Ee Bin Liew is Group Executive Director of Access-2-Healthcare, a global commercialisation and market access consulting company that physically executes end-to-end market entry and product launch activities to help overcome various challenges faced by medical technology companies globally - specifically in areas of healthcare business due diligence, commercialisation solutions from concept to market, and market access activities such as regulatory, quality and trade compliance.
Prior to founding the company, he spent most of his career in the medical device industry with MNCs, from product development to manufacturing, operations and product commercialisation. He held executive management and leadership roles of multi-cultural teams in Asia Pacific. He has the practical experience in various medical device environments and functions for turn-key go-to-market solutions through integration of marketing, IP, clinical affairs, reimbursement and regulatory affairs, and now lends his experience and energy to the medtech SMEs around the world.
Ee Bin is in the forefront of the key Standards and Regulations development in the medical device industry for 12 years working directly in several drafting committees in the International Organisation on Standardisation (ISO) – namely, the TC210 Working Group 1 that was responsible for releasing the ISO13485:2016 and the Practical Guide to ISO13485:2016; ISO14971:2019 and its Technical Report; ISO TR20971 for Risk Management under Joint Working Group 1, as well as ISO TR20416 in Working Group 6 for Post-market surveillance. Ee Bin is also the Asian Harmonisation Working Party Technical Committee Co-Chair for Working Group 7 – Quality Management System – Operations and Implementation for the past 10 years, and its industry representative in the ISO committee. Ee Bin attained the Singapore Professional Certification in Management Consultancy in 2017 and is accredited to execute grant-funded projects.
Ee Bin combines his long-term deep relationships with the senior management of the various government agencies and standards bodies, with the technical and commercial know-how relating to product development, go-to-market, as well as every countries’ unique challenges. This allows an objective perspective to both regulators and industry, R&D and commercial, to drive the future of healthcare.
Besides his efforts for AHWP and ISO, Ee Bin also gives his time as the leader of the several medtech and digital health industry groups, fostering the growth of medical technology and Digital Health community globally. Ee Bin takes special interest in active devices and technologies involving AI software, through executing projects for his company’s clients, standards development, and being deeply involved with research projects involving software as a medical device and digital health. This balanced view, along with various market insights, provide a pragmatic approach towards regulation of software in the healthcare industry.
- Product commercialisation, product design and development, market entry access for all medical devices.
- Regional executive management of multi-racial/cultural teams and organisations, especially Asia Pacific Project Management in various industries, scope and complexities.
- Global leadership in regulatory harmonisation efforts, industry expert contributor, draft international standards.
- Healthcare - Certification/Regulatory Compliance