Public bodies, medical device companies, suppliers and academia collaborate in the development of advanced manufacturing techniques.
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Banding together
Medical device manufacturers face an ever growing set of challenges including heightened regulatory scrutiny, cost reduction pressure, shrinking product life cycles and increasing competition. It is becoming more difficult for any one company to address these challenges alone.
While there is no perfect solution, Singapore’s government is working with medical multinational companies to address these challenges using a holistic approach. Government agencies, medical device manufacturers, suppliers and educational institutions partner to provide a platform that supports market entry, supplier identification, supplier capability enhancement and targeted R&D initiatives.
Enhancing the medtech infrastructure
Consortia play a key role in Singapore’s holistic approach. For example, the Medtech Manufacturing Consortium is led by the Singapore Institute of Manufacturing Technology (SIMTech), a research institute of the Agency for Science, Technology and Research (A*STAR). Its goal is to enhance Singapore’s existing medical manufacturing infrastructure by establishing a framework to improve or create new medical manufacturing capabilities. It creates a mechanism for sharing experience, knowledge and best practices in medical manufacturing technology, whilst facilitating research collaboration among consortium members and research institutes. Consortium membership isn’t limited to local suppliers; instead, it groups suppliers, medical device manufacturers, support service providers, government agencies, associations and universities.
In this framework, government agencies, medical device manufacturers and universities can collaborate in driving specific types of manufacturing technology development within the supply chain. For instance, SIMTech has identified 10 focal areas in its medtech industry infrastructure improvement initiatives. These are forming technology, precision machining, precision measurements, supply chain management and RFID, flexible and conformal technologies, mechatronics, surface finishing, joining technology, microfluidics systems manufacturing, and medical device design and development. Within each of these areas, specific projects are underway to address identified needs. Examples of these R&D initiatives include:
- precision forming technologies for medical devices and medical equipment components of polymeric, metallic or ceramic materials for use in safety needles, lenses, polymer-based microfluidic chips for DNA analysis and diagnostic applications
- surface finishing techniques to anodise and polish surgical materials and improve corrosion resistance, bio-inertness, lubricity and durability
- the use of carbon coatings on implantable metal parts to increase biocompatibility and mechanical performance
- flexible and conformal technologies for wearable medical electronics and sensors
- laser-based microwelding to join heat-sensitive dissimilar materials
- mass finishing of small medical components by abrasive flow machining when conventional methods are unable to access complex internal passages.
SIMTech and the Singapore Workforce Development Agency (WDA) have also developed a Graduate Diploma in MedTech Manufacturing. The goal of the one-year part time course is to provide key staff, engineers and manufacturing managers in the medtech supply base with a comprehensive training programme that enables them to better understand the needs of medical device manufacturers. The programme covers medical regulatory requirements, medical device design innovation and development, medical manufacturing and quality system requirements, medical manufacturing processes, and supply chain management for medical manufacturing. The first class of 30 convened in January 2010.
Some of the consortium’s other participating agencies such as Singapore’s Economic Development Board (EDB) and International Enterprise (IE) Singapore are assisting medical device manufacturers with market entry strategies that either launch new products and technologies or modify existing products to better address regional market needs.
Membership within the supply base includes traditional manufacturing service providers for plastics, polymers, EMS, precision machining, coating, surface treatment and contract sterilisation services, as well as companies that provide services both to OEMs and the manufacturing supply base. These include product development companies, CAD software developers, process control and factory automation system developers, third-party test laboratories, and custom IT platform developers.
The consortium offers a defined package of benefits to its members including technology workshops, competitive intelligence reports, alliance with the Biomedical Engineering Society, business matchmaking opportunities, focused OEM/supplier partnership projects, training and a consultancy service that could be tapped for technology roadmapping, device design or feasibility studies, and supply chain optimisation recommendations.
iPartners strengthens suppliers’ value propositions
IE Singapore’s International Partners (iPartners) programme is another consortia incubator. IE Singapore is an agency under the Ministry of Trade and Industry. It helps Singapore-based suppliers wishing to expand to new markets and foreign multinational corporations wishing to find new suppliers through a range of programmes. In the case of iPartners, individual consortiums are set up to target specific market needs. An anchor company experienced in the target overseas markets leads the effort by adapting or integrating the alliance partners’ existing products or services. The alliance partners help strengthen the anchor company’s current products or services in the target marketplace. A business development manager champions the goals of the alliance and leads in the execution of the alliance business plan.
