Speakers

Aggie Cox

Aggie Cox

Marketing Director
Hologic
View Bio
Anthony Liveris

Anthony Liveris

Chief Executive Officer
Proto Axiom
View Bio
Bronwyn Graham

Bronwyn Graham

Director of the Centre for Sex & Gender Equity in Health & Medicine; Professor of Psychology
The George Institute for Global Health; UNSW
View Bio
Catherine Hon

Catherine Hon

HR Director
Medtronic Australasia
View Bio
Ceri Cashell

Ceri Cashell

GP and Co-Founder Healthy Hormones
Healthy Hormones
View Bio
Chelsea Cornelius

Chelsea Cornelius

CEO
Stratos MedTech Pty Ltd
View Bio
Cheryl Carcel

Cheryl Carcel

Neurologist, Head of the Brain Health Program
The George Institute for Global Health
View Bio
Dina Titkova

Dina Titkova

Senior Manager, Startups & Partnerships
UNSW Founders (University of New South Wales)
View Bio
Falko Thiele

Falko Thiele

Director Clinical and Regulatory Affairs
BIOTRONIK Australia
View Bio
Gabrielle Jackson

Gabrielle Jackson

Deputy Editor
Guardian Australia
View Bio
Gillian Scott

Gillian Scott

Associate Director, HR ANZ
Vantive Pty Ltd
View Bio
Grace Toombs

Grace Toombs

Founder
June Health
View Bio
Helen Souris

Helen Souris

CEO & Executive Director
Cardihab
View Bio
Ian Burgess

Ian Burgess

Chief Executive Officer
Medical Technology Association of Australia
View Bio
Jasjit Baveja

Jasjit Baveja

Director, Regulatory & Industry Policy
MTAA
View Bio
Jen O’Neill

Jen O’Neill

Social Worker
Australian Public Service
View Bio
Joey Man

Joey Man

Investment Associate
Tenmile
View Bio
Leanne Weekes

Leanne Weekes

Director of Research and Policy
Bellberry Limited
View Bio
Melina Georgousakis

Melina Georgousakis

Founding Director
Franklin Women
View Bio
Nicki Luther

Nicki Luther

Senior Director of Human Resources
Stryker
View Bio
Olena Ivanova

Olena Ivanova

Senior Research Fellow
SPHERE CRE, Monash University
View Bio
Payal Mukherjee

Payal Mukherjee

Professor
RACS
View Bio
Prue Torrance

Prue Torrance

General Manager and COO
National Health and Medical Research Council
View Bio
Robyn Langham

Robyn Langham

Chief Medical Adviser
Therapeutic Goods Administration
View Bio
Sam Ho

Sam Ho

Director Market Development, Asia Pacific
Pulsenmore
View Bio
Sarah White

Sarah White

Chief Executive Officer
Jean Hailes For Women's Health
View Bio
Shona Sundaraj

Shona Sundaraj

Group Medical Director
Medibank
View Bio
Susannah Rooney

Susannah Rooney

Founder & Executive Director
Amplify51 Limited
View Bio
Talat Uppal

Talat Uppal

Associate Professor & Director
Women's Health Road
View Bio
Talia Avrahamzon

Talia Avrahamzon

Head of Policy, Projects and Advocacy
Research Australia
View Bio
Tara Croft

Tara Croft

CEO
Baymatob
View Bio
Tracey Duffy

Tracey Duffy

First Assistant Secretary, Medical Devices & Product Quality Division
TGA
View Bio

Aggie Cox
Marketing Director, Hologic

Aggie Cox is the Marketing Director for ANZ at Hologic, a global leader in medical technology focused on advancing women’s health. Her journey began as a registered nurse, where she developed a deep understanding of patient needs and the critical role of healthcare innovation. This foundation gives her a unique perspective that bridges clinical expertise with strategic marketing leadership. With over two decades of experience across medical devices, diagnostics, and pharmaceuticals. She combines strategic business acumen, clinical insight, and marketing expertise to drive initiatives that accelerate brand growth, deepen customer engagement, and expand market presence across the region. A passionate advocate for women’s health, Aggie draws on her personal and professional experience, along with insights from the Hologic Global Women’s Health Index, to spotlight critical challenges women face and spark conversations that inspire change. Her guiding mantra is: “Data tells the story, but people give it meaning.”

