Category: Future of MedTech

MTPConnect to Drive Workforce Growth Through New REDI Program

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[vc_row][vc_column][vc_column_text]To deliver the program, MTPConnect is partnering with research, training and industry organisations to deploy an integrated, three-pillar plan driving skills development and workforce training that brings together researchers, clinicians, industry and the entrepreneurial ecosystem.

MTPConnect Managing Director & CEO, Dr Dan Grant has welcomed the awarding of the program, which he says MTPConnect is uniquely placed to deliver.

“Our REDI program is all about ensuring Australia has an industry-ready MTP workforce with the skills necessary to keep pace with a rapidly changing sector,” he said.

“We’ll leverage a national alliance of proven education and training providers, research institutes and industry partners to deploy a range of activities and initiatives – all focused on enhancing the MTP sector workforce.

“As we roll out our REDI program, we’re thrilled to be working with partners including, The George Institute for Global Health, APRIntern, Industry Mentoring Network in STEM (IMNIS), the Victorian Comprehensive Cancer Centre (VCCC), the Medical Device Partnering Program (MDPP), MedTech Actuator, the Bridge and BridgeTech programs (Queensland University of Technology) and ANDHealth.

“The program will also leverage the expertise and experience of Research Australia, CSL, Innovative Manufacturing CRC, the Medical Technology Association of Australia (MTAA), Pharmaceutical Manufacturing Industry Reference Committee, the University of NSW and the NSW Office of Health and Medical Research,” Dr Grant said.

In addition to the program partners and associates, MTPConnect Chair Sue MacLeman says the MTPConnect REDI program will be engaging widely across Australia’s MTP sector.

“The MTPConnect REDI program has a national remit and sector-wide focus,” she said.

“Our program will provide researchers across Australia with a diverse range of experiences and exposure to entrepreneurism with the aim of strengthening Australia’s success with translation and commercialisation.

“The MTPConnect REDI program will also systematically address current gaps in workforce skills and put in place programs to meet the challenge of developing and retaining world-class talent who have industry experience in research translation, clinical development and commercialisation.”[/vc_column_text][/vc_column][/vc_row]

Poorly written standards perpetuate questionable medical equipment repair practices in health facilities

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[vc_row][vc_column][vc_column_text]The picture in Figure 1 shows a “repaired” endoscope by a hospital contractor hired to repair medical equipment. In order to repair the tip of this endoscope the repairer used an adhesive with a softer consistency than that specified by the original manufacturer. Instead of achieving a smooth surface, the poor quality of the adhesive and workmanship resulted in cracks and pin holes left at the bonding site. Cracks and pin holes are notoriously difficult to clean and sterilise. The tip of this “repaired” endoscope becomes a cross-contamination hazard.

Representatives of businesses selling repairs of medical equipment and maintenance-related services to hospitals are quick to point to standards such as AS/NZS 3551 and AS/NZS 2500 as the “bible” of clinical engineering. Both standards were written by these vested interests with little or no input from other stakeholders such as MedTech industry or consumer groups.

For example, AS/NZS 3551 Management program for medical equipment contains aspirational, conveniently vague statements such as: “modification shall not reduce the safety of medical equipment or accessories for patients, operators or the environment”, but fails to provide specifics on requirements for repairs and modifications performed by or on behalf of health facilities, i.e.:

  • repaired medical equipment must continue to meet the safety and performance specifications as defined by the original manufacturer;
  • modified medical equipment must comply with all applicable Essential Principles of safety and performance defined in the Australian Therapeutic Goods Act 1989.

AS/NZS 3551 and AS/NZS 2500 are long overdue for a substantial revision to align them with international standards and best practices, such as these IEC and ISO standards:

  • IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment;
  • ISO 55001:2014 Asset management – Management systems;
  • IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and e performance. This international standard has already been adopted as an Australian & New Zealand standard: AS/NZS IEC 60601.1:2015.

