medical device

ABOUT Medical devices field

Growth strategies
for the medical devices field,
to support an aging society

We manufacture medical devices (implants) such as artificial joints and bone-junction plates, utilizing our precision forging technology and processing technology for medical alloys (titanium alloys, cobalt-chromium alloys, and high-nitrogen stainless steel). Our integrated in-house system covers everything from CAD/CAM to inspection, allowing us to flexibly handle small-batch high-mix production with short lead time.
In 2011, we obtained ISO 13485 certification* and entered the medical device industry. Since then, we have earned the trust of companies active all over the world.
We will continue to promote research and development in anticipation of increasing demand from aging populations in the Asia region. The medical devices field is highly specialized, and we aim to achieve sustainable growth by promoting the kind of technological innovation that only Endo Manufacturing can achieve.

ISO 13485 (obtained by Medical Devices Department)

Examples of products

Hip stems

Acetabulum cups

Trauma plates

Knee joint and femoral components

Shoulder joint stems

REASON Why choose Endo Manufacturing
for the medical devices field?

    REASON 01.

    Integrated in-house system for speedy response and lower costs

    We have established an integrated system covering everything from CAD/CAM-based 3D modeling to mold and jig fabrication, forging, machining, polishing, and inspection. We can also handle new product launches and prototype fabrication with short delivery times, as well as small-batch high-mix production. We can respond quickly to sudden changes in demand, such as quickly handling new medical devices.

    REASON 02.

    Net-shape forging to reduce post-processes

    We use net-shape forging by applying our extensive track record and technology developed in the golf field. We reduce material costs and post-processes, and improve cost efficiency, by designing and fabricating high-precision molds, setting optimal forging conditions, and designing advanced processes to forge parts to a state close to that of the final product shape. This has also helped to optimize QCD.

    REASON 03.

    Reliable quality system backed by international standards

    ISO 13485* certification, an international standard for quality management systems specifically for medical devices. Our quality control system, compliant with international standards, ensures high safety. We have built a solid track record of trust from medical device manufacturers in many countries throughout the global market.

    ISO 13485 (obtained by Medical Devices Department)

    REASON 04.

    On-site capabilities that combine the benefits of automation and the skills of master craftsmen

    In order to improve productivity and ensure consistent quality, we actively introduce the latest automation and labor-saving technologies, such as robot-based polishing. Meanwhile, manual polishing is performed by skilled workers for processes that require fine sensitivity and decision-making. We utilize the skills of our workers, which cannot be reproduced by machines, to realize consistent product manufacturing of high quality. It is this combination of automation and human skill that forms the strength supporting Endo Manufacturing’s production sites.

    REASON 05.

    A wide variety of manufacturing methods, from forging to casting

    We are now focusing on acquiring new technologies, with an eye on the aging populations in Japan and throughout the Asia region. In addition to our existing forging manufacturing methods, we have acquired casting technology that makes use of the lost wax manufacturing method. While maintaining our commitment to high-quality ENDO products, we are now also able to handle products that cannot be made by forging. From technological surveys to prototyping and research, we continue to take on the challenge of developing new manufacturing methods for the next generation.

  • 01
  • 02
  • 03
  • 04
  • 05

PROCESS Manufacturing processes
for medical devices

1

3D modeling

We fabricate forged models based on specifications, drawings, and models from our customers. When provided with materials, we check them in detail and correct any defects. This allows us to create beautiful models that perfectly reflect the designer’s intentions.

2

Mold fabrication/processing

We design molds using CAE analysis results to avoid the risk of rework due to processing defects. We fabricate molds in-house, allowing us to respond quickly and reduce development lead time.

Our equipment

  • Three-axis machining centers
  • Five-axis machining centers
  • Horizontal machining centers
  • Wire processing machines
  • Surface polishers
  • Fine hole drilling machines
3

Forging

We use net-shape forging to form shapes very close to those of the final products. We can reduce material costs and post-process work time by delivering highly complete parts. This also improves overall productivity by reducing costs and shortening lead times.

Our equipment

  • Forging presses
  • Continuous heating furnaces
  • Tumbler shots
  • Drum shots
  • Swaging machines
  • Vacuum heat treatment furnaces
  • Chemical milling equipment
4

Machining

We use molds and jigs designed and fabricated in-house to process complex shapes using three-axis and five-axis processing machines. This allows us to meet the high precision required of medical device parts.

Our equipment

  • Five-axis vertical machining centers
  • All-in-one processing machines
  • Three-axis machining centers
  • Lathes
5

Polishing

We use a combination of robot-based polishing and manual polishing by skilled craftsmen to ensure dimensional accuracy and excellent surface quality. The beautiful finish and high precision with little variation contributes to the medical device functionality and enhances safety and reliability.

Our equipment

  • Polishing robots
  • Manual polishing lines
  • Centrifugal barrel polishing machines
  • Cleaners
6

Inspection

We use state-of-the-art testing equipment such as 3D measuring equipment to perform dimensional and visual inspections, tensile strength tests, metallographic observations, and hydrogen analysis.

Our equipment

  • Fluorescent penetrant inspection equipment
  • 3D coordinate measuring instruments
  • Image dimension measuring instruments
  • Surface roughness measuring instruments
  • Projectors
  • Tension and fatigue testers
  • Hydrogen analyzers
  • Inverted metallurgical microscopes
CONTACT US CONTACT US
CONTACT US CONTACT US

CONTACT US Contact us for a medical device VA/VE proposal
or OEM work.

We provide integrated services covering everything from 3D modeling to forging, processing, inspection, and mass production.
Endo Manufacturing’s medical device manufacturing continues to provide reliable products and value without compromising quality, responsiveness, or speed. We specialize in prototyping, new launches, and small-batch high-mix production. We respond quickly to the rapidly changing market with high-precision and high-reliability manufacturing. Feel free to contact us for details.