Workshop, Adelaide, 22 November 2013
About 30 Fellows participated in the ATSE Health Technology Workshop in Adelaide on 22 November 2013, which centred on the future of disruptive technologies in Australia.
Speakers and participants discussed current and emerging disruptive technologies in Australia and the benefits such technologies have for society. A key theme of the discussions surrounded the issues associated with commercialisation of assistive technologies including the barriers to gaining funding and the need to remove cultural barriers to enhance a medical industry in Australia.
Further messages included the need for Australia to create an environment that encourages people to be entrepreneurial; the need to foresee the potential future medical needs of society (future prevention); reducing barriers and encouraging researchers to commercialise products; the benefits of keeping development and production of products in Australia; gaining and retaining confidence in companies who can assist with funding and commercialisation; and discussions surrounding the funding divide for medical research.
The workshop was chaired by Professor Greg Tegart AM FTSE and featured presentations by:
The panel discussion also included:
Currently, there are many implantable devices making significant impacts to health. They are by essence multidisciplinary and have all gone from the bench to in-vitro and in-vivo preclinical evaluation before clinical trials and regulatory approval.
Commercial devices include heart pacemakers (600,000 implanted each year around the world), spinal cord stimulators (15,000 per year) and cochlear implants (a total of 330,000 patients). Australian company Cochlear manufactures the most advanced bionics implant in the world.
The “valley of death” is a developmental barrier to the commercialisation of medical research such as applications in medical bionics. There is little commercial and venture capital (VC) funding in Australia so taking promising clinical research to the market is a challenge.
Iconic Australian companies such as ResMed and Cochlear have international dominance of their respective markets. We have been citing these companies for three decades as great exemplars – but it is time we added more names to this prestigious list.
In Australia and worldwide the focus is mostly on curative, rather than preventive, medicine and in the medical device space particularly, most preventive devices tend to be bed lifters or similar devices. There is a significant opportunity for new technologies for use in preventive medicine.
Disruptive technologies don’t need to be based on long-term, blue-sky research. Current research at Flinders University, together with industry collaborators, is making fundamental changes to bone implants through use of custom mathematical and computational models enabling implants to be modelled for each individual rather than a standard-size-fits-all approach.
Major interests are looking at new materials to assist with wound healing and the application of novel plasma (electrically excited gases) directly to wounds. Room temperature, atmospheric plasmas can provide key oxygen, nitrogen species (known as RONS) which are known to actively intervene in known biological processes (for example wound healing).
Plasma has the potential to be an extraordinary disruptive technology in a wide range of medical indications including wound healing, tissue generation and cancer. However to date most work has been in-vitro. But recently Phase 2 trials show that plasma can decontaminate wounds.
However, there is still a very long way to go. We need to ask the right questions about mode of action (which raises safety?) and how do we deliver plasma species in a controlled manner? We also need also to ask how much to deliver (dose), etc.
Companies like Cochlear will work with organisations but they are reluctant to do it. They are very conservative and look after their core area.
Funding is always a challenge. NHMRC has a development grant program but this represents less than 0.9 per cent of budget so it isn’t making a significant contribution to commercialisation.
For example, with Cochlear, funding came from the public. Cochlear was implanted in one patient, and while it was a very crude prototype that initially failed, it was enough to gain interest. From there they were able to implant two more people and the market was open in large numbers, which resulted in funding.
In addition to funding we need to stimulate a culture of collaboration between research and industry and a “can-do attitude”. We can have a home-grown industry. the Medical Device Partnering Program at Flinders University is an example of a successful research and industry engagement program.
We tend to sell out early, but if we focus on building enterprises in Australia there can be better outcomes for the Australian community as a whole. We need to create a safe environment for people to be entrepreneurial and adventurous.
We need funding, we need a good culture but the other issue is communication and collaboration between academic research and research and development companies. Compared to other OECD countries we are at the bottom in terms of collaboration. KPIs do not reward or encourage researchers to be involved in commercialisation and even though they may want to work in this area they cannot. There is a need to look at addressing performance indicators.
