MEDTECH LIFE CHANGING IMPACT HEADS TO CANBERRA

[vc_row][vc_column][vc_column_text]The event is expected to attract well over 100 attendees from the sector and policy-makers and will include speeches by both the Minister for Health, the Hon. Greg Hunt MP, and Shadow Minister for Health, Catherine King MP.

One of the patients telling their story will be former NSW Deputy Premier, the Hon. John Watkins AM who was diagnosed with Parkinson’s disease seven year ago, a condition he has kept private until earlier this year. In January he agreed to undergo a seven-hour operation to attach a pacemaker device with leads into his brain known as deep brain stimulation.

“I often wish I didn’t have Parkinson’s but I can’t help thinking that as I do I am very fortunate to live in Australia and have access to first class surgical technology such as deep brain stimulation,” Mr Watkins said.

“As the disease has progressed I have developed an overwhelming sense of gratitude for life and for the medical research that has given me another chance at that life. It means that I can again travel, continue to work, play with my grand-kids, go for a walk, roll over in bed, and be involved in life rather than being an observer. To live rather than watch life pass by.”

Jenny Casey, another medtech beneficiary, will also be in attendance to share her story. Ms Casey received catheter ablation for the treatment of atrial fibrillation over a 5-year period, experiencing a staggering 15 attacks.

Atrial fibrillation is a major public health issue affecting around 460,000 Australians and is characterised by symptoms of shortness of breath, palpitations and chest pain. It is also associated with a 5 to 7-fold increase in the risk of stroke. The burden and impact of atrial fibrillation on our community is significant, financially and emotionally.

Along with the patients the event will hear from healthcare professionals speaking about the importance of co-designing devices with medical technology companies to deliver ongoing innovation which ultimately benefit patient outcomes.

Parliamentarians will be exposed to a range of technologies from the medical technology industry including an orthopaedic robotic arm and virtual reality device for the training of cataract removal.[/vc_column_text][/vc_column][/vc_row]

NSW BUDGET: FUNDING BOOST TO FIGHT HEART DISEASE

[vc_row][vc_column][vc_column_text]Premier Gladys Berejiklian, Treasurer Dominic Perrottet and Health Minister Brad Hazzard said the landmark funding in the NSW Budget 2018 would start with a $60 million rollout to researchers over the next four years.

“Heart disease remains Australia’s number one killer but with greater investment, researchers can predict, prevent and treat it more accurately,” Ms Berejiklian said.
“If we want to keep people healthy, and reduce pressure on our clinical services, we have to curb the growing epidemic of cardiovascular disease.”

Mr Perrottet said: “Cardiovascular disease affects one in six Australians, and living with a heart condition can be frightening. It is critical we make this investment in long-term research funding for the wellbeing of NSW.”

Heart disease kills one person every 12 minutes.

Mr Hazzard said the 10-year funding certainty makes NSW an immensely attractive option to cardiovascular disease researchers and clinicians from around the world.
“We need skilled partners to beat heart disease and this investment guarantee will make us the first choice for researchers, the pharmaceutical sector and biotechnology industry,” said Mr Hazzard.

“The funding pipeline also allows us to support more clinical trials and leverage the existing research already underway across institutes, hospitals and universities.”

“We are committed to partnering with industry to grow health and medical research jobs, and bring new discoveries to market as quickly as possible to benefit individuals and their families, as well as the broader NSW economy,” said Mr Hazzard.

The record investment builds on the work of the Cardiovascular Research Network, a collaborative of 15 member organisations and more than 50 affiliated research institutions supporting cardiovascular research and the NSW research workforce.

The Heart Foundation’s NSW CEO Kerry Doyle said: “The NSW Government has shown vision and foresight in making this commitment, guaranteeing the next generation of research excellence and first-class care for the community.”