The World Health Organisation has also published a series of guides for the management of resources in healthcare. In the WHO Guide 5 How to Organize the Maintenance of Your Healthcare Technology, the authors state:

The quality and effectiveness of a repair job is often jeopardized by the use of low quality parts and materials. Poor parts and materials may break if they are not strong enough, they may fail earlier than expected, or they may rub, corrode, or in some way damage other parts of the machine. Even if you do a first class repair job:

  • poor quality engine oil means the engine will not last as long as it should
  • poor quality batteries affect the performance of the equipment, have a short life, and leak
  • poor tyres compromise the safety of a vehicle
  • poor quality solder evaporates or cracks easily
  • poor gaskets and seals leak, or perish quickly.

Cost and quality often go together. Equipment manufacturers’ own brand of spare parts and maintenance materials often produce better results than ‘lookalikes’. Many companies are set up solely for the purpose of manufacturing lookalikes – these products are often (but not always) cheaper, but may be of inferior quality. We recommend that, as the items get more technically complex or critical, you should try and buy better quality spare parts and maintenance materials. A discussion on sourcing and obtaining good quality products can be found in Guide 3 on procurement and commissioning.

The TGA has no jurisdiction over repairs and modifications to medical equipment taking place in health facilities. Original manufacturers have no say on what happens to their equipment once it is purchased and put into service by health facilities. There is a need for appropriate regulatory oversight and better standards to address repairs and modifications of medical equipment performed by health facilities or on their behalf. Patient safety should always come first.

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ALLEVIATING PAIN FROM INJECTIONS

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As a Clinical Nurse Specialist, NeedleCalm Pty Ltd Director, Lauren Barber, saw first-hand the pain and anxiety experienced by patients undergoing needle-related procedures.

After witnessing many patients with a fear of needles, particularly children, Lauren forged the idea for a medical device technology to help alleviate this pain and ultimately improve compliance with needle-related procedures.

“After being a patient myself a number of times and as a healthcare professional, I recognised and began to understand patterns in patients. I realised that something needed to change in the way that we do things as clinicians,” says Lauren.

Lauren saw that to make a sustainable change in the healthcare system, a lot of focus was needed to solve the root cause of problems that clinicians and patients face.

“Our drive is reinforced daily from everyone we speak to. It just makes sense to provide a practical solution to a problem,” says Lauren.

Currently in the final stages of preparing for commercialisation, the technology, NeedleCalm™, is a cost-effective, single-use device intended to be applied on the skin at the planned site for injection.

From day 1 Lauren had been searching for a program that could assist with bringing her idea to market, however none of them seemed like the right fit.

“We joined the MedTech Actuator Accelerator Program in our third year, as we realised that we were entering an increasingly complex environment. We saw that the program would provide us with the necessary skills and knowledge to navigate our way through the commercialisation process,” says Lauren.

Lauren and her co-founder, Megan Guy recently completed the 6-month intensive and now have a plan for the future of NeedleCalm Pty Ltd.

“It’s been great to get all of the necessary documents and presentations in place whilst also establishing crucial networks with leading industry experts,” says Lauren.

For Lauren, the most beneficial aspects of the program have been finding support and building confidence, allowing her to build a solid foundation of skills required to run a successful business.

“It can be a really busy time for anyone starting a new business, especially when you may be still juggling another role, but making time for the Accelerator program has been worthwhile. The mentoring helped us to stay on track and bring our product closer to market as quickly as possible.”

In an exciting development, Lauren was recently elected to the Medical Technology Association of Australia’s Board of Directors and will manage the Women in MedTech Committee.

To learn more about NeedleCalm Pty Ltd and follow their journey go to www.needlecalm.com.au.

Do you have a MedTech idea to change lives? Apply now for the MedTech Actuator Accelerator Program!

Apply Now

This article first appeared on the MedTech Actuator website: http://medtechactuator.com/

POOR QUALITY REPAIRS OF AND MODIFICATIONS TO MEDICAL EQUIPMENT PUTTING PATIENTS AT RISK

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[vc_row][vc_column][vc_column_text]Playing cards are fine for playing poker, not for gambling with a patient’s safety. The picture in Figure 1 shows a “repaired” endoscope by a hospital contractor hired to repair medical equipment. The playing card was used to separate the angulation wires from the image and light guide bundles to protect them from the open solder joints. No heat shrink was used to provide environment sealing protection. This is a serious material incompatibility issue. The paper of the playing card is flammable and its use on open solder joints can lead to fire and serious patient injury.

