Category: Community

MEDTRONIC FOUNDATION COMMITS AN ADDITIONAL $10M TO GLOBAL COVID-19 EFFORTS

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[vc_row][vc_column][vc_column_text]The Medtronic Foundation’s global and local response includes a comprehensive approach that is inclusive of cash contributions to over a dozen health and community nonprofits and will be used to fund:

  • Training and supervising frontline health workers
  • Ensuring the safety and well-being of frontline health workers, including provision of personal protective equipment (PPE) and critical supplies
  • Supporting preparedness efforts for the health workforce, including surge capacity; caring for chronic, at-risk patients; and remote patient monitoring
  • Offering local community support of health, economic and food assistance for vulnerable populations
  • Providing flexible support to nonprofit partners working in underserved communities

 

“With roots in the world’s largest medical technology company, the Medtronic Foundation has a responsibility to be a leader on global issues impacting access to healthcare,” said Paurvi Bhatt, president of the Medtronic Foundation. “During this unprecedented global health crisis, we are committed to supporting and equipping the courageous frontline health workers who are delivering critical care to those in need. Through volunteerism and financial investments, we continue to partner with thought leading partners working globally, nationally and locally – with the flexibility and investment required to meet this critical need.”

 

In addition to financial contributions, the Medtronic Foundation is organizing virtual volunteer opportunities to help the more than 90,000 Medtronic employees globally support non-profit organizations that are responding to this global health crisis. Many of these opportunities will engage Medtronic employees in skills-based volunteerism where they leverage their professional skills to support organizations in need.

 

The Medtronic Foundation also will continue to match Medtronic employee donations to nonprofit organizations. These efforts will contribute to the immediate response, and as the situation evolves, the Medtronic Foundation will evaluate needs and consider additional contributions and volunteer opportunities as appropriate.

About Medtronic Foundation

Medtronic plc is the sole funder of Medtronic Foundation, whose focus is on improving health for underserved populations worldwide, as well as supporting communities in which Medtronic employees live and give. For more information, please visit medtronicfoundation.org.[/vc_column_text][/vc_column][/vc_row]

THREE NEW “PANTHERS” JOIN QUEENSLAND’S COVID FIGHT

Posted on | by pulseline

Mr Miles said the machines are just like their namesake – fast and intelligent. These new machines will be based at Toowoomba, the Sunshine Coast and Rockhampton Hospital laboratories, adding to the four Panthers bought earlier this year for the GCUH, Cairns, Townsville and Central Laboratories.

“This new equipment will mean tests will no longer need to be sent to Brisbane from those areas and will dramatically improve turnaround times for a range of important tests, including in the very near future COVID-19.

“Queensland’s laboratory testing is among the best in the world, and we’re continuing to lead the way,” Mr Miles said.

“Our capacity extends across the state, with testing hubs topping and tailing Queensland.

“And this Palaszczuk Government investment of over $897,000 will buy three new Hologic Panther Fusion Instruments to expand testing further, building on its initial investment of $1.098 million for the first four Panthers.”

Currently, the Pathology Queensland Central laboratory, Pathology Queensland Townsville laboratory and FSS Coopers Plains laboratory have the capability to undertake respiratory virus and COVID-19 testing.

“Queensland Health is uniquely placed as a public pathology provider – it has two distinct analytical test platforms and assays, and has plans to install more ,” Mr Miles said.

“This ensures we are well prepared and well placed for all novel coronavirus scenarios as demand increases for worldwide stocks.

“This will support us not just as we continue to respond to COVID-19 in 2020, but for the upcoming influenza season, and COVID-19 over the coming years as the globe continues to learn, diagnose and treat our community.”

The current diagnostic test used to screen for cases of COVID-19 looks for indicators of the virus in samples of people’s sputum, and from specimens from the nose and throat.

Queensland Health uses the gold standard of viral testing, known as Polymerase Chain Reaction testing. This is a three phase test, which involves the extraction, purification, amplification and detection of virus DNA.

Queensland’s two largest private pathology providers Queensland Medical Laboratories (QML) and Sullivan and Nicolaides Pathology (SNP) also have recently developed testing capability and are supporting most of the private sector demand.

