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To target barriers and unlock opportunities, this road map will support manufacturers to translate good ideas into commercial products in Australia. In doing so, it will provide a pathway for Australian manufacturers to scale domestic production.

Commercialisation

For small companies with a good idea, the translation pathway in Australia can be challenging and costly. Medical products are highly regulated, have long development timelines and require specialist skills to design, test and manufacture. Some companies also lack the translation skills and funding to take great ideas and turn them into bankable products for manufacture in Australia.

Faced with a complex commercialisation pathway, many Australian businesses license or divest their innovative products for manufacture overseas. If the late stage commercialisation steps occur overseas (such as clinical trials and first production runs) the likelihood of reshoring full-scale medical product manufacturing is very low.

A critical step to commercialising and manufacturing products in Australia is securing access to accredited production facilities for prototyping and first production runs. This allows companies to demonstrate repeatability and scale. Access to appropriate facilities for late stage commercialisation is difficult and expensive. Consultation has indicated it could take up to 2 years to get access to appropriate facilities. For small companies, funding can also be a barrier to meet the high cost of prototyping, clinical trials and initial manufacturing runs. This is causing some manufacturers to enter a ‘valley of death’ as they seek to scale up their operations.[42]

Once companies complete these late stage commercialisation steps and gain regulatory approval they can access commercial finance to build scalable manufacturing facilities in Australia, or work with an Australian based contract manufacturer to expand their operations.

Actions

Stimulate co-investment in projects that help companies to finalise their commercialisation steps so their products can be manufactured in Australia

These co-investments could assist medical products companies in their late stage commercialisation by funding:

  • demonstration of product scalability to unlock private investment. This would include assistance with late stage clinical trials, first production runs and prototyping in Australia
  • assistance to ensure commercialised products meet relevant health and quality control standards to get regulatory approvals.

Priority should be given to projects that use high-value manufacturing processes and techniques to manufacture cutting-edge medical technologies and products.

Co-invest in facilities that allow companies to undertake first production runs and prototyping

Securing more medical product manufacturing in Australia requires companies to have ready and affordable access to facilities which validate the commercial viability of a manufacturing process. First production runs that help demonstrate repeatability and scale are a crucial step to basing manufacturing in Australia.

Co-investments could leverage state governments and industry funding to support shared facilities which meet International Organization for Standardization (ISO) and Good Manufacturing Practice (GMP) standards. This would help Australian companies access production facilities for first production runs which meet required regulatory standards. Facilities could include:

  • clean rooms which are often required for manufacturing medical devices
  • short-run production lines for high-value medicines
  • commercial lab environments for regenerative medicines
  • integrated advanced manufacturing facilities for diagnostic products.

These facilities would have a primary focus on helping companies finalise their production methods and receive regulatory approval in Australia. They could then access commercial finance to scale their manufacturing operations.

Engagement and partnerships

This road map will target barriers and unlock opportunities for manufacturers to get competitive products into global markets by supporting business access to local and international supply chains.

Australia is a small medical product market with a small population. Selling products in international markets is a key pathway to scale because it allows Australian businesses to increase their customer base and find a competitive edge. Industry stakeholders highlighted the importance for medical products businesses to scale by seeking out foreign markets and integrating into international supply chains. Manufacturing high-value pharmaceuticals, for example, requires large markets to justify the significant investments and timeframes required for development.

Despite our distance to key markets, there are substantial opportunities for Australian businesses to grow their exports. However, many Australian manufacturers are struggling to access international markets. Small businesses often experience complex overseas regulations, lack of connections in overseas markets and difficulties in joining multinational distribution networks. So while many Australian manufacturers are competitive, some are not able to market their value to global audiences.

Large-scale contract manufacturers are also a critical part of the medical products ecosystem that can support Australia’s integration into global supply chains. There may be opportunities to attract large global companies who are seeking an Asia-Pacific hub for their operations, or encourage Australian manufacturers to scale their operations here. This will have spill-over benefits for Australia’s broader medical ecosystem.

Actions

Co-invest in projects that help manufacturers expand or launch new manufacturing operations in Australia

Co-investments with industry could attract new and expanded manufacturing facilities in Australia. Potential co-investments include:

  • helping companies who have completed their commercialisation steps to build new manufacturing facilities for their products in Australia
  • supporting existing businesses to onshore manufacturing they are currently sourcing internationally 
  • attracting new businesses with new capabilities. 

This could involve a grant to offset capital investment costs in new or expanded facilities, or to develop ‘plug and play’ facilities to attract international manufacturers to base themselves here.

Co-invest in projects that assist manufacturers to integrate into local and international supply chains

Co-investment could support businesses to access supply chains and international markets. Potential projects include:

  • infrastructure investments that enhance the export capability of multiple manufacturers through sharing the cost of packaging, storage and distribution. For example, establishing cold rooms near airports could streamline logistics and cut costs when exporting internationally
  • investments in digital infrastructure such as autonomous sensors, blockchain verification, anti-counterfeiting authentication and verification technologies to track quality control in Australian exports, could provide overseas markets with confidence they are getting a ‘clean and safe’ Australian product
  • helping companies to access international experts in international supply chains will assist companies to target their products at key international distribution partners.

Collaboration

Supporting greater levels of collaboration between government, businesses, venture capitalists and researchers will ensure we realise the benefits of innovation, harness Australia’s world-class research capabilities and translate our great ideas into commercial outcomes. Businesses are more likely to grow and attract investment when they are supported by a thriving business environment. Working with industry to co-invest in projects could:

  • create collaborative environments which support manufacturing to grow
  • encourage the market to invest
  • facilitate collaboration between business, research organisations and state and territory governments. 

By developing these road maps the Government is ensuring science and technology work for industry by fostering the environment needed to improve collaboration to support the sector make more medical products here in Australia. Through strong collaboration across industries and between government and the private sector, we will provide the pathway forward for the sector to leverage economies of scale, share knowledge and drive innovation.

This will aim to grow a globally recognised Australian medical products industry with the capability, capacity and expertise to locally manufacture specialised products and equipment for exporting to international markets and to support domestic health outcomes in Australia.

Actions

Co-invest in vibrant manufacturing ecosystems that support commercialisation and expand manufacturing output

Medical precincts can drive scale by enabling knowledge transfer, downstream processing and pooling of resources to reduce the cost of key inputs. These precincts produce a network-effect increasing collaboration and helping participating businesses to build scale.

Co-investment could be in precincts that have a primary focus on manufacturing. Support would depend on key factors of success including a key anchor tenant (a large successful medical company), proximity to a hospital precinct, and access to research spaces or shared infrastructure. Proximity to transport routes, and packaging and distribution warehouses would also be a consideration. It may be more timely and effective to support sites where many of those elements already exist.

Digital services could expand the potential of these clusters by establishing streamlined pathways to share, collaborate and distribute technologies, skills and products. This could include advanced manufacturing and Industry 4.0 technologies such as 3D printing.

Funding available

The Modern Manufacturing Initiative is now open for medical product manufacturing projects that meet eligibility under its Translation and Integration streams.

Footnotes

42 Prgomet M, Li L, Niazkhani Z et al. (2017) Impact of commercial computerized provider order entry (CPOE) and clinical decision support systems (CDSSs) on medication errors, length of stay, and mortality in intensive care units: a systematic review and meta-analysis, Journal of American Medical Informatics Association, 24(2): 413–422.

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