final product.

“I’m not an engineer myself, but many of the follow-through tasks in my research projects require engineering support,” says Dr Zainal Abidin. “Luckily, it’s very easy to get that support at SIRIM. Scientists here are quite happy to interact with researchers in other disciplines and to explore domains outside their own area of specialisation. We have a lot of synergy in that way.”

to enhance innovation activities in the country, SIRIM intends to concentrate its energies on developing private-public partnerships. In addition to ready-to-use innovations, SIRIM will also consider taking up a stake in companies that licence its technologies. the idea here is to share the burden of risk with clients and to ensure that the technologies are properly applied, exploited and commercialised.

“SIRIM may even set up spin-off companies for its most promising technologies, thus allowing us to enjoy the fruits of our research directly,” says Dr Zainal Abidin.

SIRIM will also be able to combine its competence in quality to enhance the applications of the various technologies that its researchers develop. one important area in which this will work will be in medical devices, where products and standards are highly regulated: SIRIM is able to incorporate the regulatory requirements and international standards necessary during both the research stage and the pilot production stage.

“our quality and standards knowledge make us the ideal R&D partner for developing medical devices that are acceptable to the market and which meet international regulations and technical specifications,” says Dr Zainal.

“We are going to change the way we undertake research and commercialise our technologies.”

TRANsfORMiNg siRiM


LABOR ATORY CONUNDRUM

In modern medicine, most doctors rely on the results of diagnostic tests conducted by automated instruments and devices in laboratories to diagnose their patients.

Unfortunately, these test results frequently differ depending on the device manufacturer or procedure used, leading to underdiagnosis, overdiagnosis and even misdiagnosis.

Regulators, doctors and metrologists are working together to resolve this predicament.

A p o p U L A R paediatrician in Kuala Lumpur has a rather unusual approach

to calibrating the infant weighing machine in the waiting room at his clinic. Every Monday morning, he hefts a 5 kg tin of formula onto the scales and adjusts the needle until it points to “5”. When asked whether or not he is sure that the tin weighs exactly what it claims, the doctor blushes: “The actual weight of a baby is not all that important,” he says. “We are more concerned with the pace of the baby’s growth – as long as it gains weight consistently

and it’s graph trends upward, it doesn’t matter if our scales are off by a few pounds.”

Which makes perfect sense, of course. Most people are able to live quite splendid lives in spite of being several kilos over-or-underweight. Similarly, one’s quality of life is not really affected by how tall or short one is. So perhaps the good doctor is right: height-and-weight scales do not have to be completely accurate for routine medical purposes.

Unfortunately, the same cannot be said for other, more vital health markers, such as cholesterol,

blood sugar and antibodies. Indeed, the margin of error for some less obvious markers is so narrow that false positives – or negatives – can sometimes lead to fatal misdiagnoses. the trouble is, measuring these health markers is a lot harder than stepping onto a set of scales. Instead, one has to measure the concentration of certain chemicals in the patient’s blood, such as sterol lipids (cholesterol), glucose (blood sugar) and white blood cells (antibodies).

the problem is further compounded by home self-test

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LABOR ATORY CONUNDRUM

In modern medicine, most doctors rely on the results of diagnostic tests conducted by automated instruments and devices in laboratories to diagnose their patients.

Unfortunately, these test results frequently differ depending on the device manufacturer or procedure used, leading to underdiagnosis, overdiagnosis and even misdiagnosis.

Regulators, doctors and metrologists are working together to resolve this predicament.

kits that are designed for end users, such as pregnancy test kits, cholesterol test kits and glucose test kits. these are typically not as accurate as clinical grade test procedures and users are frequently misled by erroneous results. for example: a study by researchers at the University of New Mexico on home pregnancy test kits in 2004 found that only one out of the 18 brands tested was able to consistently confirm a pregnancy within the first and second day after a missed period. these brands fared better in tests conducted during later stages of a pregnancy, but are still only 95-to-99-percent accurate.

this means that between one to five pregnancies go undetected by users, which is why women are always told to have a clinician confirm the results of a home test kit, even if it is negative.