Although medical devices are regulated by the Therapeutic Goods Administration (TGA), the TGA does not have jurisdiction over hospitals. A lack of regulatory oversight has resulted in a proliferation of businesses selling repairs of medical equipment and maintenance-related services to hospitals. Most if not all of these businesses have no links to the original manufacturer. Therefore, it is anyone’s guess how hospitals ensure that medical equipment under their care remains safe and works as per the manufacturer’s original specifications, and who checks whether these contractors and consultants have the minimum level of competence and training to perform repairs and maintenance on medical equipment.

If a patient is injured by a poorly repaired medical equipment or by a medical device rendered unsafe by modifications, the hospital has no obligation to report the adverse event to the TGA. The poor level of incident reporting by hospitals is reflected in the TGA statistics (shown in Figure 2). According to the current law, only manufacturers and sponsors of medical devices have an obligation to report incidents and adverse events to the TGA. It is safe to assume then that, unless a hospital informs the manufacturer or sponsor, incidents involving medical equipment repaired and maintained by the hospital or on behalf of the hospital will go unreported.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”4286″ img_size=”full” add_caption=”yes”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Even if the original manufacturer is informed of adverse events involving repaired/ serviced medical equipment, the hospital has no obligation to provide TGA or anyone else with information and records related to repairs and modifications undertaken by the hospital or on behalf of the hospital.

Patient and consumer groups such as CHOICE or Consumer Health Forum (CHF) have a right and indeed an obligation to understand what is happening in relation to post-market repairs and modifications of medical devices. The Australian Commission for Safety and Quality in Health Care (ACSQHC) has issued a number of National Safety and Quality Health Service (NSQHS) standards. Unfortunately, none of the NSQHS standards cover repair and maintenance of medical equipment in hospitals. The only standardisation of repair and maintenance of medical equipment in healthcare facilities is left to Standards Australia HE-003 committee, however neither the ACQHC, nor the CHF are represented in HE-003.

Playing cards have no place in healthcare.[/vc_column_text][/vc_column][/vc_row]

$14.7 Million for Innovative Medical Projects

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[vc_row][vc_column][vc_column_text]The Federal Government has announced it is investing more than $14.7 million in these projects through the Medical Research Future Fund (MRFF), comprising $8.9 million through the BioMedTech Horizons (BMTH) program and more than $5.8 million through the Biomedical Translation Bridge (BTB) program.

The BMTH program is a $45 million government initiative, made possible through the Strategic Agreement between MTAA and the Federal Government, that aims to move technologies to proof-of-concept and commercial development.

As part of the second funding round of the BMTH program $8.9 million will be invested in nine projects:

  • Cyban Pty Ltd, Victoria, is developing a novel brain pulse oximeter to monitor brain oxygen levels following traumatic brain injury.
  • Macuject Pty Ltd, Victoria, is developing artificial intelligence-based clinical decision support software for intravitreal management of age-related macular degeneration.
  • PolyActiva Pty Ltd, Victoria, is developing sustained release ocular implants for delivery of steroids and non-steroidal anti-inflammatory medications to the eye for the prevention and treatment of macular oedema.
  • Enlighten Imaging Pty Ltd, Victoria, is developing a novel hyperspectral retinal imaging platform for next generation artificial intelligence diagnostics.
  • Kunovus Technologies Pty Ltd, New South Wales, is developing an elastomeric motion-preserving implant to treat lumbar spine osteoarthritis as an alternative to fusion.
  • IDE Group, New South Wales, is developing a control sleeve for intravitreal injection systems.
  • IntelliDesign Pty Ltd, Queensland, is developing portable bedside low field magnetic resonance imaging.
  • WearOptimo, Queensland, is advancing cardiac microwearables for rapid, minimally-invasive personalised cardiovascular medicine.
  • Advanced Genetic Diagnostics Pty Ltd, Western Australia, is developing genetic tests to identify people at high risk of heart disease.