The Victor Chang Cardiac Research Institute’s Executive Director Professor Robert Graham said: “With this initiative, we will be able to rapidly convert groundbreaking discoveries into better treatments for patients with heart disease.”[/vc_column_text][/vc_column][/vc_row]

PULSELINE SITS DOWN WITH DR EMILY KOTSHCET

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Dr Kotschet is a Cardiologist and Electrophysiologist with a particular interest in inherited cardiac arrhythmias, including cardiac genetics and atrial fibrillation.

Emily finished her cardiology training then completed a three year fellowship in Electrophysiology with 2 years training in Canada, subspecialising in ablation.

Emily has a public hospital appointment at MonashHeart, Monash Medical Centre, performing device implantations and catheter ablations and is the Director of Cardiology Outpatients. She also works at Cabrini Hospital in Malvern, Linacre Hospital in Hampton and the Valley Private Hospital in Mulgrave. Consultation is available at Monash Medical Centre (Private Suite B), Brighton, Hampton (Linacre Hospital) and Frankston (Peninsula Private Hospital). She also provides cardiac services in rural Victoria visiting Alexandra and Morwell.

Emily’s interests include atrial fibrillation management including catheter ablation, device implantation (pacemakers, defibrillators and cardiac resynchronisation devices and subcutaneous devices) and inherited arrhythmias such as Long QT syndrome, Brugada Syndrome and sudden cardiac death, including cardiac genetics. She is happy to consult families and children regarding these conditions.[/vc_column_text][/vc_column][/vc_row]

UNIVERSITY OF NEWCASTLE SEEKS INDUSTRY PARTNERS TO PROVIDE ‘INVALUABLE EXPERIENCE’ FOR STUDENTS

[vc_row][vc_column][vc_column_text]Connecting innovative and passionate students with industry partners has been a primary focus for the University of Newcastle for more than 50 years.

The Biomedical Science field continues to expand, and so too does the need for partnerships that allow students to gain quality industry experience.

University of Newcastle Program Convenor, Doctor Karen Mate, highlights that students benefit greatly from gaining real-world experience with industry partners.

“The University of Newcastle is recognised for producing world-class graduates who are leaders in their field,” said Dr Mate.

“By providing students with the opportunity to complete work placements with industry partners, they are able to further develop their skills and can also contribute significantly to individual business outcomes.

“We are interested in connecting with new biomedical science industry partners to discuss how engaging our student-base can help with meeting their business needs.

“Our students have the skills and knowledge needed to impact the global advancement of medical research practice and policy, and industry have the opportunity to utilise this fresh talent to deliver innovative results, added Dr Mate.

Professor Robert Rush, Founder and Managing Director of biotech company Biosensis, who has partnered with the University of Newcastle for more than three years, comments on how engaging with students has benefited research advancement.

“The project has been useful and resulted in sufficient progress being made so far. In doing so, Biosensis has committed funds to employ the student as a post-doctoral fellow on completion of his degree,” said Professor Rush.

“We would certainly seriously consider further commitment in the future. Biosensis has a number of collaborations with global universities and enjoys the academic-industry approach which benefits both parties,” concluded Professor Rush.

Thanks to industry partners like Biosensis, student Sam Faulkner was able to collaborate with Biosensis on common research interests, gaining invaluable real-world experience.

“Industry support for undergraduate programs and students provide invaluable experience and insight into corporate research and corporate science and technology ways,” said Mr Faulkner.

“Traditionally, students get a taste of a variety of health and medical research disciplines but rarely work directly with industry to understand science on a commercial level.

“I have benefited significantly from this exposure and am grateful this experience has allowed me to foster networking and future study opportunities,” concluded Mr Faulkner.

While the University of Newcastle maintains existing partnerships with industry, there is a growing need to provide additional placement opportunities for students.

“These partnerships are vital to the academic and professional development of our students and also to the evolving landscape of local industry, Dr Mate continued.

“If you are a business in the biomedical field who is looking for access to students with select academic backgrounds, if you require expertise that is flexible and responsive to industry needs and would like to build research collaborations with the support of the University of Newcastle, we encourage you to get in touch with us.