Anthony Liveris
Chief Executive Officer, Proto Axiom

Anthony Liveris is CEO of Proto Axiom, an Australian life sciences company-creator and investor that builds next-generation biotech firms from first experiment to scale. Proto Axiom partners with leading researchers to form, fund, and grow companies including Endo Axiom, SWAN Genomics, JumpStart Fertility, Onyx Axiom, and Advancell. Anthony serves as Chair of the St Vincent’s Hospital Discovery and Innovation Fund. He previously co-founded Applecart, a data platform serving Fortune-level clients, and held roles with Malcolm Turnbull, the Tony Blair Institute, and US policy campaigns. Anthony holds an MPP from the University of Oxford and a BA from the University of Pennsylvania.

Bronwyn Graham
Director of the Centre for Sex & Gender Equity in Health & Medicine, Professor of Psychology,
The George Institute for Global Health, UNSW

Bronwyn Graham is a Professor in the School of Psychology at UNSW Sydney and the inaugural Director of the Centre for Sex & Gender Equity in Health & Medicine at the George Institute for Global Health. A clinical psychologist and behavioural neuroscientist, Bronwyn has dedicated her career to improving women’s mental health by researching how the female brain regulates emotions and translating the findings to clinical settings and beyond. At the Centre for Sex & Gender Equity, Bronwyn’ team has led policy changes to improve the quality of medical research and healthcare by accounting for the influence of sex and gender on health outcomes. Bronwyn is funded by the Australian Research Council, the National Health and Medical Research Council, the Wellcome Trust Foundation, and she has held numerous national and international fellowships. She has published over 80 peer-reviewed research articles and chapters, and supervised over 40 honours and postgraduate students.

Catherine Hon
HR Director, Medtronic Australasia

Catherine (Cat) is a senior HR Professional with over twenty years HR experience across a diverse range of industries and workplace cultures including Medical Devices, Telecommunications and Hospitality.
Highly collaborative with a proven track record as a strategic partner and program leader, Cat is adept in building trusting partnerships at the leadership level across multiple stakeholders and domains.
Globally orientated with professional experience in the UK and Australia and Program Management experience across Asia Pacific, Cat’s passion partnering with the business to drive innovative and equitable talent strategies that result in a highly engaged and high performing culture within Medtronic. Cat is also a highly committed and effective in driving Inclusion, Diversity & Equity programs with a goal to create the best and most inclusive environment to work for all.

Ceri Cashell
GP and Co-Founder Healthy Hormones, Healthy Hormones

Dr Ceri Cashell is a UK-trained GP based in Sydney and co-founder of Healthy Hormones, the world’s only menopause app integrating clinician education, real-time support and a rapidly growing public community in one digital ecosystem.
Struck by the gender gap in medical research and her own lack of menopause training, she built the platform to do what the system hadn’t. Today Healthy Hormones upskills thousands of clinicians through AI-enabled learning and multidisciplinary support, while empowering women with evidence-based information and access to menopause-trained providers: free for both.
Dr Ceri is a speaker, educator, researcher and advocate, working to ensure Australian women are no longer the casualties of a healthcare system not designed with them in mind.

Chelsea Cornelius
CEO, Stratos MedTech Pty Ltd

Chelsea Cornelius is CEO of Stratos MedTech and an MTAA Board Director. She leads PeriCoach, a clinically validated pelvic floor solution, and is passionate about advancing women’s health through scalable innovation that improves access and connects care pathways.

Cheryl Carcel
Neurologist, Head of the Brain Health Program, The George Institute for Global Health

Associate Professor Cheryl Carcel is the Head of the Brain Health Program at The George Institute for Global Health. She also works part-time as a clinical neurologist. Cheryl is an NHMRC Emerging Leader Fellow and a World Stroke Organization co-chair for the scientific statement on Sex Differences in Stroke.

A/Prof Carcel’s research focuses on health equity, in particular working on sex and gender differences, women’s brain health and policies encouraging disaggregation of data by sex and gender.

Dina Titkova
Senior Manager, Startups & Partnerships, UNSW Founders (University of New South Wales)

Dina Titkova works at the intersection of innovation and entrepreneurship, with over 15 years’ experience across partnerships and venture development in Australia and Europe. At UNSW Founders, she leads the team delivering the university’s flagship startup incubators and accelerator programs.
A strong advocate for health equity, Dina launched the Health 10x program in partnership with The George Institute for Global Health, backing innovations addressing major unmet health needs. In 2023, she established the first Women’s Health Accelerator in APAC within Health 10x. Under her leadership, the program has supported over 250 startups and invested in 40, with a growing share focused on women’s health across conditions that affect women uniquely or disproportionately.

