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SUPPORTING AUSTRALIA’S PLAN TO BE A GLOBAL LEADER IN CLINICAL TRIALS

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[vc_row][vc_column][vc_column_text]Working with the state and territory governments, we will reduce red tape and end duplication, making it easier to conduct clinical trials in Australia.

This will mean Australian patients will have greater access to the world’s best medical breakthroughs.

Today at the global biotechnology and innovation convention in Boston, United States, I reaffirmed Australia’s commitment to be the world’s best destination for clinical trials.

We are providing $7 million to support states and territories to redesign their trial systems to make it easier for researchers and companies to conduct clinical trials.

This will ultimately mean Australian patients get first access to the best medicines, devices and treatments in the world.

The concept will be informed by a review of the clinical trial registry system in Australia.

Our commitment to clinical trials is rock-solid and it builds on our unprecedented investment in health and medical research.

We recently launched a national awareness campaign to get to get more Australians into ground-breaking clinical trials, opening up access to life-saving new medicines and treatments.

The Turnbull Government recently announced a $248 million investment to support clinical trials for Australian patients with rare cancers and rare diseases, and unmet need clinical trials and registries program.

In the 2018-19 Budget we announced our commitment to deliver $6 billion in record funding for Australia’s health and medical research sector, including $3.5 billion for the National Health and Medical Research Council, $2 billion in disbursements from the Medical Research Future Fund and $500 million from the Biomedical Translation Fund.

The foundation of the Government’s commitment to health and medical research is a new job boosting $1.3 billion National Health and Medical Industry Growth Plan, to improve health outcomes for hundreds of thousands of Australians, create tens of thousands of new jobs, and develop the next generation of Australia’s global leading industries.[/vc_column_text][/vc_column][/vc_row]

STRATEGIC AGREEMENT, WHAT STRATEGIC AGREEMENT?

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[vc_row][vc_column][vc_column_text]Another issue mentioned, but not analysed in depth, is the future of the various healthcare agreements signed by the current government with major industry bodies such as the MTAA and Medicines Australia amongst others.

Labor’s Shadow Minister for Health, Catherine King, has made no secret of the fact that such agreements will not be binding on a future Labor Government, having stated at her post-budget breakfast briefing: “governments sign agreements not oppositions”.

In and off itself, it is not a major revelation, and not unexpected.  What has been missed though is that it would not make sense for Catherine King to honour such industry agreements.

With Labor committed to a two-year 2% freeze on private health insurance premium increases while it awaits the report of the Productivity Commission, come the third year of a Labor Government and it will face both a major policy and political challenge.

In the absence of major and wholistic structural reform of the healthcare system in its entirety following the two-year review, then in isolation Labor will be looking at a catch-up increase in PHI premiums of anywhere up to 10% or more.

The political challenge for Labor is this would coincide with preparations for an election at the end of what would be their first term.

Presiding over a potential 10% increase in PHI premiums going into a Federal Election would not be a political winner.

It is for this reason Catherine King and Labor in Government need maximum flexibility to deal with major healthcare stakeholder groups. Standing by individual industry agreements, with different cessation dates and different policy objectives, would not be in their interests.

In order to have a credible policy response to keeping any PHI premium increase as low as possible, Labor in Government and Catherine King as Health Minister would need to be able to articulate a wholistic policy response across the entirety of the healthcare supply chain and not its individual components.

Hence while some healthcare industry players may consider that Labors freeze of PHI premiums at 2% is of no consequence to them, they will need to think again.

It also explains why Catherine King has stated emphatically that in government she is not necessarily committed to the various industry agreement struck by the current government.

Something for all players in the healthcare industry to digest and calibrate strategically.[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Jody Fassina is the Managing Director of Insight Strategy and has been an strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column][/vc_row]

MEDTECH LIFE CHANGING IMPACT HEADS TO CANBERRA

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[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

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[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]

10 PER CENT “A VERY SMALL NUMBER”

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[vc_row][vc_column][vc_column_text]It was good to see official recognition of the contribution the MedTech sector has made to keeping this year’s PHI premium increase to the lowest it has been in years.

