Category: Future of MedTech

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

Posted on | by Team

[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]

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

Posted on | by Team

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

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

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

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

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

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

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

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

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

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

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

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

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

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

WESTMEAD PRIVATE INVESTS IN INDUSTRY LEADING 3D SURGERY TECHNOLOGY

Posted on | by Team

[vc_row][vc_column][vc_column_text]This new technology means that complex surgeries can now be performed with laparoscopic surgery rather than open surgery, reducing pain and recovery time. This is particularly important for complex bariatric surgery, lung and liver resection surgeries.

VISERA ELITE II restores natural 3D vision and depth perception, providing improved speed, accuracy and precision for surgical tasks. It is unique in offering a rigid 3D video laparoscope that supports seamless direction-of-view rotation to mimic the traditional camera head / telescope configuration without rotating the image on screen. This significant technological development overcomes a major hurdle to 3D adoption. It ensures a level surgical horizon is maintained at all times, while removing the learning curve traditionally associated with 3D imaging.

Dr Brendan Ryan performs bariatric surgery at Westmead Private and recently had the opportunity to use the new Olympus 3D system for gastric sleeve and gastric bypass procedures. “The increased depth of vision is amazing and makes my surgery more precise. It allows me to undertake my more complex operations with greater surety. I am so excited about this enhanced technology and am constantly impressed by the extra vision I can get,” said Dr Ryan.

Westmead Private is committed to providing the best in health care, offering surgical options that achieve the most optimal outcomes for patients.

“It is wonderful to be able to offer such cutting edge technology to our patients, which will help us deliver enhanced, faster and more effective care. Further enabling us to become the first choice for patient care in our community,” said CEO Mike Flatley.[/vc_column_text][/vc_column][/vc_row]

NEW RESEARCH HUB TO TRANSFORM AUSTRALIA’S MEDICAL TECHNOLOGY SECTOR

Posted on | by Team

[vc_row][vc_column][vc_column_text]Above: ARC CEO, Prof. Sue Thomas (second from right) officially launches the ARC Research Hub for the Advanced Manufacturing of Medical Devices (AMMD Research Hub) with Director of the Advanced Manufacturing Growth Centre Mr Michael Grogan, Member for Sunnybank Mr Peter Russo MP, AMMD Research Hub Director Prof. Matthew Dargusch, Cook Medical Australia General Manager Dr. Samih Nabulsi at, Director – APAC and VP Cook Inc. Mr. Barry Thomas and UQ Vice-Chancellor and President Prof. Peter Høj at Cook Medical Australia in Brisbane today.[/vc_column_text][vc_separator][vc_column_text]While a key aim of the research hub is the transformation of Australia’s medical technology sector by developing competitive technologies for the rapid production of medical devices, it is patients who are set to benefit most from the industry-research partnership.

One of the key goals for the AMMD Research Hub is to improve health outcomes for patients in Australia, and around the globe, by improving the time it takes to design, manufacture and supply customised medical devices such as endovascular stent grafts for patients with aortic aneurysm—a condition that currently has post-rupture survival rates of only 10 to 20 per cent.

Cook Medical Australia General Manager Dr Samih Nabulsi said the AMMD Research Hub would deliver outcomes for patients by fostering growth in the medical technology sector in Australia.

“Our primary goal is to improve patient health outcomes, but we are also growing workforce capability in the medical device industry and increasing the translation of new technology,” Dr Nabulsi said.

“Research and industry partnerships like the AMMD Research Hub are vital to increasing and accelerating the translation of new technology in the medical device industry.”

From a patient and treating doctor perspective, the AMMD Research Hub’s approach to research and innovation offers the promise of improvements to patient care and clinical outcomes by reducing the complexity associated with manufacturing medical devices.

From a manufacturing perspective, the AMMD Research Hub represents a critical mass that can take advantage of the synergies and strengths of the individual participants and deliver productivity benefits that would not be independently realisable.

AMMD Research Hub Director and University of Queensland Professor Matthew Dargusch said that effective collaboration between diverse industry and university partners is the key to addressing challenges in the advanced manufacturing of medical devices.

“It is the knowledge transfer that comes from taking a collaborative, cross-disciplinary and cross-sectoral approach to medical technology that will lead to making game-changing innovations in the sector,” said Professor Dargusch.