Falko Thiele
Director Clinical and Regulatory Affairs, BIOTRONIK Australia

Falko Thiele is a senior medical technology executive with more than 30 years of global experience across R&D, marketing, business development, regulatory affairs, and clinical research. He holds a Master of Science in Biomedical Engineering from the University of Virginia and an MBA from Anglia Ruskin University, Cambridge (UK).

As Director of Clinical and Regulatory Affairs for BIOTRONIK Australia, Falko leads regional clinical strategy and regulatory operations for advanced cardiovascular technologies, including pacemakers, defibrillators, and electrophysiology solutions.

Falko is a long‑standing member of the Medical Technology Association of Australia (MTAA) Regulatory Affairs Committee and co‑chair of its Clinical Investigations Forum.

He is passionate about enabling equitable, timely access to innovative medical technologies and improving health outcomes for diverse patient populations.

Gabrielle Jackson
Deputy Editor, Guardian Australia

Gabrielle Jackson is deputy editor at Guardian Australia, where she has worked since 2014. She was previously head of multimedia and was an associate editor for news and opinion editor before that. She is the author of Pain and Prejudice: How the Medical System Ignores Women and What We Can Do About It, which has been published in Australia, New Zealand, United Kingdom, Ireland, United States, Canada and China and optioned for a documentary. She won the 2016 National Medicinewise Award for her reporting on endometriosis.

Gillian (Gil) Scott
Associate Director, HR ANZ, Vantive Pty Ltd

Gillian Scott is Associate Director, Human Resources for ANZ at Vantive, a leading vital organ therapy organisation focused on extending lives and expanding possibilities for patients worldwide. With deep experience partnering across commercial, functional, and supply chain teams, Gillian brings a practical, people centred approach to enabling performance, capability, and sustainable growth.
She is recognised for her work in leadership development, talent strategy, and organisational transformation, supporting leaders to translate strategy into meaningful employee experiences. Gillian is particularly passionate about building strong performance cultures through clear goals, effective check ins, and inclusive leadership practices.
Based in Sydney, she works across the Asia Pacific region and, outside of work, can often be found curiously people watching, laughing with friends, travelling near and far, enjoying good food and wine, or indulging her love for pub choir—bringing the same energy and warmth to life as she does to leadership.

Grace Toombs
Founder, June Health

Grace Toombs is the founder of June Health, an Australian women’s health startup working to make cervical screening, STI testing and reproductive care more accessible, private and stigma-free. With a background in health and research, she combines clinical insight and lived experience to advocate for earlier intervention and better pathways into primary care for young women. Grace is passionate about challenging systemic gaps in healthcare and building bold, user-centred solutions that change how women engage with their health.

Helen Souris
CEO & Executive Director, Cardihab

Helen has a BA in Statistics and Computer Science and over 20 years of commercial expertise spanning FMCG, digital innovation, MedTech, Biotech, and digital health.
As CEO of Cardihab, Helen is focused on delivering innovative solutions that harness the power of technology and data to improve outcomes for patients and healthcare professionals.
She is a strong advocate for evidence-based digital health innovations that support the growth of the Australian digital health ecosystem.
Helen also serves as a Board Member of the Medical Technology Association of Australia (MTAA) and is the Chair of the MTAA Digital Health Advisory Group (DHAG).

Ian Burgess
Chief Executive Officer, Medical Technology Association of Australia

Ian is CEO of the Medical Technology Association of Australia, the peak national association representing companies in the medical device industry.

Ian’s previous CEO roles have included commercial health organisations and also medical professional associations – the Australian Dental Association (NSW) and the Australian Orthopaedic Association.

Ian holds an MBA from Macquarie University and a Bachelor of Economics from the Australian National University, and he is a member of the Australian Institute of Company Directors.

Ian is also a non-executive director of Red Nose, formerly known as SIDS & Kids, a well-respected not-for-profit organisation that is dedicated to saving the lives of babies and children.

Jasjit Baveja
Director, Regulatory & Industry Policy, MTAA

Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation.

A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.