Industry is backing the BMTH projects by providing $10.6 million in matching contributions.

The BTB program is a $22.3 million initiative that will fund up to $1 million in matched funding to nurture the translation of new therapies, technologies and medical devices through to proof of concept.

Eight projects will share in more than $5.8 million in the first funding round of the BTB program:

  • AdAlta Limited, Victoria, has identified a therapeutic i-body protein, a class of next generation antibodies that demonstrates potent anti-fibrotic properties, and is being developed for the treatment of the lung fibrosis condition Idiopathic Pulmonary Fibrosis (IPF).
  • DBS Technologies Pty Ltd, Victoria, is developing an innovative device providing adaptive deep brain stimulation for people with Parkinson’s disease.
  • MecRx Pty Ltd, Victoria, is developing novel, small molecule therapeutics for the treatment of lung cancer.
  • University of Melbourne’s Melbourne Dental School, Victoria, is progressing a novel dental implant to commercialisation.
  • The Australian National University, Australian Capital Territory, is developing rapid and objective eye and brain testing for better management of ophthalmic and neurological diseases.
  • SpeeDx Pty Ltd, New South Wales, is seeking to commercialise its ResistancePlus® MABSC/MAC test, a rapid in vitro diagnostic tool to accurately and quickly identify bacterial infections related to cystic fibrosis, while using gene markers to predict antibiotic susceptibility or resistance.
  • Vast Bioscience, Queensland, is developing 3D small molecule sodium channel inhibitors for the treatment of postsurgical pain.
  • Noisy Guts Pty Ltd, Western Australia, has developed a non-invasive acoustic belt that uses artificial intelligence to decode gut noises to accurately diagnose and monitor common gut disorders such as irritable bowel syndrome.

Industry is providing an additional $14.6 million in support of the BTB projects.[/vc_column_text][/vc_column][/vc_row]

Trailblazing Entrepreneurs On Track To Commercial Success And Healthcare Impact

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[vc_row][vc_column][vc_column_text]At MedTech’s black-tie night of nights, entrepreneurs revealed new healthcare solutions fuelled by insights into real needs and moving first-hand experiences.

Uniting these changemakers was a clear passion for collaborating and bringing to life the profound impact that MedTech can have in the lives of individuals, communities and people around the world.

Judges had a tough job cut out for them, with each and every entrepreneur showing huge potential to shake up healthcare for the better. In the end, the following startups won a share in $50,000 and fast-tracked application to the MedTech Actuator Accelerator program:

  • Johnson & Johnson Award: Cogniant – ensuring care continuity for people with mental health conditions – Neeraj Kothari – mentored by Hayley Quinn, Medtronic.
  • Medtronic Award: Injectra – a new cannula that saves lives through simplicity – Maryam Soomro – mentored by Jamal Elsheikh, MedTech Actuator.
  • Cook Medical Award: SoundSense – helping blind and visually impaired people see with sound – Jonathan Hribar – mentored by Ingenuity.
  • LaunchVic Award: Rapid Motion – a new test for infection to improve cancer patient quality of life and outcomes – Hannah Wardill – mentored by Michelle Kleynhans, MedTech Actuator.
  • MedTech Actuator Award: Lactamo – bringing breastfeeding benefits to more mothers and children – Etta Watts-Russell – mentored by Ann Damien, Cook Medical.

The $1000 People’s Choice Award for the night was taken out by Maryam Soomro from Injectra.

This year’s Challenge was bigger and better than ever – in an exciting development, the competition scaled beyond our shores to welcome entrepreneurs from India.

Primary school students also graced the night for the first time, sharing their ideas to improve lives with MedTech innovation. The MedTech Actuator team hopes to see them in the competition in years to come and know that they’ll inspire other young changemakers to follow their lead.

“I’d like to congratulate all teams, finalists and students on their courage to put themselves out there last night in the name of innovating for healthcare impact,” says Dr Buzz Palmer, MedTech Actuator CEO.

