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MTAA endorses the Prime Minister’s Modern Manufacturing Strategy

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[vc_row][vc_column][vc_column_text]This week’s announcement was widely welcomed by many in the MedTech industry, with leaders signalling that the almost $1.5 billion in new investment to be a clear indication of the Morrison Government’s commitment to ensuring Aussie Manufacturing, particularly MedTech, can continue to be a global leader.

Medical Technology Association of Australia (MTAA) CEO, Ian Burgess, has congratulated the Morrison Government on its policy and called upon the industry to take it up in full.

“More than half of Australian medical device companies have grown from local start-ups, so today’s announcement will make an important impact where it is needed most, shoring up Australia’s MedTech innovators now and into the future,” Mr Burgess said.

The Australian MedTech sector has been steadily growing, and now has over 19,000 people directly employed by the industry – many of these in manufacturing. The MedTech industry is an employer of choice; 78% of employees in the industry have a degree, 25% have a postgraduate degree. Today’s announcement will ensure that employment in the sector continues to grow.

The $107.2 million allocated to the Supply Chain Resilience Initiative will mean industries such as MedTech can continue to ensure all Australians have access to medical devices when they are needed.

“During COVID-19 the Government asked MedTech to supply 7,500 ventilators, the MedTech supply chain worked, and the ventilators and other essential medical equipment were delivered,” Mr Burgess said.

MTAA and its MedTech members have thrown their support behind the measures the Prime Minister has today outlined, which, we believe, will improve Australians access to the best and latest medical technologies they need, and can distribute these to the world.[/vc_column_text][/vc_column][/vc_row]

Corporate Health Insurers Raise Premiums

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[vc_row][vc_column][vc_column_text]Corporate health insurers are being accused of increasing their premiums, not to increase patient outcomes, but rather to line their own pockets.

APRA’s mandatory private health insurance reporting data shows in the three months to June, corporate health insurers raked in gross mega-COVID-profits of $1.03 billion, despite bringing forward $1.4 billion in deferred claims, which has been labelled clever accounting to hide real profits. The data also shows a 15.8% rise in management expenses, which include employee bonuses are now at a record high of $650.1 million, every three months.

The Medical Technology Association of Australia (MTAA) has said the Federal Government and MedTech innovators are playing their part in trying to reduce the rise of insurance premiums. Specifically, an October 2017 Agreement, between the MTAA and Minister for Health, Greg Hunt, was signed to provide Australians with private health insurance a saving of $1.1 billion in payments for medical devices, over four years.

Private Healthcare Australia (PHA), the industry lobby group for corporate health insurers, have said that a reduction in device prices would lead to a decrease in insurance costs. Despite this claim and the signed Agreement, it appears corporate health insurers are continuing to raise their premiums for struggling families, regardless of the MedTech industry’s $1.1 billion olive branch.

Professor for Health Economics at the University of Melbourne, Yuting Zhang, recently wrote “the reasons insurance companies are using to justify their price rise don’t stack up”.

Not all insurers seem to be rising their premiums. HBF and some smaller funds have decided to cancel their 2020 premium increases, knowing that during COVID-19, it is not the time to make it harder for their customers.

MTAA CEO, Ian Burgess, has called on corporate insurers to ditch their premium increases and return the money to families who need it most.

“MTAA and the Government delivered $1.1 Billion in savings, now is the time to pass this on in full: insurers must forgo their premium increase, give money back to Aussie Mums and Dads – it’s time they put people before profits.”[/vc_column_text][/vc_column][/vc_row]

Digital transformation to deliver more timely medicines for Australians and improve patient safety

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[vc_row][vc_column][vc_column_text]The Government is investing $12 million over four years to digitise, transform and modernise the TGA’s business systems and infrastructure, better connecting services to get medicines and devices to patients sooner.

New digital processes will deliver simpler and faster interactions between industry and government. This means earlier approvals of medical products, reduced administrative effort, and timelier decision-making by the TGA.

Under this Deregulation Agenda, the Government has said focused on ensuring regulation is and remains fit-for-purpose – making it easier to do business while ensuring essential safeguards with the lightest touch.

This measure will yield a significant reduction in red tape, cutting costs for the medicines and medical devices industry. It will also position Australia to more quickly access emerging and new health technologies in the international market.

