Medical Device Commercialisation Training Program

3D Fractional Moving Blood Volume is a non-invasive measurement of perfusion using ultrasound. This technology combines medical image analysis and power Doppler ultrasound, to enable a sonographer or doctor to evaluate the amount of blood flow (perfusion) in a particular organ, tissue or tumour. This technique provides a marker of organ function and can detect change over time. The technology uses machine learning and image analysis to automatically and in real-time generate a value of blood flow in a given area that compensates for differences in machine settings, depth and attenuation.

Having understood the challenges of commercialisation of this device, I intend to continue its development to provide strong clinical evidence of its efficacy. In parallel with this, I intend to work with partners at public clinics and eHealth NSW to understand potential cross-over in image collection and analysis at a State level.

Congenital heart disease is associated with high levels of morbidity. At least a third of patients born with congenital heart disease will require one major open-heart operation. Often, this heart surgery involves construction of a valved conduit connecting the right ventricle and pulmonary artery to repair complex defects. Current modalities for tissue repair are homografts (from cadaver) and xenografts (from animal). Both have shortfalls in biocompatibility and durability, and most importantly, growth potential. As such, paediatric patients require up to four operations to replace the conduit throughout childhood and adolescence.

At TrueHeart, we aim to overcome the key complication of reoperation through the research and translation of novel medical implants. We have conceptualised a tissue engineering solution that utilises bespoke implant fabrication and 3D printing. This technology will allow us to improve the health are outcomes and quality of life for young patients affected by congenital heart diseases.

During the Medical Device Commercialisation Training Program, we have developed a straightforward business model canvas for this technology. In the next 12 months, we will focus on two aspects of this technology. From a technical point of view, we need to conduct large animal studies to prove the functions of the designed biomaterial. On the business side, we need to continue interviewing potential customers and key partners to finalise the business model canvas boxes.

Device-related infection represents a significant public health issue and financial burden on governments around the world. Antimicrobial coatings based on antimicrobial peptides and quorum sensing inhibitors were developed by our group at University of New South Wales to prevent such infections.

Quorum sensing is a cell-to-cell communication mechanism between individual bacterial cells, which coordinates gene expression and behaviours for bacteria cells in close proximity.

Our antimicrobial coatings have broad spectrum activity against bacteria, including drug-resistant strains, as well as fungi and protozoa. The coating could be applied to a variety of materials such as polymers and metals, making it suitable for a range of applications such as contact lens and implants.

The antimicrobial coatings are composed of two classes of bioactive agents, antimicrobial peptides and quorum sensing inhibitors with unique advantages over current antibiotics. Antimicrobial peptides are nature’s defence against bacteria found in humans as well as a variety of animals and plants. These peptides act primarily through the disruption of bacteria membrane, which bacteria is unlikely to develop resistance for, leading to cell death.

I would like to apply all the things I’ve learnt in the Medical Device Commercialisation Training Program to make the technology into a viable business. In the next 12 months, we will look to conduct further experiments and product development to gather data to satisfy the substantial regulatory approval process required for the future.

StandingTall is an engaging home-based exercise program using mobile technology for preventing falls in older people. StandingTall runs on any tablet device and can be used at home. It is tailored to the user’s ability and utilises advanced algorithms to progress difficulty over time. Because of this and the large variety of exercises, it is motivating and effective.

Now that I have completed the Program, I plan to revisit some of the topics. I will perform additional customer interviews to validate my current business model. These steps will allow me to advance the business case for StandingTall and put us in a good position to seek funding.

With a current world population of 900 million people aged 65 and over, a number that is expected to double by 2050, injurious falls and their prevention are a major, and growing societal issue. Implementation of cost-efficient and scalable fall prevention, such as StandingTall, is timely and urgent.

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. This is 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 and licenced globally by Allegra Orthopaedics. 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.

Over the next 12 months I will continue with my customer interviews and discussions with surgeons who are supportive of the technology. My key goal is to design and implement much of the pre-clinical studies.

SIXTH SENSE – Your Balance Right tests peripheral vestibular (balance) function. If you have ever had motion sickness or alcohol poisoning, then you may have experienced a balance sensor dysfunction. For vestibular patients these acute symptoms last weeks and chronic symptoms can be permanent and notoriously difficult to diagnose. Patients are incapacitated and terrified they have a brain tumour, a stroke, are dying or ‘going crazy’. Patients go from general practitioner to neurologist to rehabilitation for years, with no diagnosis or the wrong diagnosis (migraine, depression, mental illness) in some instances.

