Paul is a seasoned, entrepreneurial professional with a passion for driving positive change in the healthcare industry, with a career marked by pioneering leadership and unwavering dedication. With over 23 years of independent consulting experience, Paul's mission is clear: to assist start-up companies in navigating the complex landscape of clinical research, regulatory affairs, and quality strategies. His track record speaks volumes as he has successfully shepherded numerous products from conceptualization through clinical phases to regulatory approval and quality certification. Driven by a passion for addressing unmet medical needs, Paul carefully selects companies and products that hold the potential to make a significant impact on human health. This commitment extends to his coaching company, "Beyond the Shell," where the primary goal is to guide staff through the unique challenges of the start-up environment, both professionally and personally. Paul's journey in healthcare began as a biomedical scientist in pathology, where he spent 20 years immersed in the use and development of pathology tests, diagnostics, and in-house in vitro diagnostics (IVDs). His enthusiasm for this field remains palpable, particularly for software as a medical device (SaMD) and companion diagnostics. Having held senior roles in multinational pharmaceutical companies and start-ups, Paul boasts broad therapeutic expertise across drugs, vaccines, biologics, and medical devices, earning him the prestigious ARCS Professional Membership status. With a keen eye for operational excellence, Paul has played a pivotal role in developing operational procedures for clinical research, regulatory affairs, and quality management. His dedication to professional development is evident in his role as an educator, where he develops and delivers educational programs in medical devices and IVDs for organisations like ARCS. Additionally, Paul serves as a mentor to PhD students through the Industry Mentoring Network in STEM (IMNIS), partnering with MTP Connect. An advocate for system and process improvement, Paul has implemented change initiatives and re-engineered processes at esteemed organizations like Wyeth Ayerst Research, Aventis Pasteur, ARCBS, Columna, RCPAQAP, and Roche Diagnostics Australia. With a strong focus on quality, he has established and implemented 14 Quality Management Systems adhering to regulatory standards such as cGMP, GDP/GWP, PIC/S, ISO 9001, ISO 13485, 21 CFR 820, and MDR/IVDR. In addition to his consulting endeavours, Paul has held senior roles within large multinational companies in the pharmaceutical, medical device, and diagnostics fields, further enriching his wealth of experience and perspective. Paul's contributions extend beyond mentoring and education; he played a key role in developing the Master of Health Technology Innovation (MHTI) post-graduate course at the University of Sydney/Charles Perkins Centre. His commitment to personal and professional growth led him to complete a Cert IV in life and business coaching, further enhancing his ability to guide individuals towards success in the dynamic healthcare landscape. In addition to his professional achievements, Paul has demonstrated a keen understanding of the challenges faced by start-up ventures. He has successfully managed start-ups and greenfield ventures, providing leadership in Quality, Clinical, Regulatory, and Pharmacovigilance domains. Mentoring senior management teams and utilizing certified life and business coaching, Paul has guided individuals through the complexities of start-up environments, fostering both professional and personal growth. Through his expertise, mentorship and dedication, Paul wishes to continue to shape the future of healthcare, leaving a lasting impact on both organisations and individuals alike.

Fiona McCormack is the Director of the Devices Emerging Technology Section within the Medical Devices Surveillance Branch at the TGA. Fi’s background is a Medical Scientist, and she has worked in various technical roles within the TGA for the past 18 years. Fi has extensive regulatory and technical knowledge across multiple areas, including in vitro diagnostics (IVDs) and medical devices, software and AI-based products, quality management systems, auditing and the certification of device manufacturers.

Maria Ong is the Director of the Devices Vigilance and Policy in the Medical Devices Surveillance Branch. She has been at the Department of Health since 2010 and has held roles in the Office of Health Technology Assessment, regulatory policy and governance and International Engagement and Trade. A pharmaceutical patent examiner and senior policy officer at IP Australia, she was a member of the Australian delegation for several free trade agreements in the IP chapters. Since joining the TGA she has been involved in several medical devices reform projects and was the Director of the Medical Devices Reform Unit. She is responsible for the Medical Device Vigilance Program, the Mandatory Reporting of Adverse Events by Healthcare facilities and TGA’s Medical Devices Consumer Working Group.