Author: Team
WESTMEAD PRIVATE INVESTS IN INDUSTRY LEADING 3D SURGERY TECHNOLOGY
[vc_row][vc_column][vc_column_text]This new technology means that complex surgeries can now be performed with laparoscopic surgery rather than open surgery, reducing pain and recovery time. This is particularly important for complex bariatric surgery, lung and liver resection surgeries.
VISERA ELITE II restores natural 3D vision and depth perception, providing improved speed, accuracy and precision for surgical tasks. It is unique in offering a rigid 3D video laparoscope that supports seamless direction-of-view rotation to mimic the traditional camera head / telescope configuration without rotating the image on screen. This significant technological development overcomes a major hurdle to 3D adoption. It ensures a level surgical horizon is maintained at all times, while removing the learning curve traditionally associated with 3D imaging.
Dr Brendan Ryan performs bariatric surgery at Westmead Private and recently had the opportunity to use the new Olympus 3D system for gastric sleeve and gastric bypass procedures. “The increased depth of vision is amazing and makes my surgery more precise. It allows me to undertake my more complex operations with greater surety. I am so excited about this enhanced technology and am constantly impressed by the extra vision I can get,” said Dr Ryan.
Westmead Private is committed to providing the best in health care, offering surgical options that achieve the most optimal outcomes for patients.
“It is wonderful to be able to offer such cutting edge technology to our patients, which will help us deliver enhanced, faster and more effective care. Further enabling us to become the first choice for patient care in our community,” said CEO Mike Flatley.[/vc_column_text][/vc_column][/vc_row]
2018 BUDGET REVIEW
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OVERVIEW
Treasurer Scott Morrison has handed down this third, and likely last budget before the next federal election. The theme of this year’s budget was focused on governments living within their means, keeping spending and taxes under control, and providing essential services.
In the weeks leading up to the budget, the Turnbull Government had begun announcing its commitments, giving the public a sneak-peek into what to expect when the budget was officially handed down.
The government used the budget head-start to differentiate itself from what it describes as the ‘high-taxing’ Shorten Opposition. As speculated, the government reaffirmed its commitment to cutting the corporate tax rate, and to the introduction of phased income tax relief, spread across seven years. As a result, low and middle-income earners will see immediate tax relief from 1 July 2018, with the Low-Income Tax Offset to almost double to $1,000 a year.
During his budget speech to the House of Representatives, the Treasurer announced the 37 per cent marginal rate will be abolished from 2024-25 and replaced with a simplified tax scale that includes a new rate of 32.5 per cent – making bracket creep a thing of the past for most working-class Australians. It’s also worth noting that the top marginal tax rate won’t see a threshold rise until, at least, 2024, increasing to $200,000.
The Treasurer’s pledge of $140 billion in personal income tax relief over the decade is optimistic as that seven years will run over two electoral cycles, meaning it could be susceptible to revision if there is a change of government.
Treasury modelling shows an optimistic return to wage growth of 3.25 per cent, which currently sits at approximately 2 per cent.
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Health portfolio
The 2018-19 budget builds on the government’s investment in health, which is expected to increase from $78.8 billion in 2018-19 to $85 billion in 2021-22. The Health portfolio now accounts for 16.13% of overall government expenditure.
As the nation’s fiscal situation continues to improve, the government is being encouraged to prioritise health expenditure for Australians. The current service delivery system in Australia provides fragmented care. If Australia seeks to become the “healthiest nation on earth” it will need to transform its healthcare system to be fit for the 21st century. While the healthcare industry will continue to advocated for reforms that shift away from volume and towards value-based healthcare (VBHC), this year’s budget made no commitments to aligning reform to VBHC.
The government has pledged to deliver $6 billion in record funding for Australia’s health and medical research sector, including $3.5 billion for the National Health and Medical Research Council, $2 billion in disbursements from the Medical Research Future Fund and $500 million from the Biomedical Translation Funding. The government will also invest an additional $10 million towards the BioMedtech Horizons program for which the Medical Technology Association of Australia (MTAA), through its Agreement, has ensured an additional $30 million.