Around four per cent of adults report a chronic problem with balance and 35 per cent of adults 40 years and over have experienced vestibular dysfunction. For older people (aged 65 years and older), 80 per cent have experienced dizziness.

Sensory disorders are a large health burden. The dominant test for the last 100 years, caloric irrigation, evaluates only two of 10 sensors. In 2009, we published one of our dozen vestibular testing tools (vHIT) that evaluates six sensors. Our new device, Micro Vestibular Evoked Myogenic Potentials (uVEMP), tests the remaining four sensors. Together vHIT and uVEMP can test all 10 sensors.

Coeliac disease is a condition in which the body’s immune system is unable to properly process gluten – a protein found in consumed wheat, barley and rye. It causes inflammation and damages the small intestine, and if undiagnosed can lead to small bowel cancer.

Coeliac disease effects on average one in 70 Australians. Around 80 per cent of coeliac sufferers are undiagnosed as many symptoms are similar to other disorders.

Our team has developed a noninvasive test to screen for coeliac disease by simply using saliva and obtaining a result within minutes. Our saliva-based test offers a cheap, accurate, simple and safe point-of-care test that could potentially be available to the general public and clinicians.

This Program has helped us to shape our idea and create a solid evidence for the need of our technology. We will put into practice all the skills the Medical Device Commercialisation Training Program has equipped us with and start our commercialisation journey.

We leave Cicada with a better understanding of our market and the network of people who can help us navigate the next 12 months.

InKardia is a dream that started over 10 years ago in the United States and is based on the development of the biological ink (or “bio-ink”) that acts as a mini-human heart tissue in a test tube. This technology starts from understanding how the heart develops in nature and uses patient-derived stem cells. The bio-ink is used to build human heart tissues using a “bioprinter” that 3D prints, layer-by-layer, within a cardiac-tailored bio-paper (“hydrogel”). Patient-specific bioinks are used as diagnostics for cardiovascular disease patients or to prevent side effects. Bioprinted heart tissues are also used to treat heart failure in patients that cannot receive a heart transplant.

In Australia, only 95 out of over 13,000 heart failure patients received a heart transplant in 2015. Given the calibre of the potential market for this technology and the lack of heart transplants available for patients, in the next year my main goal is to establish a company based on this novel technology, and seek funding to support clinical studies. I will also look to partner with experts with different skills in the commercialisation of medical devices to take with me in this long journey.

Respia is an asthma management system that tracks and records the wearer’s respiratory health. It’s a wearable patch for children with asthma that detects early signs of asthma before they become noticeable symptoms or worse, asthma attacks. It’s a communication link between parents and children with asthma. Our goal is to reduce the number of preventable hospitalisation events for kids with asthma. In doing so, we will save children from trauma, parents from stress, and the public health system money.

In the next 12 months Respia will open a seed round of funding. We will use this funding to build a higher fidelity prototype for upcoming clinical studies and trials. Respia is also looking to strengthen its management team with business and regulatory expertise.

The long-term vision of Respia is to provide preventative health solutions to markets where reactivity is the established norm. Respia wants to help parents understand their child’s asthma and make informed decisions on how to best manage the condition.

Rheumedica is a precision medicine company that is transforming the way we diagnose patients with autoimmune arthritis. The company has made a ground-breaking discovery that explains the pathological mechanisms involved in autoimmune arthritis. The device is a companion diagnostic to the current test and the first specific test for these patients. This technology has greater accuracy compared to the current test which has on average a 30 per cent false-negative result. This is the only specific test which is accurate and specific to autoimmune arthritis.

Over the next 12 months we will work in collaboration with rheumatologists and dermatologists to complete a clinical trial using our technology. We will publish the results in a reputable journal and apply for compliance/registration of the technology in the main continents. We will work with our early market adopters to achieve market share and partner with an established company to distribute our technology.

We are establishing a new service to test for human papillomavirus (HPV) and vaginal microflora for women to take their own vaginal swab samples in the privacy of their own home. Self-sampling is a simple procedure which involves collecting a vaginal sample by the woman. After collection, the sample is sent to a registered pathology lab for testing with the results sent to the woman via a general practitioner. This provides an alternative to presenting at a doctor’s office in managing a woman’s vaginal health and can increase the detection of HPV by encouraging more participation in screening.

My goal after completing the Medical Device Commercialisation Training Program is to gain more knowledge about business. As most ambitious people, I came into the course thinking that I could be an entrepreneur and start my own business. The course has made me recognise that in order to be a successful entrepreneur I need to obtain specific business knowledge and develop my skills, which is now my goal for the coming year.

