Gap analysis in manufacturing, innovation and marketing of medical devices in the Asia-Pacific region

ABSTRACT

Introduction

Although similar in many aspects of manufacturing and regulatory provisions to medicines, medical devices have their provisions and attract considerable investments in manufacturing and innovation. While the U.S. holds the leading global position in the devices market, Asia Pacific (APAC) countries like China, Japan, Singapore, and South Korea have proved tremendous market potential holding top ten positions. Still, many APAC countries are import-reliant due to hurdles in technological innovation and regulatory provisions.

Areas covered

The review aimed to explore those predictors or hurdles and analyzed these to enhance the region’s export capacity gradually.

Expert opinion

Policymakers in APAC countries with no device manufacturing and health technology assessment capacities would be benefited from the review. The findings showed the presence of a gap in manufacturing, innovation, and marketing of devices within the APAC region and between APAC and western countries. Stringent regulatory measures and quality indicators are still lacking in many APAC nations, and there is an urgent need to harmonize regulatory standards. Being a region constituting over one-third of the global population, a considerable investment in innovation, manufacturing, and establishing quality standards is urgently needed among APAC countries to ensure an adequate supply of quality medical devices.

KEYWORDS:

• Asia Pacific region
• device market
• innovation and technology
• medical devices
• regulatory authority

Article highlights

• Although medical devices are similar in many aspects of manufacturing and regulatory provisions to medicines, these have their provisions and attract considerable investments in manufacturing and innovation.

• While the U.S. holds the leading global position in the devices market, some of the Asia Pacific (APAC) countries like China, Japan, Singapore, South Korea have tremendous market potential holding top ten positions in the medical devices sector.

• Many of the APAC countries (e.g. Nepal, Bhutan, Afghanistan and others) are import-reliant for medical devices due to hurdles in technological innovation and regulatory provisions.

• There are gaps in manufacturing, innovation, and marketing of devices within the APAC region and between APAC and western countries.

• Stringent regulatory measures and quality indicators are still lacking in many APAC nations, necessitating harmonization of the same.

Funding

This paper was not funded.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contribution

B Sapkota conceptualized and designed the study, performed a literature review, and prepared the final manuscript. S Palaian, S Shrestha, A Ozaki, M Ibrahim and M Jakovljevic contributed to literature review and drafting the final version, and critically reviewed and revised the manuscript. All authors read and approved the final manuscript to be published.

Data sharing statement

All data supporting the findings of this study are contained within the manuscript. Any additional information regarding the study including the questionnaires would be shared by the corresponding author upon request.