The TGA receives around 26,000 applications every year for medicines and medical devices to be listed or amended on the Australian Register of Therapeutic Goods (ARTG), which allows them to be imported, sold and used in Australia.

The digital changes will enable simpler and more secure interactions between Government and industry to apply for, track, pay, and manage listings for regulated and subsidised health related products and services.

The TGA receives 15,000 adverse drug reaction reports on patient safety per year which are entered manually through PDF rather than through a central database.

With these reforms, medical companies will now be able to use an electronic database to report these patients safety events with automatic data transfer – saving them up to 15 minutes per report.

All Australians will benefit from a streamlined process which increases the timeliness of decisions on the safety, quality and efficacy of therapeutic goods, and their approval for listing on the ARTG.

Consumers and health care professionals can also have greater confidence in the safety and efficacy of therapeutic goods, with increased transparency built into the reforms.”

Cyber security will also be bolstered to ensure the protection of commercial-in-confidence information from industry.[/vc_column_text][/vc_column][/vc_row]

AHHA CALLS FOR BETTER COVID-19 DOCUMENTING

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[vc_row][vc_column][vc_column_text]The COVID Screen Audit study has been published in Australian Health Review, the journal of the Australian Healthcare and Hospitals Associations (AHHA).

Research team leader and professor at the University of Melbourne, David Story, said the study analysed the admission records of 2,197 patients who underwent elective and non-elective surgery at two major Melbourne hospitals between 1 April and 10 May 2020.

“Despite the national imperative to screen for COVID and communicate the results, the documenting of COVID-19 screening fell short of our proposed lower acceptable limited on 85% in almost all surgical groups,” Professor Story said.

“We are not saying screening wasn’t done – that that the information wasn’t readily available for clinical teams caring for some patients.

“The percentages of surgery patients observed to have had both COVID-19 screening and temperature documented could be improved, from 72% among elective patients and 38% among non-elective patients.”

The study found that documenting screening varied markedly across surgical groups. In particular, it found that non-elective surgical patients had the lowest rate of documenting and also the highest rate of COVID-19 related history and signs.

Identifying surgical patients with SARS-CoV-2 and COVID-19 disease is important for several reasons, including that patients with COVID-19 may have more complications and greater mortality after surgery. COVID-19 may also further increase the already increased risk for complications and mortality among non-elective patients.

Professor Story added that the results of the COVID Screen Audit were likely to apply to other Australian hospitals, and noted both hospital had instituted far more rigorous documenting during Victoria’s second wave of the pandemic.[/vc_column_text][/vc_column][/vc_row]

COVAX commitment a big step forward

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[vc_row][vc_column][vc_column_text]Australia has confirmed it will participate in the COVAX purchasing mechanism, which involves the World Health Organisation, the vaccine alliance Gavi, and the Coalition for Epidemic Preparedness Innovations.

COVAX pools the resources of wealthier and poorer nations to create global demand for two billion vaccines, accelerating the development and distribution of a successful COVID vaccine or vaccines.

Australia’s participation means Australia and poorer nations in our region are far likelier to have early access to a vaccine, said Reverend Tim Costello.

“This announcement helps secure vaccines for Australian citizens, and people in vulnerable nations who have no hope of producing or purchasing vaccines on their own,” Reverend Costello said. “It is an important development and the Australian Government should be commended for meeting its moral obligation to help others also defeat this virus.

“COVID-19 does not respect borders or political systems. It rips through societies like wildfire, wrecking industries and livelihoods. No community is immune and it is in everyone’s interest to suppress this virus as effectively as we can possibly can.

“Australia’s participation in the COVAX effort is incredibly worthwhile. This could be bolstered by additional aid efforts. We know the pandemic is creating serious roadblocks to combating existing epidemics such as HIV, tuberculosis and malaria. COVID is impeding the economic empowerment of women and girls as resources are stretched to deal with the pandemic.

“The Australian Government should build on this announcement with further support for the heath and economic development aspirations of poorer nations. It is profoundly in Australia’s interests to foster a healthier, more prosperous environment in its region and beyond.”

Indonesia has now recorded more than 9,000 COVID-10 related deaths, and in recent weeks the average number of new cases has risen from about 2,000 per day to more than 3,500.

In the Pacific the economic impact of COVID-19 could result in an additional 1.2 million people in the Pacific and Timor-Leste being pushed into extreme poverty.