“It’s never easy, but well worth it for the difference you can make in the lives of people around the world. We’re thrilled to support emerging talent and promising ideas, in deep collaboration with our region’s innovation ecosystem.”

To learn more about entrepreneurs from this year’s Challenge and how they’re making waves in healthcare, visit www.medtechactuator.com/news.

Applications for the MedTech Actuator Accelerator program open in January 2020 at www.medtechactuator.com.[/vc_column_text][/vc_column][/vc_row]

Digital Health the Focus at NBN Workshop

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[vc_row][vc_column][vc_column_text]CEO Dr Gabrielle O’Kane said that the workshop, which was attended by Minister for Communications Paul Fletcher, brought together key stakeholders including health practitioners, advocates and consumers.

“Digital health is key to delivering quality health care services to people in rural Australia in the 21st century,” said Dr O’Kane. “But while digital health provides many opportunities for practitioners and consumers, there are still significant challenges to overcome.”

“That’s why today’s workshop brought together people from across the sector who have an interest in digital health.

“There is lots of innovation happening in this space. But there are also many barriers that stand in the way, including poor connectivity and lack of affordability. Service designs need to fit the diverse needs of the 7 million people living in rural and remote Australia, and not just those in the major cities.

“It’s heartening that the Minister, Paul Fletcher, attended the workshop and indicated that the Federal Government was committed to improving digital health connectivity. The rural health sector will continue to work with the Minister and the Government to make sure that happens.

“There is important work taking place, such as My Health Record, but more needs to be done to ensure that people in rural Australia are included and have the same access to quality health services as people in the major cities.

“We need national coordination and collaboration in order to improve quality health care for people in the bush. The National Rural Health Alliance will continue to work with government to make this happen and today’s digital health workshop was an important first step.”[/vc_column_text][/vc_column][/vc_row]

A Conversation with Guy Leech

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[vc_row][vc_column][vc_column_text]IN GUY’S WORDS:

In Feb, 2016 that all changed for me.

A shocking tragedy, that made me rethink my entire life purpose and question everything that I was doing both personally and professionally.

When one of my best mates “Chucky” collapsed after one of our paddling sessions, I found myself in an impossible situation.  I quickly did what I thought was the right thing, Airway, Breathing, Circulation… no pulse, no breathing.. call the ambulance.. start CPR… everything will be ok… Chucky will be fine.

The ambulance arrived around 10 minutes after the phone call, and they quickly set up the defibrillator as I continued CPR on Chucky.  Once they had him in the ambulance they took him directly to the Royal North Shore Hospital.  He was in the best possible care.  Chucky was fit, he was healthy.

He suffered a Sudden Cardiac Arrest (SCA).  He was not alone.  In Australia, around 30,000 people suffer a Sudden Cardiac Arrest (SCA) each year.  Only around 6% of these people survive, because there wasn’t a defib close by – if you can get a defib on the patient in the first three minutes you increase the chance of survival to over 70%!

Unfortunately, Chucky never recovered and passed away after a week in hospital.

One of life’s most haunting questions I ask myself is “What if?” What if I had a defib in the car, What if I the cafe nearby had a defib? What if I could have put Chucky on a defib in that first 180 seconds?  If any of my other fit and healthy friends, my kids, my wife were to suffer from a Sudden Cardiac Arrest?  Where is the nearest defib right now?  Does anyone know how to use it?

As an athlete, my life had been all about looking after myself, and a few seconds would determine winning vs losing.  Since retiring, I have built my business on the idea of looking after your body and your mind was the most important thing in life.  When Chucky died, I realised that it was not enough.

People need to know that 180 seconds could be the difference between life and death.

Everyday, fit and healthy people suffer from Sudden Cardiac Arrest.  Whilst good diet, exercise and managing stress can reduce the incidence of heart disease, Sudden Cardiac Arrest can strike anyone, any time.  When it does, over 90% of these people will die.  Chance are the ambulance won’t get there in that first three minutes.  If a defib is put on the victim in that time we increase the chance of survival to over 70%!

