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Digital Health Needs To Be Safe, Seamless And Secure

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[vc_row][vc_column][vc_column_text]Australian Digital Health Agency CEO Tim Kelsey delivered his Your Health in Your Hands – the Digital Evolution of Health and Care in Australia speech at the National Press Club today and outlined the collaboration needed between governments, consumers, clinicians, and entrepreneurs to make data and technology work better for modern health.

“Australia has one of the best systems in the world – by any measure. We are at the forefront of medical research, we have world-class facilities, and the people that provide care are among the most highly skilled and committed professionals anywhere.

“But the hum and whirr of the fax machine in the background of our care services reminds us that there is more to do: paper based healthcare means that clinicians do not always have the right information at the right time to make the best decision,” Mr Kelsey said.

Mr Kelsey said that Australia’s National Digital Health Strategy – Safe, Seamless, and Secure underpins the country’s vision for digital health. My Healthy Record is the strategy’s top priority because it puts consumers at the centre of their health care and provides choice, control, and transparency.

More than 5.7 million Australians currently have a My Health Record. By the end of 2018 Australia will be the first country of its size in the world to provide mobile records to every person, unless they choose to opt out. By 2019, every registered clinician will have a secure means of communicating digitally, without resort to paper or a fax machine.

Damien Taylor is one of many parents who has experienced firsthand the benefits of My Health Record. His young daughter Maggie underwent open‐heart surgery for a congenital heart defect at seven months old.

“Maggie’s medicines, conditions, and hospital stay information were captured in My Health Record so we won’t need to keep hard copy records and try and remember everything at each medical appointment in the future,” Mr Taylor said.

Dr Elizabeth Jackson also believes digital health is the way forward for Australia’s healthcare system. The Cairns-based obstetrician and gynaecologist uses My Health Record to provide her expectant patients with peace of mind throughout their pregnancies.

“My Health Record is an incredibly valuable tool. It allows 24/7 access to patient records and allows us to work together as a team to deliver high-quality and cost-effective medical outcomes,” Dr Jackson said.

A national communications strategy will be implemented to inform all Australians of the benefits of digital health, and to explain the opt out process. During the opt out period individuals who do not want a record will be able to opt out by visiting the My Health Record website or by calling 1800 723 471 for phone based assistance.

Engagement at a local level in community and in trusted healthcare provider settings is a central pillar of the communication strategy with research confirming that 89% of people will expect to receive information about My Health Record from their health care provider.

“The benefits of My Health Record must be accessible to all Australians. There has been a particular focus in our communications research on developing appropriate support for people with limited digital literacy or access, and other groups including people from culturally and linguistically diverse (CALD) backgrounds, Aboriginal and Torres Strait Islanders, and people living in rural and remote communities,” Mr Kelsey said.

The Agency is also working with more than 100 partner organisations, including the Primary Health Networks, the Australian Health Practitioner Regulation Agency, and Australia Post to inform the Australian public about My Health Record, its security controls, benefits, and their rights to opt out.

Information will also be made available in over 15,000 health care locations including general practices, pharmacies, public and private hospitals, and via Aboriginal Medical Services and National Aboriginal Community Controlled Health Organisations.

Australia Post Chief Executive Christine Holgate said the company is pleased to announce that it will be working closely with the Agency to support the national expansion of My Health Record with 3600 Australia Post outlets reaching up to two million Australians over the three month opt out period.

“Australia Post recognises the critical benefits of My Health Record for improved health sector outcomes. We will support the expansion program through traditional postal and parcel services, and promotion through our extensive post office network,” Ms Holgate said.[/vc_column_text][/vc_column][/vc_row]

My Health Record Data for ´Research and Public Health Purposes´

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[vc_row][vc_column][vc_column_text]The Medical Technology Association of Australia (MTAA) welcomes the release of the framework to guide the secondary use of My Health Record system data. The guiding principles within the framework align with MTAA´s position to allow third parties access the data for public health and research purposes.

To inform on how data on the My Health Record system can be used for research and public health purposes while preserving privacy and security of data in the system, the Australian government developed the framework in consultation with key stakeholders.

Minister for Health, Greg Hunt, said My Health Records “provides many benefits to patients, including reduced duplication of tests, better co-ordination of care for people with chronic and complex conditions, and better-informed treatment decisions”.

“I would encourage each and every Australian to use their My Health Record and to speak with their healthcare providers regarding these benefits,” he said.

The Australian Medical Association President, Dr Michael Gannon, said the current system meant many patient records were incomplete especially if the patient has seen another specialist or has been discharged from a hospital.