Globally already in 2020, the pandemic has pushed almost 37 million people below the[/vc_column_text][/vc_column][/vc_row]

Nominations Open for 2020 Kerrin Rennie Award

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[vc_row][vc_column][vc_column_text]MTAA and the #MedTech community would like to recognise that technology at the upcoming Australian MedTech Industry Awards.

If you know of an innovative product launched in Australia within the last two years used in the diagnosis, prevention, treatment or management of disease and disability, we encourage you to nominate that technology for the 2020 Kerrie Rennie Award.

Other award categories are available on the MTAA website.[/vc_column_text][vc_zigzag][vc_btn title=”SUBMIT NOMINATION” color=”turquoise” align=”center” link=”url:https%3A%2F%2Fwww.mtaa.org.au%2Faustralian-medtech-industry-awards|||”][/vc_column][/vc_row]

$12.5m enables new research approach to Parkinson’s

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[vc_row][vc_column][vc_column_text]“The outcomes of this research promise to provide new insights into the genetics of what determines the development and progression of Parkinson’s disease, “said Professor Deniz Kirik, Faculty of Medicine, Lund University who will be the lead investigator on the research project for the University of Sydney as an Honorary Professor for the duration of the research.

ASAP seeks to support international, multidisciplinary, multi-institutional research teams to address key knowledge gaps in the basic disease mechanisms that contribute to Parkinson’s. The initiative is focused on understanding the dynamics of Parkinson’s from its earliest stages and before it presents as a fully-recognisable condition.

The research being funded is focused on how mutations and/or deletions in specific genes result in a high probability of developing Parkinson’s disease (PD), suggesting their critical role in the health and survival of specific brain cells.

“Curiously, it is not yet clear how specific types of brain cells are functionally impacted by genetic mutations that result in the neuronal loss defining Parkinson’s. The research supported by this grant will address that,” said Professor Kirik.

Previously, affected cells have mainly been examined as cultured cells in petri dishes but this project will focus on using cells from patients with Parkinson’s to study them in the environment of the living mouse brain. This is a completely new way of exploring the cellular components and underlying biology of the disease. The researchers will then explore how gene editing could address the underlying basis of the disease.

“This generous grant allows Professor Kirik to build new research capabilities in neuronal transplantation at the University of Sydney, and collaborate on genomics and human neural stem cells with myself and Professor Carolyn Sue from the Kolling Institute,” said Professor

Glenda Halliday, one of the lead researchers from the University of Sydney’s Faculty of Medicine and Health and member of the University’s Brain and Mind Centre.

“It will also build on Professor Kirik’s strong collaborations with Professor Claire Parish and Associate Professor Lachlan Thompson at the Florey Institute in Melbourne, and Jennifer Johnson at NysnBio in California.”

Professor Sue, Executive Director, Professor and Director of Neurogenetics, Kolling Institute, University of Sydney said: “We have world- leading expertise in this field and have been selected to take part after a worldwide search for innovative programs to speed up the search for new treatments for Parkinson’s disease. The program illustrates the importance of our translational research at the Kolling Institute, where we can directly incorporate scientific breakthroughs to improve clinical care for our patients.”

The research team members are:

 Project lead: Professor Deniz Kirik, Faculty of Medicine Lund University, Sweden, has over 25 years’ experience in the development of cell and gene therapy for treatment of neurodegenerative diseases, with special emphasis on Parkinson’s disease. He has made significant contributions to cell therapy for PD which have been instrumental in taking novel treatments into clinical testing. (Professor Kirik and his team will eventually be based at the University of Sydney for the duration of the research, once COVID conditions permit).

Core leadership and Collaborators:

  Professor Glenda Halliday,NHMRC Senior Leadership Fellow, Faculty of Medicine and Health and Brain and Mind Centre, University of Sydney. Expertise in the development of neurodegenerative disorders including Parkinson’s disease and the role of Lewy bodies (clumps of proteins that form in the brain). Her current work focuses on how proteins identified through genetic studies are involved in neurodegeneration.

Professor Carolyn Sue, Executive Director, Professor and Director of Neurogenetics, Kolling Institute, University of Sydney and Director of Neurogenetics at Royal North Shore Hospital, University of Sydney. A clinician-scientist, whose research team combines the use of genomics, molecular neuroscience, and adult stem cell models to identify pathogenic mechanisms and develop targeted therapies for Parkinson’s disease and other related neurodegenerative disorders.

