AI Revolutionising MedTech Symposium 2025

Sam Burrett, Director, Consulting Lead - AI Advisory

Sam advises organisations on how to implement AI and other emerging technologies to achieve strategic, commercial, and risk outcomes. With a background in law and experience in management consulting, Sam supports ASX-listed companies across several industries, including financial services, healthcare, and government. Sam helps executive teams and boards design and embed AI tools, systems, and governance frameworks that are practical, compliant, and value-driven. As Consulting Lead in Minter Ellison’s Responsible AI matters, he has guided leadership teams through AI governance strategy, risk assessments, and the safe and effective application of emerging technologies. Sam also works in MinterEllison’s Legal Optimisation practice, supporting General Counsel's and in-house legal teams to modernise legal operations, adopt emerging technologies, and embed governance frameworks. He advises on strategies to improve efficiency, manage risk, and better align legal functions with broader business goals.

Chelsea Gordon, Legal Lead - AI Advisory

As the Legal Lead for AI Advisory at MinterEllison, Chelsea advises organisations about how to implement AI and other emerging technologies to achieve legally sound, commercial and strategic outcomes. Chelsea guides boards and executive teams on AI governance frameworks, Responsible AI implementation and regulatory compliance. Chelsea is also a senior health regulatory lawyer. In addition to regulatory advice, she supports clients in developing privacy and contract settings that protect personal information and intellectual property and align with AI risk management obligations. Chelsea advises ASX-listed companies and government across regulated sectors, including healthcare, education and financial services. Chelsea also serves as the Australian Ambassador for the Global Council of Responsible AI, reflecting her leadership in shaping AI ethics, policy and best-practice governance.

Julian Adler, CEO of Radiology, Sonic Healthcare

Dr Julian Adler is a radiologist with subspecialty training in neuroradiology. He is CEO of Sonic Healthcare’s Radiology division, providing radiology services across the country. He represents Sonic on the boards of several of its joint venture radiology businesses and, in addition, he continues to practise as a clinical radiologist in Sydney. He is a past president (and current vice president) of the private radiology industry association. Prior to his involvement with Sonic, he was a co-founder of an international tele-radiology business that now operates in five countries.

Bettina McMahon, CEO, Healthdirect

Bettina McMahon is the Chief Executive Officer of Healthdirect Australia. She is on the Board of SNOMED International, and former Board Chair of the Australasian Institute of Digital Health. She has considerable experience in digital transformation in the health sector over the past 15 years, and across the public sector prior to that. Prior to joining Healthdirect, Bettina was the Interim Chief Executive Officer at the Australian Digital Health Agency, where she had also held executive roles since 2009. Bettina has postgraduate qualifications in public policy, applied finance, and business and technology.

Mahesh Datar, Senior Manager, Regulatory Affairs, Medtronic Australasia

Senior RA professional with over 25 years of experience in Medical Devices across different functions. Currently leading Medtronic ANZ RA premarket team as well as chair of MTAA Reg Affairs Committee.

Andrew Wiltshire, Head of Healthcare Public Policy, Amazon Web Services Australia

Pacific, where he leads strategic healthcare policy initiatives and stakeholder engagement across the region. With nearly four decades of healthcare experience, he brings deep expertise in digital health transformation, healthcare policy development, and government relations. Prior to joining AWS, Andrew held senior executive positions at Medtronic Australasia, including Senior Director of Market Access and Public Affairs, where he played a pivotal role in shaping healthcare policy reforms and industry negotiations. His leadership was instrumental in securing significant policy outcomes, including successful negotiations with federal health ministers and the development of key funding initiatives. As a member of Medtronic's Asia-Pacific Leadership Team, he demonstrated strategic vision in navigating complex regulatory environments across multiple jurisdictions. Andrew currently serves on the Boards of ARCS Australia and Hearts4Heart and chairs the Medical Technology Association of Australia (MTAA) Digital Health Advisory Group, and the APACMed Health Data Committee. He has commissioned and led the development of several influential cloud-based digital health white papers and is recognized as a thought leader in healthcare policy and digital transformation. Andrew holds an MBA from the University of New England and is a graduate of the Australian Institute of Company Directors, combining his clinical background as a Registered Nurse with extensive executive experience in the medical technology sector to bring unique insights to healthcare policy development.

Penny Shakespeare, Deputy Secretary, Dept. of Health, Disability and Ageing

Penny Shakespeare brings a wealth of expertise and experience to a wide range of policy making across Australia’s health and aged care system.

As Deputy Secretary of the department’s Health Resourcing Group, she oversees a broad spectrum of health policy. This includes Medicare and Pharmaceutical Benefits Scheme policies and integrity, ensuring Australia has a planned, highly trained and well distributed health workforce advancing digital health solutions and harnessing the potential of genomics.

