Around The Globe
Convergence, Disruption, and Talent Development
Insights from the Asia-Pacific Medical Device Regulatory Summit 2018
Silke Vogel
Ananda Padmanabhan Muthalagu
Hozanna Ngoh
Duke-NUS Medical School, Singapore
he medical technology industry in Asia-Pacific is set for continued expansion with an expected market growth to about $133 billion (US) a year by 2020.
This positive outlook is largely due to the rapid rate of technological development coupled with increasing demand for innovative healthcare technologies to meet the needs of a growing and aging population burdened with high prevalence of chronic diseases. The medical technology industry and regulatory stakeholders in the region are gearing up for the inevitable challenges that will also come with these evolving trends.
To facilitate the exchange of key regional stakeholders’ perspectives on these emerging challenges and opportunities, the Asia Pacific Medical Technology Association (APACMed) organised its third Asia Pacific Medical Device Regulatory Summit in Singapore on October 11, 2018. APACMed was launched in 2015 to provide a common platform for medical device associations and companies in Asia-Pacific to jointly advance regional issues such as access, innovation, and collaboration to improve standards of care for patients in the medical device sector.
At this Summit, regulatory professionals from industry and regulatory authorities discussed key issues such as regulatory convergence, regulation of disruptive innovations, and building the talent pipeline.
Regulatory Convergence
Regulatory convergence efforts are being led by various workgroups and organizations at the local, regional, and global levels, such as the AHWP, AMDC, APEC RHSC, IMDRF, and WHO. Sustaining these efforts for the long term is essential to progress towards achieving efficient regulation of medical devices across the region. The Medical Device Single Audit Program initiated by IMDRF is a key example of a successful convergence initiative and sets the pace for many such projects. Further, international standards are an effective means to improve convergence by enabling harmonization of technical validation across the globe.
Disruptive Innovation
Advances in wireless technology, miniaturization, and computing power are driving rapid innovation by significantly reducing overall product lifecycles. This shortened innovation cycle in turn enables and contributes to rapid developments of artificial intelligence applications for healthcare, medical robotics, and connected devices. Note of caution from the Summit: While digitally connected medical devices can improve the effectiveness of patient care, their vulnerability to security breaches must be recognized.
Abbreviations at a glance:
AHWP: Asian Harmonization Working Party
AMDC: ASEAN Medical Device Committee
APEC RHSC: APEC Regulatory Harmonization Steering Committee
IMDRF: International Medical Device Regulatory Forum
WHO: World Health Organization
Furthermore, innovative products necessitate innovative regulatory approaches. In this context, the FDA’s Digital Health Software Precertification Program and the Korea Ministry of Food and Drug Safety’s Modular Review Process for Innovative Devices are two examples of initiatives by regulatory authorities to address the unique regulatory challenges posed by disruptive innovations.
Talent Development
To adapt to and implement developments in medical technology, and to achieve convergence, building regulatory capacity and capability amongst various stakeholders is crucial. A structured training curriculum based on stakeholders’ needs is a vital component of facilitating consistent competency development and sustaining the regulatory talent pipeline. Centers of excellence for medical device regulation established in partnership with academia can further support and promote such regulatory training. In addition to structured learning, the Summit highlighted cross-discipline training, hospital induction programs, and manufacturing site visits as value-added training activities that could encourage more systematic thinking and a better understanding of the impact of regulation in the real world.
Looking Ahead
A fragmented regional regulatory system, a shortage of relevant regulatory talent, and inadequate understanding of how to regulate innovative products are some of the major challenges that the innovative medical technology sector faces in Asia-Pacific. Moreover, within a heterogeneous Asia-Pacific, developing economies are further constrained by limited resources and access to expertise, and must also address other national health priorities. This myriad of challenges requires deliberate and well-planned collaborative efforts to overcome hurdles in this journey. Routine, ongoing dialogue between relevant stakeholders is essential for greater regulatory convergence that better ensures timely access of safe, quality, and effective medical devices to patients.