2018 MedTech Kerrin Rennie Award goes to Boston Scientific HeartLogic

[vc_row][vc_column][vc_column_text]With 67,000 new cases each year, Australia spends $3.1B annually on heart failure diagnosis and management. HeartLogic is a heart failure diagnostic tool available to patients with certain Boston Scientific implantable cardiac devices and remote monitoring system. HeartLogic incorporates multiple sensors (heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity) into one composite index to detect gradual worsening of heart failure over days or weeks and sends a single actionable web-based alert when the trend crosses a clinician-set threshold.

This multi-sensor approach allows physicians to detect early warning signs of worsening heart failure symptoms and adjusting treatment to avoid potential hospitalisations.

The other Awards recipients included:

  • Gavin Fox-Smith, Johnson & Johnson Medical APAC – Outstanding Achievement in MedTech;
  • Yolanda Mallouhi, Edwards Lifesciences – Women in MedTech Champion; and
  • Baxter – Women in MedTech Champion.

The Outstanding Achievement Award is open to individuals who have contributed in a significant way to the development of the medical technology industry through improvement to patient outcomes or excellence in leadership and innovation.

With more than 30 years’ experience in the industry, including 21 years at Johnson & Johnson, Gavin Fox-Smith has an extensive background as a senior executive in the Asia Pacific region. Mr Fox-Smith is well known for his track record of developing and exporting outstanding leaders and ensuring a truly diverse and inclusive workforce. He is a passionate advocate for efforts that improve health, literacy and education, particularly for Indigenous communities.

Women in MedTech is a Board led initiative which started in July 2015 in response to the gap of women in leadership positions across the industry. The support and engagement on this issue from members of our industry has been overwhelming, making it a clear issue of importance for MTAA to support. The Women in MedTech Champion is awarded to an individual or a company who has contributed to advancing the mission and goals just mentioned.

The Women in MedTech Individual Champion was awarded to Yolanda Mallouhi. Yolanda has been with Edwards Lifesciences for nearly 11 years as the Senior Manager, HR, responsible for identifying, attracting, retaining and building the talent capabilities of Edwards to meet not only today’s and future business needs. Yolanda has been a key contributor to advancing the women in MedTech agenda in Australia by officially kicking off the E.NOW (Edwards Network of Women) in October 2017.

 The Women in MedTech Company Champion was awarded to Baxter Healthcare. Baxter was once again named among the top 100 companies in Australia for gender equality (Australian Government – Employer of Choice for Gender Equality: 2017, 2016, 2015). With its 16-person Senior Leadership Team for ANZ equally represented by women and men, in line with the industry’s benchmark metrics, Baxter has put gender equality and diversity at the core of its business in Australia.

 Ian Burgess, Chief Executive Officer of the Medical Technology Association of Australia said:

 “The MTAA Annual Industry Awards are an opportunity to recognise our members and individuals who have contributed to improving patient outcomes through MedTech.

“This year we received some fantastic entries, so much so the difference between first and second place for the Kerrin Rennie Award was just one point.

“It’s inspiring to be part of the medical technology industry that every day is focused on improving the health and wellbeing of patients.”

Paul Braico, Vice President and Managing Director, Australia and New Zealand said:

“Boston Scientific is incredibly proud and honored to be awarded the prestigious Kerrin Rennie Award.

“The HeartLogic Diagnostic tool provides physicians the ability to pivot from reactive heart failure treatment to proactive care with an overall goal of improving patient outcomes and reducing heart failure-related hospitalisations.

“This is a really exciting time at both Boston Scientific and for those working in the heart failure space, and we look forward to the results produced from this innovative technology.”[/vc_column_text][vc_separator border_width=”3″][/vc_column][/vc_row][vc_row][vc_column][vc_video link=”https://www.youtube.com/watch?v=GByCBDykhwc”][/vc_column][/vc_row]

Therapeutic Goods Advertising Changes

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The following information has been provided by the TGA:

 

Advertising pre-approvals and the new code

We advise advertisers that the date on which an application for pre-approval is decided will determine the version of the code that the advertising must comply with.

Advertisements for medicines that are to appear in specified media require pre-approval under Regulation 5G of the Therapeutic Goods Regulations 1990. The requirement for pre-approval will continue until 1 July 2020.