“Through our research, and strong national and international partnerships, we’re driving innovation that challenges conventional thinking, breaks new ground and changes lives.

“Let our students help your business,” concluded Dr Mate.

For more information on how University of Newcastle biomedical science students can benefit your business, contact Dr Karen Mate – Program Convenor on Karen.mate@newcastle.edu.au or 02 4921 5983[/vc_column_text][/vc_column][/vc_row]

BEHIND THE SCENES, AMERICA’S MEDICAL TECHNOLOGY COMPANIES ARE FIGHTING THE CYBERSECURITY BATTLE

[vc_row][vc_column][vc_column_text]Globally healthcare regulators have identified cyber security as a key issue for medical devices such as infusion pumps, implantable pacemakers, cardiac defibrillators and telemetry heart monitors. Experts and regulators worldwide are focused on reducing device vulnerability and mitigating risks of hacking and malware attacks.

AdvaMed has recently praised the U.S. FDA for its proactive leadership and for working collaboratively with the MedTech industry and the broader healthcare community in the cybersecurity space.

Ensuring medical devices are shielded from cybersecurity threats is, in the words of the U.S. Food and Drug Administration, a “shared responsibility” among all stakeholders.

Medical technology companies, hospitals, physicians, IT professionals, providers, regulators and patients all need to work together so that the safety and integrity of interconnected medical devices – everything from pacemakers and ICDs to monitors and infusion pumps – is not compromised due to cyber threats.

No one takes this responsibility more seriously than America’s medical technology companies, for whom patient safety is the #1 priority. Unfortunately, little is known or understood about the extensive work medical technology manufacturers have done and are doing to address this potential threat.

Medtech companies continuously assess the security of their devices in a world where the risks continuously evolve. They address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment, maintenance and disposal of the device and associated data.

Similarly, manufacturers implement proactive measures to manage medical device cybersecurity, including but not limited to routine device cyber maintenance, assessing post-market information, employing risk-based approaches to characterizing vulnerabilities, and timely implementation of necessary actions. These requirements are a matter of law, as FDA has in place comprehensive regulations prescribing these risk management programs, and manufacturers face severe penalties for failing to follow the rules.

But addressing this issue goes beyond an individual company’s merely meeting current regulations. Cybersecurity is ever-evolving, and the medical technology industry recognizes that it must constantly evolve to meet potential threats. That’s why we collectively developed our own set of medical device cybersecurity principles. These principles ensure device manufacturers build a cybersecurity program based on the best available information, such as FDA guidance, NIST publications, and consensus-based standards.

Our industry also recognizes that cybersecurity threats require the cooperation and collaboration of multiple stakeholders in the health care ecosystem. And that’s why we have committed to working with regulatory agencies, industry partners, health care providers and others to address this challenge to ensure that everyone takes this threat as seriously as we do.

FDA is to be commended for the proactive leadership it has taken in recent years when it comes to cybersecurity. The Agency has worked collaboratively with our industry and the broader health care community to ensure medical device cybersecurity is considered and addressed throughout all stages of product design and use. While manufacturers have long included cybersecurity considerations in premarket development and postmarket surveillance, the Agency’s detailed guidance on these issues has provided important instruction and clarification for medtech companies. FDA should also be commended for their work engaging with other Federal agencies in their area, including DOJ, FBI, DHS and NIST.

Open communications is a key strategy in combatting cybersecurity threats. To that end, the medical technology industry has worked closely with public-private organizations – with the encouragement of FDA – to establish a medical device information sharing and analysis organization. Similar to systems successfully used in the energy and finance sectors, this program provides a streamlined mechanism for companies to submit and share information concerning cybersecurity-related issues.

However, despite manufacturers’ best efforts, many cybersecurity threats remain outside their control. Most connected devices are linked to third-party networks, such as a hospital’s IT system or a patient’s home-based Wi-Fi network. A chain is only as strong as its weakest link, so if these systems or networks are vulnerable the medical devices they are connected to are vulnerable as well.