“The My Health Record now provides patient medications, referrals, shared health summaries, pathology and diagnostic imaging reports and, increasingly, hospital discharge summaries”, Dr Gannon said.

Consumer Health Forum CEO Leanne Wells welcomed the government´s announcement.

“The clinical benefits of My Health Record for patients are significant and compelling: hospital admissions avoided, fewer adverse drug events, and better-informed treatment decisions. For too long, healthcare has lagged behind in exploiting the clear benefits of information technology,” Ms Wells said.

However, issues and concerns would remain to be addressed, especially enforcing law protecting security and privacy.

Australian Digital Health Agency CEO Tim Kelsey says, “Strict privacy control, set by an individual, is a central feature of My Health Record. Each person can control the information in his or her My Health Record, and the healthcare provider organisations that can have access.”

Ultimately, patients will be the biggest beneficiaries of this framework development.

Now under the framework, My Health Record system data may be linked to other datasets, such as the Pharmaceutical Benefits Scheme (PBS) or the Medicare Benefits Scheme (MBS). This is a great opportunity for the medical device sector.

Ian Burgess, CEO of MTAA said: “The development of My Health Record will provide a tremendous opportunity to improve data collection across the whole health system and across the patient journey. We believe the government should prioritise consideration of the inclusion of medical device data in the My Health Record,”

“This would allow for improved post-market surveillance. While registries can be invaluable they’re complex and expensive. Ultimately, My Health Record should be the main data infrastructure system, rather than maintaining separate data collection systems,” Mr Burgess said.[/vc_column_text][/vc_column][/vc_row]

PRIVATE HEALTH INSURERS NEED TO FOCUS ON VALUE

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[vc_row][vc_column][vc_column_text]As Sydney Morning Herald reporter, Esther Han said earlier this week “it appears the federal government’s private health insurance reforms – including cutting the cost of devices on the prostheses list and allowing insurers to offer discounts to young adults – have done little to stem the flow of members heading to the exits.”

CEO of the Medical Technology Association of Australia (MTAA), Ian Burgess, said under MTAA’s Agreement with the Government to reform the Prostheses List, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of private health insurance.

“APRA quarterly figures show that private health insurance benefits paid for prostheses decreased by 13%, saving the private health insurance industry $72 million in the March quarter alone.

“We’re the major reason this year’s average private health insurance premium increase was the lowest in 17 years,”

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia, however private insurance needs to provide consumers value and that value needs to be better communicated. This value currently includes the choice of medical technology that a patient’s treating doctor considers to be the most clinically appropriate, generally with no gap payment applying to that technology,” Mr Burgess said.

The latest APRA data shows that in the 12 months ending March 2018, private health insurers increased premium revenue by 4% and retained more of that revenue, with total benefit payments increasing by just 3%. As a result, gross margin increased from 13.6% to 14.41% and profit before tax increased by 3.9% to $1.8 billion.

Private health insurers have managed to consistently increase margins and profit levels, compared to three years ago profit before tax has increased by 20%.

Referring to Roy Morgan research that in the year to March 2018, an estimated 256,000 people decided not to renew their private health insurance, Norman Morris, Industry Communications Director, Roy Morgan said “there is major doubt among many members regarding the current value to them of retaining their private health insurance. It is up to the health funds to communicate the value of having private health insurance”.  

“Our research on member satisfaction with private health funds has shown major differences in satisfaction across funds and as a result the poorer performers could learn from the top ones and so improve their chances of member retention,” Mr Morris said.

While the latest APRA data for the year to March shows a decline of 36,742 in the number of people with hospital insurance and an increase of 52,977 in those with general insurance (extras), these represent net movements (exits and new). The Roy Morgan data represents an exit rate in the order of 1.9%, which is broadly in line with industry modelling published by the Department of Health.

The APRA figures show the number of people with hospital cover as a proportion of the population is continuing to decline – down another 0.1 per cent in just three months to 45.5%.

Private Healthcare Australia CEO Dr Rachel David said: “In fact more Australians than ever currently hold PHI. What people say they might do and what they actually do can be quite different and our research has repeatedly shown than 80% of people with PHI value it and want to keep it.

“Of course, members are concerned about rising premiums and out-of-pocket medical costs but they also understand that premiums are rising because the funds are paying for more healthcare,” said Dr David.

“We are working with the government and stakeholders to improve affordability by addressing issues such as cost-shifting from the public sector, low-value and wasteful care, fraud and compliance issues with the MBS”, Dr David said .

Meanwhile the Australian Private Hospital Association (APHA) pointed out the statistics released this week showed a 4% increase in privately insured patients treated in public hospitals this quarter.

