About us

Our Business

Leveraging decades of expertise in materials such as resins and metals, together with processing technologies cultivated through our automotive control cable business, we develop and manufacture medical devices and components.

Our portfolio spans microcatheters, guidewires, functional components for endoscopes, and a wide range of catheter tubes for medical applications.

Quality is managed through an ISO 13485–compliant quality management framework, aligned with international requirements for medical devices. The application of this system does not encompass all products or medical device components.

Within our Medical Device Department, we address a broad spectrum of needs—from the supply of components to the marketing and sales of medical devices approved by Japan’s Ministry of Health, Labour and Welfare.

Our Philosophy

Engineering responsibility, guided by clinical insight and patient care.

At HI-LEX, our philosophy is rooted in a simple belief: medical technology exists to support clinicians and, in turn, the patients they care for.

To put this belief into practice, we listen carefully to the voices of physicians in Japan and around the world, seeking to understand real clinical needs beyond specifications and drawings.

Our development and manufacturing teams operate within the same manufacturing site, enabling us to respond quickly and collaboratively as an all-in-one manufacturer.

This structure allows us to translate clinical insight directly into engineering decisions, manufacturing processes, and practical solutions—without disconnects between teams.

For our partners, this philosophy means more than technical capability.

It means working side by side, visiting clinical sites ourselves, and collaborating closely to think through challenges together.

When needs arise or ideas are discussed, we aim to be the first call you make—and the final choice you trust.

By combining precision engineering with an open, patient-first mindset, we strive to be a reliable partner throughout development, manufacturing, and beyond.

Our History

  • June 2001
    Establishment of the Medical Devices Group
  • April 2002
    Obtained Medical Device Manufacturing License (Japan)
  • October 2005
    Achieved certification to ISO 13485:2003
  • April 2007
    Obtained First Class Medical Device Marketing Authorization Holder (MAH) License (Japan)
  • January 2008
    Reorganized from the Medical Devices Group to the Medical Device Department
  • January 2010
    Establishment of the Takarazuka Medical Plant
  • October 2017
    Transitioned from ISO 13485:2003 to ISO 13485:2016

QMS

Quality and safety are fundamental to everything we do.

HI-LEX operates a quality management system that is compliant with ISO 13485, the international standard for medical devices. The application of this system does not encompass all products or medical device components.

Our quality management system supports the entire lifecycle of medical devices—from development and manufacturing to marketing authorization—ensuring consistent quality, traceability, and regulatory compliance.

By integrating quality management into daily operations, we strive to deliver reliable solutions that clinicians and patients can trust.

Our Group companies

JAPAN

U.S.A