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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 57 ResMed open frst Asian manufacturing site in Singapore In a sign of expansion into the Asia Pacific region, ResMed has launched its frst Asian manufacturing site in Singapore. The manufacturing operation, which commenced production in late 2008 and was offcially launched in May 2009, is located on a 2,500-square-metre site at Loyang. The state-of-the-art facility is operated by 60 specially trained, local employees. The facility produces approximately 100,000 SWIFT Pillow breathing masks per month for export to the company's largest markets of Europe and the USA. The site also manufactures flow generators that treat patients with sleep apnea. Over 100 million people worldwide are affected by snoring or sleep apnea, a serious condition identified by pauses in breathing, narrowing of the airway and restricted breathing during sleep (Obstructive Sleep Apnea). ResMed estimates that 90% of people with OSA remain undiagnosed and untreated. "The global sleep disorder market, in particular in Asia, is hugely underserviced. It offers ResMed significant opportunities for global growth and a means of helping millions of sufferers worldwide," said Mr Rob Douglas, ResMed Chief Operating Officer, Asia Pacific. Growth in demand fuelled ResMed's decision to complement its large manufacturing operation in Sydney, with a centre closer to Asia. Singapore was selected as the springboard for strategic expansion into Asia because of its skilled workforce and geographic location. In addition to the current Loyang employees, ResMed sees Singapore's graduates and engineers as an essential source of expertise to support the company's future growth. ResMed worked closely with Singapore's Economic Development Board (EDB). "The EDB is a valuable business partner, whose local insights and expertise ensured us a swift entry into Singapore. Just three months after the site was leased our first products rolled off the production line," said Mr Douglas. "As our base at Loyang grows we hope to see ingaporeans contributing to innovative R&D that improves the quality of health and life for people with sleep-disordered respiration," he concluded. ` For more information on ResMed, visit www.resmed.com. Steve Marshall AIPM, Chief Executive O cer Sean Williams BE (Elec) (Hons) Dip Eng Practice, Principal Systems Engineer Dr John McCarthy BSc (Hons) MSc PhD, Principal Scientist Ben Johnston BE BMedSc (Hons), Mechatronics Engineering Pierre Vancaillie BE BmedSc (Hons), Biomechanical Engineering Leanne Maslen MM, Management Systems and Administration Perficio Product Development, Suite 304, Studio 54 Foveaux Street, Surry Hills, NSW 2010 t +61 2 9211 0399 f +61 2 9211 0424 e email@example.com www.perficiopd.com.au Perficio Product Development introduces IVD Design and Development Training Course The TGA intends to introduce new regulations covering the development and use of In Vitro Diagnostic Systems (IVD) in Australia prior to the end of the year. In effect, the new regulations will bring IVDs within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002. Perficio Product Development has initiated the IVD Design and Development Training Course to assist companies in becoming familiar with the practical implications of the new regulatory requirements and to support with the transition to conform to the new regulations. IVD Design and Development is a one day course designed for those involved in the development of IVDs who wish to have not only an enhanced understanding of the requirements of ISO 13485:2003-Medical devices-Quality Management System Requirements and a method of implementation of each of the provisions of this standard, related to product realisation; but who are also determined to efficiently develop IVD technology for commercial success. The course is specifically aimed to communicate how an effective product development process facilitates a smooth regulatory pathway, avoiding the many pitfalls along the way, and resulting in a reduction in project duration. For more information contact Steve Marshall on +61 2 9211 0399 or firstname.lastname@example.org go to our website www.perficiopd.com.au