Overall, stakeholders are positive about the budget’s health commitments. It is believed the Minister for Health, Greg Hunt, is taking a much more proactive approach with the sector, countering past negatives such as the ‘medicare’ campaign. One example of this is the government’s commitment to improving rural health services through the Stronger Rural Health Strategy, underpinned by this year’s budget commitments.
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Other insights from the health budget include:
- $1.3 billion over 10 years to establish a National Health and Medical Industry Growth Plan.
- $2.2 million in 2018-19 for the operational costs of the Australian Breast Device Registry and the Cardiac Devices Registry. The registries contribute to the long-term sustainability of the health system by supporting improved clinical care and better patient outcomes. This measure further extends the 2017-18 Budget measure titled Operational Costs for Cardiac and Breast Device Registries — extension.
- $2.4 billion for the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS over five years from 2017-18 to fund more medicine listings, including $241 million for SPINRAZA, a medicine to treat Spinal Muscular Atrophy (SMA), and $703.6 million for breast cancer treatment Kisqali.
- $338.1 million for mental health funding, focusing on suicide prevention, research and older Australians.
- Additional $10 million for the BioMedTech Horizons program.
- $40 million for whooping cough immunization.
- $25.4 million over four years for new and amended Medicare Benefits Schedule and Veterans’ Benefits items.
- $83.3 million for mental health nurses in rural areas.
- $106.8 million over four years to modernise health and aged care payments systems.
- $30 million over four years to the Australian Institute of Health and Welfare to improve accessibility to health information and statistics, including better data sharing capability and information and communications technology upgrades.
- help women take advantage of opportunities in the health care and social assistance industry by providing $64.3 million to establish a Jobs and Market Fund to grow the National Disability Insurance Scheme’s workforce.
- $37.6 million over four years from 2018-19 to improve follow-up care for people discharged from hospital following a suicide attempt — the highest at risk group in Australia — including:
- $10.5 million for beyondblue to provide national support and oversee the implementation of the Way Back Support Service (WBSS) in Primary Health Networks.
- $27.1 million for Primary Health Networks to commission services to be accessed by WBSS clients (contingent on co-contributions from States and Territories).
- $33.8 million funding boost for Lifeline will enable the mental health helpline to continue to save lives every day.
- $12.4 million over four years from 2018-19 to strengthen the National Mental Health Commission.
- As expected no announcement related to the Prostheses List or private health insurance.
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Budget Reply
The opposition used their budget reply speech to promise voters that, if elected, Labor would be able to deliver a larger tax break for low and middle-income earners than a coalition government. The opposition’s Working Australians Tax Refund, delivered at a cost of nearly $6 billion over four years, equates to $928 per year, which the opposition says would represent a tax refund of $400 more than offered in the budget.
The opposition is trying to position itself as the party of health and education by outlining a number of key policy announcements including a promise to reverse the government’s policies on hospitals by creating a $2.8 billion Better Hospitals Fund.
Opposition Leader Bill Shorten has said the funding would mean more beds to reduce emergency room wait times, a reduction in waiting lists for elective surgery, and upgrades to emergency departments in the suburbs and regions.
Stakeholders welcomed the opposition’s promise to provide new MRI machines to 20 hospitals and imaging centres in the regions and outer suburbs, giving Australians with cancer a better level of care. Worth noting is that while 40 per cent of cancer cures involve radiation therapy, only nine cents in every dollar for cancer treatment is spent on radiation therapy. Promising $80 million to pay for the machines if Labor won the next election, MR Shorten said Medicare would cover the costs of 500,000 more scans for cancer sufferers.[/vc_column_text][/vc_column][/vc_row]
Tessa Kowaliw speaks with PulseLine
Medtech’s Growing Role in Clinical Trials in Australia
[vc_row][vc_column][vc_column_text]The country’s regulatory environment and organizations such as the MTAA have helped to nurture the increasing interaction between industry and clinical researchers, ushering in more trials that help to improve medical therapy and offer benefits to both patients and the economy. In celebration of International Clinical Trials Day, let’s take a look at the study landscape in Australia and how it has transformed in recent years.