As many a frustrated patient has found out, however, clinic and laboratory test procedures are often wrong, too. Both humans and machines are prone to making mistakes, and laboratory errors are thus a statistical certainty. the good news is that pre-and post-analytical errors make up 93-percent of all laboratory test errors, mostly due to things like mislabelling,

contamination and sample swaps. the bad news is that this means 7-percent of all lab blunders occur during the analytical stage of the test.

“Human error can account for some of these slip-ups, but many errors during this stage are due to the tools used,” explains Dr osman Zakaria, Head of Chemical Metrology Section at NML-SIRIM. “poorly calibrated instruments will yield less accurate results, which in turn will lead to misdiagnoses.”

Getting lab equipment up to speed is not difficult – in


most cases, one need only call the National Metrology Laboratory (NML-SIRIM) at Sepang. As the national custodian of weights and measures, NML-SIRIM is ideally suited to calibrate highly sensitive machinery. It is a member of the International Bureau of Weights and Measures (BIpM) and conducts frequent interlaboratory comparisons with other national metrology institutes worldwide. All of its reference weights and measures are traceable back to the

SI-units as published in the key comparison database (KCDB) maintained by the BIpM. In the field of medical devices, NML-SIRIM currently offers calibration services for thermometric, photometric and optical spectrometric instruments.

“the more frequently calibration is carried out, the more accurate a laboratory’s instruments tend to be, as long as the operator is dilligent of course,” add Dr osman.

Easy enough for things like thermometers and X-ray machines, of course. But when it comes to instruments that measure physicochemicals in human bodies, things get a tad trickier.

no eAsy cure

The world has grown accustomed to the metric system by now. We’ve all heard about the platinum-iridium bars in Paris that were adopted as the world reference standards for the kilogram and the metre way back in 1889 (although the reference standard for the metre has since been replaced by something more sophisticated), However, few people realise that these reference standards are also used to set national standard metres and kilograms in almost every country around the world, and that millions of businesses in these countries rely upon them to fine-tune their machines and production processes.

Unfortunately, coming up with reference standards for bodily chemical solutions is a lot more complex, although regulators and scientists are doing what they can. In 1998, the European Commission published the in vitro Diagnostic Medical Devices Directive 98/79/EC, which required manufacturers to ensure that the traceability of values assigned to the calibrators or control materials they used in their labs be assured through available reference materials of a higher order. the highest order of reference materials, or “analytes”, is maintained by the Joint Committee on traceability in Laboratory Medicine ( JCtLM) at

THE DANgERs Of iNACCURACYThischartshowsthenumberof errorsalaboratorywillsufferdepending

onhowaccurateitsmeasurementprocessesare.Alaboratorythatisonly

95-percentaccurate(red)willproduceoneerrorinevery20testsitconducts,

whereasaslaboratorythatis99.99-percent(green)accuratewillonlydoso

onceevery10,000tests.

Inpracticalterms,thismeansthatonlyoneinevery10,000patientsisatrisk

of beingmisdiagnosedbydoctorsreadingtestresultsfromLaboratoryA,

whereasdoctorsreadinglabresultsfromLaboratoryDmaymisdiagnose500

patientsoutof every10,000.Inaddition,noonecanidentifytheexactsource

of theselaboratoryerrors.Statisticalanalysisonlyprovesthatmistakesdo

happen–7-percentduringtests,and93-percentduringpre-and–post-test

processes–butcannottelluswhereandwhentheytakeplace.

Forthisreason,itisabsolutelycrucialthatalaboratorybeasaccurateas

possibleinallitsmeasurements–doingsocouldmeanthedifferencebetween

lifeanddeath.

METROLOgY AND MEDiCAL DEViCEs

17siRiMLink 02/2012

BIpM in two categories: analytes that are metrologically traceable to the SI-Units (type A), such as electrolytes, glucose and steroid hormones; and analytes that are not traceable to SI (type B), such as tumor markers, coagulation parameters, endocrine hormones, immune factors, virology markers, and bacteriology markers.