With researchers based at Cook Medical Australia, the AMMD Research Hub has already begun work in the areas of lean manufacturing to improve the production times, adaptive automation systems, metallic biomaterials and collaborative robotics.

Director Asia-Pacific and Vice President of Cook Incorporated, Barry Thomas said the AMMD Research Hub is an important example of the advanced manufacturing sector working together with researchers and universities.

“The AMMD Research Hub will make a significant contribution to advancing the medical device industry in Australia through efficiency of processes, materials and technologies, and realise further export opportunities for IP derived from manufacturing process improvements.”

“The collaboration is key for sustaining innovation and manufacturing excellence and will contribute positively to the economy, create jobs, and strengthen the advanced manufacturing sector,” Mr Thomas said.

The AMMD Research Hub brings together researchers from the University of Queensland, the University of the Sunshine Coast, the University of Sydney, RMIT, with industry partners including Cook Medical Australia Pty Ltd., Robert Bosch (Australia) Pty Ltd.; Heat Treatment (Qld) Pty Ltd. and QMI Solutions Ltd.

In 2016, the AMMD Research Hub was awarded $2.8 million in ARC funding for five years. This investment was matched by industry partners, with a total value of more than $10 million of cash and in-kind funding.[/vc_column_text][/vc_column][/vc_row]

LAUNCHING THE BRIDGETECH PROGRAM FOR THE MEDTECH MINDED

Posted on | by Team

[vc_row][vc_column][vc_column_text]Professor Lyn Griffiths, Executive Director of QUT’s Institute of Health and Biomedical Innovation (IHBI) and Director of The BridgeTech Program, said 100 applicants will be selected from around Australia who want to bolster their knowledge of the scientific, legal, financial, clinical, regulatory and reimbursement disciplines related to taking developed medical technology to market.

The BridgeTech Program is open to mid-career entrepreneurs, researchers, business development professionals, IP lawyers, regulatory officers and others in the med-tech ecosystem.

Led by QUT, The BridgeTech Program involves a consortium of partners including medical technology companies, universities and industry associations: Flinders University, Siemens Healthcare, Cochlear, Hydrix, Magnetica, University of Newcastle, MTAA, University of Western Australia, AusBiotech, and many others.

The BridgeTech Program is also supported by MTPConnect – the Medical Technologies and Pharmaceuticals Industry Growth Centre – which is providing industry-matched funding to run the program.

Professor Griffiths said today’s launch, at Tonsley Innovation District in Adelaide, was held in conjunction with the 10-year anniversary of the Medical Device Partnering Program led by BridgeTech consortium partner Flinders University.

“This is an important partnership, linking research and technology development with entrepreneurship,” she said.

“Through its consortium of partners, The BridgeTech Program is unique in its ability to incorporate industry expertise, create key collaboration opportunities and draw on the breadth of knowledge needed to design an effective course.”

The BridgeTech Program launch was followed by a panel discussion on the MedTech entrepreneurship landscape in Australia with MTPConnect CEO Sue MacLeman, Ferronova CEO Stewart Bartlett and Managing Director of Micro-X Peter Rowland.

Professor Griffiths said The BridgeTech Program is structured to accommodate the busy researcher/entrepreneur as a self-paced online learning program incorporating a three-day workshop to consolidate learning and create key sector networks.

“Developing this important educational initiative in partnership with industry means that participants will be provided with relevant and specific commercialisation training, advice and networks to better assist the commercialisation of medical technology and medical devices in Australia,” she said.

Managing Director and CEO of MTPConnect Sue MacLeman said medical technology is the fastest growth area in the Australian med-tech, biotech and pharma sector.

“The BridgeTech Program will provide practical and important support to develop a more vibrant and impactful MTP sector ecosystem, contributing to the growth of our sector on the world stage,” Ms MacLeman said.

“As part of our mission, we are funding big, bold ideas that will deliver results on a national scale, have sector-wide impact, and are aligned with the Sector Growth Priorities identified in our 10- year Sector Competitiveness Plan. We are very proud to be supporting this truly collaborative initiative that brings together expertise from industry and research, building on the success of pharmaceutical-focused Bridge Program.”