If you intend to lodge an application for advertising pre-approval between now and 31 December 2018, you should keep this in mind and allow time for revisions if necessary.

If you are in doubt about the application of the 2018 Code to your advertising, please contact us at tga.advertising@tga.gov.au.

Application decided Assessed against
On or after 1 January 2019

(This includes decisions on applications for minor variations to advertisements that were approved before 1 January 2019.)

2018 Code
On or before 31 December 2018 2015 Code

For pre-approval applications lodged prior to 1 January 2019 but decided on or after 1 January 2019, the decision will be made based on whether the advertisement complies with the 2018 Code.

Education activities

In addition to finalising a further two elearning modules, we are preparing a number of face to face and webinar information sessions over the next few months to educate advertisers on the 2018 Code and the advertising complaints handling framework. We are working with key industry bodies to deliver some of these activities.

To receive more information as it becomes available, please subscribe to the TGA website updates.

Advertising complaints handling framework

We have published information about the framework under which we receive and process advertising complaints. See – Complaints handling for the advertising of therapeutic goods to the Australian public.

Assessment of complaints

For complaints about pre-approved advertisements, compliance will be assessed against the version of the Code under which the advertisement was approved.

For all other advertisements, the version of the Code applied will depend on the date/s on which the advertisement aired or was published:

Advertising occurred Assessed against
On or after 1 January 2019 2018 Code
Before 1 January 2019 and is no longer occurring 2015 Code
Before 1 January 2019 and is still occurring 2018 Code

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Varian Medical Systems & GenesisCare Forge Alliance

[vc_row][vc_column][vc_column_text]The partnership between Varian, a global leader in developing and delivering cancer care solutions, and GenesisCare, Australia’s largest private provider of cancer care, will involve the roll-out of a range of world-leading hardware and software over the ensuing five years.

An estimated 138,000 new cancer cases will be diagnosed in Australia this year, with that number set to rise to 150,000 by 2020.1 Radiation therapy contributes to 40 per cent of all cancer cures world-wide, helps to relieve symptoms, such as pain, and improves patient quality of life.

According to radiation oncologist and GenesisCare’s Australian Chief Medical Officer, Associate Professor Peter O’Brien, Newcastle, radiation therapy is a highly effective cancer treatment, but is under-utilised in Australia, despite costing less than nine cents in every dollar spent on cancer diagnosis and treatment.

“The advances in radiation therapy technology in recent years have been quite phenomenal, and we’re now able to use platforms that give us pinpoint accuracy and streamlined access to patient data. This helps us deliver better outcomes for our patients, which is ultimately what matters most.”

In addition to the installation of up to 35 Varian linear accelerators and the use of Varian’s Eclipse treatment planning software as the preferred GenesisCare solution in Australia, the partnership will also include support for skin cancer clinical trials utilising Varian’s RapidArc technology.

“Improving the quality of life for skin cancer patients is a major research focus for GenesisCare, so we’re thrilled that Varian will be investing in new skin cancer trials as part of this partnership,” Prof O’Brien said.

“Radiation therapy can be transformative for people with chronic skin cancer, and we aim to be at the forefront of research that can advance treatment for patients, both in Australia and internationally.”

Skin cancer is among the nation’s most prevalent cancers.3 It accounts for around 80 per cent of new cancer diagnoses, with two-in-three Australians diagnosed with skin cancer by 70 years of age.

GenesisCare Chief Executive Officer, Dan Collins, Sydney, says the partnership with Varian will support advances in radiation therapy and the evolution of Varian’s products and services to deliver proven new technology to patients as quickly as possible.

“GenesisCare is excited to be partnering with Varian to accelerate the roll-out of ground-breaking radiation therapy technology that’s set to improve clinician efficiency and accuracy. We’re committed to increasing access to world class patient care, and will be installing up to 70 new linear accelerators internationally, as part of this agreement. This will mean a big boost in high quality cancer treatment in areas of need,” said Mr Collins.

Varian Australasia Managing Director Chris Cowley, Sydney, says the Varian/GenesisCare partnership represents another significant step towards Varian’s aim of achieving a world free from fear of cancer.

“Varian is delighted to be partnering with GenesisCare to increase Australian patient access to our radiation technology, and to ultimately improve the cancer treatment experience, and hopefully outcomes, for those in need.

