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Mark Flynn

Current positions held

Principal and Founder, Global Edge Medtech Consulting
Special Advisor, Hemideina Ltd
Clinical Affairs Advisor, Atmo Biosciences Ltd
Resident, FASTLAB (Future Arts Science and technology Lab, for Creative Industries School, University of Newcastle

Current interests in research and development relevant to the Hub

Dr Mark Flynn is a highly experienced MedTech leader and strategist, particularly in identifying and solving the wicked challenges in healthcare. He has been responsible for the launch of over 20 medical devices for many millions of people globally. He is a clinical strategist who is adept at R&D and new product introduction into global markets. During his career he has worked and lived in Australia, Europe, USA, China and Latin America. For his product innovation he is the inventor of 17 international patent families, author of over 100 publications, and raised over $59M in non-dilutional project funding.

Mark will be working together with FASTLab at the University fo Newcastle and his company Global Edge MedTech Consulting to enable partner organisations to deliver sensor-based technology matched to patient outcomes. His work is focused on matching technology capability to the wicked challenges of the health system and facilitating clinician led change and translation through co-production and implementation science. While the translation of healthcare innovation is hard, he has aligned the North Star of organisations, clinical units and universities to address the needs of the clinicians and consumers over the capabilities of technology to deliver improved long-term health outcomes to patients. He focuses in particular on early-stage companies and research teams who wish to build the clinical and regulatory evidence for their innovation. He has led R&D projects globally, including in emerging markets such as Latin America, Middle East and China. Post-market clinical and medical surveillance across multiple medical device classes within globally complex organisations. I have significant experience with regulatory approvals (FDA, EU, TGA), QMS systems, ISO13485, ISO14155, change management, and reimbursement requirements in key markets such as USA, Europe, and emerging markets. In terms of innovation leadership, he holds a PhD in Medicine combined with an MBA for Georgetown University.


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