With the industry having contributed over $1 billion in cuts that goes directly into the bottom lines of PHI companies and their promise to ‘pass on every dollar’ in savings to consumers, it was heartening to see the Department of Health officially recognise MedTechs role.

In evidence to the Senate Estimates Committee the Department of Health stated the MTAA Agreement with the Government has directly resulted in delivering the lowest premium increase in 17 years.

Ian Burgess, Chief Executive Officer of the Medical Technology Association of Australia said “we welcome comments from the Department of Health that our Agreement has directly resulted in delivering the lowest premium increase in 17 years, which has been directly attributed to the $1.1 billion cuts in revenue to the medical device industry.

“The medical technology industry believes access to a full range of medical technology is the most valuable component of a private health insurance policy and we’re committed to doing what we do best – assist patients lead healthier and more productive lives.”

What is clear is that the MedTech industry has done some heavy lifting in regard to aiding Australian consumers in helping to keep PHI premium increases as low as possible.

It is a shame that the PHI insurance has not done the same and continues to blame everybody else.

Only this week Medibank CEO Chris Drummond was in the press complaining about how they have no control over their claims or costs. Laying the blame at the feet of the medical profession as the main driver of claims he stated, “We control our own costs which is 10% of what we pay out”.

He makes no mention though of looking at PHI costs, profits or excess capital.

According to Mr Drummond they have a $600m management cost base and pay $5.2b in claims. This is a cost to claims ratio of 11.5%. Is this acceptable or not? That is a good community debate to have.

It is also very telling though that Mr Drummond has said if Labor win and impose a 2% premium cap, then they will most likely seek to cut payments to dentists, physios and hospitals. This means even less value for money for PHI policy holders.

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia,” said Mr Burgess.

“But we’ve always maintained that given we represent 10% of private health insurers overall costs a reduction in costs for medical technology would only ever result in a modest reduction in premium increases.[/vc_column_text][/vc_column][/vc_row]

DISRUPTION IN HEALTHCARE: WHAT IS CHANGING

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[vc_row][vc_column][vc_column_text]Although disruption has not yet reached healthcare there are signs that that is beginning to change. The increasing focus on technology particularly wearables, entry of innovative giants into the healthcare space and renewed government investment and interest in fixing a public hospital crisis mean that disruption is coming. The clear warning to healthcare companies is adapt or die. Meanwhile for consumers this disruption could lead to healthcare as a whole shifting to the service driven model adopted by the likes of Uber. This model could dramatically improve consumers’ experiences and healthcare outcomes.

Medical technology has taken off in recent years drawing increasing investment and public attention. Of particular importance is the growth in health ‘wearables’ such as Fitbits. This sector has exploded in recent years with experts predicting wearables to be worth US$12.1 billion by 2021. Wearables are important as they are a consumer rather than expert driven product and allow users to track and monitor their own health.

In combination with developing diagnostic tools and the potential for AI health assistants such as Amazon’s ‘Alexa’, wearables could fundamentally change the way that we approach healthcare. This new focus on technology for individual users is a far cry from healthcare delivery even a few years ago. This new focus on individual users’ health outcomes (rather than the time spent treating them) could help companies disrupt the current fee-for-service model.

In addition to empowering individual consumers and shifting the healthcare delivery model wearables have allowed companies to gather health data on an unprecedented scale. These companies are beginning to enter the healthcare space with past disruptors Amazon and Apple both developing healthcare solutions. Amazon in particular with its focus on disrupting brick-and-mortar stores could pivot into providing online pharmacy services and through cutting out the pharmacist provide significant savings to consumers.