“We are dedicated to combining the ingenuity of people with the power of data and technology to achieve new victories against cancer, and are therefore thrilled that GenesisCare has put their faith in our products with this volume commitment to both our hardware and software platforms,” Mr Cowley said.

The partnership will also focus on the emerging field of theranostics, also known as molecular targeted radiation. Theranostics uses nanoscience to unite diagnostic and therapeutic applications to form a single cancer fighting agent. Utilising Varian’s expertise in image-guided technology and GenesisCare’s experience in clinical and research domains, Varian and GenesisCare will partner to develop image-guided treatment monitoring solutions in this evolving area.[/vc_column_text][/vc_column][/vc_row]

Cook Medical Recognition Continues – This Time for Investment In Brisbane

[vc_row][vc_column][vc_column_text]Managing Director Dr Samih Nabulsi said the award is a humbling recognition of Cook Medical Australia’s commitment to Brisbane and its people.

“We are humbled and honoured to receive the Investment in Brisbane award particularly knowing the achievements and contributions of our fellow finalists to business and the community in Brisbane.”

“Our win is a reflection of our team and their hard work,” said Dr Nabulsi.

The Investment in Brisbane award follows the company’s announcement earlier this year that it was expanding capacity with the establishment of a second manufacturing shift and the addition of 94 new jobs to meet increasing export demand. The company also launched the Australian Research Council Research Hub for the Advanced Manufacturing of Medical Devices with the goal of transforming Australia’s medical technology industry.

“Manufacturing is essential to the economy and this expansion demonstrates Cook Medical’s commitment to manufacturing, innovation and jobs in Queensland,” said Dr Nabulsi.[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC CO-FOUNDER EARL BAKKEN PASSES AWAY AT AGE 94

[vc_row][vc_column][vc_column_text]“Today we are saddened by the passing of Earl Bakken, but we also honor and will forever cherish the life of a beloved man whose brilliance and vision have improved the lives of millions of people around the world,” said Omar Ishrak, Medtronic chairman and chief executive officer. “The contributions Earl made to the field of medical technology simply cannot be overstated. His spirit will live on with us as we work to fulfill the Mission he wrote nearly 60 years ago – to alleviate pain, restore health, and extend life. Our thoughts and prayers are with the Bakken family during this difficult time.”

In 1949, Mr. Bakken founded Medtronic with his brother-in-law, Palmer J. Hermundslie. Before retiring as chairman in 1989, Bakken led Medtronic for 40 years, guiding the company from humble roots into the world’s premiere medical technology company.

Born in Columbia Heights, Minn., Mr. Bakken graduated from high school in 1941 and enlisted in the Army Signal Corps where he served in World War II as a radar instructor. After leaving the Army, he attended the University of Minnesota, earning a degree in electrical engineering.

While a graduate student, Mr. Bakken did part-time work repairing delicate lab equipment at Northwestern Hospital in Minneapolis. Demand for these services grew, and on April 29, 1949, Bakken and Hermundslie formed a business partnership. They called the company Medtronic, with its headquarters in a modified garage in northeast Minneapolis.

While installing and servicing devices used during early open-heart surgeries, Bakken and Hermundslie built relationships with physicians at University Hospitals, Minneapolis. The late C. Walton Lillehei, a young staff surgeon at the time, was pioneering procedures to help “blue babies” born with often-lethal heart defects. Following a power outage in the Twin Cities that caused the death of an infant, Dr. Lillehei asked Bakken to find a solution. Bakken responded by building the world’s first wearable, transistorized pacemaker. He adapted a circuit described for an electronic transistorized metronome in the magazine Popular Electronics. This milestone is viewed by many as the “birth” of Medtronic. Pacemakers, however, were only one product in a growing, but increasingly diverse, product line.

In 1960, in an effort to more clearly define Medtronic’s areas of concentration and its values, Mr. Bakken wrote the Medtronic Mission, which has guided the company and remains unchanged.

In 1994, Bakken moved to the Big Island of Hawaii. As a resident, he was a prominent volunteer and philanthropist. He became Chairman of the Board of Directors of the Five Mountain Medical Community as it developed the North Hawaii Community Hospital. While on the board, he also helped to establish Tutu’s House, a community resource center promoting careers, education, and effective health outcomes, and the Kohala Center, a community-based center for research, conservation and education.