Professor Clare Parish, The Florey Institute of Neuroscience and Mental Health, Victoria is a developmental neuroscientist with 20 years of experience in Parkinson’s disease research. Expertise includes using advanced stem cell-based therapies for neural repair in Parkinson’s disease. She has an international reputation in improving the safety and functional integration of stem cell-derived neural transplants for Parkinson’s disease.

Associate Professor Lachlan Thompson, The Florey Institute of Neuroscience and Mental Health is a neurobiologist specialising in neural transplantation both as a therapeutic approach for brain and spinal cord repair, and as a way to understand the properties of neurons generated from human stem cells. He is the inaugural co-chair of the Asia-Pacific Association for Neural Transplantation and Repair.

Jennifer Johnston, CEO NysnoBio, California, has been studying neurodegenerative disease for the last 20 years. NysnoBio is a biotech company focused on the modulation of the parkin enzyme pathway for critical unmet medical needs in neurology and oncology (Parkin plays an essential role in maintenance of brain cells that create dopamine, which degenerate in Parkinson’s disease).[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC STUDY FINDS OPIOID-INDUCED RESPIRATORY DEPRESSION IN THE HOSPITAL MORE COMMON AND COSTLY

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Importantly, conclusions from the study data enabled the development of the PRODIGY Risk Score, an easy-to-use risk prediction tool to identify patients at high risk of respiratory depression who would benefit from continuous monitoring with capnography and pulse oximetry.

The study, which analyzed 1,335 patients across 16 sites in the United States, Europe and Asia, found that respiratory depression, as defined by changes in pulse oximetry and capnography monitoring parameters, occurred in 46% of medical and surgical patients evaluated who were receiving IV opioids for pain. This incidence rate is significantly higher than previously reported in clinical literature.1 The complete study results are published online in Anesthesia and Analgesia1, the official journal of the International Anesthesia Research Society (IARS).

“PRODIGY data confirms that respiratory depression in patients receiving parenteral opioids occur frequently and are potentially unknown to hospital healthcare providers,” said Ashish K. Khanna, M.D., primary study investigator and an associate professor of Anesthesiology, section head for Research and intensivist at the Wake Forest School of Medicine. “Together with risk assessment using the PRODIGY Risk Score, the use of capnography and oximetry for continuous monitoring of patients identified as high risk for respiratory depression may increase safety when parenteral opioid analgesia cannot be avoided.”

Currently, there are no universally accepted guidelines to direct effective and safe assessment and monitoring practices for patients receiving in-hospital opioid analgesia. In addition to providing insight into the rate of respiratory depression, a key objective of PRODIGY was to develop and validate an accurate and easy-to-use risk assessment scoring tool. The PRODIGY Risk Score uses risk factors including: age > 60 years, male gender, opioid naïvety, sleep disorders and chronic heart disease for respiratory depression events risk prediction.

“The PRODIGY Risk Score has acceptable accuracy for risk stratification using several robust methods of internal validation, addressing significant gaps in preventing this common and potentially deadly condition,” said Frank Chan, vice president and general manager of the Patient Monitoring business, which is part of the Minimally Invasive Therapies Group at Medtronic. “Patients with respiratory depression were more likely to experience an adverse event that prolonged hospitalization and more likely to require rescue action, including rapid response team activation.”

The PRODIGY study is the largest known study using continuous capnography and pulse oximetry data on surgical and medical patients collected by Medtronic Microstream and

Nellcor monitoring technology. The study design used an innovative mechanism of data collection whereby bedside providers were blinded to continuous monitoring systems and all alarms were also silenced. All patients experiencing respiratory depression were reviewed and confirmed by an independent clinical event committee of physicians with expertise in perioperative respiratory medicine.