Maybe Chucky would have lived, I will never know.

My mission now is to help people become Heart Smart by making sure that we have defibs available, and people are trained in how to use them confidently in the case of Sudden Cardiac Arrest.  The reality is we can get the defib on the patient in the first 180 Seconds, to give them their best chance of living. To find out more about defibrillators and how to buy them go to my site HEART180.com.au[/vc_column_text][/vc_column][/vc_row]

BioMedTech Horizons: Round 3 Applications Are Now Open

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[vc_row][vc_column][vc_column_text]Expressions of interest are now open for the third tranche of funding, with grants of up to $1 million available for medical device projects targeting innovative solutions to address unmet clinical needs in three key focus areas:

Digitally enabled medical devices in mobile health, health information technology, wearable devices, telehealth and telemedicine, and digitally enabled personalised medicine Digitally enabled implantable medical devices addressing unmet needs in any therapeutic area General medical devices in the areas of regenerative medicine, women’s health, cardiovascular, orthopaedics, neuroscience, general surgery and oncology.

This funding, BMTH3.0, is delivered via the Medical Research Future Fund (MRFF), and administered by MTPConnect, the Medical Technology and Pharmaceutical Industry Growth Centre.

Investments from the program are focused on funding proof-of-concept to commercial development of biomedical and medical technologies (biomedtech).

The funding provided for the BioMedTEch Horizons initiative is thanks to an Agreement signed between MTAA and the Commonwealth Government.

For more information and to apply, visit https://www.mtpconnect.org.au/biomedtechhorizons.[/vc_column_text][/vc_column][/vc_row]

Australians say health and medical research matters!

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[vc_row][vc_column][vc_column_text]National peak body, Research Australia, has asked Australians for their opinions on health for the past 17 years and they consistently tell us that research is crucial to better health and living our best lives.

The Minister for Health, the Hon. Greg Hunt launched the 2019 consumer poll Australia Speaks! at Parliament House yesterday to an audience of Research Australia’s Members along with government representatives, sector leaders and other health organisations.

The Hon. Greg Hunt expressed how heartening it is that Australians value health and medical research and are so willing to participate and contribute in the process.

“Health and medical research is about people so each year, with the generous help of Roy Morgan, we ask consumers for their opinions to enable us to reflect their values, and those of our Members, to ensure policy supports our health system.” says Nadia Levin, CEO of Research Australia.

“It is clear Australians see improving hospitals and healthcare as the number one spending priority for the Australian Government, even ahead of infrastructure, education standards and employment opportunities.

“Three quarters of Australians say they are interested in health and medical research. However, while confident in their ability to contribute to decision making about the future direction of the sector, most Australians don’t know how, and many don’t believe they’d be heard. Our governments and research organisations clearly have more work to do to meaningfully engage with the broader community.”

The results also confirmed that Australians are willing to embrace technology that can help them better manage their own health. They trust healthcare professionals to assist them with choosing those technologies and directing them to other credible online information sources. Professor Mary Foley, Managing Director Telstra Health and Research Australia Director shared her views around the impact of data in supporting improved health and what the future holds with the ongoing advances in technology.

The subject of ‘The empowered patient and consumer – managing our own health’ was discussed in a panel made up of sector leaders including the CEO of the Foundation for Alcohol Research & Education Michael Thorn, the CEO of Diabetes Australia, Greg Johnson and Jeppe Theisen, Vice President and General Manager Oceania, Novo Nordisk. Each discussed the importance of preventative medicine and what they are doing in this space to support Australians.

The poll also covered donations and government funding, and once again support for health and medical research is widespread. And at a time when we see the government partnering with the not for profit sector to support health and medical research, people indicated they would be more likely to donate a higher amount if the government would match their donation – a sentiment also reflected in previous polls.

Australian’s opinions continue to shape Research Australia’s strategies and priorities and observations of the changing trends and current attitudes will be shared widely to help shape policy and change to enable a healthier Australia.[/vc_column_text][/vc_column][/vc_row]