Ian Burgess, CEO of the MTAA said as the peak industry body for medical devices we’re pleased to be supporting an initiative that will help develop those in their mid-career stage get to the next level.

“Global advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years.

“Technology allows patients to hear, to walk, to see, to live or to have a quality of life that they otherwise would not have.

“MTAA looks forwards to welcoming the first 100 applicants to Sydney for the three day residential prior to our Annual Conference on the 7-8 November.”

The BridgeTech Program is the sister program of The Bridge Program, which is now in its second successful year and focuses on the skills needed for research translation and the commercialisation of medicine in the pharmaceutical industry.

For information on The BridgeTech Program, contact bridgetech.program@qut.edu.au.

To submit an application please complete an EOI here.[/vc_column_text][/vc_column][/vc_row]

CALL FOR LARGE-SCALE INVESTMENT IN AUSTRALIAN MEDICAL INNOVATIONS

Posted on | by Team

[vc_row][vc_column][vc_column_text]Australia has the potential to lead markets and create new ones by applying cutting-edge science and technology to new, first in world applications that improve human health.

Frontier technologies in areas like precision medicine, machine learning, the human microbiome, gene and cell-based medicines, space medicine and immunotherapy are being researched in Australia. Innovations such as these will fundamentally change the way future generations manage their health. The challenge is to make sure this research is commercialised in Australia and that the health benefits are enjoyed by Australians.

“The Medical Research Future Fund is a once in a generation opportunity to change our future. In a series of conversations with health funders – both Government and the private sector – we have been canvassing ways in which we could use the MRFF to make large-scale investment into a suite of research at the outer limits of what we currently know about human health.

“We don’t want to be too definitive about exactly what areas of research this should cover, but it should certainly be focused around disciplines and technologies not yet routinely applied in mainstream healthcare settings,” said Research Australia CEO, Nadia Levin.

Under Research Australia’s Medical Frontiers proposal, the Government could invest around 10 per cent of the MRFF in frontier research with the potential to transform how healthcare is practiced in Australia and overseas. You might have seen this proposal in our Pre-Budget Submission and in our ongoing political engagement activities.

“Essentially it is about economies of scale – we’re asking the Government to inject significant amounts into existing potential frontier research projects to exponentially boost their progress towards a translatable stage. The project which emerges as leader of the pack of these “boosted” projects will receive large-scale funding to enable a frontier outcome.

“This is innovative HMR funding. It’s new and bold and importantly, it positions Australia as a valuable contender in the global health space which means more opportunities for us all,” Ms Levin said.

Smarter investment in innovation in the health and medical research sector contributes to ensuring Australia’s future wealth is built on the capacity and ingenuity of its people.

“We put ideas like this on the table for the consideration of both public and private sector research funders because as the national peak body, we have a responsibility to talk more about how health and medical research can contribute to Australia’s health wealth and economic wealth.”[/vc_column_text][/vc_column][/vc_row]

MEDICAL TECHNOLOGY WITH THE POTENTIAL TO TRANSFORM LIVES GETS CASH INJECTION

Posted on | by Team

[vc_row][vc_column][vc_column_text]The Minister for Health, the Hon Greg Hunt MP, the Medical Technology, Biotechnology, and Pharmaceutical (MTP) Industry Growth Centre and the Medical Technology Association of Australia (MTAA) announced earlier this week the first 11 recipients of a $10 million investment from the Australian Government’s $35 million BioMedTech Horizons program.

The program aims to help Australia move more cutting-edge ideas and breakthrough discoveries towards proof-of-concept and commercialisation, and stimulate collaboration across disciplines and between the research, industry and technology sectors to maximize entrepreneurship and idea potential.

Investments from the program are focused on precision medicine and 3D anatomical printing. Successful projects in this first round include a fully synthetic 3D printed spinal cage, a genome profiling platform to enable precision cancer medicine, a wireless Brain-Machine Interface suitable for treating neurological disorders, and microwearables for precision medicine.

Minister Hunt said  the Government is committed to improving the health services for all Australians and will continue to invest in better treatment, care and medical research.

“Our researchers are innovators, and this investment will speed up the journey from idea to reality. These technologies have the potential to create better health outcomes for Australians, while driving investment and strengthening our economy. All Australians benefit from investment in health and medical research,” Mr Hunt said.