Medical device companies are playing an increasingly important role in Australia when it comes to clinical research. The number of new clinical trials involving medical devices increased greatly by 12.6% annually between 2010 and 2015. In comparison, the growth rate for new pharmaceuticals trials was only 2.7% during the same period. Overall the number of new trials rose by 4.7%.
A number of global medical technology companies are already taking advantage of the favourable conditions that Australia offers for early-phase clinical trials. The regulatory environment is conducive to first-in-man studies and there are dedicated research teams with a strong commitment to data quality. However, more needs to be done for Australia to remain competitive in the international clinical trials landscape. Especially when it comes to early phase studies, time is essential. Recent reforms have targeted limitations such as slow study start-up due to duplication of ethical review of the same study across multiple hospital sites. The MTAA plays an active role in informing public debate as well as government during the reform process via its Clinical Investigations Forum which was formed in 2011.
Fundamentally, clinical trials with medical devices serve patients. They benefit from access to the latest technologies that may not yet be available commercially, advice from and treatment by leading medical practitioners, and, in many cases, closer monitoring of their treatment. Moreover, from a healthcare system perspective, clinical research promotes the use of best evidence in medical decision-making based on health economic value. A vibrant clinical trials infrastructure attracts academic talent with positive flow-on effects for hospitals, communities and even the entire country. Clinical trials have a positive economic impact as well. Not only through the direct investment in clinical studies and infrastructure, but also by rigorously testing innovative technology, thus preparing it for market launch based on solid clinical evidence. For those reasons, the Australian government continues to strongly support clinical research activity.
An example of a recent and potentially guideline-changing trial is CASTLE-AF, which was conducted with BIOTRONIK’s support. The multicentre trial showed a 38% reduction in the composite endpoint of all-cause mortality and hospitalization for worsening heart failure, when catheter ablation was used to treat heart failure patients with atrial fibrillation (AF). All patients in the study had implantable cardioverter-defibrillators or cardiac-resynchronisation defibrillators with BIOTRONIK Home Monitoring technology. The reduction was observed when comparing these patients to patients treated with the pharmacological therapy recommended by current guidelines.
Dr. Johannes Brachman, Coburg Clinic, Germany, who led the trial together with Dr. Nassir Marrouche, CARMA Center, University of Utah, Salt Lake City, US, said: “These findings indicate heart failure patients with coexisting AF should be treated with catheter ablation as a first-line therapy.” The CASTLE-AF study thus contributes to enriching clinical knowledge and further developing therapy options for heart failure patients. Notably, this clinical trial also included two Australian investigators (Dr. Prash Sanders, Royal Adelaide Hospital, Adelaide, SA and Dr. Paul Martin, Royal Brisbane and Women’s Hospital, Brisbane, QLD).
When conducting clinical trials, medtech companies follow strict ethical principles. Each trial needs to be assessed by an independent Human Research Ethics Committee prior to being allowed to commence. The safety of the individual patient in a clinical trial always has priority over the trial itself. Patients choose whether or not to participate and they can withdraw their consent at any time.
On the occasion of International Clinical Trials Day we recognize clinical research and the people that make that research possible. The medical device industry is very fortunate to work with Australia’s brightest and most dedicated clinical research professionals for the benefit of our patients. We congratulate them on their achievements.[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1971″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]
ABOUT THE AUTHOR
Falko Thiele, is the Director Clinical and Regulatory Affairs at Biotronik.[/vc_column_text][/vc_column][/vc_row]
DR DAN GRANT ANNOUNCED AS NEW CEO OF MTPCONNECT
[vc_row][vc_column][vc_column_text]Dr Grant joins MTPConnect from his position as Pro Vice-Chancellor for Industry Engagement at La Trobe University in Melbourne, where he leads the University’s innovation, commercialisation and industry engagement activities. Dr Grant also oversees the University’s R&D Precinct and was responsible for establishing La Trobe’s business accelerator program and Strategic Innovation Fund.
Prior to joining La Trobe, Dr Grant was the Senior Director and Head of Pfizer’s External Research and Development Innovation group for Australia, New Zealand and Singapore. He has also held roles as Senior Business Development Manager at Melbourne Ventures, a member of the Investment Committee for Uniseed, and as a Senior Business Development Manager for Biocomm Services.
