The development of medical devices is a growing area in Australia. Success stories such as Cochlear come to mind with its cochlear implant and behind-the-ear speech processor. Medical devices cover a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators and heart valves.1
‘Companies are finding this area interesting because it’s innovative, very high tech and there are good routes to market all over the world,’ said Thor North, Senior Associate, Litigation. ‘This is a buoyant market because people value their health.’
‘On a global basis, medical devices are second on the list (behind pharmaceuticals) for IP litigation spend,’ continued Patrick Sands, Special Counsel, Litigation. ‘Litigation in this field is common, particularly in the United States where there are substantial court cases around technologies like vascular stents. This trend is growing in Australia. We recently were successful in obtaining a contested interlocutory injunction for our client KCI Medical, a subsidiary of Kinetic Concepts Inc (KCI), a global medical technology company which specialises in negative pressure wound therapy (NPWT).’
Partners visit AusMedtech 2009
‘The AusMedtech conference is an important event on the medical devices and diagnostics calendar,’ said Mr Sands. ‘We went along because it gave us the opportunity to meet with key stakeholders in the medical technology field in Australia, including companies with products at various stages of development as well as regulatory and financial advisers to those companies. It also gave us the opportunity to understand the commercial drivers for this industry and how the current economic climate is having an impact.’
Latest developments from the TGA and getting into the United States market
‘AusMedtech is an excellent forum to discuss developments in the regulatory environment administrated by the Therapeutic Goods Administration (TGA),’ said Mr North.
The TGA regulates the uniform national controls over goods used in the prevention, diagnosis, curing or alleviation of a disease, ailment, defect or injury. ‘There are many hoops that our clients have to jump through to get their medical devices cleared by the TGA,’ said Mr North. ‘The approval process requires a considerable financial and time commitment and it is not surprising that companies in this area turn to their IP rights to protect their investment, both in product development and regulatory approval.’
‘Sessions on the Australian and United States regulatory environment at AusMedtech were invaluable in helping us to better understand the challenges faced by our clients.’
MedTech trends
‘Research is on the rise and it is becoming cross-disciplinary,’ said Mr North. ‘AusMedtech was interesting because I saw biologists mixing with electrical engineers, mixing with IT professionals. People are working together from computing and statistical fields which are not traditional medical fields.’
‘This is such a dynamic area and we plan to become more involved in its future in Australia,’ concluded Mr Sands.
Endnotes
1. Therapeutic Goods Administration website
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