Similar services are already available in the UK where companies are allowing consumers to order repeat scripts online significantly improving compliance with medication directions. Meanwhile Apple is leveraging health data from the Apple Watch and its own employees through developing an in-house medical service to test future med-tech products and service delivery methods.

The Australian Government is also taking steps to encourage innovation in the healthcare space. Recent budgets have focussed on health spending and through programs like the Medical Research Future Fund the government is investing in Australia’s future healthcare needs. The government is also taking steps to assist innovators, through R&D tax incentives smaller start-ups get access to refundable credits while larger companies receive a tax offset.

Despite the changes following the 2018 budget, R&D tax incentives will still assist start-ups, especially in the area of healthcare where clinical trials have been exempted from the $4 million cap on cash refunds for companies with a turnover less than $20 million. These tax incentives have allowed Australian companies to focus on research and development and create innovative solutions to healthcare problems. For example, CancerAid has credited the scheme with providing them with the funding they needed to develop an app to allow cancer patients to connect with each other.

In addition to specific programs, the national focus on the failings of public hospitals could serve as a flashpoint that could encourage greater innovation and in turn disruption. In the last article we discussed how the fee-for-service model inherently disincentivises innovation and addressing this could disrupt the industry as a whole.

The current public hospital crisis has led to high costs and poor health outcomes and repeated attempts to fix it through increasing funding or pushing for efficiency the system continues to fall short. This suggests that innovation and disruption may be the only solution to ‘fix’ public hospitals in Australia, and as such will continue to receive both government and industry attention and support.

The final article in this series will discuss how disruption can be measured and what conclusions can be drawn from this in an Australian context.

Health Horizon is a start-up that empowers health consumers by allowing them to find and track health innovations that interest or affect them so that they can gain control over their health future.

*Regina E. Herzlinger, original article here.[/vc_column_text][/vc_column][/vc_row]

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

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[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]

Public Hospital Admissions Rising Fast

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[vc_row][vc_column][vc_column_text]Admissions to public hospitals are growing faster than admissions to private hospitals, according to a new report from the Australian Institute of Health and Welfare (AIHW). The report, shows that of the 11 million admissions to hospitals in 2016–17, 6.6 million were in public hospitals and 4.4 million were in private hospitals.

“Admissions rose by 4.3% on average each year for public hospitals and 3.6% for private hospitals between 2012– 13 and 2016–17, and these were greater than the average growth in population of 1.6% over the same period” said AIHW spokesperson Jenny Hargreaves.

In 2016–17, the majority of admissions to public hospitals (83% or 5.5 million) were for public patients – however, about 1 in 7 (14% or 912,000 admissions) were for patients who used private health insurance to fund all or part of their admission.

There were 2.2 million admissions involving elective surgery in total. In terms of the safety and quality of care delivered, the report shows that in 2016-17 there were more than 186,000 hospital-acquired complications or 2.2% of 8.6 million in-scope admissions. Overall, the average length of stay in 2016-17 was 3.2 days in public hospitals and 2.2 days in private hospitals.

Australian Private Hospitals Association (APHA) CEO Mr Michael Roff said the report reveals public hospitals have not shied away from taking privately insured patients, while forcing those on public waiting lists to wait longer for treatment.

“The latest data shows privately insured patients continue to jump the queue in public hospitals. The median wait time for elective surgery for a public patient is 42 days. That’s twice as long as the privately insured who wait a median of 21 days,” Mr Roff said.

“The AIHW data show one in seven public admissions were for privately insured patients – that’s 14 percent of all admissions to public hospitals,” he said.

Meanwhile the peak body for the Private Health Insurance industry said: “The harvesting of patients from public emergency departments and pressuring them to go private, risks undermining Medicare and the Australian health system,” Dr Rachel David, CEO of Private Healthcare Australia.

“As a result of this cash grab, public patients are waiting longer for their surgery in public hospitals and the practice adds more than $1 billion to the cost of health fund premiums per year.