Ian Burgess, CEO of MTAA, said the industry was proud to be part of the BioMedTech Horizons program and supporting Australian innovation.

“Our Agreement with the Government to reform the Prostheses List has provided an additional $30 million towards the BioMedTech Horizons program and has doubled the funding available for these first recipients,” Mr Burgess said.

“Global advances in medical technology have resulted in a 56 per cent reduction in hospital stays and a 16 per cent drop in annual mortality rates over the past 20 years.

“If we want to see further advances on these figures we need to address the inequity of treatment options in our health system by removing the barrier for non-implantable devices such as catheter ablation in the private health system.

“This shows the significant value that medical technology can provide – saving and improving the lives of patients, and saving costs to our health system. These exciting technologies  being supported by the BioMedTech Horizons program can similarly lead to saving and improving lives, and contributing enormous value to the Australian health system.”

Sue MacLeman, Managing Director and CEO of MTPConnect, said the delivery of the BioMedTech Horizons program is providing the necessary support to boost investment, commercialisation and success of health innovations in Australia.

“These first investments from the BioMedTech Horizons program are set to fuel ongoing innovation in Australia, in line with MTPConnect’s priorities for growth of the medical technology, biotechnology and pharmaceutical sector,” Ms MacLeman said.

“These 11 outstanding projects address identified global megatrends including precision healthcare and the digital evolution, as well as forecast areas of unmet clinical need, such as immunology, advanced prosthetics and infectious diseases including sepsis.

“MTPConnect is dedicated to working with the sector to ensure growth in collaboration between research and industry, to drive greater commercialisation. The BioMedTech Horizons program is set to address barriers of funding to support viable, new health biological and medical technologies to reach proof-of-concept, clinical trials and beyond, in line with our vision to advance the vibrant sector.”[/vc_column_text][vc_single_image image=”1875″ img_size=”full”][vc_separator][vc_column_text]The Gennaris Neural Systems project led by Director of Monash Vision Group, Professor Arthur Lowery, said the Federal Government’s support for this project would enable them to bring manufacturing back to Australian shores, allowing Australia to become a leading provider of advanced medical prosthetics that place sophisticated electronics within the human body.

“This funding is key to translating the First in Human trials of our cortical visual prosthesis to a successful commercial product,” Mr Lowery said.

“Bringing together advances in electronics and implantable devices open up a huge range of potential applications and potential treatments for neurodegeneration.”

Partner to the Gennaris Neural Systems project and Grey Innovation Group Chairman, Jefferson Harcourt, said the BioMedTech Horizons program is very well targeted and plays an important role in translating research.

“It is very encouraging to see us working together and playing to our strengths as a sector”, said Mr Harcourt.

“Delivering real collaboration takes time and trust from all sides, and in the past frankly there has been a lot of hype. Times are clearly changing, and I applaud the Government and MTPConnect for having the conviction to allocate meaningful funds to targeted and well-constructed consortia. This will significantly increase the chances of success.”

The medical technology industry currently employs more than 17,700 people and adds $1.9 billion to the Australian economy. This is a high skilled, high net worth industry with over 52 per cent of employees having a tertiary qualification, and 25 per cent having a postgraduate qualification.

MTPConnect will continue its work with the sector to support initiatives addressing identified barriers to growth in the sector, increasing the number of innovations to reach proof of concept and clinical trials in key knowledge priority areas.

The 11 projects selected for the initial $10 million BioMedTech Horizons program investment are listed below:[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_tta_accordion color=”turquoise” active_section=”1″][vc_tta_section title=”3D printed graft for surgical repair of the wrist ligament” tab_id=”1524111574159-3ca495cd-2645″][vc_column_text]Griffith University, Orthocell, University of Western Australia, Queensland University of Technology