As you can see, the more important tests appear to require

type B materials. But unlike the standard metre, kilogram or second, there is no “one size fits all” reference standard for these physicochemicals in the human body – the ideal range changes from person to person depending on your lifestyle, how old you are and what your health objectives are. for example: pregnancy test kits are designed to detect elevated levels of the human chorionic gonadotrophin (hCG) hormone to

determine whether or not a user is with child, but the same hormone is also present in some forms of cancer. How can one tell good news from bad?

In addition, different ethnicities carry different biological characteristics that are more than just skin deep – Africans apparently have a more favorable lipoprotein profile than Americans, while Asian-Indians and African-

Primary reference measurement procedure

SI-Unit (definition)

Primary calibrator

Secondary reference measurement procedure

Secondary calibrator

Manufacturer’s Laboratory’s working (master) calibrator

Manufacturer’s Laboratory’s selected measurement procedure

End-user’s routine measurement procedure

Manufacturer’s Laboratory’s standing measurement procedure

Routine sample

RESULT

Manufacturer’s Laboratory’s product calibrator

BIPM

NMI, ACL

NMI, ACL

NMI, ACL

ACL, MCL

MCL

ML

ML

ML/End-User

ML/End-User

ML/End-User

ML/End-User

TRAC

EABI

LITy

dECR

EASI

Ng

UNCE

RTAI

NTy

fig 1: Metrological traceability and hierarchy of procedures and materials. BIPM: International Bureau of Weights and Measures; NMI: National Metrological Institute; ACL: Accredited Calibration Laboratory; MCL: Manufacturer’s Calibration Laboratory; ML: Manufacturer’s Laboratory. Adapted from BIPM.



Caribbean are significantly more predisposed to diabetes compared to Europeans. Creating physicochemical reference standards for all the major ethnic groups in the world would still leave out the many thousand possibilities of mixed ethnicities, some of which go back several generations.

Getting the reference materials right is only half the problem though. the second challenge is in documenting reference measurement procedures. Scientists and manufacturers often develop different investigative procedures (or “assays”) to evaluate the same health marker in an attempt to differentiate themselves from the

competition. And yet the hallmark of any scientific observation is reproducibility. to meet the requirements of new regulatory directives, an assay must therefore be both technically reliable and reproducible. this means that an analysis on any given substance (say, a blood sample) should produce the same results no matter where the test is conducted. this is rarely the case, of course, which is why Directive 98/79/EC also requires traceability in routine measurement procedures.

the Joint Committee for traceability in Laboratory Medicine( JCtLM) database at the BIpM currently lists more than 200 certified reference materials (CRMs) for about 130

measurands together with more than 125 reference

measurement procedures for 76 different health markers. Calibrations and tests that rely on any of these may all be traceable back to these higher order references (see fig 1).

NML-SIRIM is the primary calibrator in Malaysia and is

also the reference for primary reference measurement

p r o c e d u r e s , a l t h o u g h

Malaysian industr y has a

limited scope of requirements for these services at the present time.

“Ideally, all medical device measurements and calibration must be traceable to the Higher order Reference Materials or Reference Method maintained by BIpM,” says Dr osman. “However, many hospitals choose to calibrate their instruments on their own with tools provided by manufacturers. these tools are not authorised and may not be as accurate as they should. Even a small variance in the measurement could have catastrophic results to patients.”

this lack of oversight is one of many issues being tackled by the Medical Devices Board (MDB) of the Ministry of Health. the Medical Device Act 2012 specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration. the Ministry is currently drafting the subsidiary legislations and guidelines, but the basic idea is to ensure that all medical devices placed on the market are safe and accurate and that they meet the performance requirements of specified standards. Authorised testing and calibration laboratories will certify production processes, and manufacturers will be subject to regulatory audits (see table 1).

the Medical Device Act 2012 will come into full force in 2014 and will apply to medical manufacturers, exporters, importers and distributors of medical devices.

“the measurements and calibrations conducted during the manufacture or testing of medical

DR OsMAN: “Even a small variance in [the] measurement could have catastrophic results to patients.”