A MESSAGE FROM IAN BURGESS, CEO, MTAA

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On behalf of the MedTech industry, MTAA is collating and sharing information on changes in the supply chain and emerging issues; significant pain points for MedTech businesses; and how company business practices are evolving to respond to COVID-19, particularly in the areas of work-from-home, travel restrictions, face-to-face meetings and business continuity planning.

MTAA is working closely with the government to address emerging supply chain impacts on business and broader industry as a result of COVID-19. The industry is represented on a regular roundtable convened by the Minister for Industry, Science and Technology, together with other key stakeholders. An initial meeting was held last week, with the second meeting held on Thursday 19 March.

The roundtable is being held to discuss emerging supply chain impacts on business and broader industry as a result of COVID-19. Discussion will focus on what sectors are being impacted by supply chain issues, including how business is managing these challenges. The Minister welcomes any insights or suggestions about the best way forward to ensure business and industry are supported during this time.

MTAA is also engaging closely with the Chief Medical Office and the Federal Health Minister. Most recently this has been regarding the Government’s immediate priorities – the supply of respirators, reagents for testing and also masks. We have also facilitated relevant companies engaging with the Government regarding supply.

These are challenging times for our community, our industry and please take care of yourself and others.

MTAA PRECAUTIONARY MEASURES

Our events that were scheduled for the near future have been postponed and we plan to conduct webinar events where possible. Our face-to-face training courses, Operating Theatre Protocols, have been postponed.

All committee meetings are now taking place via teleconference/videoconferencing and the majority of MTAA staff are working from home.

CORONAVIRUS ROUND-UP: WEEK OF 15 MARCH 2020

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SUNDAY

  • Prime Minister, the Hon Scott Morrison MP, announced that all overseas arrivals would be required to self-isolate for 14 days. In order to enforce this, new offences in each state and territory were introduced to enforce the mandatory self-isolation period, with significant fines for those who breach the self-isolation period.
  • In addition, Mr Morrison announced a ban on large public gathering of more than 500 people and recommended that people undertake social distancing measures. As part of these measures, the Government is recommending that people remain at least 1.5 meters away from each other and not undertake unnecessary social contact.

MONDAY

  • The Reserve Bank of Australia announced that it is considering purchasing government bonds following continuing economic pressure due to COVID-19. The purchasing of government bonds by the Reserve Bank is a sign that there are significant economic issues as government bonds are risk-free investment, and investors are flocking to them given that the ASX 200 was down 9.7% on Monday and fell by more than 10% last week.
  • The Australian Capital Territory, Victoria and Western Australia all announced that they were entering a state of emergency due to COVID-19. The state of emergency will give each state and territories Chief Health Officer the power to enforce the 14-day self-isolation period as well as a ban on gatherings of over 500 people. The state of emergency in each state and territory is initially set to last for four weeks and may last further depending on how COVID-19 develops.
  • In addition to the state of emergency, WA Premier, the Hon Mark McGowan MP announced a range of measures designed to stimulate the WA economy and mitigate the impact of COVID-19. As part of the package, WA residents will see their household charges frozen including electricity, water and vehicle registration. In addition, WA small and medium businesses will also receive relief, with previously proposed changes to payroll tax being fast tracked by six months.
  • After news emerged last week that the Minister for Home Affairs, the Hon Peter Dutton MP had tested positive for COVID-19, he announced that he had departed hospital after being cleared. However, news broke that Mr Dutton’s Coalition colleague and Senator for Queensland, Senator Susan McDonald, had tested positive for COVID-19. Senator McDonald began feeling unwell on Friday 13 March 2020, and has since tested positive and was admitted to hospital as a result.
  • A range of Australian sporting events have been affected by coronavirus, especially following the Government’s announcement of new social distancing measures. Football Federation Australia and the NRL announced that each of their respective seasons would continue behind close doors, while the AFL announced that they would be reducing the length of their season, with only 17 rounds where every team will play each other once. This is in addition to Super Rugby suspending their league due to COVID-19.
  • Woolworths and Coles have introduced an elderly shopping hour from 7am to 8am every day in order to mitigate the effects of panic buying which has seen mass shortages of essential items including toilet paper, rice and pasta. In addition, Coles announced that it was bringing on an additional 5,000 new casual staff who will help stock shelves and serve customers.
  • RSL branches in NSW, Queensland, Victoria, Tasmania and Western Australia have cancelled ANZAC Day commemorations in order to protect veterans and ensure compliance with the new social distancing guidelines. Some dawn services will still be held across the country, but members of the public will be asked to not attend.