Development of a 3D printed, personalised graft for surgical repair of the Scapholunate interosseous wrist ligament (SLIL) is set to produce the first SLIL repair product on the market. SLIL injuries are common and can severely impair wrist function for the 69 cases of wrist trauma per 10,000 individuals. SLIL injuries are most common in young individuals, causing long-term chronic difficulties. Therefore, a product that offers better health outcomes is likely to significantly reduce economic burden on healthcare systems over the life time of such patients. This project will support pre-clinical research and development to enable Orthocell to start human clinical trials, seek regulatory approval and commercialise.[/vc_column_text][/vc_tta_section][vc_tta_section title=”B3D Cervical Interbody Fusion Device ” tab_id=”1524111549409-5fdd9e13-a87f”][vc_column_text]Allegra Orthopaedics, University of Sydney, University of Wollongong, Boron Molecular, Sabre Medical

The Allegra Orthopaedics fully synthetic spinal cage works to regenerate bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials – making it a one-of-a-kind innovation. The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at The University of Sydney. The synthetic bone possesses the mechanical strength required for load-bearing conditions, bioactivity needed for outstanding bone regeneration, and resorbability that reduces the risk of rejection and infection – all in a customisable structure. No bone graft is required as the device material induces bone graft. This project will provide the necessary funding for device production for preclinical testing.[/vc_column_text][/vc_tta_section][vc_tta_section title=”BioPen” tab_id=”1524111512736-be45f446-cc84″][vc_column_text]The University of Melbourne, St Vincent’s Hospital Melbourne, University of Wollongong, Swinburne University of Technology

The BioPen is set to provide the first in-situ bioprinting treatment for cartilage injuries, developed at the St Vincent’s Hospital Melbourne biofabrication facility, BioFab3D@ACMD. Cartilage injuries occur in two thirds of all joint trauma, with many leading to osteoarthritis that cannot be adequately prevented or treated using current complex surgery interventions. The BioPen project is working to accurately repair the joint injury, by rapidly isolating stem cells from a patient, loading these into a gel scaffold then printing new cartilage using a hand-held device directly into the defect. The combination of stem cell technology, engineering and surgical innovation promises to simplify surgery through a one-off surgical procedure with the capacity to bank cells for future use if repeat surgery is required. The BioMedTech Horizons funding will enable this project to advance a prototype device, methodologies and bio-ink formulations towards a commercialisable therapy.[/vc_column_text][/vc_tta_section][vc_tta_section title=”CAR-T immunotherapies for solid cancers” tab_id=”1524111469305-4815abcc-1e35″][vc_column_text]Carina Biotech, Seattle Children’s Research Institute, The University of Adelaide, Women’s and Children’s Hospital Adelaide, CTM@CRC

Chimeric Antigen Receptor T-cell (CAR-T) therapy is an individually customised approach to cancer treatment that genetically engineers a patient’s own immune cells to react to a specific molecular marker on their cancer. CAR-T therapy has shown extraordinary efficacy against blood cancers, however solid cancers have been less responsive to CAR-T therapy to date. Carina Biotech has produced CAR-T cells targeted to a solid cancer molecular marker, which has been published as present in many solid cancers, while having no expression on healthy cells. BioMedTech Horizons investment will allow Carina to work to achieve in-vivo proof of concept for its CAR-T cells across multiple animal models of human solid cancer.[/vc_column_text][/vc_tta_section][vc_tta_section title=”A clinically-accredited and commercial-ready genome profiling platform to enable precision cancer medicine” tab_id=”1524111421463-67e12ef9-3bab”][vc_column_text]Garvan Institute of Medical Research, Genome.One, Illumina

Precision cancer medicine is set to transform the clinical trial industry, with international trials attracting heavy investment. This next generation of clinical trials requires fast, comprehensive and cost-effective genomic profiling of patient tumours. The FDA recently approved two US cancer genomic tests, however, their cost (AU$5,500) is prohibitive for routine use in Australia and their matching to US-approved drugs and trials are of limited utility to Australians. Offshore testing also fails to develop necessary domestic infrastructure for precision cancer clinical trials.  The genome-profiling platform for precision cancer medicine is set to include a clinically-accredited tumour profiling test and a cancer genomics data platform that incorporates a national patient matching system for precision cancer clinical trial access. It aims to provide competitively priced and rapid local testing. These solutions work to ensure that, in the face of increasing global capabilities and investment in precision cancer clinical trials, Australia will remain an attractive trial site and leader in precision medicine.[/vc_column_text][/vc_tta_section][vc_tta_section title=”EarGenie: Personalised management of hearing impairment for infants” tab_id=”1524111262689-0113ff94-a030″][vc_column_text]Bionics Institute, Hydrix, Taralye Early intervention Centre, Plunkett Consulting Group, Australian Hearing