Penny joined the department in 2006. Since then, Penny has held a number of senior leadership positions, including First Assistant Secretary of the Technology Assessment and Access Division and Health Workforce Division. Penny has been a member of the Workplace Relations Ministers Advisory Council and the National Occupational Health and Safety Commission and represents the Commonwealth on the board of the
National Blood Authority.

Before joining Health, Penny was an industrial relations lawyer in the Department of Employment and Workplace Relations and worked in regulatory policy roles, including as head of the Australian Capital Territory’s Office of Industrial Relations.

Penny has a Bachelor of Laws, a Master’s degree in International Law and is admitted as a Barrister and Solicitor.

Joern Lubadel, Global Head of Product Security, B. Braun Australia Pty Ltd

Joern Lubadel is a global leader in healthcare IT and cybersecurity with more than 25 years of experience driving secure innovation in digital health. As Global Head of the B. Braun Product Security Office, he ensures cybersecurity is embedded by design across the entire product lifecycle—delivering solutions that are safe, compliant, and scalable worldwide. Renowned for transforming complex regulatory demands into actionable engineering practices, Joern brings deep expertise in global standards and frameworks, including FDA 21 CFR Part 820 & 11, EU MDR/IVDR, ISO 13485, ISO 14971, ISO/IEC 27001, ISO/IEC 81001-X, and IMDRF guidance. His leadership spans building secure software development lifecycles, risk management systems, and post-market surveillance programs that meet the highest technical and regulatory benchmarks. Beyond operational excellence, Joern advises organisations on technology strategy, due diligence, and regulatory readiness. He actively contributes to international standards bodies, shaping the future of medical device cybersecurity and health IT.

John Jamieson, Assistant Secretary, TGA

John Jamieson is the Assistant Secretary, Medical Devices Authorisation Branch at the Therapeutic Goods Administration (TGA). John also represents the TGA on the International Medical Device Regulators Forum (IMDRF) Management Committee and on the Regulatory Authority Council of the Medical Devices Single Audit Program (MDSAP). John’s branch assesses the compliance of software as a medical device supplied in Australia, including medical device software with artificial intelligence.

Ashley Mancuso, Vice President, MedTech BISO & Product Security, Johnson & Johnson Medical

Ashley West Mancuso is the Vice President, MedTech Business Information Security Officer (BISO) & Product Security at Johnson & Johnson. In this exciting role, Ashley leads a team of cybersecurity professionals who are laser-focused on their critical mission. The world's largest Pharmaceutical and MedTech company, we are solving the toughest health challenges by building a world where complex diseases are prevented, treated and cured, treatments are smarter and less invasive and solutions are personal. Ashley is responsible for securing all MedTech information assets, as well as the Information Security & Risk Management (ISRM) product security function. As part of the BISO function, she & her team embed directly with J&J IT, Supply Chain and MedTech teams whose mission is to reach more patients and restore more lives to provide proactive security and risk management leadership in the design, implementation and testing of applications, cloud environments & digital capabilities across MedTech globally. Additionally, she is accountable for the ISRM product security function. In this role, she manages and maintains enterprise product security policies and procedures to ensure J&J maintains a secure and compliant portfolio of global products and drives a consistent security by design approach. In 2023, Ashley was recognised for her industry impact by receiving the Cyber Security Summit Visionary Leader Award. Additionally, she is passionate about developing and leading high-performing teams and is the ISRM leadership team Talent sponsor with a focus on accelerating & advancing inclusion efforts. Ashley holds a BS degree in Decision and Information Science from the University of Florida. She is based in Irvine, CA at the Johnson & Johnson MedTech Electrophysiology business.

Tam Nguyen, Director of Research & Innovation, Monash Health

Associate Professor Tam Nguyen has over 25 years of experience spanning clinical trials, health and medical research and research innovation sector, including tertiary teaching hospitals, medical research institutes and universities across Australia. Tam is the Director of Research & Innovation at Monash Health - Victoria's largest public health service, providing safe and high-quality healthcare to a quarter of the state population across the entire lifespan. Tam also serves as a board director on various organisations, including ARCS Australia & advisor to several medtech and health tech start-ups + scale-ups. He's a co-editor of a recent book: AI in Medicine (Springer Nature) DOI: 10.1007/978-981-19-1223-8. Tam holds academic appointments with Melbourne Medical School, Monash Medical School, RMIT University and is a Visiting Professor with the Sichuan Academy of Medical Sciences.