TUESDAY

  • It was announced that the Prime Minister, the Hon Scott Morrison MP and the Leader of the Opposition, the Hon Anthony Albanese MP had come to an agreement to significantly pare down the number of MPs present in Canberra for next week’s sittings. It was announced that only 90 MPs will be present in Canberra next week, with 30 MPs from both major parties staying home. At this stage, the Government has not announced what will happen with the Senate.
  • NSW Premier, the Hon Gladys Berejiklian MP has announced a $2.3 billion stimulus package including extra funding for additional health measures as well as payroll tax relief for business with payrolls of up to $10 million. NSW Health will receive $700 million to boost a range of services across NSW. Other measures include a waiving of fees and charges for small businesses, increased funding for schools to hire cleaners and $750 million spent on capital works and maintenance of public assets.
  • Due to the rapid spread of COVID-19 and the resulting decline in international and domestic travel, Qantas and Jetstar announced that they were significantly reducing their capacity, with the airline cutting 90% of its international services and reducing its domestic capacity by 60% at least until the end of May 2020. As a result, Qantas has grounded 150 aircraft and announced that the measures would affect its entire workforce of 30,000 people. Qantas has workers may be forced to utilise their paid leave allowances or take unpaid leave due to its decision.
  • Tasmania has declared a Public Health Emergency due to COVID-19, following the declaration of a state of emergency in the ACT, Victoria, Western Australia and South Australia. The Public Health Emergency gives the Director of Public Health, Dr Mark Veitch, the power to quarantine, isolate or evacuate people. At this stage, Tasmanian Premier, the Hon Peter Gutwein MP, has said he will not declare a state of emergency, with Tasmania only having seven confirmed cases of COVID-19. Hobart’s Museum of New and Old Art has also announced that it will be closing due to the risk of COVID-19.
  • A third federal parliamentarian has contracted COVID-19, with reports breaking that Senator for NSW, Senator Andrew Bragg, contracting the virus. Senator Bragg suspected that he contracted COVID-19 while attending a friend’s wedding at Stanwell Tops on 6 March 2020.

WEDNESDAY

  • ­Prime Minister, the Hon Scott Morrison MP, announced a range of stringent measures to combat the spread of COVID-19. As part of the measures, Mr Morrison announced that there would be further restrictions placed on large gatherings of people, with a maximum of 100 people allowed in a single indoor area under new measures. The 500-person limit remains for gatherings that take place outdoors. Furthermore, Mr Morrison announced that there would be restrictions on visits to aged care facilities, with residents allowed to have a maximum of two visitors daily. Other measures included the introductions of an indefinite travel ban, as well as utilising 20,000 student nurses in Australia by lifting work restrictions.
  • Minister for Finance and Leader of the Government in Senate, Senator the Hon Mathias Cormann released a statement regarding the operation of the ‘scaled-back’ parliamentary sittings that are scheduled to take place next week. Despite confirming the news which broke on Tuesday which said will only be 90 members in the House of Representatives, with 30 pairs of MPs from the major parties staying home, Senator Cormann had no further updates on the operation of the Senate, saying that arrangements would be released later in the week following consultation with Labor and the Senate Crossbench.
  • Australia had its sixth death from COVID-19, with NSW Health officials confirming that an 86-year-old man died in hospital. This death is the fifth fatality from COVID-19 in NSW, with Australia’s only other death occurring in WA, after a 78-year-old man passed from the virus after contracting it on board the Diamond Princess cruise ship which was stranded off the coast of Japan. NSW still has the highest concentration of cases in Australia, with 270 confirmed cases of COVID-19 as of Wednesday.
  • NT Chief Minister, Mr Michael Gunner MP, announced a $65 million stimulus package primarily focused on ensuring that individuals and small businesses are able to cope with the effects of COVID-19. As part of the package, Mr Gunner announced $20 million scheme that would allow businesses to upgrade and improve their storefronts. In addition, $5 million has been allocated for not-for-profits, community organisations and clubs receive funding for repairs and renovations as well as $30 million for home improvement and a freeze on government fees, charges and electricity prices until July 2021.
  • Virgin Australia announced that they would be grounding all of their international services from 30 March 2020 until 14 June 2020 and will be also cutting domestic capacity by 50 per cent effective immediately until 14 June 2020. Virgin Australia has been hit hard by COVID-19 and Virgin’s stock price falling over 50 per cent in the last month. Similar to Qantas, Virgin Australia has indicated that its entire workforce will feel the affects of COVID-19, with full-time workers being asked to transition to part-time temporarily as well as people being asked to take existing leave or take unpaid leave.