With a strong background in University research and industry, Dr Grant will work with the MTPConnect Board and Chair to further develop the organisation by building relationships with industry, government and other stakeholders, both nationally and internationally.
Dr Bronwyn Evans, the chair of MTPConnect, said the appointment of Dr Grant brings new opportunities for growth and advancement, not just within MTPConnect, but for the entire MTP sector in Australia.
“The Board is delighted to welcome Dr Grant to MTPConnect. Under the leadership of Sue MacLeman, MTPConnect has become an extremely valuable contributor to the MedTech and Pharmaceuticals sector. MTPConnect has an impressive reputation for making a difference, and Dan’s business and academic background make him the ideal person to take up the mantle as CEO. I look forward to seeing the organisation continue to flourish under his leadership.”
Dr Grant said he was very excited to be joining MTPConnect in July.
“I am honoured to be joining MTPConnect and to be given the opportunity to work closely with the entire MTP sector, to represent the sector’s interests and act as a champion for change. Building on the success that MTPConnect has achieved under Sue MacLeman’s leadership, I relish the opportunity to ensure that MTPConnect continues to have a leading role in guiding and promoting the sector’s long-term success.”
MTPConnect was formed as a not-for-profit organisation in November 2015 as part of the Australian Government’s Industry Growth Centres Initiative. MTPConnect sits at the nexus of the sector, driving collaboration, acting as an independent voice for change, working to establish Australia as an Asia-Pacific hub for MTP companies, and funding big, bold ideas to accelerate growth and drive greater commercialisation opportunities.
As announced in February 2018, Sue MacLeman, the first CEO of MTPConnect, will assume the Chair position in place of Dr Bronwyn Evans who is stepping down.
To ensure appropriate governance, there will be a gap between Ms MacLeman stepping down as CEO and taking up the role as Chair. During this three-month period, Dr Evans will remain the Chair and work with the new CEO, with Ms MacLeman to be appointed as a Non-Executive director to assist in transition. In October 2018, following three months as a Non-Executive board member, Ms MacLeman will move to the Chair role and Dr Evans will step down from the Chair and Board role with MTPConnect.[/vc_column_text][/vc_column][/vc_row]
Department of Health’s Mark Cormack sits down with PulseLine
ACCESS TO MEDICAL TECHNOLOGY: MRI LICENCES IN THE SPOTLIGHT
[vc_row][vc_column][vc_column_text]One of the biggest advancements in medical technology is in the diagnostic assessment of patients through Magnetic Resonance Imaging technology or the MRI scan as it is more commonly known.
The history of MRI can be traced all the way back to 1971 when physician and experimenter Raymond Damadian discovered that the hydrogen signal in cancerous tissue is different to that of healthy tissue because tumours contain more water.
Jump forward a few years and in 1977 Raymond Damadian built the first MRI scanner and achieved the first MRI scan of a human body. A truly amazing technological achievement.
As with most medical technology, questions of cost and access are always at the forefront of public debate and a constant challenge for policy makers to be able to meet public expectations.
Recently, the Senate Community Affairs References grappled with this very issue through its’ inquiry into access to diagnostic imaging equipment around Australia.
A key focus of the inquiry was how are MRI licences granted and who gets them. What is the process and how does it work?
Unlike with pharmaceuticals which is subject to a rigorous process of independent assessment via the pharmaceutical benefits advisory committee (PBAC) no such process exists for a sponsor wanting to apply for a full Medicare rebate able MRI licence.
MRI licences are granted solely by the Minister for Health of the day. Consequently, successive Governments have been left open to the accusation that MRI licences are granted to meet political objectives as opposed to patient need based on such key criteria as population growth and changing demographics.
To emphasise the importance of this point the Senate Committees first recommendation was that:
“…. the Commonwealth Government immediately implement an application process with clear, objective and transparent assessment criteria to permit hospitals and radiology practices to apply for licences for Magnetic Resonance Imaging machines”.
With Australia facing an increasing ageing demographic and the welcome fact that we are all living longer, community expectations will always be a constant challenge for policy makers when it comes to access to medical technology.
Access to diagnostic imaging services like MRI scans is but one example of this constant challenge.
