Overview Medical Devices and Diagnostics
Medical devices and diagnostics is a broad category ranging from hospital beds to diagnostic devices, drug delivery systems, wound care products, medical aids and implantable devices such as stents and pace makers. Medical technology companies develop, manufacture and supply a wide variety of products that fall within the category of medical devices and diagnostics.
Diagnostics are tools which support clinicians in the investigation and identification of disease states in medicine and veterinary science. The diagnostic industry generally falls into two broad categories: in vitro diagnostics (IVD) and in vivo diagnostics. IVD involves the removal of samples of tissue such as blood from a living organism for examination. In vivo diagnostics involves observing and testing tissue and function in a living organism, and includes techniques such as medical imaging (e.g. magnetic resonance) and monitoring (e.g. electrocardiography, electroencephalography).
Australia-wide there are more than 500 medical technology companies, and separately, approximately 54 IVD companies supplying medical devices. Approximately 12 per cent of these companies are located in Queensland. The Australian industry had a turnover of approximately AU$11 billion in 2012 and is expected to grow at a rate of 5.4 per cent per annum until 2018. The industry was responsible for 43,952 medical devices listed on the Australian Register of Therapeutic Goods (ARTG) including IVDs.
The majority of Australian-manufactured medical technology products are exported, with a value of AU$2.23 billion in 2013-2014. Comparatively, the value of Australia’s medical technology imports for 2013-2014 was AU$5.59 billion.
Queensland’s biomedical industry includes companies operating in a range of these specialist fields, with many well supported by the State Government. Consider just some of the many leading companies selling or utilising their innovations in Australia and around the world – Tissue Therapies’ VitroGro® ECM wound care product, currently seeking regulatory approval internationally); Melcare Biomedical and their innovative use of honey-based eye care and wound care products; ImpediMed, who develop bioimpedance devices with a focus on medical applications for use in a variety of healthcare segments; Ellume, who are developing state of the art point of care diagnostic tests; or Magnetica and its highly super conducting magnets – including the very high field extremity magnet, gradient and RF coils which received a Queensland Government Smart Futures Fund Grant of AU$1 million. The State Government has also invested heavily in initiatives involving the State-developed NanopatchTM; including a project to develop a dengue vaccine delivered by the device under the Accelerate Fellowships grant scheme.
Queensland is home to a number of multinational companies such as Cook Medical – the largest privately held medical device manufacturing company in the world, with over 15,000 separate product lines. The company has achieved success with its cardiovascular stents and IVF products to assist families. Cook Medical is situated at Brisbane Technology Park (BTP), a former Queensland Government initiative set up to facilitate interaction between technology and research-focused national and multinational companies in one location.
Cochlear Limited’s Queensland facility employs approximately 200 people and the facility produces more than 400 different types of products through a combination of high technology automation and painstaking manual micro assembly work. Cochlear have been manufacturing in Queensland since 2007 and in 2013 opened a new state of the art microchip processing operation in their facility in Brisbane.
The Office of Devices Authorisation (ODA) – part of the Therapeutic Goods Administration (TGA), which is a division of the Australian Government’s Department of Health – is responsible for pre-market regulation of medical devices, while the Office of Product Review (OPR) regulates post-market. In 2014, the Australian Government announced changes in the TGA approval processes for medical devices, making it easier for Australian and international companies to release products in this country.
Every medical device sold in Australia conforms to the relevant provisions of the OGD and TGA. For more information, contact LSQ and we would be happy to direct you to one or more of our Members who are most appropriate to your needs.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has announced the Therapeutic Goods Administration (TGA) of Australia has ICH observer status.
Highlighted at December 2015 Jacksonville ICH Assembly to attend future ICH Assembly meetings and continue participation in ICH activities, including at expert level in the Working Groups, a formal status of either ICH Member or ICH Observer is required.
The TGA has joined other ICH observers; the Southern African Development Community (SADC), the Gulf Cooperation Council (GCC), the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, the Pan American Network for Drug Regulatory Harmonization (PANDRH), and the Asia-Pacific Economic Cooperation (APEC).