Jen O’Neill
Social Worker, Australian Public Service

Jen O’Neill is a Social Work Program Manager and mother of two from the Central Coast, NSW. At 36, she experienced her first spontaneous coronary artery dissection (SCAD) heart attack and has since survived two further SCADs before age 43. Her lived experience has driven a strong commitment to heart health advocacy, focusing on improving education, research, and clinical understanding of cardiovascular disease in women without typical risk factors. Jen is a board member of SCAD Research Australia and serves on the Women’s Health Program Consumer Panel at The George Institute for Global Health. She is an ambassador for Heart Research Australia’s Red Feb campaign and participates in studies including with the Victor Chang Cardiac Research Institute and Mayo Clinic. She also supports community fundraising initiatives, including the Central Coast SCADaddle for Research Walk. She is recognised for leadership in advocacy and advancing cardiovascular health informed by lived experience.

Joey Man
Investment Associate, Tenmile

Joey Man is an Investment Associate at Tenmile, the dedicated health technology investment business owned by Tattarang. She brings a background in scientific research, venture capital and company formation, with experience across early-stage investing, commercial analysis, and strategic initiatives across Tenmile’s portfolio. She previously worked on company spinouts through the CSIRO Accelerator, and academic roles focused on breast cancer metastasis and stem cell biology.

Joey holds a PhD in Biochemistry and Molecular Biology from the Biomedicine Discovery Institute at Monash University.

Leanne Weekes
Director of Research and Policy, Bellberry Limited

Leanne Weekes is the Director of Research and Policy at Bellberry Limited. Her work focuses on advancing ethics, policy, and sector-wide initiatives, including thought leadership, aimed at strengthening Australia’s clinical trials sector.

Prior to joining Bellberry, Leanne established and led Clinical Trials: Impact & Quality (CT:IQ), an MTPConnect-funded initiative that brought together the clinical trials sector to develop and implement recommendations to improve impact, quality, and efficiency.

She has over 12 years of experience in biopharma research and development, managing clinical trials and programs for pharmaceutical companies and CRO’s across Australia, New Zealand, the UK, and Europe. Earlier in her career, Leanne worked in pre-clinical drug and diagnostic development for Australian and US biotechnology start-ups, having begun her career in bench research.

Leanne holds a first-class Honours degree in Pathology and a first-class Master’s degree in Public Health.

Melina Georgousakis
Founding Director, Franklin Women

Dr Melina Georgousakis is an academic, social entrepreneur and governance-experienced leader with over a decade of experience across the Australian health and medical research ecosystem.

Melina’s experience spans research, policy, philanthropy and entrepreneurship, giving her a strong understanding of how ideas are funded, scaled and connected with government and community priorities. Her work has focused on strengthening workforce capability, driven by a commitment to building an ecosystem that values diverse experiences and perspectives which enables innovation and impact.

She is the Founder and former Director of Franklin Women, a national social enterprise advancing women’s representation and participation across the health and medical research ecosystem. Under her leadership the organisation delivered national impact supporting more than 1,000 members and partnering with 27 organisations in a shared mission to drive systemic change.

Melina holds a PhD and a Master of Public Health and has completed the McKinsey Executive Leadership Program. She has served as a judge for the Australian Museum Eureka Awards and the Australian Technologies Competition, and her work has been recognised through several awards.

Nicki Luther
Senior Director of Human Resources, Stryker

Nicki Luther is Senior Director of Human Resources at Stryker, where she leads enterprise people strategy across the South Pacific region. With more than 22 years’ experience in human resources and having been with Stryker since 2012, Nicki partners closely with senior leaders to align people, culture, and capability with commercial outcomes.
Stryker is a Fortune 500 medical technology company with revenues exceeding US$20 billion, driven by a clear purpose of making healthcare better. Employing over 50,000 people globally, the organisation is known for its strong culture and sustained recognition as one of Australia’s Best Workplaces.
Working in a business where talent is core to strategy, Nicki is passionate about strengths-based leadership and building systems that enable leaders and teams to perform at their best. Her work focuses on scaling impact through leadership capability, pragmatic people strategy, and culture that drives results. Nicki has featured on Gallup’s Called to Coach podcast and Theme Thursday (Developer Season 3), sharing insights on strengths-based leadership in complex organisations.