19siRiMLink 02/2012

devices must be traceable to the SI-Units or similar internationally-accepted procedure,” explains Dr osman. “If not, such measurements or calibrations may be considered void.”

there are about 1.5 million different medical devices worldwide, with many thousands more being introduced every year. Manufacturers may claim that all this regulation will only increase the costs of doing business. In truth, however, these regulations and specifications will save them a bundle of money in litigation.

“If you can demonstrate that your device has been manufactured and tested according to international standards and that the materials used are traceable all the way back to the Higher order Reference Materials or Reference Method maintained by BIpM, no one can argue with you,” says Dr osman.

NML-SIRIM is able to help manufacturers to design and develop medical devices that meet many of these international requirements. In fact, Dr osman urges manufacturers to engage with metrologists sooner rather than later to avoid a lot of rework.

“A fully developed product that fails the demanding metrological standards required of medical devices has to be dismantled and built from the ground up all over again,” explains Dr osman. “If we are engaged during the research and design phase, we can avoid that. We know what materials and standards to use ensure that the device will meet technical and regulatory requirements.”

Table 1: summary of requirements for different classes of medical devices

Medical Device Class

Risk Level Device Examples

Regulatory requirements

Class A Low Individual Risk and Low Public Health Risk

Clinical Chemistry Analyser, Prepared Selective Culture Media

• Simple Summary Technical Documentation

• Documented Good Manufacturing Practice (GMP), normally not audited

• Simple post-market surveillance system as appropriate in relation to risk

• Registration listing may be required

• A blanket Declaration of Conformity

Class B Moderate Individual Risk and/or Low Public Health Risk

Vitamin B12, Pregnancy Self Testing, Anti-Nuclear Antibody, Urine Test Strips

• Summary Technical Documentation to be held by the manufacturer

• Either a full Quality Management System (QMS) in place OR design verification through ‘type-testing’ by an accredited and independent third-party testing laboratory

• A post-market surveillance system for all devices produced


• A blanket Declaration of Conformity

Class C High Individual Risk and/or Moderate Public Health Risk

Blood Glucose Self Testing, HLA Typing. PSA Screening, Rubella

• Summary Technical Documentation will be examined during audits

• Either a full Quality Management System (QMS) in place OR design verification through ‘type-testing’ by an accredited and independent third-party testing laboratory. Each device must also undergo a final test before being placed on the market.

• Documented procedures for a post-market surveillance system on all devices produced

• An audited QMS and Summary Technical Documentation document.


• Declaration of Conformity required for all devices

Class D High Individual Risk and High Public Health Risk

HIV Blood Donor Screening, HIV Blood Diagnostics

• Summary Technical Documentation will be examined during audits

• A full Quality Management System (QMS) in place

• Documented procedures for a post-market surveillance system on all devices produced

• Audits on the QMS, post-market surveillance system and Declaration of Conformity

• Declaration of Conformity required for all devices

Source: Medical Device Control Division, Ministry of Health



Chitosan has long been famous for its biocompatibility. Researchers at SIRIM have now developed a skin regeneration system based on this

wonder polysaccharide which allows wounds to heal inside out.

THE CHITOPR ACTORS

Chitosan film pads are cured in an oven and sterile-packaged before being shipped, allowing surgeons to use them right out of the box.

21siRiMLink 02/2012

NEARLY SEvEN million people suffer severe burn injuries every year, and

in Malaysia, 70-percent of all burns are a result of domestic accidents. Severe burns often leave survivors with disabilities, bringing needless economic hardship on households and families. And, unlike victims of many other injuries, burn patients tend to be shunned, further impacting their ability to integrate into society and workplaces.

It does not have to be that way though. Numerous advances in burn management techniques and systems over the years have given surgeons a mind-boggling array of products that can help alleviate the worst of the damage suffered by burn victims, including anti-haemorrhagic dressings that are more effective than ever before. However, many of these advance wound management systems are prohibitively expensive.

Not so with chitosan: a naturally abundant substance sourced from the exoskeletons of crustaceans that is relatively inexpensive. Widely used in drug delivery systems, stem cell studies and tissue reengineering, this wonder polysaccharide is biocompatible, biodegradable, hypoallergenic and antibacterial, all of which make it perfect for protecting open wounds and encouraging auto-cellular proliferation.