EarGenie is an innovative system for personalised management of hearing impairment, aiming to enable life-long benefits using a novel combination of electrophysiology and functional near-infrared spectroscopy (fNIRS) to perform a diagnostic hearing evaluation. Deaf infants face delayed and inadequate language development, affecting education, social participation, and even employment later in life. Major contributing factors are the delay between diagnosis and the selection and accurate adjustment of hearing devices, delayed individualised optimisation of device features, and difficulty choosing a specific therapy to optimise language development. EarGenie is set to transform the precision of diagnosis and optimisation of hearing instrument function, to deliver major benefit to language development in deaf children. This project will allow for the development of a clinical prototype as well as plans for regulatory approval and clinical trials.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Gennaris Neural Systems (GNS)” tab_id=”1524111262606-419c966c-a95e”][vc_column_text]Monash University, Alfred Health, MiniFAB, Grey Innovation

Monash Vision Group (MVG) has developed a wireless Brain-Machine Interface (BMI, offering the potential to bypass damage to nerves and neural pathways, restoring function to affected areas of the brain. MVG’s Brain-Machine Interface has been implemented in a cortical vision prosthesis that is designed to bypass damage to the visual pathway and restore basic vision. This funding will assist the transition between preclinical and clinical programs, allowing the utility of the visual prosthesis to be demonstrated. A company will be established to manufacture MVG’s Brain-Machine Interface and commercialise the visual prosthesis. The aim of this company is to bring the product to market by 2021 to address the unmet need of a treatment for complete blindness. MVG’s cortical vision prosthesis has been designed to treat a range of blindness causes, such as glaucoma and optic nerve damage, which are not suitable for retinal implants. The successful commercialisation of this technology will establish Australia as an exporter of implantable medical devices, and global market leader in BMI manufacturing.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Leaping towards precision medicine: Microwearables” tab_id=”1524111599138-bf1ca2f8-1b66″][vc_column_text]WearOptimo, The Australian National University, Queensland Government, Johnson & Johnson Innovation, Australia National Fabrication Facility

Microwearables (simple, wearable devices) have the opportunity to be a cornerstone of precision medicine by offering personalised diagnostics across a range of diseases. These devices are minimally-invasive, pain-free sensors applied to the skin to access biomarkers and biosignals. Microwearables transduce electrical, optical or biochemical biomarkers from a hair’s width depth within the skin for both episodic and continuous monitoring. In doing so, it aims to leapfrog traditional diagnostics: based on lab-based assays of blood samples and histopathology – with the costs, risks and time-delays. WearOptimo will be developed as a fit-for-purpose enterprise to rapidly compete at scale – meeting the unique opportunity at the nexus of three growing markets: IoT for medicine; personalised medicine; and wearable electronics for healthcare. This project will take the next critical step in working to advance Microwearables into an enterprise – to commercial, proof-of-concept, and investor ready.[/vc_column_text][/vc_tta_section][vc_tta_section title=”‘PoreStar’ – Porous Polyethylene Implant Material ” tab_id=”1524111692209-71cba53e-1736″][vc_column_text]Anatomics

In 2014, Anatomics, in conjunction with CSIRO and Australian universities, developed a breakthrough pHDPE implant material, PoreStar. PoreStar’s material advantages include its superior tensile and flexural strength avoiding cracks when bent, the ability to adhere with screws very close to the implant margins without material breakage, and a unique scaffold architecture that facilitates tissue ingrowth. This project aims to advance the state-of-the-art in craniomaxillofacial (CMF) implant manufacturing, leveraging 3D printing to reduce process complexity, product turnaround time and cost of goods. Moreover, the project seeks to improve surgical practice by extending the use of temporary implants to patient-specific CMF surgeries, and develop improved software solutions for surgical planning and preoperative estimation of cosmesis, aiming to reduce complications and reoperation rates for CMF surgeries.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Rapid diagnostic for the pathogens that cause sepsis” tab_id=”1524111727437-fcd722ee-5f3b”][vc_column_text]Biotech Resources, Monash University Centre for Biospectroscopy, The Alfred Hospital, Monash Health, Hydrix