Olena Ivanova
Senior Research Fellow, SPHERE CRE, Monash University

Dr Olena Ivanova is a Senior Research Fellow at the SPHERE Centre of Research Excellence with a PhD in Health Sciences, a medical degree, and a Master’s in Public Health from leading European institutions. Her international, multidisciplinary research focuses on advancing equity and innovation in sexual and reproductive health. Olena is the founder of Women’s Health & FemTech Ukraine, co-founder and board member of FemTech Germany, and creator of SxRx Collective in Australia. She drives change through evidence-based research, community building, and strategic advisory, and was named one of the 200 Trailblazing Leaders in Women’s Health and FemTech by Women of Wearables.

Payal Mukherjee
Professor, RACS

Prof Mukherjee is an Adult and Paediatric ENT surgeon in Sydney subspecialising in hearing and balance disorders, Cochlear Implants and the lateral Skull base tumours. Her research specialises in ear bionics using 3D bioprinting. Awarded the prestigious RACS Michael Donellan medal for outstanding contribution to the art and science of surgery and a Eureka prize finalist for interdisciplinary research in 2022, she has a passion for global translation of Australian innovation in biotechnology. She is Royal Australasian College of Surgeons councillor, Chair of the RACS, Section of Academic Surgery and ASERNIPS (Australian Safety and Efficacy register of new interventional disorders), co-director of an NSW based innovation program called Beyond Science that supports early career researchers, an expert panel of the Medical Devices fund, NSW health and a past committee member of the Advisory Committee of Therapeutic Goods Administration. She is passionate about gender equity in Surgery as well as developing STEM skills in young girls. She was awarded a Women in Surgery Leadership award in 2022 and was finalist of the NSW Premier Women of the year award in 2019.

Prue Torrance
General Manager and COO, National Health and Medical Research Council

Ms Prue Torrance (she/her) is the General Manager and Chief Operating Officer at the National Health and Medical Research Council (NHMRC). She has extensive leadership experience in science and research policy and programs, as well as having held senior public service management roles in corporate governance and finance. She holds a Master of Studies (Public Policy) from the Australian National University and a Bachelor of Arts (Hons in Political Philosophy) and Science (Psychology).

Robyn Langham
Chief Medical Adviser, Therapeutic Goods Administration

Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration in Australia. She is a nephrologist and clinician researcher, focusing on drug development of novel anti-inflammatory and anti-fibrotic agents. Professor Langham is also a director of the Australian Medical Council and chairs the Human Research and Ethics Committee at the Royal Children’s Hospital in Melbourne.

Sam Ho
Director Market Development, Asia Pacific, Pulsenmore

Sam brings with him a wealth of experience spanning across both clinical and commercial expertise having worked as a clinician and also as commercial operator across the region. He is passionate about improving outcomes through innovative products and processes. He is currently focused on introducing an innovative product that can enhance antenatal care into Australia and the surrounding region.

Sarah White
Chief Executive Officer, Jean Hailes For Women's Health

Dr Sarah White is Chief Executive Officer of Jean Hailes for Women’s Health, Australia’s leading non-profit provider of women’s health information. Prior to Jean Hailes, Dr White headed Quit, Australia’s most comprehensive tobacco control program and, for more than a decade, led science and health communications teams in Melbourne and New York.
Dr White is a member of the Therapeutic Goods Administration’s Women’s Health Products Working Group and the Victorian Women’s Health Advisory Council, and was a member of Australia’s former National Women’s Health Advisory Council.

Dr White has extensive experience in advocacy, communications, consumer engagement, policy development, program management, research translation, government relations and media relations. She is applying this experience to further Jean Hailes’ work to provide practical, accessible, evidence-based information to improve the health and wellbeing for all Australian women and girls.

Shona Sundaraj
Group Medical Director, Medibank

Dr Shona Sundaraj MBBS, FRACGP, BAppSc (Phty), MBA
Shona is the Group Medical Director of Medibank and brings a senior clinical lens to thought leadership, strategy and advocacy. She also leads the Medibank Better Health Research Hub and chairs Medibank’s Health Research Governance Committee, providing grant funding to multiple universities, translational research facilities and peak professional bodies.

Her passion is healthy ageing which begins at birth and continues at all ages. This is the driver and lens that she uses for her systems approach to healthcare as a senior leader at Medibank.

Shona has a 20+ year understanding of the Australian health ecosystem initially as a Physiotherapist then General Practitioner. She is a Fellow of the Royal Australian College of General Practitioners. Shona completed her MBA through Imperial College London Business School. She is a non-executive director and regular invited speaker.

Shona is a Sydney native. She is a mother of 2 beautiful kids and enjoys running and walking her 2 dogs along Sydney’s harbour and beaches.

