Regulatory Shift Healthcare Applications in Industry 5.0

Background

Over the last decade, there has been an emerging interest in understanding the link between Industry 5.0 and healthcare applications. Healthcare consumers today strongly emphasize tailoring products to meet their specific needs. The term “industry 5.0” refers to a fifth industrial revolution where the tailored needs of consumers involved in the provision of health care might be met. This chapter explores regulatory changes in Healthcare applications in Industry 5.0. It can develop and deliver affordable healthcare products.

This section provides information on developing and developed countries' medical device markets and regulatory systems. As one of the world's most competitive medical device industries, the UK is renowned for its capacity to innovate medical equipment for the UK and international marketplaces consistently (Morrar et al., 2017). This is partly attributed to more excellent R & D investment levels and easier access to venture capital than the SA industry, which lacks government backing and access to venture capital—support for R & D and technical advancement (Foray et al., 2012). Despite the UK's solid domestic product development capacity and strict regulations, most of the treatment equipment supply in Southeast Asia comes from imports. There are limited regulations there, creating significant prospects for international device producers. As a result of increasing expenses related to healthcare technology R & D, clearance, compliance, and quality control in the UK and Southeast Asia are not widely accessible (World Health Organization 2013). Its purpose is to investigate how legislative changes affect industrial capacity and the creation of affordable medical equipment for regional communities in the UK and Southeast Asia, respectively.

By constantly changing health regulations, society's safety has been altered (Kushi et al. 2012). For example, medical device issues in the UK, such as hip replacements and breast implants, were essential in developing new regulations (Melvin & Torre, 2019). Because of these concerns, the Southeast Asian government implemented a series of health regulatory adjustments (Bao et al., 2020). Processes such as the use of surprise inspections of manufacturing facilities by notified bodies, improved cooperation in the oversight of notified bodies, preservation of uniformity in recognition of notified entities across EU member states, improvement of monitoring systems, and the use of medical device traceability tools, all contributed to regulatory changes.

The rising manufacturing process and rules have changed due to a demand for health technology. This governs the availability of such devices on the market (Dawoud et al., 2021). Other catalysts for the change are the shifting legal landscape around medical care delivery and the concerns expressed by patients about their experiences with poor medical treatment. As a result, there is a void in our knowledge of how legal changes impact efforts to make affordable medical technology and gadgets available in developed and developing countries. As a result, this chapter fills in the knowledge gaps left by past research. The following section gives a technique for doing a literature study on healthcare technology and medical device regulation.