In 1975, he founded The Bakken Museum, a nonprofit library, museum and education center in Minneapolis. The museum is devoted to the history of electricity and magnetism and their uses in science and medicine.

Mr. Bakken’s passion for philanthropy did not wane in his later years. In 2013 he launched The Bakken Invitation, which honors patients whose lives have been extended thanks to medical technology and who have used this “gift of extra life” to make an impact through service and volunteerism. Bakken Inivitation honorees receive a donation to their cause along with a trip to Hawaii to take part in a special ceremony.

Mr. Bakken also was involved in several other philanthropic ventures, including the Na Kalai Waa Moku O Hawaii, Friends of the Future and the Imiloa Astronomy Center of Hawaii.

In Dec. 2007, at age 83, Bakken became the first recipient of an honorary Medical Degree from the University of Minnesota, recognizing his contributions in the medical field. During his life, he also received honorary doctorates from the Universities of Hawaii, Tulane, and the Albany College of Pharmacy. In 1995, Mr. Bakken was named to the Minnesota Inventors Hall of Fame and received an Outstanding Achievement Award from the University of Minnesota in 1981. In 1984, his cardiac pacemaker was named one of the 10 most outstanding engineering achievements of the last half century by the National Society of Professional Engineers. In 2014, Bakken received the Lifetime Achievement Award from the Advanced Medical Technology Association.[/vc_column_text][/vc_column][/vc_row]

Cook Medical recognised for contribution towards the Health and Biotechnology sector in Queensland

[vc_row][vc_column][vc_column_text]Managing Director Cook Medical Asia-Pacific and Vice President Cook Incorporated, Mr Barry Thomas said the award is a welcome recognition of the company’s commitment to innovation, investment in people and drive to expand into new markets.

“It is an exciting time for Cook Medical Australia. Such recognition enhances our opportunity to make advancements in the medical device industry, enabling us to deliver value for our customers and to continue helping to improve patient outcomes.”

“We thank our entire team for their collective efforts in helping us win this award,” said Mr Thomas.

Cook Medical was also selected as a Finalist for the Export Award for Manufacturing.

“We’re honoured to be recognised among the other award winners and finalists and congratulate Tritium for winning Queensland’s Exporter of the Year Award for 2018,” Mr Thomas said.

Earlier this year the company announced that it was expanding capacity with the establishment of a second manufacturing shift and the addition of 94 new jobs to meet increasing export demand. The company also launched the Australian Research Council Research Hub for the Advanced Manufacturing of Medical Devices with the goal of transforming Australia’s medical technology industry.[/vc_column_text][/vc_column][/vc_row]

St Charles’ Catholic Primary School: “Mars here we come!”

[vc_row][vc_column][vc_column_text]Mr Alexander said: “Wow! That is all I can say about the brilliant designs, high quality presentations, and interplanetary – even interstellar, actually inter-galactic – levels of enthusiasm that was put on display by our local Bennelong students.

“Congratulations to all the participating schools and students. I hope you got a lot out of the experience, and that it will put you in good stead for the future. Well done to the category winners and to St Charles’ Catholic Primary School who nabbed the overall winner award for their MACER entry.”

Mr Alexander started the competition last year to promote the study of science, technology, engineering and mathematics (STEM). Partnering with innovative biomedical device creators Medtronic and then this year also with the Re-Engineering Australia Foundation, the competition has evolved into one of the premier STEM competitions available in Sydney.

Medtronic donated the exhibition space at their headquarters in Macquarie Park, lunch for everyone, and the prizes. They also made their research, development, biomedical devices and staff available to the students to investigate and ask questions throughout the day, hopefully inspiring them to seek careers in the STEM fields of the future.

Medtronic Australasia Managing Director Tim Fortin said: “We are proud to support the Medtronic Bennelong STEM Challenge because we believe in the importance of bringing STEM to life.

“Innovation and collaboration are central to who we are at Medtronic, so we see this initiative as an opportunity to support our future generations of researchers, healthcare professionals and providers, and to encourage them to take bold moves in applying their learnings through STEM,” Mr Fortin said.

Re-Engineering Australia Foundation (REA) Founder and Chief Executive Dr Mike Myers OAM added: “It’s important to engage kids in STEM subjects in a way that they can relate to, and in a way that is relevant to problem solving in the real world.”