Financial resources are always limited and finite, yet Government will always face the constant demand to fund more health services, more pharmaceuticals and new medical technology.
For any Government allocating scarce resources, particularly in health then transparency should be welcome and more help than hinderance.
While there are regular complaints with the speed at which some new and innovative drugs get listed on the PBS, the independence of the PBAC is never called into question, for the simple fact that it is an independent process.
For diagnostic imaging services and in this case access to MRI licences, the lack of an independent process for allocating those licences, will leave the Government of the day open to criticism as to the allocation of those licences.
With the Senate Report now handed down, the ball is now in the Governments court as to how they respond to the recommendations.
The community should know in the next few months what the Government response will be to this challenging issue.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]
ABOUT THE AUTHOR
Jody Fassina is the Managing Director of Insight Strategy and has been an strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column][/vc_row]
NEW RESEARCH HUB TO TRANSFORM AUSTRALIA’S MEDICAL TECHNOLOGY SECTOR
[vc_row][vc_column][vc_column_text]Above: ARC CEO, Prof. Sue Thomas (second from right) officially launches the ARC Research Hub for the Advanced Manufacturing of Medical Devices (AMMD Research Hub) with Director of the Advanced Manufacturing Growth Centre Mr Michael Grogan, Member for Sunnybank Mr Peter Russo MP, AMMD Research Hub Director Prof. Matthew Dargusch, Cook Medical Australia General Manager Dr. Samih Nabulsi at, Director – APAC and VP Cook Inc. Mr. Barry Thomas and UQ Vice-Chancellor and President Prof. Peter Høj at Cook Medical Australia in Brisbane today.[/vc_column_text][vc_separator][vc_column_text]While a key aim of the research hub is the transformation of Australia’s medical technology sector by developing competitive technologies for the rapid production of medical devices, it is patients who are set to benefit most from the industry-research partnership.
One of the key goals for the AMMD Research Hub is to improve health outcomes for patients in Australia, and around the globe, by improving the time it takes to design, manufacture and supply customised medical devices such as endovascular stent grafts for patients with aortic aneurysm—a condition that currently has post-rupture survival rates of only 10 to 20 per cent.
Cook Medical Australia General Manager Dr Samih Nabulsi said the AMMD Research Hub would deliver outcomes for patients by fostering growth in the medical technology sector in Australia.
“Our primary goal is to improve patient health outcomes, but we are also growing workforce capability in the medical device industry and increasing the translation of new technology,” Dr Nabulsi said.
“Research and industry partnerships like the AMMD Research Hub are vital to increasing and accelerating the translation of new technology in the medical device industry.”
From a patient and treating doctor perspective, the AMMD Research Hub’s approach to research and innovation offers the promise of improvements to patient care and clinical outcomes by reducing the complexity associated with manufacturing medical devices.
From a manufacturing perspective, the AMMD Research Hub represents a critical mass that can take advantage of the synergies and strengths of the individual participants and deliver productivity benefits that would not be independently realisable.
AMMD Research Hub Director and University of Queensland Professor Matthew Dargusch said that effective collaboration between diverse industry and university partners is the key to addressing challenges in the advanced manufacturing of medical devices.
“It is the knowledge transfer that comes from taking a collaborative, cross-disciplinary and cross-sectoral approach to medical technology that will lead to making game-changing innovations in the sector,” said Professor Dargusch.
With researchers based at Cook Medical Australia, the AMMD Research Hub has already begun work in the areas of lean manufacturing to improve the production times, adaptive automation systems, metallic biomaterials and collaborative robotics.
Director Asia-Pacific and Vice President of Cook Incorporated, Barry Thomas said the AMMD Research Hub is an important example of the advanced manufacturing sector working together with researchers and universities.
“The AMMD Research Hub will make a significant contribution to advancing the medical device industry in Australia through efficiency of processes, materials and technologies, and realise further export opportunities for IP derived from manufacturing process improvements.”
“The collaboration is key for sustaining innovation and manufacturing excellence and will contribute positively to the economy, create jobs, and strengthen the advanced manufacturing sector,” Mr Thomas said.
