Oracle and Eclevar drive success for medical device corporations in Japan

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.

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.

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.

Please join me at the HS Connect London event – FREE registration

Or contact me if you have additional questions.