Dr Ahmad Hazri Abdul Rashid and Dr Kartini Noorsal of SIRIM were awarded a technofund grant to develop six medical-grade products that take advantage of these natural properties of

chitosan: a thin film, a sheet, a paste, a scar cream, a sponge and a skin regenerating template (SRt). Although the products were designed with burn victims in mind, they may also be used on bed sores, diabetic wounds, chemical and acid wounds and electrical burn wounds. (the technofund is managed by the Ministry of Science, technology and Innovation (MoStI) and aims to stimulate the growth and successful innovation of Malaysians enterprises).

“Advanced wound management techniques are very popular in developed countries, but not here,” says Dr Kartini. “few local hospitals offer them, and if they do, the options available are very expensive.”

the first of these products, ChytoSponge, is a simple wound dressing designed for first-degree burns and is used for s u r f a c e injuries. It e n h a n c e s the body’s n a t u r a l ability to heal the epidermis by itself with little or no i n t e r v e n t i o n by doctors. A second product, the chitosan-based thin film, may be used to complement the treatment of surface wounds with conventional dressing.

the chitosan skin regenerating template (SRt), or ChytoSRt, is a lot more exciting. It has two layers, comprising a porous matrix at the bottom and a semi-permeable dense film on top. the porous matrix of ChytoSRt is much like a sponge: it soaks up excess fluid and allows blood vessels and dermal skin cells to creep into it. there the cells multiply, integrate and eventually form a new layer of skin. the dense film on top keeps bacteria out and allows the wound to ‘breathe’, thereby aiding the healing process.

At this point, one might ask: “What happens to the spongy matrix with the new skin? Does it stay in my body?” the answer is No, and this is where the

DR HAZRi: “With these products, we hope patients will be able to return to the comfort of their homes sooner rather than later.”

CHiTOsAN iN MEDiCiNE

THE ART Of CHiTOpRACTiCEsiRiM’s chitosan series of products help patients to heal faster and go home sooner.

1

2

3

4

5

6

7

Damagedskintissue(epidermisanddermis)isremoveddowntothesubcutaneousfatlayer.

Subcutaneous tissue (fat)

ChytoSponge

ChytoSRT

Epidermis

Dermis

TheChytoSRTiscuttofitthecavity.Alayerof ChytoSpongeisplacedontoptokeepinfectionatbay.

BloodvesselsanddermalskincellsbegintoinvadetheChytoSRTmatrix.Thepatientmayreturnhomeandneedonlyvisitthehospitaloccassionallyforcheck-ups.

Asmoreskincellsmigrateintothechitosanspongymatrixisslowlydegradedintothebodyandreplacedwithproteinthatisnaturallyproducedbytheskin.Thespongymatrixiseventuallyreplacedbynewskintissue.TheChytoSpongelayeris

removedwhenthedermisisfullyhealed.

Asimpleskingraftallowstheepidermislayertoformandintegratewiththeneighbouringcells.

Whentheskingraftiscomplete,thewoundishealed,andsweatglandsandhairfolliclesmaystarttogrowagain.


beauty of chitosan comes in: because chitosan biodegrades so readily, the spongy matrix actually dissolves into the body, leaving only new human tissue in its place. the dissolved chitosan is perfectly harmless.

“once the skin is healed, all you have to do is peel off the top film,” says Dr Kartini. “After that, a simple skin graft will complete the procedure. If all goes well, the patient’s nightmare will be over within six weeks.”

only skin deep

Compared to many other medical technologies, chitosan pads are surprisingly easy to make.

the entire production cycle takes about a month, two weeks of which is spent on preparing the chitosan solution. first, the chitosan powder is irradiated until it is the right molecular weight – the higher molecular weight is used for the top-layer film, and a slightly

lower molecular weight is used for the sub-layer sponge. the chitosan solution is then prepared by mixing the irradiated chitosan powder with other chemicals at a precise temperature, pH and pressure. the solution is then measured and poured into square moulds of a size requested by the collaborating surgeons. the lower molecular weight chitosan solution is freeze dried to make the sponge matrix, while the higher molecular weight chitosan solution intended for the top layer is cured in an oven.


