Bench to Bed: Researchers’ Limited Awareness of Regulatory Requirements to Market Medical Devices

• Main Authors: Tan, X. J. A., Heng, J. G. K. H., Chua, K. P., Foo, J. Y. A.
• Other Authors: School of Mechanical and Aerospace Engineering
• Format: Conference or Workshop Item
• Language: English
• Published: 2016
• Subjects: Medical devices; regulatory; product development; commercialisation
• Online Access: https://hdl.handle.net/10356/80610; http://hdl.handle.net/10220/40564; http://sdiwc.net/conferences/iccebe2015/
• Institution: Nanyang Technological University

In the healthcare industry, medical devices have been long used for diagnostic, therapeutic or rehabilitation purposes. Presently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the purposes, there are then different regulatory requirements when a said device is to be marketed. While medical grade device manufacturers may know these requirements, it appears that many researchers may only have a limited understanding of them. Moreover, it is becoming increasingly common that providers of public-funded research grants are expecting that researchers to commercialise their research in order to benefit the community. In view of these, researchers now need to be more aware of these various regulatory requirements as they progress with their research grant’s development. Thus, the aims of this paper are to detail the considerations in marketing a developed product in countries that are sizable and well regulated like the European Union, cover the general approval process for the different types of devices, and describe the possible confusions pertaining to the various regulatory requirements from a researcher’s perspective and possibly that of the general public.