The invention is a bioresorbable subdural drain to be used for the treatment of chronic subdural haematomas. The drain design includes a z-bend in the cranial end for ease of insertion through a burr hole, bioresorbable tubing to be tunnelled through subcutaneous tissue to land within a pouch formed for drainage and interstitial absorption. This drain will reduce recurrence rates of chronic subdural haematomas, the need for surgical revision, allow patients to move soon after the procedure, and reduce the overall hospital length of stay.

Over the next few months my goal is to continue working on a viable prototype which will eventually be implanted and trialled. If the drain proves viable and becomes the standard for treatment of chronic subdural haematomas, I would like to see its possible applications expanded beyond neurosurgery into other surgical specialties.

A diagnosis of a brain disorder is often made worse by the lack of effective treatments and the substantial side effects of current treatment. Despite over 200 million people facing this problem, many companies have stopped developing new brain disorder treatments. Current methods for predicting the effectiveness of brain disorder drugs have shown to be of little help, with failures costing the industry many hundreds of millions of dollars in the past decade.

VitroQuest is addressing this problem by providing a drug validation service built on the actual human disease biology to test ineffective treatments early in development. By using our validation platform, drug developers will reduce the risk of future efficacy failures and increase their confidence in the remaining treatment candidates. This will improve the financial viability of developing brain disorder treatments.

The Program content together with the learnings from the customer discovery interviews has given me the confidence to bring this technology to the market. I am confronted daily by the desperate need for better treatments of brain disorders. I believe I can help improve this dire situation by putting all my energy into making this technology available to drug developers.

Proton-X is a revolutionary patient positioning system for use in proton therapy systems. This patient positioning device integrates into current Proton therapy systems. It introduces two major changes to proton therapy:
- positioning the patient in an upright position from the horizontal plane delivers better clinical results and allows proton vendors to fix their radiation beams, and
- rotating the patient rather than the machine reduces infrastructure size and cost.

Having completed the Medical Device Commercialisation Training Program, I have strengthened my commercial skills along with my overall understanding of how product development fits within the wider business context. Over the next 12 months I would like to take the business model canvas developed during this course and expand on it, working with a proton therapy vendor to strengthen the business case for upright proton therapy.

The end goal will be to see an upright proton therapy patient positioning device delivered to the market through an Original Equipment Manufacturer relationship between Leo Cancer Care and a leading proton therapy vendor.

Watery, blurry, red, itchy or dry eye, are all symptoms of dry eye disease. This disease is caused by the tears of the eyes not forming an effective protective film over the eyes after blinking. In severe cases, this diminishes the quality of life to the same level as having a badly broken hip. Confirmation that these symptoms represent dry eye
disease is difficult because it is a complex disease with multiple causes and current diagnostic tests for dry eye disease are not effective. Even though dry eye disease
affects 15 per cent of the population, 82 per cent of clinicians believe it is under-diagnosed. As diagnosis is a problem, treatment is generally a best guess for a particular tear substitute and the treatment cannot be monitored objectively. TearView breaks this cycle because it enables visualisation of the tear film in real time which can be used to determine the nature of the dry eye disease. Consequently, the treatment can be targeted and the effects of treatment can be objectively observed and evaluated. The ability of TearView to see the tear film means that it can also be used for diagnosis of other eye problems that affect the tear film.

Focal therapy is a well-established technique of targeting and treating benign and cancerous lesions throughout the body. It has been used for years for brain, lung, liver,
bladder, pancreas and kidney cancers. In recent years more powerful MRI (magnetic resonance imaging) machines have become available and enabled clinicians to
visualise prostate cancer for the first time. The visibility of these cancers with MRI has enabled the development of ProFocal-Rx targeted laser therapy. ProFocal-Rx allows
for at least 30 per cent prostate cancer patients to have minimal invasive therapy instead of surgery or radiotherapy. It also allows curative treatment and peace of mind for patients who would have chosen active surveillance for their prostate cancer.

The ProFocal-Rx laser delivery unit is introduced in the proven abnormal cancerous area. ProFocal-Rx allows for real-time interactive treatment ensuring that the cancer is
eradicated and ablated. The treatment is performed as a short outpatient procedure with the patient going home the same day. The side effects of the treatment are less
than the diagnostic biopsies that are currently performed.