23siRiMLink 02/2012

once the chitosan squares are ready, they are sandwiched, packaged and sterlised so that surgeons can use them right out of the pack in the operating theatre.

“A large scale manufacturing process could opt for larger trays, after which the chitosan pads may be sliced to any size they want,” says Dr Kartini. “A manufacturer might want to offer chitosan pads in large rectangles for limb wounds, or as small circles for chemical burns. the process is easily scaled to allow for these modifications.”

Because the raw material (chitin) used to make chitosan is inexpensive, chitosan products may be priced very competitively compared to pricier alternatives – a collagen and silicon-based bioscaffold from the U.S. retails for RM12,900 per piece, for example, but the ChytoSRt costs only a fraction of that. And, according to the surgeons collaborating on the project as well as lab studies on rats, the

performance of the chitosan pads are on par with those imported collagen pads.

Clinical trials of ChytoSRt kicked off in June 2012 with prof. Dr Ahmad Sukari Halim, one of the reconstructive surgeons roped in as

collaborators on the project. trials will be conducted at three hospitals across the country, including the Burn Unit at Hospital USM in Kubang Kerian, Kelantan. Samples have also been sent to Australia for biocompatibility and toxicology studies as part of the process for getting Good Laboratory practice (GLp) certification.

More than anything else, though, it is hoped that SIRIM’s chitosan medical products will help patients heal better and faster. As it stands, patients have to be warded for weeks to protect their wounds from infection. Wound dressings have to be changed frequently by nurses, and so patients are not allowed to go home until the healing process is well under way and the risk of infection is minimal.

“With these products, we hope patients will be able to return to the comfort of their homes sooner rather than later,” Dr Hazri adds. “they just have to visit the hospital once a week to get their chitosan dressings changed.”

“Because the raw material

(chitin) used to make chitosan is inexpensive,

chitosan products may be priced very

competitively.”

DR KARTiNi: “Once the skin is healed, all you have to do is peel off the top film. After that, a simple skin graft will complete the procedure.”


DR AfiAN: “Today we can do things with metal injection that were not even thought possible just a few years ago.”


MEtAL IS A t o u g h material to work with. Ev e r y t h i n g

from teaspoons to car doors seem to require enormous machines to bang, cut, squeeze and bend them into shape. And although these things can generally be relied on to stay in shape once they are formed, they nonetheless consume huge amounts of energy and resources to make.

Not so with metal injection moulding (MIM): a popular and very sophisticated metalworking process that takes all the brawn out of the job and replaces it with cleverness instead. Unlike other metalworking processes that start off with a finished, hard-to-manipulate metal, metal injection moulding starts off with a soft, easy-to-form metal paste. Because of this, MIM has a very good track record when it comes to making complex and intricate objects.

“It also makes MIM ideal for making medical implants,” says Dr Mohd Afian omar, an award-w i n n i n g

researcher at SIRIM. “We can do things with MIM today that were not possible even just a few years ago, such as making components for micromachines and other tiny devices.”

the metal injection moulding (MIM) process is fairly straightforward if you ignore the physics behind it. first the raw material is carefully measured out to make the metal feedstock. Most of the mixture comprises medical-grade stainless steel powder, while the rest consists of the ‘binder’ of paraffin wax, stearic acid and polyethylene (the binder holds the metal powder together and is removed later). this feedstock is then thoroughly mixed to achieve the optimum homogeneity and viscosity, after which it is put

into the injection moulding machine.

once formed, the shapes are transferred to a special heat chamber where the binder is removed through a process called ‘debinding’. this literally means heating up the shapes and waiting for the binder molecules to melt away, leaving only the stainless steel behind. there are many binder systems available on the market, and Dr Afian himself invented one based on waste rubber a couple of years ago. However, he decided that organic feedstock was unsuitable for commercial-scale production.

“It was perfect for lab scale production, because we only needed a few hundred grams of the raw material to work with,” explains Dr Afian. “But scaling up would have involved hundreds of kilos of the stuff, and it would pick

up fungi and other organic contaminants in storage that would have to be removed later. It’s shelf-life was just too short.”

once the binder has been removed, the shapes

are sintered at extremely high temperatures until

the stainless steel molecules bond to each other, at which

SIRIM is among the first companies in the world to pioneer the use metal injection moulding for manufacturing stainless steel surgical implants.