There are benefits to keeping production of medical devices and biologicals in Australia - we keep the technology in-house which can prevent the it from being leaked. Regulatory approval can also determine if the production is conducted in Australia or overseas.
The strength of an individual can determine if the production is in Australia or overseas. If an individual is strong, it is more likely that the production will remain onshore for longer.
We need to make sure that we do not focus on just the big opportunities. Quite often the smaller opportunities are what we can do in Australia. We should not be embarrassed to support small opportunities.
It is important to identify champions of venture capital early. Australia lacks the pool of funds to get good ideas, concepts and projects off the ground.
We need to demonstrate that the devices are worth investing in. Good business partners who can write business cases and review the landscape may assist researchers in demonstrating this.
There are lessons to learn from cases that didn’t work and it may be worthwhile to use these as case studies to highlight what didn’t work.
There is a divide of funding for early-stage applied research and perhaps there is a role for the Academy to try and fix the problem.
Many consider that the healthcare system is broken. Fixes promised by managed care have not materialised, costs are rising and an ageing population means the problems will worsen and new challenges will arise. There is an urgent need to focus on preventative medicine, find cures instead of treating symptoms, and improve the quality of life of an ageing population. Importantly, new medical approaches need to be affordable and accessible to the general population.
Current and emerging disruptive technologies will be an important part of the solution to this complex problem. Australia is well positioned to be at the forefront of new medical technologies – cochlear implants, spinal cord stimulators, pacemakers, visual prostheses, fall monitors and other monitoring technology, and neurobionics – to name a few.
(For example, the Lysosomal Diseases Research Unit (LDRU), in the Women’s and Children’s Hospital, North Adelaide is a world leader in early diagnosis and effective therapy of a devastating genetic condition - Lysosomal Storage Disorder (LSD). LSD is where the body cannot recycle complex materials to their basic building blocks. Instead partially degraded materials are stored in cells to cause tremendous harm to that cell. There are more than 60 different types of LSD and death generally occurs in a person before they reach the age of 20. The total incidence for classical LSD is as high as 1 in 5,000 and for non-classical possibly 1 in 200.
LDRU research to develop therapies commenced in 1980. In partnership with US Pharmaceutical companies two therapeutic products were ready for clinical trial in the early 2000’s to obtain approval from the US Food and Drug Administration (FDA). Five Australian patients participated in one FDA trial in Adelaide with other trials conducted internationally. In 2006-2007 the FDA approved drugs for the treatment of two different LSD types. This enabled thousands of patients to be treated world-wide. In a matter of 20 years the LDRU went from starting the project to gaining FDA approval for this previously intractable condition.)
Implantable devices offer another disruptive technology that is making significant impacts to health worldwide. The success of these medical bionics devices has relied on miniaturisation as well as low power integrated circuits with significant computational capacity. There are now many commercial devices including heart pacemakers (600,000 implanted each year around the world); spinal cord stimulators (15,000 per year); and cochlear implants (a total of 330,000 patients). Other devices in development include brain computer interfaces; vision prostheses; and deep brain stimulators. This is a field in which Australia excels – Australian company Cochlear manufactures the most advanced bionics implant in the world.
The recently established Cooperative Research Centre for Cell Therapy Manufacturing is using novel plasmas to develop new surfaces and materials that will facilitate affordable and accessible treatments for a range of diseases such as diabetic foot ulcers, cardiovascular disease, diabetes and immune diseases.
Australia has an enviable track record in the development of disruptive medical technologies, with iconic companies such as ResMed and Cochlear having international dominance of their respective markets.
However, there are significant barriers to overcome if we are to capitalise on the opportunity to be a world leader in this exciting field. Notably, we need to be much more proactive in taking novel research discoveries to market, and address the lack of commercial and venture capital funding required.
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