Blount’s disease is a form of bowleg, which means that as a child grows their tibia grows at a different angle to the rest of their leg. It is a progressive disease, meaning surgical intervention is required to prevent the deformity getting worse. Currently, if the child is older than around 4 years, the treatment of Blount’s disease involves an
osteotomy, or cut in the bone, with a gradual correction using an external fixation frame. These frames are bulky, uncomfortable and require a significant and costly 4 to 6
month commitment on behalf of the patient, family and healthcare team.

The Blount’s plate is an orthopaedic plate that can be used for the internal correction of Blount’s disease. This approach transforms the surgical management of Blount’s disease into a fully internal one, meaning that there is no need for an external fixation frame. The Blount’s plate would give the patient the freedom to play as a child without the restrictions of an external frame. This plate has the potential to save the healthcare system from 4 to 6 months of intensive outpatient follow up care, including appointments with the surgeon, radiology, physiotherapy and a specialist care nurse. This plate has the potential to improve the experience and effectiveness of patients being treated for Blount’s disease without sacrificing quality of care.

Two out of every three Australian women are overweight or obese, equating to 6.5 million women nationally. Research shows that women who are overweight or obese have 2-3 times the breast volume of women of a normal body mass. With a limited range and availability of bras designed to cater for these larger sizes, this can lead to problems finding a bra to both fit and sufficiently support their breasts during exercise. As a consequence of ill-fitting or unsupportive sports bras many women with large breasts are not gaining sufficient support from their sports bra. This can lead to pain and embarrassment during physical activity and can be a barrier to participating in physical activity. Removing the bra-barrier to physical activity for overweight and obese women with large and hypertrophic breasts is important from a public health perspective in order to enable these women to enjoy the benefits of physical activity, which in turn leads to improved health outcomes.

BraVo Sports Bras provide a better solution by using accurate and detailed three-dimensional body scan data of the breasts and torsos of women in conjunction with a deep biomechanical understanding of how the breasts move during motion. That is, sports bras specifically designed to comfortably fit and support the breasts of overweight and obese women with large and hypertrophic breasts.

Current methods of obstetric monitoring are cumbersome, restrictive and rely on subjective interpretation which is known to increase intervention. This poses a problem for mother and baby, clinicians, hospitals and health systems. When a mother is monitored with current methods it can be a distressing experience, compromising her comfort and mobility while impacting outcomes for herself and her child. Subjective interpretation of data often results in inappropriate and late intervention, requiring substantial resources, placing significant burden on the health systems.

Oli is a non-invasive patch which monitors pregnancy and labour progression. The technology allows for more objective measures to identify complications, assess intervention performance and improve outcomes. Oli provides real time feedback on uterine activity, maternal and fetal well-being, exertion, movement and how these all correlate to progression. Oli allows for remote monitoring without impacting maternal activity.

One in six couples worldwide experience infertility and approximately 3-4 per cent of all babies born in most western countries are the result of advanced assisted reproductive technologies, such as in vitro fertilisation (IVF). Despite its widespread use, IVF remains inefficient with only a 17.9 per cent success rate (live birth/IVF cycle initiated) , and it is expensive. Egg (oocyte) quality is one of the key ratelimiting factors in IVF success.

Joi is the world’s first non-invasive in vitro diagnostic test that directly measures key biomarkers produced by the oocyte from multiple biological samples. By better selection and implanting a healthy egg, it is anticipated that the success rate in patients undergoing IVF treatment will be improved. Compelling evidence has been generated using a variety of clinical samples from healthy volunteers and patients with ovarian diseases. In addition, to assessing the quality of oocyte, this test may also be used to estimate the quantity of eggs available and to diagnose certain ovarian diseases such as endometriosis.

Exoskeletons promise to significantly improve the daily lives of the sufferers of paralysis, if they can be made easier to control. Spinal cord injuries are relatively rare in Australia, but they often occur to young people leading to lifelong disability. The direct costs to the healthcare system are consequently very high, estimated at more than $10 billion for cases that occurred in this year alone (Access Economics “The economic cost of spinal cord injury and traumatic brain injury in Australia”). The indirect costs to families and caregivers are even higher. XoCo is developing a closed loop neuroprosthetic controller for a lower body exoskeleton, to assist with balance and gait coordination during operation by spinal cord injured users.

With an ageing population and a growing number of people living with chronic or complex health conditions, people’s health needs are changing and demands on the
health system are increasing. health.ly, a digital integrated healthcare platform, creates better connected models of healthcare that improves outcomes for health consumers by making it possible to access high quality care - anytime anywhere. health.ly improves health outcomes by providing patients with a more convenient and
personalised service through informing, educating, and supporting treatment adherence. It helps with sharing of clinical information between hospitals, specialists and
general practitioners, and reduces unnecessary duplication of pathology and radiology tests.