THURSDAY

  • Prime Minister, the Hon Scott Morrison MP, announced all foreigner travellers will be banned from entering Australia from 9:00pm AEDT on Friday. The ban applies to all non-citizens and non-residents. Australians will still be able to return from overseas but they will be required to self-isolate for 14 days.
  • The Reserve Bank of Australia has cut official interest rates to a record low of 0.25 per cent as it seeks to protect the economy from the financial fallout of the coronavirus pandemic. The Morrison government is in the process of finishing a second round of economic stimulus, badged as a multibillion-dollar “safety net” package. The package would be in addition to $17.6bn in economic measures in response to the downturn caused by Covid-19, on top of a $2.4bn health package.
  • Qantas announced it will be suspending all international flights and standing down two-thirds of its 30,000 workers in the face of the escalating COVID-19 pandemic. Qantas chief executive Alan Joyce says the coronavirus outbreak will hit Australia’s economy harder than the global financial crisis with Qantas staff potentially being redeployed to stock supermarket shelves.
  • Home Affairs Minister, the Hon Peter Dutton MP, has vowed to ‘come down like a ton of bricks’ on possible crime syndicates who have been busing it out to regional supermarkets and clearing out shelves. Minister Dutton indicated there was an operation underway with federal, NSW and Victorian police, and border force involved to crack down on hoarders selling essential items on the black market.

FRIDAY

  • Prime Minister, the Hon Scott Morrison MP, announced due to the outbreak of Covid-19, the Government will not be able to table the budget until the first Tuesday in October. The Prime Minister also confirmed the national cabinet had agreed to a cap of one person per four square metres for indoor gatherings, including in pubs, cafes and restaurants, as was recommended by Australia’s chief medical officers. The national cabinet will also consider adopting further travel restrictions next week.
  • With Treasurer, the Hon Josh Frydenberg MP, admitting it would be hard for Australia to avoid its first recession in 29 years, the RBA cut official interest rates to 0.25 per cent, revealed plans to buy government debt to keep borrowing rates low and said it would lend at least $90 billion to banks on the condition they passed on that cash to small and medium sized businesses.
  • Australia has more than 700 confirmed cases of coronavirus, with four confirmed cases in the ACT. There have been six deaths and 41 recoveries as of this morning. The fourth ACT patient contracted the virus while travelling in the US and has been in isolation since returning home. The ACT government will announce a $137 stimulus package, which Chief Minister Andrew Barr hopes will save jobs and deliver immediate relief to individuals and sectors most severely affected by measures to slow the spread of COVID-19.
  • Health authorities in NSW have confirmed another death from coronavirus, bringing the state’s total COVID-19 fatalities to six. NSW Health said an 81-year-old woman with the virus died last night. There have been 46 new coronavirus infections in NSW in the past day, taking the state’s total number of cases to 353.

Increasing domestic manufacturing during COVID-19

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Med-Con Pty Ltd – a manufacturer near Shepparton in regional Victoria – has increased production with the support of the Government and the Australian Defence Force.

Minister for Industry, Science and Technology Karen Andrews said work is underway to significantly increase their manufacturing capability over time to meet demand as the COVID-19 situation continues to evolve.

“From helping to access new equipment to providing staff, we are doing what we can to enable companies like Med-Con to ramp up production and boost our domestic capacity,” Minister Andrews said.

