About us

Dr Martin A. Devitt BMed GAICD
Medical Director

Martin graduated with a Bachelor of Medicine from the University of Newcastle (Australia) in 1997. He initially went on to become a registrar in anaesthetics and intensive care, but in 2000 joined the Therapeutic Goods Administration (TGA), a statutory body of the Australian Government that regulates the supply of therapeutic goods (medical devices, medicines, etc.) in Australia.  He eventually became the Head of the Clinical Section in the Office of Devices, Blood and Tissues, underpinned by a sound knowledge of the regulatory requirements for medical devices in Australia and internationally. His role included the provision of high level advice on clinical considerations in the regulation of medical devices; participation on the TGA’s Medical Devices Expert Committee (MDEC) and Medical Device Incident Review Committee (MDIRC); the development of legislation and policy initiatives both nationally and internationally, including input into the workings of the Global Harmonisation Task Force (GHTF); participation as a member on a committee of Standards Australia; and the auditing of quality management systems to ISO 13485.

In 2005, he joined Cook Australia (the Australian subsidiary of Cook Medical, a global medical devices company) to undertake the position of Medical Director in a global capacity, providing high-level clinical advice on pre- and post-market safety, quality, performance, and marketing issues pertaining to the manufacture and supply of medical devices globally. 

Martin is a founding member of Mobius Medical and is the company’s Medical Director.  He brings medical devices experience from both the regulator and the industry.  His expertise encompasses clinical and regulatory input into all aspects of medical device research and development, manufacturing, and commercialisation, including clinical trials, clinical evidence, and post-marketing issues; health technology assessment of medical devices for reimbursement; and quality management system auditing to ISO 13485 and clinical trial auditing to ICH GCP.

Martin has successfully completed the Company Directors Course (CDC) through the Australian Institute of Company Directors (AICD) and is a Director on a number of Boards.  He is able to provide corporate advisory services to companies pursuing the commercialisation of medical devices.

Martin also practices emergency medicine part-time.

Mobile +61 403 226 310
Email:martin@mobiusmedical.com.au

Mr Stefan Czyniewski BMedSci
Clinical Affairs Director

Graduating with a bachelor degree in Medical Science from the University of Sydney in 2000, Stefan initially worked as a research assistant for an orthopaedic surgeon. Stefan worked primarily on, hip and knee resurfacing prosthesis and autologous chondrocyte implanting in post market research.

In 2003, Stefan joined the clinical research team at Fornier Pharma (now Solvay Pharmaceuticals) and was based at the Clinical Trial Centre at the NHMRC. Stefan worked as a clinical research associate and data manager on the FIELD study, a multicentre, international, phase III study. His role at the clinical trials centre included project management for Australian and New Zealand clinical sites, coordinator of a cardiovascular sub-study and assisting with laboratory data processing.

In 2006, Stefan moved back into the device space working as a Senior Clinical Research Associate at Ventracor (makers of the Australian designed VentrAssist left ventricular assist device). Stefan was placed in charge of the clinical dossier for CE Marking of the VentrAssist which was achieved in December 2006. In 2007 Stefan was promoted to Clinical Affairs Manager at Ventracor and continued this posting until 2009.

Stefan is a founding member of Mobius Medical and is the company’s Clinical Affairs Director.  Stefan brings with him a sound knowledge and experience of clinical trial management and regulatory report submission requirements required for device approval. His experience includes clinical trial design, database design, project management and regulatory reporting requirements.

Mobile: +61 414 669 565
email: stefan@mobiusmedical.com.au

Suzanne M. Williams BSc Hons
Clinical Research Director

Suzanne studied Applied Biological Science at Manchester University in the UK graduating in 1993. Suzanne joined ICON Clinical Research (UK), as a Clinical Research Associate shortly thereafter, enjoying exposure to many therapeutic areas within the pharmaceutical clinical trials arena. Following a year sabbatical in their Chicago office, and armed with a sound understanding of FDA as well as European regulations, Suzanne moved to Australia to help establish ICON’s new Sydney office in 1997. Here in Australia Suzanne went on to gain extensive experience of ‘big pharma’ clinical trials management at Searle, Pharmacia, and Pfizer.

In 2003 Suzanne set up her consulting business independently contracting for several overseas companies, solely in the arena of medical device clinical trial management. Managing the local sites for a number of diverse studies, Suzanne gained expertise in medical device clinical trials in a diverse range of therapeutic areas including cardiovascular, gynaecology, and reproductive medicine. In 2006 Suzanne joined the clinical team at Ventracor assisting with the successful completion of the pivotal trials which enabled the company to obtain the CE Mark of the device.

Suzanne is one of the founding members of Mobius Medical Pty Ltd and her role focuses on liaising with clients and the clinical investigational staff to develop, initiate, resource and project-manage a wide variety of medical device clinical trials. Armed with her thorough understanding of theoretical and practical aspects of GCP, Suzanne also offers advice and conducts training programs for clinical research personnel.

Mobile: +61 411 018 464
Email: suzanne@mobiusmedical.com.au