CEO of the Medical Technology Association of Australia (MTAA), Ian Burgess, said under MTAA’s Agreement with the Government to reform the Prostheses List, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of private health insurance.

“We’re the major reason this year’s average private health insurance premium increase was the lowest in 17 years,”

“MTAA strongly supports the need for a healthy and viable private health insurance sector in Australia, however private insurance needs to provide consumers value and that value needs to be better communicated. This includes the choice of medical technology that a patient’s treating doctor considers to be the most clinically appropriate, generally with no gap payment applying to that technology,” Mr Burgess said.

And don’t miss ABC 4 Corners this Monday as it looks at what’s driving up your out of pocket costs. This will air just before Senate Estimates providing another opportunity to put healthcare costs front and centre. PulseLine will continue to look at the fierce debate and asked the question, is Private Health Insurance worth it? [/vc_column_text][/vc_column][/vc_row]

DISRUPTION IN HEALTHCARE: WHERE ARE THE PROMISED CHANGES?

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[vc_row][vc_column][vc_column_text]Disruption is the ‘it’ word associated with companies like Uber, Amazon, eBay, SpaceX and Airbnb. These companies have disrupted the taxi industry, hotel sector, brick-and-mortar stores and even government space programs.

In many of these examples companies have used a consumer focussed service model and purported to return power to traditional consumers, who can now earn money from renting out a spare bedroom, selling second-hand possessions or through ridesharing.

The healthcare sector is a large and slow-moving beast which accounts for over 10% of Australia’s GDP. Some critics believe it to be inefficient with poor patient outcomes despite increasing government spending. Although these factors suggest that healthcare is a sector primed for disruption, to date there has been limited adoption of new technologies with no major changes to the healthcare delivery model.

Regulation has been acknowledged as an impediment to disruption. It slows down innovators and increases the cost of bringing new products to market. The healthcare sector in particular is extensively regulated, a ‘necessary’ measure given the high cost of mistakes. As lives are on the line, regulations often require lengthy and expensive clinical trials to determine whether a product is safe.

In addition, separate regulations around privacy and data storage requirements increase the complexity of the system for tech developers. This increases the costs faced by innovators, which in turn limits the number of newer start-ups and benefits larger already existing companies. As disruption has traditionally come from outside the industry, this concentration of development into larger companies in turn slows the speed of innovation.

The healthcare sector is known for its strong bias towards specialist knowledge. Doctors can train for up to ten years, at great expense. This centralisation of specialised knowledge means that innovators must convince key hospital staff to adopt their product for it to be successful. Given the length of their studies doctors have been trained to prefer particular methods for detection and treatment of certain illnesses.

Additionally, the strict licensing requirements and the risks posed by doctors if they go too far outside the realm of ‘accepted thinking’ mean that doctors are relatively set in their ways and are less likely to favour innovative solutions, especially where those solutions would cut doctors out the equation.

This concentration of knowledge also means that innovation is slowed by the current fee-for-service model. Under this model doctors and hospitals are rewarded for the time spent treating patients, not the time they saved through, for example, adopting an internet-based consultation system.

This means there is no incentive for doctors or hospitals to adopt technology that would reduce the time they spend with patients. It is this logic that led Goldman Sachs to suggest that developing cures could be bad for business. This means that uptake of any technology that would actually ‘disrupt’ the industry is slow, even where that disruption could be better for patients’ and government’s bottom lines.

Despite these factors, there are signs that innovation is starting to accelerate. The Australian Government is taking steps to accelerate this process, moving Australians’ health data onto a digital platform and providing additional funding for start-ups through programs like MTPConnect or the recently announced National Health and Medical Industry Growth Plan.

In the next article in this series we will address why disruption is a good thing and how organisations are working to bring change to the healthcare sector.

Health Horizon is a start-up that empowers health consumers by allowing them to find and track health innovations that interest or affect them so that they can gain control over their health future.

Read the original article here.[/vc_column_text][/vc_column][/vc_row]

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

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[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]