Arthur Brandwood - Managing Director
Arthur Brandwood, Ph.D., MIMMM, CEng, AIMM has over 20 years experience in the medical technology field in industry, academia and government including responsibilities as Director of Devices Registration and Assessment and of the Biomaterials and Engineering laboratories at the Australian Therapeutic Goods Administration (TGA). Arthur is heavily involved with the Australian medical devices industry association and also represents Ausbiotech in consultations with government, particularly in the medical devices area. Arthur is both a biologist and a materials engineer and has particular scientific expertise in biomaterials and implants, especially interactions between materials and living tissues.
Arthur has held academic positions in Australia and the UK and has lectured widely on regulatory affairs and medical device testing and development including delivery of training courses to industry and government in Australia and SE Asia. He is the accredited Australian expert to several international medical device standards committees in the area of implants and biocompatibility and has served as chair of the ISO Working Groups on Tissue Engineered Medical Products and on Implant Tracking.
Paul Cohen - Senior Consultant
Paul Cohen, B.App. Sc.(Biomedical), Grad. Cert. Health Economics, MAIMS, MASM, has 15 years of experience in the medical device and pharmaceutical fields, both in the private and public sector. Paul's experience includes Regulatory and Medical Affairs, Quality & Technical Operations, Pharmaceutical/Vaccine Clinical Research,Training, Project Management, Business Process Re-engineering and Strategic Planning. Paul also has extensive experience in the implementation of quality management systems, NATA certification and training programs.
Paul has extensive experience in global pharmaceutical companies as well as start up ventures, managing in excess of 20 Phase I-IV clinical and health outcome projects, both locally and globally. Before joining the Brandwood Biomedical team, he was most recently employed as the Clinical Affairs and Quality Manager for an Australian start up spinal device company specialising in emerging technologies in spine surgery. Here he was instrumental in gaining ISO 1345:2003 certification and in the establishment of a global clinical trial and regulatory program. Paul is an active member of the Association of Regulatory and Clinical Scientists (ARCS), Regulatory Affairs Professionals Society (RAPS) and Drug Information Association (DIA).
Kevin Badin - Senior Consultant
Kevin's particular field of expertise lies in Quality Management Systems as well as Compliance, Project Engineering, Product Development, Documentation and Manufacturing in a diverse set of industries ranging from Electronic Equipment and Defence Systems to Medical Devices. Kevin brings a wealth of experience in Implementing, Auditing and Managing Quality Management Systems where he lead a number of Medical Devices Companies to achieve their certification to ISO13485:2003 and others to ISO 9001:2000.
Kevin’s qualification includes a Masters in Projects Management, a degree in Industrial Engineering, a Certificate IV in Workplace Safety (OH&S) and a Certificate IV in Assessment & Workplace Training and has been a long standing member of the Australian Institute of Management.
Joshua Griffin - Consultant
Joshua graduated with a BE in Biomedical/Mechanical Engineering from the University of Sydney with First Class Honours in 2007. He wrote his undergraduate thesis in conjunction with a medical device company, developing a surgical instrument for use with the spinal column.
Joshua joined the Brandwood Biomedical team in 2006, and has worked on a variety of projects since. Joshua's experience includes quality systems implementation, product development, technical and quality document development, the development and implementation of post market monitoring systems and regulatory requirements for product labelling and advertising.
Joy Woods - Consultant
Joy joined Brandwood Biomedical early 2007 and has qualifications in Biomedical/Mechanical Engineering with First Class Honours from the University of Sydney. Joy's experience includes working as a design engineer at Resmed, research engineer for China Lighting and Power in Hong Kong and projects with the Warren Centre for Advanced Engineering where she continues on as a volunteer. In 2007 Joy wrote her thesis on tissue engineered biomaterials, specifically the development of bone substitute materials. Joy has experience in product development, biomaterials, the development and implementation of ISO13485 quality systems for medical devices, regulatory strategies for the medical industry and technical and quality document development.
Paul O'Byrne - Associate
Paul joined the Brandwood Biomedical team in 2008 whilst completing his studies at the University of Sydney where he graduated with First Class Honours in Biomedical Engineering. Paul completed his final year thesis on an alternative polymeric material for use in orthopaedic implants.
Paul has worked for two Australian orthopaedic companies and has gained experience in design, surgical instrument and implant manufacture and ISO13485 quality systems.