Biotech Resources (BTR) is working to develop the world’s first rapid diagnostic test ‘Aimalux’ for the direct detection of the bacteria and fungi that cause sepsis from whole blood. The technology and platform has been developed by the Monash University Centre for Biospectroscopy in Melbourne Australia. Sepsis is a life-threatening disease that results in the deaths of over 6 million people every year around the world, and more than 5,000 Australians. It is time critical medical emergency. Every hour without treatment increases a patient’s chance of dying by 7.6%. And yet there is no definitive test for sepsis with more than 30% of cases going misdiagnosed. If the symptoms of Sepsis are missed and treatment is not administered, then this can result in patient death. This also means that many patients are treated unnecessarily as a precaution, which has its own detrimental consequences as well as adding to the rise of antibiotic resistance super bugs. Aimalux aims to provide a diagnostic result within 35 minutes, to revolutionise the way sepsis is currently diagnosed, reduce healthcare costs, and save lives.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Towards bedside gene therapies: Development of a microfluidic gene delivery device for immune cell modification and optimisation for clinical use” tab_id=”1524111767698-bd213694-22ad”][vc_column_text]Indee, University of South Australia Future Industries Institute, Main Sequence Ventures, Defence Science Technologies Group, University of Sydney, Becton Dickinson

Pioneering cures for terminally ill patients, with conditions including many forms of cancer, are now available thanks to a new generation of treatments called gene-modified cell therapies (GMCTs). Indee Labs plans to make GMCTs accessible to the masses by solving manufacturing issues responsible for their high price tags. It also aims to reduce the lead times for a treatment from months to weeks, saving the lives of patients with aggressive conditions. Gene delivery to cells is the most critical and problematic step in manufacturing GMCTs. This project aims to will develop the only practical gene delivery technology, microfluidic vortex shedding (µVS), into a product that will be trailed by pharmaceutical companies. µVS will offer revolutionary improvements over existing gene delivery methods including high yield, negligible immune cell perturbation along with rapid processing of research-, clinical- and commercial-scale samples with a simple workflow and a small footprint.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]For more information on the BioMedTech Horizons program and first round recipients, visit www.mtpconnect.org.au/biomedtechhorizons.[/vc_column_text][/vc_column][/vc_row]

CONNECTING THE BEST MEDTECH IDEAS TO GLOBAL MARKETS

Posted on | by Team

[vc_row][vc_column][vc_column_text]Australia’s largest medical device accelerator program, MedTech’s Got Talent, will receive a $500,000 grant through the Incubator Support initiative to build start-ups in the fields of medical devices, laboratory equipment, diagnostics, bionics and eHealth.

MedTech’s Got Talent provides entrepreneurs with mentoring, resources, knowledge and access to business networks to help them develop their ideas, generate investment and get their products to market.

Minister for Jobs and Innovation, Michaelia Cash said the Incubator Support initiative was encouraging incubators and accelerators like MedTech’s Got Talent to improve the prospects of Australian start-ups.

“The Turnbull Government is committed to assisting STEM professionals with access to commercial opportunities and global markets in order to create jobs here at home,” Minister Cash said.

“The MedTech’s Got Talent program equips our scientists and researchers with the capability needed to transform ideas into viable businesses and access international markets faster than they otherwise would,” Minister Cash said.

Minister for Small and Family Business, the Workplace and Deregulation, Craig Laundy said the program provided many benefits for start-ups across the country.

“Programs like this level the playing field to allow start-ups to access the same resources as their multinational counterparts,” Minister Laundy said.

“The access to real talent, mentors, money, expertise and networks will put these start-ups in the best position for commercial success.”

The Federal Government is investing in science and innovation to ensure we grow new businesses and create jobs. The Incubator Support initiative is part of the continued implementation of the Government’s National Innovation and Science Agenda.

