The two-day conference is split into four themes:
- The power of Politics
- Let’s talk Patients front and centre
- Innovation gets Personal
- Public Perception gets real
One of the big issues to be discussed will be the challenges of regulating software as a medical device. We’ve just seen last week Apple launch the next generation Apple Watch that has FDA approved electrocardiogram (ECG) app, capable of tracking and recording electrical signals from your heart in 30 seconds. Unfortunately, this will not be available in the Australian model due to not having TGA approval.
Given the barrier to entry for these apps is so low how does industry and regulators ensure the quality of the technology can be directly linked to clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose? Timothy Plante Assistant Professor, Larner College of Medicine at the University of Vermont has claimed this area of digital health apps is no better than “snake oil”.
Another issue that will be a focus of discussion on day two will be the innovation of medical technology through physician collaboration. Invention that is wholly original certainly takes place, but often in medical technology the innovation is incremental, modifying, upgrading, or improving existing devices.
Physicians as the primary users of medical technology which means much of the feedback that spurs the creation of the next generation of innovative products comes from physicians who share with manufacturers their real-world experience.
One of those speaking on this issue is Professor Hala Zreiqat who was earlier in the year announced as the 2018 NSW Women of the Year. The award recognises NSW women who have excelled in their chosen career, field or passion and Professor Zreigat is a perfect example of Australia’s multicultural success story.
Hala Zreiqat grew up, studied and worked in Jordan before moving to Sydney to do a PhD in Medical Sciences – a decision that transformed her life.
Today she is recognised internationally for her extraordinary contributions to regenerative medicine and translational orthopaedic research.
She’s Professor of Biomedical Engineering at the University of Sydney, where she founded the Tissue Engineering and Biomaterials Research Unit in 2006. Pioneering the invention of new biomaterials and biomedical devices, the unit’s work is giving NSW a place at the table in the highly competitive global orthopaedic market.
Described as a trailblazer in championing opportunities for women, Hala was the first female president of the Australian and New Zealand Orthopaedic Research Society. A Senior Research Fellow of the National Health and Medical Research Council for the last 10 years, she was also the first person in NSW to receive a prestigious Radcliffe Fellowship from Harvard University.
She was recently involved with Allegra Orthopaedics successful application for Commonwealth funding through the BioMedTech Horizons program. The project seeks to commercialise a fully synthetic spinal cage which works by regenerating bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials – making it a one-of-a-kind innovation. The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at The University of Sydney.