“There’s a lot of fear in the community at the moment but Australians should know that work is happening to help us best respond to this unfolding crisis.

“This is important work but it’s also essential we get it right – this equipment needs to be produced to the highest standards.”

Minister for Defence, Senator Linda Reynolds said around a dozen ADF personnel are helping under Defence Assistance to the Civil Community (DACC) arrangements.

“The team, which is comprised of highly qualified engineering maintenance specialists from the Army Logistic Training Centre and the Joint Logistics Unit – Victoria, are supporting the request,” Minister Reynolds said.

“These skilled soldiers are with the company’s existing staff on production, maintenance and warehousing tasks.

“The Defence support will fill a short-term gap while Med-Con Pty Ltd recruits and trains supplementary staff. This is an example of the kind of exceptional circumstances which the DACC rules are designed to cover.”

In addition the Government has put out a Request for Information (RFI) to get a further understanding of the manufacturing capability and capacity that exists domestically, so that as a country, we are well-positioned to increase production of these products at home.

Minister Andrews added, “we are casting the net as widely as we can, asking manufacturers if they have the ability to diversify the work they do.”

“As those opportunities continue to present, we will work with manufacturers to support their transition.

“Australian manufacturers have already been reaching out with offers to help. I’m confident our Aussie ingenuity will guide us through this difficult time.”

MEDTECH CELEBRATES INTERNATIONAL WOMEN’S DAY

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[vc_row][vc_column][vc_column_text]This year’s theme, Each for Equal, challenges everyone to actively choose to fight bias, broaden perceptions, improve situations and celebrate women’s achievements.

Guests at the event heard from Sheena Vinden, Senior Partner at Atkinson Vinden Lawyers, Trish Bramble, General Manager of the Manly Warringah Women’s Resource Centre and Dr Elizabeth Shoesmith, Founder and CEO of The Inclusive Organisation Group.

All the speakers challenged guests to individually champion greater equality for women in the workplace and in our community, whilst giving a timely reminder that we still have a long way to go.

Women continue to face active bias in the workplace and, whilst progress is being made, there is still a struggle to achieve financial equality and attain senior leadership roles. We all have a role to play to ensure this is addressed.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_images_carousel images=”4411,4412,4413″ img_size=”full”][/vc_column][/vc_row]

AUSTRALIANS LACK AWARENESS OF A SERIOUS HEALTH CONDITION

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[vc_row][vc_column][vc_column_text]The reality is that more than 43,500 Australians die from cardiovascular disease with a further 41,400 deaths associated from it.[1] Heart disease remains the most expensive disease with more hospitalisations than any other disease, costing over $12 billion per year and estimated to increase to over $22 billion by 2032-33.[2]

What if I told you there is a disease that impacts 1 in 8 Australians over 75 and, of those, 1 in 3 are under-recognised and under-treated? The real kicker is that up to 50% of those Australians with the severe form of this disease will die within 2 years[3] unless they get surgery.

It’s a condition that’s as common as breast cancer.

Aortic stenosis is the narrowing of the aortic valve that restricts blood flow and, too often, the symptoms, such as chest pain, fainting upon exertion, shortness of breath and reduced activity, are dismissed as “getting old”.

With an ageing population, we will all need to look at ageing through a different lens. For example, Australians aged 65 years and over contribute almost $39 billion each year in unpaid caring and voluntary work. If the unpaid contribution of those aged 55 to 64 years is included, that figure rises to $74.5 billion per year.[4]

A YouGov study commissioned by Edwards Lifesciences surveyed 2004 Australians over the age of 60 and showed 79% of respondents don’t know what aortic stenosis is, despite it being the one of the most common and serious heart valve disease problems in developed countries. [5] The questions were based on a similar survey of 12,820 people aged 60 years or older in 11 European countries in 2017.[6]

Next year, 5.5 million Australians will be over the age 60 years, and this will increase to 6.9 million by 2030.[7] Of those, we estimate the prevalence of severe aortic stenosis will increase from ~35K to ~46K that’s a 31% increase in 10 years.

At present, we are only treating ~8036 Australians, leaving tens of thousands untreated and under-diagnosed.

