TECH EXPERTS

A/Prof Jack Wong has over 20 years of experience in regulatory, quality, clinical trial and pharmacovigilance in Asia, for medical devices, pharmaceuticals, nutritional, consumer healthcare and biological products. He has received awards on improving processes, including reducing 20% of time required for a product launch, and grooming people to contribute to their fullest ability. A/Prof Wong plays a leading role among all the regional regulatory professionals in the Asian Harmonisation Working Party (AHWP). He has developed the first Asia Regulatory Affairs Certificate course, which has been held since 2007 with over 2800 students from the industry, government and universities. A/Prof Wong is the founder of ARPA, which was established in 2010 with over 3600 members to date. He also wrote the first Asian regulatory book, ”Handbook of Medical Device Regulatory Affairs in Asia: Second Edition”. A/Prof Wong has a Six Sigma Black Belt certified by International Association For Six Sigma Certification (IASSC); the license as a Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices; and qualifications as an ISO 9000 Lead Auditor by British Standards Institution (BSI).

With over 30 years of experience in the luxury cosmetics, skincare and personal care industry in Europe and Asia, Domenico Balassi possesses a deep understanding of the industry on a local and global scale. He is now part of a team of consultants, located in Singapore and Milan, that provides companies with support to expand their businesses between Asia and Europe through different segments, such as advising on product regulatory and registration, designing the right strategy and finding the best opportunities. Domenico offers a single point of contact for manufacturers and brand owners in Singapore to help facilitate their product registration in the European Union.

Dr Loke Wai Mun has accumulated substantive academic and industrial expertise in functional food/nutraceutical product R&D and validation. He has authored more than 30 scientific articles in international peer-review journals, and has involved in the design and development of numerous innovative functional food and nutraceutical products. He held a lectureship and R&D position in Food Chemistry and Human Nutrition at Nanyang Polytechnic. In 2013, Wai Mun set up the Centre for Functional Food & Human Nutrition at Nanyang Polytechnic, and has since worked with many local food companies to validate and develop novel functional food products. As a convenor with the Singapore Standard Development Office, he created guidelines for the Singapore food industry to design and develop functional food products. In 2017, Dr Loke started Innovprof to bring forth his R&D capability to the functional food industry. He obtained his PhD with distinction in Chemistry and Pharmacology at the University of Western Australia, and continued his postdoctoral training at the National University of Singapore.

Dr Cheah Li Kang specialises in surface modifications and coatings. He has shared his technical expertise with numerous companies, including an MNC, to build up their core competencies in post treatment for their products, namely metal or ceramic coatings on different types of substrate. He also provides surface treatment solutions for silicone rubber to bond on surfaces like plastic and metal. Dr Cheah obtained his PhD in Electrical and Electronic Engineering Nanyang Technological University. He has been granted more than 10 patents, and authored or co-authored more than 100 papers related to diamond like carbon thin film deposition and characterisation with vacuum related technology.

May Ng is the Global Director of ARQon, Asia Regulatory & Quality Consultancy for medical devices and drugs, assisting in product development and registration in Asia, CE and global approval. She is also an advisor for National Health Innovation Centre (NHIC) on all government hospital clinical trial funding in Singapore and sits on the main committee of Singapore Manufacturing Federation's Medtech Industry Group, ASEANMed and China-ASEAN Medical. May was in Singapore Health Sciences Authority (HSA) for almost 10 years to complete the implementation of the Singapore regulatory framework based on IMDRF/GHTF principles, and reviewing/approval of companies with ISO13485/GDPMDS and medical device/IVD. She joined Biosensors drug-coated stent manufacturing headquarter in Singapore for four years as Regulatory Director after two years working in the IVD industry. May has degrees in Biochemistry & Microbiology, Biomedical Engineering, and Medtech Manufacturing.

Dr Chandrasekaran Margam is a scientist with broad expertise in processing of materials for various applications such as biomedical implants/scaffolds, automotive applications, aerospace and similar applications. He is also experienced in additive manufacturing, tribology and characterisation, regulatory standards, business and operational strategies, transfer of technology from lab to commercialisation, market and technology analysis and evaluation. Dr Margam is currently the convener for three National Mirror Working Groups on ISO/TC 210 (Quality Management and Corresponding General Aspects for Medical Devices), ISO/TC 150 (Implants for Surgery) and ISO/TC 194 (Biological and Clinical Evaluation of Medical Devices). He is also the author of two books and a chapter for Metals for Medical Devices and ASM Handbook Vol 18 Friction Wear and Lubrication.

Dr Aravind Dasari is Associate Professor at NTU, School of Materials Science and Engineering. He is experienced in the design and development of composites, nanocomposites and coatings for utilisation in construction/building sector, electrical and electronic industries, food packaging and renewable energy sector. He is involved in the study of flame retardancy, and the development of various flame retardant coatings and materials in collaboration with various industry partners. Dr Dasari holds a PhD in Materials Engineering from University of Sydney.

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.

Dr Desmond Ang provides all levels of engineering services to the manufacturing industries. He specialises in the application of green chemistry to printed-electronic technologies and molecular-science in electrochemistry. Dr Ang has helped to develop applications of metals-powder or inorganic nano powder materials. He was involved in customising the functional performance of corrugated cardboards in fully automatic manufacturing processes. Through his experiences in various R&D projects, Dr Ang also has insights on different types of magnetic alloys that are produced by adoption of Green Path Coordination Chemistry and through Metal Injection Moulding technologies respectively. Dr Ang holds a PhD in Rare Earth Metals and Coordination Chemistry from Monash University. He was the Director of Engineering at Dou Yee Group and Rohm and Haas, as well as the factory manager at various organisations like LeaRonal Asia, Shipley Far East Ltd and Printed Circuit International. His past experiences put him in good stead to help address not only material-related matters but also the subsequent manufacturing challenges.