MAN OF STEELMEDiCAL iMpLANTs

pRECisE MACHiNERY: New micro-MIM technologies allow Dr Afian’s team to make medical implants of all shapes and sizes and [see inset] with extremely intricate details.

25siRiMLink 02/2012

point the shape achieves a solid density that is so close to perfect metal that the difference may be safely ignored. the shapes are then electrochemically polished before being tested and packaged.

perfect metAl

MIM produces practically zero waste and has a very low defect rate compared to conventional machining processes, making it ideal for high-value objects made of expensive metals such as components in micromachines, automotive and aerospace applications. The only drawback is that the metal paste feedstock cannot weigh more than 100 g when it is fed into the machine, which means you cannot make large objects.

“All research data so far indicates that the quality of the stainless steel devices made by MIM is similar to that of conventional machining processes,” says Dr Afian. “visiting

researchers from Universiti Islam Antarabangsa as well as an orthopaedic surgeon from International Islamic University have also confirmed that our products meet the toxicology and biocompatibility requirements for medical grade implants .”

Dr Afian’s team has produced dozens of miniature stainless steel parts weighing mere miligrammes, with tunnels only 1 millimetre in diameter and thread points a mere 0.2 millimetres thick. Such high-precision fabrication with stainless steel was once only possible with clumsy, drill-and-saw machines, and even then only simple two-dimensional objects could be made. But new metal powder injection moulding technology now makes it possible to make medical-grade implants with extremely intricate features and complex surfaces.

Nonetheless, Dr Afian’s current focus is on simple, six-hole dynamic compression plates (DCps) designed to fix bone fractures.

DCps are among the most widely used metal implants in the world and are used to repair fractures both large and small, from femurs to phalanges. However, imported plates from Europe or the US and tend to be designed for Caucasian bones and are sometimes a poor fit for Asian bone structures which can differ widly.

“Malaysia also imports DCp plates from Asia, which tend to fit a little better but have a bad rep among surgeons,” says Dr Afian. “there have been cases where these plates actually begin to corrode in the patient’s body, which is a very unpleasant thought to say the least!”

Dr Afian’s plates are currently undergoing animal studies, and if all goes well, they will progress to clinical trials soon afterwards. Considering that they are expected to cost half as much as current Western imports while offering the same quality assurance, one hopes all will go smoothly.


Malaysia is set to become a regional hub for medical devices and equipment by 2020. SIRIM is working hard at developing the necessary standards to

support the regulatory framework that will help the country achieve this goal.

A DOSEOF

STANDARDS

ONE of tHE hallmarks of a maturing e c o n o m y is a vibrant

healthcare system in which citizens play an active role in safeguarding their health. They not only consume curative medical services, but also take an interest in preventive medical facilities. Little wonder then that the Malaysian government wants the medical devices and equipment industry to be an NKEA under the Economic transformation programme. By 2020, the industry is expected to rake in RM17 billion in revenue annually while creating 86,000 employment opportunities.

Data shows that Malaysia is a big consumer of medical devices, but it is not much of a producer – besides rubber gloves and condoms, the local medical devices industry is almost non-existent. that said, our long track record in making high quality electronics and electrical (E&E) devices means that we are uniquely positioned to break into the industry in a big way. that is what the government set out to do in 2005, when it began

work on the Medical Devices Bill and requested SIRIM to begin establishing a standards framework for the industry.

Now, the Bill has been passed as the Medical Devices Act of 2012 (Act 757) and almost 400 standards have been developed, most of which have been mapped to either ISo or IEC international standards. the few indigenous standards developed so far deal with the maintenance of medical equipment, and are necessary only because there are no universally-applicable standards or procedures for those tasks. they specify the procedures for the Who, What, When and How of maintenance tasks – hospitals have to designate a suitably qualified person to maintain all its equipment, set a maintenance schedule and make sure the maintenance and calibration complies to the required standards.