The AMMD Research Hub brings together researchers from the University of Queensland, the University of the Sunshine Coast, the University of Sydney, RMIT, with industry partners including Cook Medical Australia Pty Ltd., Robert Bosch (Australia) Pty Ltd.; Heat Treatment (Qld) Pty Ltd. and QMI Solutions Ltd.
In 2016, the AMMD Research Hub was awarded $2.8 million in ARC funding for five years. This investment was matched by industry partners, with a total value of more than $10 million of cash and in-kind funding.[/vc_column_text][/vc_column][/vc_row]
LAUNCHING THE BRIDGETECH PROGRAM FOR THE MEDTECH MINDED
[vc_row][vc_column][vc_column_text]Professor Lyn Griffiths, Executive Director of QUT’s Institute of Health and Biomedical Innovation (IHBI) and Director of The BridgeTech Program, said 100 applicants will be selected from around Australia who want to bolster their knowledge of the scientific, legal, financial, clinical, regulatory and reimbursement disciplines related to taking developed medical technology to market.
The BridgeTech Program is open to mid-career entrepreneurs, researchers, business development professionals, IP lawyers, regulatory officers and others in the med-tech ecosystem.
Led by QUT, The BridgeTech Program involves a consortium of partners including medical technology companies, universities and industry associations: Flinders University, Siemens Healthcare, Cochlear, Hydrix, Magnetica, University of Newcastle, MTAA, University of Western Australia, AusBiotech, and many others.
The BridgeTech Program is also supported by MTPConnect – the Medical Technologies and Pharmaceuticals Industry Growth Centre – which is providing industry-matched funding to run the program.
Professor Griffiths said today’s launch, at Tonsley Innovation District in Adelaide, was held in conjunction with the 10-year anniversary of the Medical Device Partnering Program led by BridgeTech consortium partner Flinders University.
“This is an important partnership, linking research and technology development with entrepreneurship,” she said.
“Through its consortium of partners, The BridgeTech Program is unique in its ability to incorporate industry expertise, create key collaboration opportunities and draw on the breadth of knowledge needed to design an effective course.”
The BridgeTech Program launch was followed by a panel discussion on the MedTech entrepreneurship landscape in Australia with MTPConnect CEO Sue MacLeman, Ferronova CEO Stewart Bartlett and Managing Director of Micro-X Peter Rowland.
Professor Griffiths said The BridgeTech Program is structured to accommodate the busy researcher/entrepreneur as a self-paced online learning program incorporating a three-day workshop to consolidate learning and create key sector networks.
“Developing this important educational initiative in partnership with industry means that participants will be provided with relevant and specific commercialisation training, advice and networks to better assist the commercialisation of medical technology and medical devices in Australia,” she said.
Managing Director and CEO of MTPConnect Sue MacLeman said medical technology is the fastest growth area in the Australian med-tech, biotech and pharma sector.
“The BridgeTech Program will provide practical and important support to develop a more vibrant and impactful MTP sector ecosystem, contributing to the growth of our sector on the world stage,” Ms MacLeman said.
“As part of our mission, we are funding big, bold ideas that will deliver results on a national scale, have sector-wide impact, and are aligned with the Sector Growth Priorities identified in our 10- year Sector Competitiveness Plan. We are very proud to be supporting this truly collaborative initiative that brings together expertise from industry and research, building on the success of pharmaceutical-focused Bridge Program.”
Ian Burgess, CEO of the MTAA said as the peak industry body for medical devices we’re pleased to be supporting an initiative that will help develop those in their mid-career stage get to the next level.
“Global advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years.
“Technology allows patients to hear, to walk, to see, to live or to have a quality of life that they otherwise would not have.
“MTAA looks forwards to welcoming the first 100 applicants to Sydney for the three day residential prior to our Annual Conference on the 7-8 November.”
The BridgeTech Program is the sister program of The Bridge Program, which is now in its second successful year and focuses on the skills needed for research translation and the commercialisation of medicine in the pharmaceutical industry.
For information on The BridgeTech Program, contact bridgetech.program@qut.edu.au.
To submit an application please complete an EOI here.[/vc_column_text][/vc_column][/vc_row]