REA currently run the successful F1 in Schools STEM Challenge, and the Subs In Schools Technology Challenge amongst other STEM challenges for schools, their involvement was critical to the success of this competition.

The Medtronic Bennelong SPACE in Schools STEM Challenge comprised three categories: Portfolio, Virtual Design and Verbal Presentation. High school and primary school were also separated. Then there was an overall winner declared.

REA also provided the expertise that allowed the designs to be uploaded to a 3D virtual reality simulator, so judges and students could literally walk around inside their designs.

Participating schools included: St Charles Catholic Primary, Putney Public, Ermington West Public, Carlingford Public, Epping Boys High School, and Marist College Eastwood.[/vc_column_text][/vc_column][/vc_row]

Stride4stroke For Someone You Love

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This November, the Stroke Foundation is challenging the community to Stride4stroke, a physical activity campaign which raises funds to support vital programs for stroke survivors and their families.

Registrations are now open and participants can set their own activity goal and fundraising target.

Queensland woman Nicola Baker will take part in Stride4stroke and will stride for her 14 year old son Jed, who had a stroke at just 11 months old.

“Jed’s stroke came as a huge shock. It not only changed his life, it changed mine too,” Nicola said.

“While life has been isolating at times and full of challenges and doctor appointments, each day is a gift. We didn’t know whether Jed would be able to go to school, let alone reach his teens.

“Jed has had three rounds of brain surgery and monitoring is just a part of life, but he is a wonderful kid who has brought me so much joy. I want to help support others in a similar position.”

Nicola will aim to walk 10 kilometres each day of November and has encouraged friends to join her. Nicola said being part of a team would ensure she walked every day and would help raise even more funds.

“Everyone I know has a personal connection to stroke – whether it be a parent, grandparent, friend or colleague. Many have seen first-hand how devastating it can be,” Nicola said.

“By taking part in Stride4stroke, we will not only be helping to raise funds to help Stroke Foundation make recovery from stroke better for families, there is the added bonus of reducing our own risk of stroke by getting active,” she said.

Stroke Foundation Chief Executive Officer Sharon McGowan congratulated Nicola on getting involved in Stride4Stroke and encouraged others to follow her lead.

“We see the impact of stroke on families, like Nicola’s, each and every day,” Ms McGowan said.

“There will be around 56,000 strokes in Australia in 2018. Stroke is one of this country’s biggest killers and a leading cause of disability.

“Frightening, stroke can strike anyone at any age, but you can make a difference.

“Every dollar raised through Stride4stroke will have an enormous impact. It will go towards vital Stroke Foundation programs like StrokeLine (1800 787 653) and follow up services which help survivors and their families transition to life back home after stroke and throughout the recovery journey,” she said.

This November who will you stride for? Get a team together for Stride4stroke or do it by yourself. Set an activity and fundraising goal and go for it! Register or donate at www.stride4stroke.org.au

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Corin To Acquire Global Orthopaedic Technology

[vc_row][vc_column][vc_column_text]The acquisition will serve to strengthen Corin’s position as global leaders in the hip and knee joint replacement market as the company continues its global expansion and innovation push.

Formed 19 years ago, Global Orthopaedics Technology (GOT) has an extensive range of orthopaedic implants including knee and hip products with enabling robotics and navigation technologies. GOT already has a significant footprint in Australia and an export business in the USA.

Commenting on the acquisition, Corin CEO, Stefano Alfonsi said the agreement will further strengthen Corin’s presence in the sophisticated and competitive Australian market.

“The combination of Corin and GOT capabilities creates a leading player in Australia with a stronger ability to fulfil the needs of hip and knee surgeons. I look forward to welcoming the talent GOT team into the Corin global family,” Mr Alfonsi said.

Chief Executive of GOT, Andrew Fox-Smith said the acquisition represented a “fantastic next step for both our people and our customers”.

“We’re very excited about what the combined business can achieve, not only here in Australia but also via faster expansion internationally of GOT’s Australian developed product portfolio.”

Corin’s R&D Hub in Australia is a key pillar of its global innovation capabilities and differentiated product offering. The combination with GOT is expected to provide significant scale to Corin’s operations in Australia – one of the world’s most attractive orthopaedics markets, as well as additional R&D expertise.[/vc_column_text][/vc_column][/vc_row]