The technology also allows patients access to high quality cost efficient healthcare at home by using digital communication such as e-visits, e-prescriptions and two-way remote monitoring. As a result more patients can be cared for in the community with a reduction in avoidable hospitalisations and emergency department attendances. The patient experience is improved by enabling the right care to the right patient at the right time – each time and every time.

Incontinence affects over 5 million Australians with one in three women and one in four men over the age of 50 suffering from loss of urinary and/or faecal control. Within the ageing population, incontinence is highly prevalent affecting up to 70 per cent of all geriatric patients in residential age care and in-home community care. The problem of incontinence is not limited to the symptoms of urgency, frequency and night time waking to relieve urinary and faecal urges. It is often the loss of dignity patients feel when they are forced into managing their incontinence with adult diapers. Pharmaceutical options are often unsuitable due to polypharmacy interaction and side effects. Surgical treatment is invasive and comes with significant risk.

InConfidence is a discreet, non-invasive, wearable medical device worn around the ankle for twenty minutes a day. It works through transcutaneous electrical stimulation of the posterior tibial nerve found on the ankle. The posterior tibial nerve is a peripheral nerve of the sacral plexus which innervates both the bladder and bowel. Stimulation of this nerve normalises the neural communication between bladder/bowel and the brain. Just like a phone call on a clear line, the brain is able to ‘hear’ exactly what the bladder and bowel are trying to communicate and restore normal continent function in the patient.

Modern radiotherapy techniques allow highly conformal radiation dose delivery to cancer. Accurate positioning of patient/tumour during the delivery of treatment is paramount to ensure the correct dose is delivered to kill the cancer cells and avoid damage to nearby normal tissues. However, the tumour position during radiation delivery can be affected by patients’ involuntary movement and the motion of internal organs. Real time tumour position monitoring ensures the accurate positioning of the tumour during radiotherapy delivery. General purpose linear accelerators (radiotherapy machines) do not have this functionality.

RO-TrackerSuite is a software system that enables the real time tumour position monitoring functionality in a general purpose linear accelerator that comes with standard x-ray imaging capability. With RO-TrackerSuite, real time tumour position monitoring can be performed for the majority of treatment sites such as prostate, liver,
pancreas, lung, brain and spine. RO-TrackerSuite has the functionality to perform real time position monitoring based on the radiopaque markers implanted in or in the
vicinity of tumour. In the treatment sites where implants are difficult or not possible, RO-TrackerSuite has the functionality to perform real time position monitoring
based on the internal anatomical surrogates that are closer to tumour.

More than 10 % of men experience prostate cancer in their lifetime. The prostate-specific antigen (PSA) test is the current golden standard method of prostate cancer detection. However, more than of half of PSA tests produce false-positive results which cause stress and anxiety in patients as well unnecessary biopsy examinations.

PC Diagnostics aims to revolutionise the way that prostate cancer detection and therapy are managed by introducing a urine test for the detection of the disease. This technology will avoid many unnecessary biopsy examinations by presenting more accurate results. This is important to reduce the psychological pressure on men who are screened for prostate cancer as well as avoiding unnecessary costs of biopsy tests. Development of this technology will also promote more regular check ups by men and may lead to earlier detection of cancer promoting more active surveillance. Solutions for more advanced prostate cancer are such asradiotherapy and surgery cause such as urinary incontinence and sexual dysfunction. The application of the PC Diagnostics technology will utilise simple urine tests for prostate cancer detection and will promote regular and more accurate prostate cancer screening.

According to the World Health Organisation’s Vision 2020 report, there are approximately 300 million visually impaired people in the world. In Australia alone, there are more than 2 million visually impaired people with nonrefractive eye conditions. These conditions obstruct the view, create blind spots or loss-in-detail at different locations of the eye. Due to the complex anatomy of the eye, the nervous system and how they interact together, an effective medical treatment has not yet been developed. However, technological advancement can offer an alternative pathway for people suffering from visual impairment.

SOOMA is an electronic vision enhancement device developed specifically for legally blind people who suffer from visual impairment. SOOMA is designed as a modular
electronic eyewear capable of producing individually customisable images. Live videos are captured by cameras mounted in the eyewear which, through a novel near real-time image processing procedure, is then displayed in front of the eyes. This is a practical solution for addressing non-refractive eye conditions to meet the needs of individuals from childhood to adulthood.