A recent report[1] from Australian researchers found high rates of mortality associated with both moderate and severe aortic stenosis during long-term follow-up. As such, previous suggestions that moderate aortic stenosis is a benign condition are wrong.

In November, Medicare raised the rebate for heart health checks to 100%, meaning more than 1.5 million Australians at risk of heart attack or stroke now have access to GP-administered heart health checks.

We hope that checking for that ‘whooshing’ or ‘swishing’ sounds, which are signs of a heart murmur, is front of mind, because it will play a critical role in getting Australians at risk of cardiovascular disease the treatment they need.

At Edwards Lifesciences, we’re proud to be the market leader in patient-focused innovations for addressing structural heart disease. We’re committed to delivering innovative therapies for patients, whether it be for the aortic, pulmonary, mitral or tricuspid valves.

Heart disease is the number one cause of death in Australia. Should you be asking your doctor for a heart health check today?

For more information on aortic stenosis please visit: http://www.HopeforHearts.com.au or https://newheartvalve.com/au/[/vc_column_text][vc_zigzag][vc_row_inner][vc_column_inner width=”1/4″][vc_single_image image=”4394″ img_size=”full”][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Pat Williams is the Managing Director of Edwards Lifesciences ANZ.

For more about Pat, watch: Pat Williams, talks about his journey into the MedTech and healthcare space.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_separator][vc_column_text][1] https://www.aihw.gov.au/reports/heart-stroke-vascular-disease/cardiovascular-health-compendium/contents/deaths-from-cardiovascular-disease

[2] https://www.baker.edu.au/-/media/documents/impact/baker-institute_no-second-chances.pdf

[3] Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-8.

[4] https://aifs.gov.au/publications/archived/1044

[5] Osnabrugge MS et al ‘Aortic Stenosis in the Elderly. Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modelling Study’ JACC 2013 Vol. 62, No 11, 2013

[6] https://link.springer.com/article/10.1007%2Fs00392-018-1312-5

[7] https://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3222.02017%20(base)%20-%202066?OpenDocument

[8] https://doi.org/10.1016/j.jacc.2019.08.004[/vc_column_text][/vc_column][/vc_row]

BAXTER NAMED TOP COMPANY FOR GENDER EQUALITY

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Baxter Healthcare Pty Ltd (Baxter) has been named among the top 119 companies in Australia for gender equality for a fifth consecutive year.

The Australian Government’s prestigious “Employer of Choice for Gender Equality” citation is awarded to organisations who set the benchmark for gender equality in the workplace.

Workplace Gender Equality Agency (WGEA) Director Libby Lyons congratulated Baxter for its continuous focus on diversity and inclusion in the workplace.

“All these organisations are at the forefront of the momentum for change towards gender equality in Australian workplaces,” Ms Lyons said.

“These industry leaders are showing other Australian businesses how to create a better and more equal future for both women and men.

“They are closing their pay gaps and increasing their representation of women in management at a faster rate than other employers in our dataset.”

General Manager Baxter Australia and New Zealand Steven Flynn said Baxter was proud of its unwavering commitment to diversity and inclusion in the workplace.

“Baxter is honoured to be named among the top 119 companies in Australia as a leader in workplace gender equality,” Mr Flynn said.

“We continue to challenge ourselves and our industry to deliver new policies and measurable targets to achieve gender equality across all levels of management.

“Thank you to all our employees at Baxter for taking ownership on this important social and workplace goal.”

In 2019, Baxter was named for a second consecutive year “Women in MedTech Champion” by the Medical Technology Association of Australia (MTAA) for its commitment to promoting gender equality in the medical device industry.

Baxter gender equality policies and practices include:

  • Proactively supporting women to succeed in leadership roles through accelerated learning programs, networking, mentoring and coaching opportunities.
  • Employment practices that ensure pay equality based on merit rather than gender.
  • Actively encouraging men and women to take paid parental leave; recognising the needs of the family unit regardless of gender.
  • Formal processes for applying for flexible working arrangements, encompassing; part-time work, job sharing and flexible working hours.
  • Domestic violence leave to support employees and foster a safe and secure workplace.