Susannah Rooney
Founder & Executive Director, Amplify51 Limited

Susannah Rooney is the Founder and Executive Director of Amplify51 and a respected executive with a strong track record in leading organisational transformation and scaling operations. Since 2020 she held senior leadership positions at Victor Chang Cardiac Research Institute, gaining comprehensive expertise in the medical research sector and a deep understanding of the funding and policy frameworks shaping women’s health in Australia. With a background in law and management, Susannah is recognised for her people-focused, inclusive leadership driven by vision, integrity, and a commitment to excellence. Founding Amplify51 in 2026, she is building collaborative communities and advocating for greater investment in women’s health by researching proven strategies implemented internationally and leveraging evidence-based data to highlight its high impact and growth potential. Her goal is to influence national conversations and drive investment in women’s health, accelerating systemic change to improve outcomes.

Talat Uppal
Associate Professor & Director, Women's Health Road

Associate Professor Talat Uppal is a distinguished gynaecologist and the Director of Women’s Health Road, where she pioneered an integrated, multidisciplinary care model. A specialist in Abnormal Menstrual Bleeding (AUB), she founded Australia’s first AUB Management Hub and established the “Bleed Better” initiative, creating International Heavy Menstrual Bleeding Day (May 11th).

Currently a Clinical Associate Professor at Macquarie University and consultant at Macquarie Hospital, her career includes over a decade as Clinical Director at Manly and Mona Vale Hospitals. Dr. Uppal is a Fellow of both the AAQHC and ACHSM and received the RANZCOG Conspicuous Service Medal in 2018 for her contributions to GP education.

A prominent advocate for digital health, she serves as an ambassador for REMIE Australia and represents RANZCOG on SPARKED.au. Through media, podcasts, and clinical education, she remains dedicated to improving women’s health outcomes, particularly regarding heavy bleeding, iron deficiency, and menopause management.

Talia Avrahamzon
Head of Policy, Projects and Advocacy, Research Australia

Dr Talia Avrahamzon is a dedicated advocate for equity, working at the intersection of policy, innovation, and impact within Australia’s health and medical research sector. As the Head of Policy at Research Australia, the national health and medical research and innovation peak, she contributes to advancing a more inclusive and equitable research ecosystem through evidence-based policy and advocacy. She is particularly passionate about reducing disparities in health outcomes through research equity and ensuring marginalised populations are meaningfully represented in research design, funding priorities, and innovation (translation and commercial) pathways as well as in the organisations undertaking the work.
With over 20 years experience in federal government, academia and not-for-profit sectors, Talia has led large reform agendas across policy, data, and research that centre on systems level responses to addressing intersectional discrimination (including in gender, racism and ableism, and place). Talia is committed to evidence-based decision-making, and sharing learnings from other sectors to build a more inclusive, equitable, responsive health and medical research ecosystem, health outcomes, and social and economic participation.

Tara Croft
CEO, Baymatob

With 20+ years in MedTech leadership, Tara leads the development and scaling of AI-enabled, wearable technologies in women’s health, with a focus on maternal and fetal care. As CEO of Baymatob, she has guided the company from early-stage development through clinical validation and growth, building a mission-driven organisation addressing a critical gap in healthcare.

She has a strong track record in securing dilutive and non-dilutive funding across venture, grants, and strategic partnerships, and brings experience in commercialising digital health products and scaling businesses.

Tara has deep expertise in global regulatory pathways, including U.S. FDA engagement, and has led regulatory and quality strategies supporting clinical trials, market approval, and international expansion.

She is committed to advancing innovation in women’s health and translating technology into strong commercial entities, alongside meaningful outcomes commercial for mothers and babies worldwide.

Credentials: GAICD, MBA, B. Engineering, B. Medical Science

Tracey Duffy
First Assistant Secretary, Medical Devices & Product Quality Division, TGA

Tracey Duffy is the First Assistant Secretary of the Medical Devices and Product Quality Division in Therapeutic Goods Administration (TGA). Her current responsibilities include the regulation of Medical Devices, Good Manufacturing Practices and Laboratory testing. Tracey was the former Chair of the International Medical Device Regulators Forum, and Chair of Medical Device Single Audit Program Regulatory Authority Council. She has chaired a number of international and national working groups and has held several leadership roles within the Department of Health, Ageing and Disability. She also has private sector experience including consultant advisory roles.

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