Patients who are granted access to the clinical notes prepared by their doctor during a consultation report a greater sense of control over their healthcare and a better understanding of their health. Kyyron offers people the ability to regain a sense of control of their healthcare by helping them to manage their health and medical data.
Initially, the product is targeted at informed health consumers who either have chronic or complex health needs, or care for a person who does. The app will provide these individuals with the ability to keep track of, and prepare for, their multiple healthcare appointments, with multiple doctors and providers. It will also provide a place to make notes and collect the results associated with these appointments. This information will then be readily available to the individual, or a healthcare provider they share the information with, whenever and wherever it is needed.

Over time, the app will expand to become a personal, historical record of individual health, bringing together a personal copy of official medical records alongside the individual’s own notes and insights, to create a single, centralised repository of an individual’s health and medical data.

One in four young people in Australia suffer from mental health disorders such as depression. Further, around half of all adult mental illnesses emerge by the age of 15. Failing to address these issues in adolescence is associated with more severe clinical presentation throughout life, as well as poor academic performance, social dysfunction, substance abuse and suicidal thinking. As the human, social and economic consequence of this can be devastating, mental health is one of the greatest challenges of the 21st century. While there is considerable evidence to demonstrate that early intervention can dramatically change the course of an individual’s mental
health trajectory, up to 60 per cent of young people will not seek help. The stigma associated with mental illness prevents many from reaching out, along with accessibility and cost of existing best practice treatment - face-to-face psychological therapy.

Delivering early intervention strategies to young people using technology will remove these barriers. Smartphone use is ubiquitous with more than 80 per cent of young people owning their own phone. As such, the Black Dog Institute developed an app that delivers best practice psychological therapy. The app focuses on sleep problems, a common precursor to the development of depression, which is less stigmatising and more appealing to young people. By utilising gaming technology to engage young people in treatment, the app overcomes existing barriers to help-seeking and ensures support is available 24/7. With young people preferring the privacy, anonymity and interactivity that this technology allows, this app will be key in preventing the emergence of mental health symptoms during the critical adolescent period.

Heart disease kills one Australian every 27 minutes. Heart attack as an endpoint of heart disease is unpredictable. During a heart attack, heart muscle is damaged as it is deprived of its normal blood supply. The extent of damage depends on severity of heart attack as well as the time between the attack and treatment.

Condicion is a non-invasive medical device that exercises the heart and stimulates the release of endogenous substances into the bloodstream that reach the heart to exert heart-protective effects. This may prevent damage to the heart muscle, or limit the extent of the damage during a heart attack.

The device can be used at home while sitting or lying down to prevent heart attacks. It can also be used in ambulance during patient transport to hospital to reduce the extent of heart damage following a heart attack. Another application of Condicion is in pre- and postoperative care of patients undergoing a heart procedure.

Currently CT scans are used to design and deliver radiotherapy treatments for cancer. However, MRI scanners provide more superior tumour and normal tissue imaging. Being able to use MR images in radiotherapy treatment and planning will allow the delivery of more targeted radiotherapy to cancers while reducing the impact on normal tissue. The technology required to combine a linear accelerator radiotherapy machine and an MRI scanner is complex and challenging.

MRI-Linac technology is working on a prototype combining a linear accelerator radiotherapy machine and an MRI scanner in order to deliver more targeted radiotherapy to cancers while sparing normal structures nearby. With $27 million of grant funding and world class research MRI-Linac technology is well placed to contribute to the future of radiotherapy treatment and transform the lives of cancer patients.

Over half of NSW adults are overweight or obese and this is now the second leading risk factor of disease in NSW, ahead of smoking. Malnutrition is also a major concern in requiring regular monitoring as it increases healing times, costs and readmissions.

This device provides an accurate measurement of percentage body fat in an instrument which is much smaller, safer and easier to use than comparably accurate devices that are much less practical.

Using IP developed at the University of Sydney and support from the Bill and Melinda Gates Foundation, the device has been validated against gold standards in over
650 participants. This device and service will aid dieticians, fitness instructors, nurses, and medical practitioners to address the clinical conditions of obesity, overweight and underweight.

The motivational way in which information is presented will increase adherence by participants and allow caregivers to track and provide quantified information on nutrition and exercise management. This will allow improved management of obesity and other clinical nutritional issues where optimised nutrition is desired including cancer care, paediatrics, aged care, intensive care, pregnancy, and eating disorders. Through better management quality of life will be improved and health costs reduced by reducing hospital readmissions and chronic disease.