Further details of the grant recipients: www.business.gov.au/incubator-recipients

Further information on Incubator Support grants: www.business.gov.au/assistance/incubator-support[/vc_column_text][/vc_column][/vc_row]

The Patient Will See You Now

Posted on | by Team

[vc_row][vc_column][vc_column_text]The details are contained in two recent publications on clinical trials activity. The June 2017 MTPConnect report titled ‘The Economic Profile and Competitive Advantage of the Sector’ is data rich and was developed with extensive input from the industry and Government. The document provides a status update and suggestions on how to further stimulate the sector. In January, Austrade issued a Clinical Trials Capability Report ‘A Dynamic Environment for Clinical Trials’, essentially a pitch to clients requiring clinical research of therapeutic products and medical devices. It highlights the range of expertise available in Australia, from cell culture and engineering to Independent Ethics Committees, by showcasing local companies and providing a directory of suppliers.

This becomes important when put in the context that approximately 75% of the direct expenditure on clinical trials in 2015 in Australia came from international inbound investment by commercial entities (pharmaceutical, biotechnology and medical device companies). Another statistic included in the Austrade report that requires consideration is that ‘medicines and vaccines are Australia’s largest manufactured export. China and the United States are the biggest markets, followed by New Zealand, South Korea and the United Kingdom.’

As Figure 1 demonstrates, multiple factors contribute to clinical trial placement. When considering the shift over time in the type of clinical trials being conducted in Australia, the influence of a number of these factors is obvious. Previously, Phase III studies were the largest component of activity, however Phase I trials numbers have increased steadily, growing 17.2 % from 2012–2015, compared with 1.8 % globally over the same period. This is a reflection of the strong competitive position of Australia in conducting complex studies as a result of our world-class healthcare system, high quality medical research infrastructure, skilled workforce of scientists and healthcare professionals, including internationally regarded clinicians.

At the same time, the later phase, higher patient number studies have been increasingly placed in more populous locations in the Asia Pacific, Eastern Europe or Latin America, as the larger patient pools shorten recruitment times, and ultimately, the time to market of new products. Additionally, Australia’s population size and distribution mean that more investigational sites must be established to reach target recruitments when studies are placed in Australia, resulting in a higher per patient cost than other countries. Significant efforts have been undertaken on a number of fronts over the past decade to increase recruitment efficiencies. These include the streamlining of ethic approval processes via mutual recognition and increased public awareness. In 2015, of the 1,305 industry-sponsored studies in Australia, Phase III accounted for 40%; Phase II, 22%; Phase I, 18%; Phase IV, 4% and Other, the remaining 16%.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1759″ img_size=”full” add_caption=”yes” title=”Figure 1 Factors considered when selecting countries in which to conduct a clinical study”][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Investigational site governance continues to be an issue that negatively impacts Australian’s overall competitiveness. At present, sponsors must negotiate indemnity contracts individually with each study site, adding to the administrative burden and time required to initiate the study.

In terms of strengths, Australia’s stable business operating environment is currently ranked 14th out of 190 countries by the World Bank in terms of ease of doing business. The fast, streamlined regulatory pathway to conduct clinical trials via the TGA Clinical Trial Notification (CTN) system continues to be the envy of many countries. Harmonised ethics review processes and availability of Ethics Committees in both the private and public sectors, provide opportunities to speed up approvals. Australia’s strong intellectual property system which, in 2017 was ranked 10th globally, in terms of security (out of 127). Finally, research & development tax incentives for clinical trials mean that for the same early phase study, Australia is up to 28 % cheaper than the US before-tax incentives, and 60% after-tax.

The 2014-15 Federal Budget established a Medical Research Future Fund (MRFF) to be an ongoing source of funding to support medical research projects and infrastructure in Australia (the Government currently spends around AU$3 billion annually). By 2020-21, the MRFF is expected to have a balance of AU$20 billion, the net earnings from which will produce a permanent source of revenue. In 2016, a Biomedical Translation Fund (BTF) was created to complement the MRFF via commercialisation of health research.

Clearly, the strength of the sector today is in no small way due to the ongoing commitment and support of successive Australian Governments.  As Figure 2 illustrates this has, and will continue to, deliver enormous value to our nation and should be acknowledged.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1760″ img_size=”full” add_caption=”yes” title=”Figure 2 The value of clinical trials in Australia”][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1750″ img_size=”large”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Nick Campbell is the Chairman of Nexus Asia Pacific and has previously worked in the MedTech and pharmaceutical industries.[/vc_column_text][/vc_column][/vc_row]