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One example of an iPartners alliance is SG-Ophthalmic and the Biomedical Consortium, which was formed in January 2010. In this case, PLC Industries Pte Ltd is the anchor company. It leads a consortium whose alliance partners are Hisaka (Singapore) Pte Ltd, Sanwa Plastic Industry Pte Ltd and Delta Optic Technologies Pte Ltd. The consortium’s goal is to become a strategic partner to major global contact lens and biomedical products manufacturers by providing one-stop design and manufacturing solutions. In terms of the actual mechanics of the alliance, PLC Industries provides precision machining components and modular and subassembly support. Hisaka brings the design, integration, commissioning and services of automation systems and supply chain management support. Sanwa Plastic Industry supplies mould design and fabrication, and manufacturing. Delta Optic Technologies furnishes optics design and prototyping, optical inserts for plastic lens moulding, the mirror and lens made of soft material, and component inserts with micro features. The end result is that the consortium’s customers can choose from a wider range of manufacturing solutions than would be possible working with one supplier alone.
Product development and market entry support
Singapore also provides cost-effective solutions for medical device manufacturers wishing to reduce cost and time in product development, prototyping, clinical trials and market entry.
The founders of Merlin MD Pte. Ltd chose Singapore and Switzerland as potential options for the company’s headquarters and primary design and manufacturing site. Their initial product was a new system for endovascular treatment of intracranial aneurysms, the X*Calibur Aneurysm Occlusion Device (AOD) system. It is placed across the neck of the aneurysm to induce thrombosis of the aneurysm sac by altering the flow exchange between the parent artery and the aneurysm. The stent-like device is covered in a semipermeable, biocompatible membrane. The treatment method excludes an intracranial aneurysm from circulation while affording a minimally invasive endovascular approach. It combines the best of surgical clipping and endovascular coiling, the two principal treatment modalities used today.
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| French company Spine-Vision set up a subsidiary in Singapore to develop a disposable wireless device that detects tissue changes during spinal surgery. |
Singapore became the company’s location of choice because its government agencies offered the best overall support package for the start-up firm’s needs. The Singapore Economic Development Board (EDB) provided a research and development grant and equity-based funding. Enterprise development agency SPRING Singapore provided a development grant, while IE Singapore provided market entry assistance in Brazil and Mexico as part of its mandate to help Singapore-based companies venture overseas. The company was also able to access qualified engineering talent through the strong engineering programmes at Nanyang Technological University, the National University of Singapore and Nanyang Polytechnic.
In another case, French company SpineVision established a subsidiary in Singapore when it began development of its PediGuard disposable, wireless instrument used in spinal surgery. The device detects tissue changes and provides visual and audio alerts to surgeons. In this case, Singapore’s strong biomedical infrastructure was leveraged. Bio*One Capital, a biomedical sciences–dedicated investment company and a subsidiary of Singapore’s Economic Development Board Investments (EDBI), led an investor group, which funded the device manufacturer’s establishment of a Singapore-based subsidiary.
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Singapore-headquartered suppliers were tapped for the product development and manufacturing effort. Beyonics Technology Ltd was the EMS provider selected to manage the overall manufacturing process. They teamed with design firm PSB Technologies (now Xentiq Pte Ltd) in the initial development effort under the supervision of SpineVision (now SpineGuard). In addition to a successful product launch, in 2007 the PediGuard was awarded the Singapore President’s Design Award.
Susan Mucha
is President of Powell-Mucha Consulting Inc., 4500 Parade Willow Way, El Paso, TX 79922, USA
tel. +1 915 585 7285
e-mail: smucha@powell-muchaconsulting.com [7]