The confluence of medical technology and communications are transforming health care, providing physicians with real-time information and the ability to remotely monitor and treat patients. Our industry is committed to doing our part to ensure this progress continues by rigorously addressing cybersecurity threats pre- and post-market. We will continue to work with FDA, health care providers, the academic community, security experts and other stakeholders to ensure the continued security, safety and effectiveness of medical devices.

Closer to home, the TGA is taking the lead in developing a strategy for cyber security of medical devices in collaboration with CSIRO and Standards Australia. The aim is to address risks associated with implantable and non-implantable devices connected to the web in an increasingly complex and interconnected healthcare system.

PulseLine understands the TGA is developing a strategy to increase stakeholder awareness of expectations regarding cyber security of medical devices across the industry. PulseLine will be asking the TGA to provide some further insights in the weeks to come.[/vc_column_text][/vc_column][/vc_row]

Medtech’s Growing Role in Clinical Trials in Australia

[vc_row][vc_column][vc_column_text]The country’s regulatory environment and organizations such as the MTAA have helped to nurture the increasing interaction between industry and clinical researchers, ushering in more trials that help to improve medical therapy and offer benefits to both patients and the economy. In celebration of International Clinical Trials Day, let’s take a look at the study landscape in Australia and how it has transformed in recent years.

Medical device companies are playing an increasingly important role in Australia when it comes to clinical research. The number of new clinical trials involving medical devices increased greatly by 12.6% annually between 2010 and 2015. In comparison, the growth rate for new pharmaceuticals trials was only 2.7% during the same period. Overall the number of new trials rose by 4.7%.

A number of global medical technology companies are already taking advantage of the favourable conditions that Australia offers for early-phase clinical trials. The regulatory environment is conducive to first-in-man studies and there are dedicated research teams with a strong commitment to data quality. However, more needs to be done for Australia to remain competitive in the international clinical trials landscape. Especially when it comes to early phase studies, time is essential. Recent reforms have targeted limitations such as slow study start-up due to duplication of ethical review of the same study across multiple hospital sites. The MTAA plays an active role in informing public debate as well as government during the reform process via its Clinical Investigations Forum which was formed in 2011.

Fundamentally, clinical trials with medical devices serve patients. They benefit from access to the latest technologies that may not yet be available commercially, advice from and treatment by leading medical practitioners, and, in many cases, closer monitoring of their treatment. Moreover, from a healthcare system perspective, clinical research promotes the use of best evidence in medical decision-making based on health economic value. A vibrant clinical trials infrastructure attracts academic talent with positive flow-on effects for hospitals, communities and even the entire country. Clinical trials have a positive economic impact as well. Not only through the direct investment in clinical studies and infrastructure, but also by rigorously testing innovative technology, thus preparing it for market launch based on solid clinical evidence. For those reasons, the Australian government continues to strongly support clinical research activity.

An example of a recent and potentially guideline-changing trial is CASTLE-AF, which was conducted with BIOTRONIK’s support. The multicentre trial showed a 38% reduction in the composite endpoint of all-cause mortality and hospitalization for worsening heart failure, when catheter ablation was used to treat heart failure patients with atrial fibrillation (AF). All patients in the study had implantable cardioverter-defibrillators or cardiac-resynchronisation defibrillators with BIOTRONIK Home Monitoring technology. The reduction was observed when comparing these patients to patients treated with the pharmacological therapy recommended by current guidelines.

Dr. Johannes Brachman, Coburg Clinic, Germany, who led the trial together with Dr. Nassir Marrouche, CARMA Center, University of Utah, Salt Lake City, US, said: “These findings indicate heart failure patients with coexisting AF should be treated with catheter ablation as a first-line therapy.” The CASTLE-AF study thus contributes to enriching clinical knowledge and further developing therapy options for heart failure patients. Notably, this clinical trial also included two Australian investigators (Dr. Prash Sanders, Royal Adelaide Hospital, Adelaide, SA and Dr. Paul Martin, Royal Brisbane and Women’s Hospital, Brisbane, QLD).

