About the Programme

This collaborative programme between Diagnostics Development Hub (DxD Hub) and Duke-NUS CoRE is designed to promote innovation and facilitate the successful translation of novel ideas to a health product in the market.

The utility and significance of in vitro diagnostic (IVD) devices is emphasised by the recent pandemic and also in tandem with the recent advances in the healthcare environment. As medical sciences move into precision medicine, the need for IVD is highlighted to complement this significant paradigm shift to identify the best patient population for a treatment. The timely access to these important health products became a pivotal issue when managing the pandemic and urgent public health situations. Therefore, innovation is required not only in the development of IVD to address the needs of healthcare, but also in the processes to facilitate timely access.

With companies and new set-ups investing in research and product development, there is a need to complement these skills at an early stage to identify commercial and regulatory barriers. Drawing on the extensive experience of DxD Hub and CoRE, the DxCODE programme was conceptualised and designed to provide participants and professionals involved in product innovation with the necessary information to plan for a successful commercialisation of their products.

Programme Objectives

This programme provides a concise coverage of the essential knowledge for bringing IVD into the market, covering topics of practical relevance which will help learners to build a strong foundation in both the scientific knowledge and understanding of the factors affecting the success of product development and commercialisation.
Through the training materials, DxCODE aims to provide you with a self-paced programme that addresses your need to understand the fundamental requirements for approval and commercialization of In Vitro Diagnostic devices.

• Obtain an overview of the landscape for IVD and the market growth
• Gain an understanding of the IVD Development Process
• Align your design concepts to commercial goals
• Integrate regulatory requirements into product development plans
• Gain insights for successful commercialisation of your IVD

 

About the Modules

Through the training materials, DxCODE aims to provide you with a self-paced programme that addresses your need to understand the fundamental requirements for approval and commercialization of In Vitro Diagnostic devices.

Fundamentals of IVD
The definition of IVD according to the health regulators from different regions of the world will be elaborated on. Through this module, learners will recognize the similarities and differences between the Laboratory Developed Tests (LDT) and IVD. The knowledge will help learners to analyse the IVD market landscape, trending technologies, and factors that drive market growth.

Regulatory Frameworks
Various IVD risk classification profiles will be showcased, including those from IMDRF, EU IVDR, ASEAN, and US FDA. The materials provide an overview of the IVD regulatory framework, regulatory controls, evaluation pathways, review processes, and conformity assessment. Importantly, learners will get acquainted with the changes and impact of the EU’s new regulation IVDR.

Product Conceptualisation and Commercialisation
The importance of the various stages IVD product life cycle is the key emphasis here. By the end of this module, learners should acquire the knowledge on the requirements for certification of a company, project management, project selection, and the process involved in bringing ideas to the product development.

IVD Product Development
A deeper understanding of the product development process of IVD will be provided, and appreciate the basis of decision-making along this journey, including No-Go decisions in conceptualization and considerations during the design and development processes.

Successful Product Commercialisation
The market success of a IVD has to consider other vital factors beyond regulations. This concluding module brings to attention important elements of market access,including marketing and sales strategy, as well are reimbursement issues and post-market responsibilities.

Course Delivery

The lectures are delivered via Voice Annotated Presentations (VAPs), which can be conveniently accessed over a smartphone, laptop or a tablet, optimised for self-directed or team-based learning. Upon successful completion of the programme, participants will be awarded a verifiable digital certificate by Duke-NUS Medical School.

Target Audience

This programme is designed to suit a wide audience within the healthcare innovation industry including physicians, researchers and health care professionals who are interested in gaining insights in commercialising their IVD innovations.

Registration Fees

SGD750.00 (Before GST)
*SkillsFuture subsidies not applicable

Refund Policy

There will be no refunds for online courses. Kindly e-mail CoRE_online@duke-nus.edu.sg for more information

CPE Points Available

Upon completion of this programme, you may email SPC@spb.gov.sg with your certificates of completion to claim 8 CPE points.