 

About Respiratory Compromise

Respiratory compromise is a potentially life-threatening, progressive condition negatively impacting a person’s ability to breathe adequately to maintain oxygenation and carbon dioxide removal. Patients with respiratory depression may experience shallow, slow or no breathing after opioid administration which undetected can lead to cardiopulmonary arrest and death.3 This condition is rapidly becoming the third-most costly hospital inpatient expense in the U.S., and dramatically increases the likelihood of adverse patient outcomes and cost of patient care.4 Not only is respiratory compromise common and dangerous, it has been very difficult to predict.[/vc_column_text][/vc_column][/vc_row]

LOCALLY MADE LIFESAVING VENTILATORS

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[vc_row][vc_column][vc_column_text]At the height of the pandemic, NSW Premier, Gladys Berejiklian, appealed to businesses to pivot their focus to producing critical medical supplies in the fight against COVID-19.

The Premier said that global supply chains were disrupted, but thanks to local universities and manufacturers stepping up, they were able to join forces to develop prototype ventilators.

“Two ventilators are on track to receive regulatory approval within weeks and, if needed, can be produced for hospitals here and potentially overseas, saving lives and boosting jobs,” Ms Berejiklian said.

The Ventilator Innovation Project was part of the NSW Government’s $800 million investment to help increase services and equipment to combat COVID-19.

The NSW Government knows that having access to a ventilator can be the difference between life and death for severe COVID cases, which have become all too apparent in situations overseas.

In some of the worst-hit nations, health staff were forced to limit who could access ventilators – a situation the Government says is why NSW needs reliable local supply chains to safeguard patients.

Minister for jobs, Investment, Tourism and Western Sydney, Stuart Ayres, said the pandemic had inspired a wave of innovation and rapid development across the globe, and local manufacturers and universities had risen to the challenge.

“One thing history has shown us is that crises stimulate innovation and this pandemic has provided an environment for launching and testing new ideas,” Mr Ayres said.

“We congratulate the successful teams behind the CoVida Ventilator, led by the University of Sydney, with clinicians at Westmead and Royal North Shore Hospitals, and Ventasys, developed by AmpControl with clinicians at the John Hunter Hospital.”[/vc_column_text][/vc_column][/vc_row]

HUNT ANNOUNCES $16.9 MILLION FOR HEALTH AND MEDICAL RESEARCH

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[vc_row][vc_column][vc_column_text]In a statement announcing the investment, Minister for Health, Greg Hunt, confirmed more than $16.9 million had been awarded to researchers to study women’s health issues and aspects of primary health care, and to facilitate more and better clinical trials of new and improved treatments.

In the lead up to Women’s Health Week – taking place from 7th to 11th September 2020 – the MRFF grants announced would include:

  • $5 million over five years for the National Women’s Health Research, Translation and Impact Network, aimed at research with strong potential to improve health outcomes for women and girls;
  • $5 million over four years to the Australian Clinical Trials Alliance to be a national partner providing specialised leadership and support to both investigator-led and industry clinical trials, and to Clinical Quality Registries; and
  • More than $6.9 million delivered to five projects to improve primary health care in the areas of contraception and abortion for rural women, health care for people in aged care, diabetes in Indigenous Australians, nutrition and heart disease, and the health of urban Indigenous people.

Compared with men, women have a higher life expectancy but experience more disease burden from living with disease, rather than dying early from disease and injury.

The Women’s Health Network are expected to use the funding for research into nine priority areas, including reproductive health, mental health, and preventing cancer and heart disease.

The Government has said the project will also boost national and international collaboration on women’s health, build health workforce capacity and develop leaders in women’s health.

In addition to these grants, Minister Hunt said he was announcing new grant opportunities worth more than $86.5 million for clinical trials and other vital research.

Clinical trial grant opportunities totally $77.2 million will provide up to:

  • $24 million for the Million Minds Mission Mental Heath Research supporting access to new approaches to prevention, diagnoses, treatment and recovery;
  • $3 million for clinical trials to examine the benefits of medicinal cannabis for managing pain, symptoms and aside effects for cancer patients;
  • $25.2 million for international clinical trial collaborations; and
  • $25 million for clinical trials of new or improved treatments for rare cancers, rare diseases and other illness with unmet clinical need.

Other grant opportunities are making $9.3 million available for research:

  • $4.8 million for primary health care research; and
  • $4.5 million from the MRFF and National Health and Medical Research Council for research into silicosis, a preventable lung disease related to inhalation of fine silica dust from artificial stone bench tops.

The Government has identified investment in health and medical research as one of its key priorities in its Long Term National Health Plan.[/vc_column_text][/vc_column][/vc_row]