When conducting clinical trials, medtech companies follow strict ethical principles. Each trial needs to be assessed by an independent Human Research Ethics Committee prior to being allowed to commence. The safety of the individual patient in a clinical trial always has priority over the trial itself. Patients choose whether or not to participate and they can withdraw their consent at any time.

On the occasion of International Clinical Trials Day we recognize clinical research and the people that make that research possible. The medical device industry is very fortunate to work with Australia’s brightest and most dedicated clinical research professionals for the benefit of our patients. We congratulate them on their achievements.[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1971″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Falko Thiele, is the Director Clinical and Regulatory Affairs at Biotronik.[/vc_column_text][/vc_column][/vc_row]

DR DAN GRANT ANNOUNCED AS NEW CEO OF MTPCONNECT

[vc_row][vc_column][vc_column_text]Dr Grant joins MTPConnect from his position as Pro Vice-Chancellor for Industry Engagement at La Trobe University in Melbourne, where he leads the University’s innovation, commercialisation and industry engagement activities. Dr Grant also oversees the University’s R&D Precinct and was responsible for establishing La Trobe’s business accelerator program and Strategic Innovation Fund.

Prior to joining La Trobe, Dr Grant was the Senior Director and Head of Pfizer’s External Research and Development Innovation group for Australia, New Zealand and Singapore. He has also held roles as Senior Business Development Manager at Melbourne Ventures, a member of the Investment Committee for Uniseed, and as a Senior Business Development Manager for Biocomm Services.

With a strong background in University research and industry, Dr Grant will work with the MTPConnect Board and Chair to further develop the organisation by building relationships with industry, government and other stakeholders, both nationally and internationally.

Dr Bronwyn Evans, the chair of MTPConnect, said the appointment of Dr Grant brings new opportunities for growth and advancement, not just within MTPConnect, but for the entire MTP sector in Australia.

“The Board is delighted to welcome Dr Grant to MTPConnect. Under the leadership of Sue MacLeman, MTPConnect has become an extremely valuable contributor to the MedTech and Pharmaceuticals sector. MTPConnect has an impressive reputation for making a difference, and Dan’s business and academic background make him the ideal person to take up the mantle as CEO. I look forward to seeing the organisation continue to flourish under his leadership.”

Dr Grant said he was very excited to be joining MTPConnect in July.

“I am honoured to be joining MTPConnect and to be given the opportunity to work closely with the entire MTP sector, to represent the sector’s interests and act as a champion for change. Building on the success that MTPConnect has achieved under Sue MacLeman’s leadership, I relish the opportunity to ensure that MTPConnect continues to have a leading role in guiding and promoting the sector’s long-term success.”

MTPConnect was formed as a not-for-profit organisation in November 2015 as part of the Australian Government’s Industry Growth Centres Initiative. MTPConnect sits at the nexus of the sector, driving collaboration, acting as an independent voice for change, working to establish Australia as an Asia-Pacific hub for MTP companies, and funding big, bold ideas to accelerate growth and drive greater commercialisation opportunities.

As announced in February 2018, Sue MacLeman, the first CEO of MTPConnect, will assume the Chair position in place of Dr Bronwyn Evans who is stepping down.

To ensure appropriate governance, there will be a gap between Ms MacLeman stepping down as CEO and taking up the role as Chair. During this three-month period, Dr Evans will remain the Chair and work with the new CEO, with Ms MacLeman to be appointed as a Non-Executive director to assist in transition. In October 2018, following three months as a Non-Executive board member, Ms MacLeman will move to the Chair role and Dr Evans will step down from the Chair and Board role with MTPConnect.[/vc_column_text][/vc_column][/vc_row]