One in three people in Australia die of cardiovascular disease. The underlying process causing the majority of these deaths is atherosclerosis. Atherosclerosis is a disease where fatty material is deposited in sections of the wall of the artery. Deaths occur when local atherosclerotic lesions rupture, stimulating clot formation, leading to occlusion of the artery. These lesions are termed ‘vulnerable plaques’. Both heart attacks and strokes can be caused by vulnerable plaques rupturing. Recent research has shown that vulnerable plaques can be identified prior to their rupture. The Stabilyzer device provides treatment that will prevent future heart attacks and strokes with the development of a locally applied treatment to stabilise these plaques.

The rise in rapid prototyping technologies has presented a unique opportunity for the creation of custom made implants. However, the logistical shift from generic high volume production systems to individually customised implants prevents its widespread usage. The Rapid Templating System aims to form patient specific implants
quickly and effectively. The system involves the production of a 3D-printed guided mould, based on patient scans, to shape terminally sterilised generic materials into patient-customised implants. The generation of custom implants within packaged materials allow implants to be immediately ready for use, avoiding treatment delays due to sterilisation post production. This approach has the capacity to significantly reduce inventory costs for medical device companies, as abundant implant-size ranges are no longer required to accommodate all patient cases. Further developments in regenerative medicine may allow further customisation material properties, allowing the implant to be patient specific anatomically as well as a biomechanically.

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure that allows access into the biliary system and has revolutionised the management of bile duct pathology. However, it is a notoriously difficult procedure to learn and even in experienced hands, this procedure is associated with complications including pancreatitis, bleeding, perforation and in rare cases, death. Cannulation of the bile duct remains the most challenging step of the procedure even with current sphincterotome technology. The Pivot Sphincterotome has been developed to facilitate easier, faster and ultimately safer biliary access. The ERCP sphincterotome US market alone is worth approximately $USD150 million and with an increasingly elderly population requiring less invasive procedures, it is expected to increase. Developed by an ERCP practitioner, the Pivot Sphincterotome aims to accommodate the shortcomings of current technology making the ERCP experience more user-friendly, efficient and safe.

To develop and commercialise a novel universal screening test for the detection of breast cancer that is highly accurate, safe, cost effective, and available to all women regardless of age, race and geographic location.

Breast cancer is the most common cancer among women, therefore, the effectiveness of the screening and diagnosis technology used is a high priority. The current model relies on a woman being physically present at a clinic for breast imaging which is not always convenient. While the present technologies are currently state of the
art, there is a high cost involved. There are also well known performance limitations that result in only a small subset of women who are actually eligible for screening.

BCAL Diagnostics aims to shift the paradigm in breast cancer screening and diagnosis by introducing a blood test for detection of the disease. The implication of such a technology could revolutionise the way breast cancer is managed by allowing a blood sample to be taken remote from the site of analysis. This technology will allow access to more women, anywhere in the world, who could provide a blood sample, at a time and place convenient to them. Such a test would fit into a woman’s routine health regime and be incorporated into their personal lifestyle. In addition, with such high levels of accuracy, this technology would provide greater peace of mind between annual checks. The BCAL Diagnostics technology could utilise a single blood test on multiple levels for disease prevention, diagnostic mass screening and postintervention.

Mitral regurgitation is a condition caused by a leaking heart valve and affects more than four million individuals in the USA. The standard method of fixing valves is with open heart surgery, a complex operation performed on cardiopulmonary bypass. The operation is expensive, and recovery time from the operation is measured in weeks or months. The SeCure Beating mitral heart repair device enables heart valve repair while the heart is still beating, with no need for bypass or long anaesthesia time or surgical scars. Patients can recover in hours or days and the cost of surgery can be dramatically reduced. The heart repair can be repeated if necessary and conventional surgery can also be performed at a later date. With the new technology many patients who have been deemed unfit for surgery could be given life saving treatment.

Backed by experts at the University of Wollongong and Swinburne University of Technology, Geldom is helping make condoms more wearable by replacing latex with
better feeling materials called tough hydrogels. These tough hydrogels are superior to latex and can improve the experience by offering more tissue like sensation. They
also have other revolutionary benefits – no bad odours or tastes, no latex allergies, inherent self lubrication, and can even be embedded with anti-sexually transmissible
infections agents or stimulants.

These new options have the potential to dramatically increase condom use. The impact – not only redefining what safe sex should feel like – but the added social benefits of improved family planning and disease prevention.