CEO of APHA Michael Roff said this means more than 800,000 public hospital episodes of care were funded through private health insurance in the past 12 months, resulting in health insurers unnecessarily paying out $1.1 billion to public hospitals and forcing premiums up.

The increase of private patients in public hospitals is costing the private health system $1 billion, further evidence of real “fat in the system”.

“It means more people without the ability to pay for private health care will be left waiting for their surgery. We know that public hospitals let private patients jump the queue, with public patients waiting twice as long for treatment compared to insured patients. So the more private patients they treat, the longer public patients have to wait,” Mr Roff said.

Earlier in the week PulseLine was present when Shadow Minister Catherine King MP delivered her Post-Budget Briefing speech at the Australian Institute of Policy Studies to a full room in Sydney. She made it clear that for Labor the priorities are threefold – Medicare, public hospitals and private health insurance.

Labor has already announced our policy to task the Productivity Commission with an inquiry into the private health system, and to cap premium increases at 2% for two years.

“This policy was driven by two messages that we heard over and over in recent years.

“The first was from consumers, who told us that private health insurance premiums have become unaffordable. And they’re right – premiums have increased by 27 per cent since 2014 – costing families an average $1,000 more. Health insurance is now a leading cost-of-living concern – right up there with energy bills. Hospital cover has dropped to its lowest level since 2011. This is a worrying portent for the future viability of this industry. But private health insurance is still a product that Australians want – and rightly so.

“The second message we heard loud and clear was from the private health insurance industry itself. It told us that governments and regulators needed to step in urgently to turn the tide. We agree. And so while Labor’s policy prescription is different than the insurers’, we have the same aim: to maintain private health insurance coverage and the unique balance between our public and private systems, said Ms King.

Ms King pointed out that it has been 20 years since the Productivity Commission has reviewed the private health system in and despite recent reviews, reforms and Senate inquiries it has barely scratched the surface of the complex private health system.

The APRA publications provide industry aggregate summaries of key financial and membership statistics for the private health insurance industry. Key performance statistics for the private health insurance industry in the year ended 31 March 2018:[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1989″ img_size=”full”][vc_column_text]Reform in healthcare is clearly a hot issue and will continue to be as we hurtle towards the next Federal election.[/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]

Medtech’s Growing Role in Clinical Trials in Australia

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[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

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[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]

ACCESS TO MEDICAL TECHNOLOGY: MRI LICENCES IN THE SPOTLIGHT

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[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

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[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

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[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]

SHIFTING FROM VOLUME TO VALUE MAKES SENSE

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[vc_row][vc_column][vc_column_text]The concept is certainly gaining increasing prominence around the world. Based on the research of Harvard’s Michael Porter, VBHC provides a framework for restructuring health care systems with the overarching goal of value for patients.

The World Economic Forum has calculated that, despite advancements in medical knowledge and innovation, society is not getting the full value of the annual AUD$8 trillion spent worldwide on healthcare.

Australia’s healthcare expenditure is $170 billion, representing 10.3% of GDP, meaning one in every $10 in the economy is being spent in the health sector.

MTAA CEO, Ian Burgess said that although Australia has a very good health system, with increasing pressure on our healthcare dollar, our current service delivery system provides fragmented care, siloed funding and differences in outcomes and clinical practices.

“If Australia seeks to become the “healthiest nation on earth” it’ll need to transform its healthcare system to be fit for the 21st century,” said Mr Burgess.

Some of the speakers noted the challenges in the current environment of elevating a value and outcomes debate when the Government has decided to remove rewarding superior clinical performance as part of the Prostheses List Agreement with the MTAA.

Healthcare should be driven by a relentless focus on delivering outcomes that truly matter to patients and to the community, in a financially sustainable manner.

The day started with Tessa Kowaliw, Women‘s Healthcare Australasia and patient advocate. It set the scene for much of the day by ensuring patients were front of mind by making sure we address outcomes that are meaningful to patients.

Mr Burgess said: “All stakeholders need to ask themselves “what will this change mean?” or “when will it happen?” but also “how do we get there?”

“The medical technology industry makes a highly significant contribution to the quality of healthcare in Australia in helping people live longer, healthier and more productive lives.

“To prepare for this changing environment, it will be important for medical technology companies to understand, demonstrate, and clearly articulate how their offerings can not only improve patient outcomes but also create value for healthcare stakeholders.”

All presenters agreed the full implementation will take time due to complexity and will require significant change and reforms.

PulseLine is pleased to say for those that missed the event in the coming weeks we will be releasing video interviews with the presenters.

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