The pulse on clinical innovations, empowering the Life Sciences industry to improve outcomes
The Japanese market represents a significant opportunity for pharmaceutical and medical device companies. Japan’s Ministry of Health, Labour and Welfare (“MHLW”) data show that the Japanese market for medical devices in 2020 totaled $38 billion and imports from the U.S. account for a significant amount of the market. Japan’s aging population, history of adopting new medical technologies and the pandemic driving the increased use of digital methods, will further drive the demand for advanced medical technologies in this region.
Regulatory compliance in Japan is unique compared to other countries, with strict regulations and requirements for medical device and drug manufacturers. To help address some of the complexities and to support growth in the region, Japan has streamlined its regulatory processes considerably in the last ten years, including a much greater willingness to accept foreign data in submissions. The Act on Pharmaceuticals and Medical Devices (PMD Act) is the main legislation governing the medical device industry in Japan, which includes requirements for product testing, quality control, and clinical trials. Medical device companies must work closely with regulatory authorities to ensure that their products meet all necessary requirements before they can be commercialized in Japan. For more complex or novel devices, PMDA may require clinical studies in Japan. While this can be a significant expense, it also creates an opportunity to build relationships with key opinion leaders (KOLs) in Japan ahead of a market launch.
Working with the right partners can significantly increase achieving successful outcomes and reliably navigate the challenging regulatory and compliance pathways in nuanced regions. ECLEVAR MEDTECH, a medical device CRO which serves customers from premarket to post-market clinical follow-up, has been an expert in working with significant KOLs and navigating complex regulatory environments for several decades.
|“Since, authorities around the world exchange information about the risk and efficacy of your products, it’s important to understand the challenges from different angles to minimize risk of failure.”|
|—Chems Hachani, CEO, ECLEVAR MEDTECH|
In recent years, Japan has been investing heavily in genomic research and real-world data to enable personalized medicine. Medical device companies and pharmaceutical corporations in Japan are working on developing new technologies to support these efforts, including advanced diagnostic tools and precision medicine platforms powered by artificial intelligence.
Oracle has partnered with several Pharmaceutical/ Biotech companies to provide strategic direction across multiple cancer indications to gain better access to genomic sequencing technologies in Japan. The team also enabled pricing, reimbursement and new launch guidance for new oncology treatments and companion diagnostics, utilizing innovative multi-stakeholder engagements to help inform decision making.
Artificial intelligence (AI) and machine learning (ML) are rapidly transforming the medical device industry in Japan, with companies developing new products that utilize these technologies to improve patient outcomes. These technologies can be used to identify patterns in large datasets and to develop predictive models that can inform clinical decision-making. This is particularly useful in the development of personalized medicine solutions, which can be tailored to the unique needs of individual patients. Japanese medical device companies are harnessing the power of AI/ML to improve the accuracy of diagnoses, optimize treatment plans, and enhance patient outcomes.
New technology and discovery tools are increasing the amount of data that is not only being generated but also that is used to refine models to predict market accessibility.
|“Medical device companies need technology partners who can acquire, manage, analyze and collaborate on data so that it provides meaningful insights that help determine the long-term market potential for products. Oracle has been supporting life science organizations with their every changing data needs for over 45 years.”|
|—Henry McNamara, Senior Vice President and General Manager, Oracle Health Sciences|
Real-world data is also becoming increasingly important, as companies seek to leverage data from clinical trials and real-world settings to inform product development and improve patient care. CROs, like ECLEVAR, have an important role to play in supporting medical device companies in these efforts. ECLEVAR joined a panel of industry experts at Oracle’s recent Innovation Series webinar: “Creating the Future in Clinical Research with CROs using Real-World Data”.
ECLEVAR will be at Medtec Japan, 19-21 April 2023, and available to discuss how your organization can grow into the Japanese market with a long-term clinical strategy that supports your business.
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Bal has over 25 years of industry experience gained at sponsor, CRO and technology vendors. Having started her career as a data manager, Bal has supported organizations to adopt new technology and working practices through enablement, process optimization and service delivery. At Oracle, Bal partners with CROs to increase their market share to meet agreed business goals.
Shruti Iyer is a Principal Innovation Architect supporting Clinical Innovation at Oracle Life Sciences. Shruti has over a decade of experience as a demonstrated subject matter expert in medical device product development. She is a thought leader who empowers life science customers to enable patients to be in control of their health. Shruti has an M.S. in Medical Device Innovation from the University of Minnesota-Twin Cities where she was a Technological Leadership Institute Fellow. Shruti is energized about driving complex and critical decisions in a highly regulated environment. She is a team-oriented and strategy-focused leader with the ability to transform abstract and complex challenges into tangible and simple solutions.