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3D PRINTING – A JOINT SUCCESS STORY FOR BOTH AUSTRALIAN INDUSTRY AND REGULATORS

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[vc_row][vc_column][vc_column_text]Historically, much has been made of Australia’s record of innovation in medical devices and pharmaceuticals. Inventions such as the Cochlear Implant, the vaccine to protect against cervical cancer, spray-on skin and penicillin have long attracted the attention of medical professionals and the public.

Parallel to this, Australia has developed a world-class regulatory regime that facilitates patients’ access to these inventions both here and overseas, while maintaining high standards of public health and safety.

Not long ago, the 3D printing of medical devices – the personalisation of a device to suit an individual’s unique physical characteristics and medical needs – seemed like science fiction. Now it’s a reality, and Australia is leading the way, quietly maybe, but in a manner that is delivering to patients, Australian businesses and the economy.

As ever, this is thanks not only to cutting edge Australian scientific and manufacturing ingenuity, but also regulatory innovation, creating frameworks that help facilitate access to safe high quality products.

Since 2017, the Therapeutic Goods Administration (TGA) has been working towards a modernisation of the regulatory regime to achieve this.  With that process now rapidly heading towards implementation, new classifications of medical devices will provide novel regulatory pathways onto the Australian Register of Therapeutic Goods (ARTG) for mass “personalised” medical devices, which were previously categorised within the much broader “custom medical device” category.

This ground-breaking regulation will support a business environment that encourages innovation and investment, whilst facilitating Australian businesses to export their devices to the markets that need them. The TGA has clearly recognised technological changes in 3D printing and the impact this has had on the market for 3D-printed medical devices.

This is particularly reflected in the harmonisation of definitions relating to personalised medical devices, with the International Medical Device Regulators Forum (IMDRF), agreed in November 2019. This development is extremely important for Australian businesses.  The global leadership demonstrated by the Australian TGA, led in this role by Dr Elizabeth McGrath, cannot be overstated.  In short, it is Australian regulators who have set the gold standard now being implemented by their peers across the world.

For pioneering Australian companies, international harmonisation facilitates access to new markets and broadens existing ones. It supports further innovation by giving greater confidence that new devices will reach sufficient markets to support the investment needed to develop them, as well as local manufacturing facilities to produce them.

This harmonisation of the regulatory approach to 3D printed and personalised medical devices is an achievement of which the Australian Government, the Minister for Health Greg Hunt, and the TGA should all be justly proud. If, as expected, the Australian regime is the first of the IMDRF-harmonised regimes to accept applications for Personalised Medical Devices to enter the ARTG, there is a very real prospect that some of the most sophisticated medical device companies from around the globe will now consider an Australia-first lodgement strategy to facilitate the fastest possible pathway to certifying safety, efficacy and conformity prior to global export.

3DMEDiTech is one Australian company poised to take advantage of the new regulatory pathway onto the ARTG and international equivalents. This Melbourne-based company aims to deliver customised 3D printed devices and manufacturing services to the health sector across the Asia Pacific region and beyond.

Each medical device the 3DMEDiTech develops requires significant research and development to allow it to be rapidly mass personalised according to the prescription of the patients health care provider.  This includes mapping and interpreting the full spectrum of the clinical problems the device aims to address, the development and application of novel algorithms, and finding solutions to significant design, material and engineering problems.

Once all those challenges are addressed, the multidisciplinary collaboration of clinicians, engineers, mathematicians, programmers and technicians needs to ensure that the devices can be produced at scale for thousands of people.  The workflow is entirely digital. This means that they can deliver the fastest and most accurate design and delivery of customised devices to healthcare providers and their patients.

3DMEDiTech has also partnered with world-leading clinical and research partners including Melbourne University, St Vincent’s Health Australia, Orthokids and Ivoclar Vivodent. The company also recently joined as foundation industry partners of the Australian Research Council Training Centre for Medical Implant Technologies “CMIT”, headed by the University of Melbourne’s Professor Peter Lee.

Printed devices developed and manufactured in Australia by 3DMEDiTech include prescription clear aligners for by dental clinicians, orthoses for prescription by orthotists and prosthetists, plagiocephaly helmets (used to help infants’ heads form properly), leg braces and ankle foot orthotics.