This work is geared towards disrupting the $6 billion condom industry desperate for innovation. This patent pending work has been supported by the Bill & Melinda Gates Foundation and has featured on ABC’s Catalyst.

CardioFlex is the next generation of cardiac pacemaker leads. Conventional pacemaker leads are comprised of a long, coiled metal wire running from the neurostimulator
to the electrode implanted in the heart. These conventional leads are prone to infection, dislodgement and mechanical failure. They are also incompatible with MRI because they act as antenna and generate unsafe amounts of heat in the body under MRI. CardioFlex leads do not use metal wires but are instead fabricated from conductive elastomers, a novel material being developed at UNSW. Conductive elastomers allow the CardioFlex lead to be soft, flexible and totally MRI compatible. This
means recipients are less likely to require a surgical lead extraction and they do not need to worry about their pacemaker interfering with ongoing or future medical treatments. Other applications of conductive elastomers being investigated include flexible electrode arrays and nerve cuffs for neural interfacing

This product allows for simple medical testing remotely from home. The home diagnostics kit consists of a small device attachable to a smartphone and together with an app, it allows for the analysis of the same urine dipsticks that are commonly used in the GP’s office. The medical results can then be shared with the GP online instead of
going to the doctor, when unwell or busy. This will assist in a comprehensive assessment of the patient’s health problem currently not possible via online consultations. This smartphone diagnostics device also features recording of the test results over time opening up numerous additional applications, ranging from personalised healthcare to new testing methods for diseases.

As the healthcare sector is moving towards a digital platform, these internet connected devices will be essential in the generation of digital medical records as
well as the successful implementation of online medical services.

Breathe Well is an interactive medical device that allows breast cancer patients to help improve their own cancer treatment, simply by breathing. In breast cancer radiation therapy, nearby healthy tissues like the heart and lungs are at risk of receiving unnecessary, and potentially fatal, radiation damage. Breathe Well shows patients how to
hold their breath to put as much distance possible between the heart and radiation beam to achieve the most accurate breast radiation treatment possible.

One in twenty cataract surgery wounds leak, causing infection and blindness to occur. Sutures cause scarring, are time-consuming to apply, require great skill, and distort vision, In addition to this, patients have poor compliance with postoperative eye drops. Cataract surgery is the most common operation and has the longest waiting list in NSW. Eye surgery costs are rising as the population ages.

Kleer-i is a next-generation “patch”, bonded over an eye wound by a low-powered laser. It falls off once the wound heals. Surgeons will use Kleer-i to rapidly seal eye wounds without sutures, while simultaneously delivering drugs. Kleer-i will save 25 to 40 per cent of operating time and promote faster wound healing, reducing vision loss from scarring, distortion and infection.

Kleer-i is unique in combining drug delivery with sutureless wound closure. It avoids the toxic side-effects and high failure rates associated with existing therapies:
sutures, histoacryl glue and fibrin sealant.

Obesity is a growing global health problem with direct costs estimated at $21 billion annually (Australian Diabetes, Obesity and Lifestyle Study). Current therapeutic and policy intervention is not working. Evidence suggests that early directed intervention for individuals with a predisposition to obesity and related co-morbidities is more effective at maintaining long term positive health outcomes. This technology measures the levels of specific modifications to a person’s DNA (DNA methylation marks) that are associated with current or future health status. The core IP is in panels of such DNA methylation biomarkers that could be used to identify an individual’s risk and likely trajectory for obesity and Type 2 diabetes mellitus. This would help direct clinicians, such as endocrinologists and dietitians, in the clinical management of patients and identify at risk people early – reducing the health burden of chronic disease.

Metered dose inhalers (MDI) are a commonly used device to deliver aerosolise medications for the treatment of pulmonary diseases. The emitted aerosols from MDI contain millions of fine particles that carry intrinsic charge that is imparted on them during the atomisation phase. These static charges can cause variations in particle
aerosolisation and dosage.

Moreover, the MDI requires manual actuation force to operate and its efficacy relies on patient’s co-ordination between actuation and inhalation, which can be difficult for elderly patients with chronic obstructive pulmonary diseases (COPD). The Electrostatic Metered dose inhalers (EMDI) is a novel electrostatic metered dose inhaler, which utilises electronic force and electrostatic charges to generate inhalable aerosol. It will reduce the need of excipients in the drug formulation to help with the aerosolisation
process, and also minimise the difficulties that can occur when using conventional MDIs. EMDI can provide more efficient treatment to people with respiratory diseases, especially for the 65 million patients who currently suffer from COPD around the world.