“the Medical Devices Act 2012 covers the whole product lifecycle of medical products, from tongue depressors to imaging machines,” says Salbiah, a consultant at the Engineering

Standards Management and Consulting Services Section. “However, the Malaysian medical devices industry is still in its early stages of development. our main products are still simple, single-use devices (SUDs) like rubber gloves, cathethers, condoms, drips and scrubs.”

HArmonised stAndArds

Naturally, the benchmark for meeting the standards for medical devices is higher than for other products. But while it is important that these standards be stringent, it is also important that they do not choke innovation – like any other industry, the medical devices business can only thrive if it has a proper legal and regulatory framework to support it.

to that end, the Global Harmonization task force (GHtf) is spearheading the regulatory convergence of the industry globally, and hopes to eventually facilitate mutual acceptance among regulators. It is hoped that this mutual

sTANDARDs fOR MEDiCAL DEViCEs

sALBiAH: “...it will one day be easier for importers to sell their products in Malaysia than it is for Malaysian manufacturers to do so.”

27siRiMLink 02/2012

acceptance will cover common data submissions, pre-market conformity assessment (including clinical evidence) processes, quality systems, quality systems auditing results, and a broad sharing of post-marketing experience for product recalls and warnings.

the aim of the GHtf is to foster medical technology innovation and facilitate global trade among major device-producing nations of the world by reducing or eliminating redundant or conflicting regulatory systems. this is particularly important in view of China’s rise as a powerhouse in medical innovation – the number of research papers published by China has risen 400% over the past decade or so, far exceeding the research output of traditional medical innovation centres like Germany, Japan, france and Canada.

Besides the Malaysia Medical Devices Act 2012, GHtf guidance documents already form a substantial basis for the medical devices regulations of Australia, Canada, EU and Japan as well as parts of the US fDA regulations. Malaysia is also a member of the Asian Harmonization Working party, which streamlines efforts to harmonise medical regulations in Asia with global trends in coordination with GHtf and ApEC. In addition, ASEAN has targeted to adopt an ASEAN medical device directive by 2013.

industry pArticipAtion

All this paperwork will eventually result in an industry as innovative and dynamic as the

electronics and electrical (E&E) or automotive industries that have given us so many wonderful products. These, too, are highly-regulated industries, but they have nonetheless yielded all manner of innovation, from smartphones to electric vehicles.

“there is a lot of opportunity for Malaysia in the medical device business,” Salbiah says. “However, Malaysian manufacturers have to step up to the challenge of developing products that can compete against imported goods, be they from China or from the US.”

the opportunity is particularly attractive at the higher end of the market, where the profit margins are larger and the competition is less stiff. Rubber gloves and other single-use devices are essentially commodities in the industry and will be subject to competitive price pressures. the real money lies in Class B or Class C devices such as blood self-test kits. these devices are just as easy but demand stricter production systems and more stringent metrological standards. SIRIM has the R&D capabilities to help companies get into this end of the market; all that is required are forward-thinking entrepreneurs ready to take on the challenge.

Sadly, there is a definite lack of direction among local manufacturers – indeed, it would appear that the Malaysian industry is being led and nurtured by import houses instead of local manufacturers. Malaysian producers may one day find themselves playing by the rules of importers rather

than their own, which would be a terrible shame.

“When it comes to medical devices, it’s all about evidence,” says Salbiah. “Importers can trumpet their products’ compliance to international standards and back up their claims with evidence. Unless Malaysian manufacturers learn to do the same, they will lose the whole local industry to foreign brand names.”

the challenge, of course, is for Malaysia to develop its own testing and certification ecosystem for medical devices. the Medical Devices Act 2012 will allow test certificates from other countries to be recognised locally through a bridging programme, whereas Malaysian manufacturers still have to send their products overseas for testing. But it is hard to develop that testing ecosystem without the participation of local industry players.

“Malaysian companies have to participate in our industry forums and tell us what they need. that’s the only way we can help them,” says Salbiah. “If not, it will one day be easier for importers to sell their products in Malaysia than it is for Malaysian manufacturers to do so.”

sTANDARDs fOR MEDiCAL DEViCEs


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