Suneeta Mall, Head of AI Engineering, harrison.ai

Suneeta Mall leads the AI Engineering division at harrison.ai, a clinician-led artificial intelligence medical technology company focused on addressing significant healthcare issues leading to inequitable diagnoses. With a Ph.D. in applied science and deep expertise in distributed computing and machine learning, she has worked across organisations including IBM Software Labs, University of Sydney, Nearmap, and Expedita. Recently recognised as Women in AI APAC 2025 in the health category, Suneeta is the author of "Deep Learning at Scale" (O'Reilly) and actively contributes to the technical community through writing and knowledge sharing. Her work focuses on applying technology thoughtfully to improve healthcare outcomes and diagnostic equity.

Dalvin Chien, Partner, Mills Oakley

Dalvin is a seasoned technology and cybersecurity lawyer with over 21 years’ specialist experience. He is a partner at Mills Oakley, where he leads the ICT & Digital Law practice. Dalvin has deep expertise in technology contracting, privacy, cybersecurity, security of critical infrastructure, data sharing, e-commerce and emerging technology, including Artificial Intelligence. He has led deal teams for significant technology transactions and advised on novel and complex cybersecurity and technology issues for clients, especially those in the health, banking, government, technology, and logistics sectors. Dalvin also advises on regulatory compliance, AI-related transactions, and data security, helping organisations build practical frameworks and response plans to manage cyber risks. With deep expertise in AI and the technology sector, and a strong grasp of evolving global regulations on generative AI, Dalvin is uniquely positioned to guide clients in mitigating legal risks associated with AI-powered software and services including in the context of buy and sell transactions, as well as those that are looking at investing in organisations with AI systems or data centres underpin such systems. Dalvin is frequently called upon to provide workshops and thought leadership pieces on procurement, technology transformation, cybersecurity, innovation, data sharing, and Artificial Intelligence, as well as assist in law reform.

Manoj Sridhar, Partner, L.E.K. Consulting Australia

Manoj is a Partner in L.E.K’s healthcare practice based in Melbourne. He brings deep experience in the pharma/medtech development lifecycle, having led a national research centre developing early-stage immunotherapies, building academia-pharma partnerships to commercialise attractive technologies, and working with MedTech and pharma clients on strategic growth initiatives. Recent projects include: - Multiple commercial due diligences of an Australian clinical research organisation for a financial sponsor - Multiple growth strategy projects for Australian clinical research organisations - Development of multiple editions of a public report for MTPConnect on the value of clinical trials in Australia, and on skills gaps across the medtech and pharma ecosystem in Australia Manoj holds a Ph.D. in Physics from Vanderbilt University (USA) and a MBA from Melbourne Business School.

Miang (Chadaporn) Tanakasemsub, Regional Regulatory Affairs Head, APJ, Johnson & Johnson Medical

Miang is a Pharmacist, MBA. She has more than 25 years of regulatory affairs experience with a number of medical devices and pharmaceutical companies. Her current position at JNJ Vision is the Regional Regulatory Affairs head, APJ. Miang has a board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific, including Japan. Prior to Cardinal Health, Miang worked for several healthcare companies (Takeda, Boston Scientific, JNJ, Actelion, Cochlear, Bausch & Lomb, Zimmer Biomet, Alcon & Cardinal Health) in different locations (Bangkok, Hong Kong, Sydney and Singapore). In addition to her current job, she has been heavily involved with harmonisation activities, including GHTF, AHWP, APEC RHSC and ACCSQ. She was one of the members of GHTF SG02 (Postmarket Surveillance). Currently, she is very actively involved of APACMED Regulatory Affairs Committee and an industry Vice chair of GHWP (Global Harmonization Working Party) Technical committee.

Timothy Panoho, Branch Manager for Architecture, Australian Digital Health Agency

Timothy Panoho is a results-driven leader with deep expertise in enterprise architecture and digital health. As Branch Manager for Architecture at the Australian Digital Health Agency, he brings extensive experience in leading large-scale EMR projects across multiple states and jurisdictions, collaborating closely with clinical teams in both public and private sectors. Recently appointed as ADHA’s Artificial Intelligence Accountable Official and a nominated representative to AIPAG, Timothy excels in shaping strategic direction, delivering innovative IT solutions, and fostering high-performing teams. His work focuses on developing strategies, roadmaps, and standards that enhance efficiency and effectiveness across complex technology landscapes.

Minta Chen, Head of Regulatory Affairs and Quality Assurance, Annalise-AI

Minta leads the Regulatory Affairs and Quality team at Annalise.ai, where she has successfully expanded regulatory approvals for the company’s AI-enabled radiological decision support software to 40+ markets over the past three years. Driven by a passion for bringing innovative medical technologies to patients and clinicians, Minta is dedicated to improving lives and advancing health outcomes. Her career spans diverse Regulatory and Quality roles across Fortune 500 companies and startups, covering a wide range of technologies—from traditional medical devices such as hip and knee implants to cutting-edge AI-powered software.