While much of 3DMEDiTech’s work is still pre-clinical and not in the public domain, several of their lower risk-class devices are already in market and have been spun out into stand-alone commercial entities.

SmileStyler® www.smilestyler.com.au makes prescription-only clear aligners which has uniquely solved the primary clinical problem that had faced both dental professionals and patients.

Serkel® https://serkel.org/ makes personalised orthoses for prescription by orthotists and prosthetists which include plagiocephaly helmets (used to help infants’ heads form properly), bracing and ankle foot orthotics.

There is enormous demand for these products across Asia Pacific. Australian excellence in the research, development and manufacture of these first-rate devices is evident, and recognised.  So too is the role of the TGA in enhancing the reputation for safety and efficacy of the companies and devices they regulate.

The TGA has recognised the opportunities that exist not just for patients, but for Australian businesses in 3D printing, and has taken a global leadership role in advancing personalised medical devices. However, to fully realise the capabilities and ingenuity of Australian companies like 3DMEDiTech, an effective regulatory system is essential.

3DMEDiTech’s founder, Paul Docherty, said: “Our company operates at the forefront of this rapidly growing sector. But we couldn’t do that if the regulations weren’t being put in place to ensure market access and help achieve a return on the substantial investment necessary. In helping deliver international harmonisation in how to define and regulate these emerging devices, the TGA has helped support Australian businesses and jobs. It’s made it possible for companies like ours to continue leading the way in the research, design and production of outstanding printed, personalised medical devices for patients across Asia Pacific.”

Like all industries, there are rogue operators in 3D printing, but the TGA’s work ensures that unscrupulous companies do not undermine patients’ wellbeing and that companies like 3DMEDiTech thrive, delivering innovation, value and better clinical outcomes both to the Australian economy and health system.

Few people recognise what has been achieved in this field in the last three years.  That is a mistake – it’s an Australian success story in the making, and another triumph in the distinguished history of Australian medical innovation. It deserves to be celebrated.[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC SEEKING PARTNERS IN INNOVATION

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[vc_row][vc_column][vc_column_text]For the first time in Australia, Medtronic Australasia will host Eureka LIVE in collaboration with AusBiotech’s premier medical technology conference AusMedtech 2020 from 20-22 May at the Melbourne Convention Centre. Applications are being called from in-market or ‘launch ready’ medtech companies who are looking for opportunities to scale their product innovations globally.

“Medtronic has the tools and experience to collaborate with inventors across a broad range of innovative ideas,” said Tim Fortin, Vice President and Managing Director, Medtronic Australasia. “We have a proven track record of bringing new products to market, by combining our research, engineering, and commercial competencies to deliver meaningful innovations at the therapeutic, procedural, and healthcare system levels.

“At Medtronic, we believe patient-focused innovation – and strong partnerships – remain key to an even better, more impactful future. We are confident that an approach focused on ANZ, which protects inventors and enhances opportunities to collaborate on innovation development, will yield excellent results and push medical technology forward,” Mr Fortin said.

Following the application process, shortlisted companies will showcase their innovations to delegates attending AusMedtech 2020 – both as part of the main Conference program and through Exhibition space at the event – before moving on to targeted and exclusive deep-dive sessions with global Medtronic executives. Successful companies will then be invited to connect with the Medtronic global network to accelerate and fund appropriate opportunities to market in the pursuit of improving community-wide health.

Eureka LIVE aims to promote innovations that add real value for better patient outcomes at appropriate costs, which are validated by solid clinical and economic evidence:

  • innovation for patients, like device technology or remote sensing and monitoring;
  • innovation for hospitals, like data-driven insights to improve processes and predictive analytics to inform patient selection and management;
  • innovation for health systems, like algorithms and data integration to produce system intelligence and transform system performance.

To apply, please visit: https://www.medtronic.com/au-en/c/eurekalive.html

Hosted by Medtronic Australasia, Eureka LIVE is supported by AusBiotech and the MedTech Actuator. It builds on Medtronic’s commitment to supporting local innovation through its web-based portal Medtronic Eureka, also hosted in collaboration with The Medtech Actuator.[/vc_column_text][/vc_column][/vc_row]