Corporate
Profile

[Company strength]
Our corporate advantages are our product planning and development capabilities and integrated production system. We have planning capabilities to commercialize products by appropriately recognizing various needs of doctors and other medical staff. We also have the development power to market over 200 kinds of medical device products annually. Our products aim to reduce surgical operation time and improve patient QOL. They are highly regarded and have received the Good Design Award many times. We also have advantages in integrated production. Our company has an integrated production system from in-house development to approval based on the Medical Affairs Act, manufacturing, and marketing. We satisfy various medical needs and demands for high-mix low-volume production. We market 600 to 700 kinds of products annually, including over 200 new kinds of articles.


[Business description]
Our company has two businesses. One involves medical device planning, design, manufacturing, and sales. We have been cultivating difficult-to-machine material processing technologies for many years. We apply these technologies to provide integrated services, including OEM production. Our services range from in-house planning, design, and evaluation to approval acquisition, manufacturing, and marketing. Our other business involves space-related precision part machining. We possess special metalworking and composite processing technologies and have experience in testing and evaluation. We make use of our technologies and experience to process difficult-to-machine materials on consignment.  Materials include titanium alloy, nickel, nickel alloy, cobalt-chromium alloy, and pure copper.


[Industry]
Machine and instrument manufacturing

[Strength of products/technologies]
Our product advantage is that we appropriately satisfy on-site needs. We have design and development as well as product evaluation capabilities to manufacture products that satisfy various needs in the medical field. We also have an advantage regarding high-precision processing technology and thorough quality management. Our company possesses a wide range of processing machines from composite lathes to five-axis and other machining centers, as well as EDM processing machines. We also possess measuring equipment and material testing machines. We have cultivated high-precision machining technologies by manufacturing parts for Japan’s H2A rockets and orthopedic implants. We acquired ISO 13485 certification in 2005. We maintain a thorough quality management system as expected for medical devices.


[Representative's message]
Our company has been taking on Monozukuri craftsmanship since its establishment in 1963. We met various people through our history who helped us improve our technical strength and flexibility. This enabled us to significantly shift our company to medical devices in 2002 and to make dramatic progress. We are also actively introducing the latest equipment and promoting equipment investments to satisfy needs in the global market. We have reached the global level with the carbon composite material processing technology we have recently been tackling for medical devices. We are considering overseas expansion based on our technology.


[Company structure for market development/overseas expansion]
We opened our Tokyo office in 2002 and Fukuoka office in 2012 for business expansion in the domestic Japanese market. We also concluded a marketing partnership agreement with Japan Medical Dynamic Marketing, Inc. in 2009, Smith & Nephew Endoscopy KK in 2012, Kisco Ltd. (Otsuka Group) in 2014, and Hoya Technosurgical Corporation in 2015. We made an inspection visit to the American Academy of Orthopaedic Surgeons in 2012 and 2015 for overseas business expansion. Our company was registered with the US Food and Drug Administration as a manufacturer in 2007. We visited MEDICA in Germany from 2011 to 2015.


[Market share/Ranking]
The thighbone joining material for orthopedic implants we developed, which was approved under the Pharmaceutical Affairs Act, has a 12% share of the Japanese market (top ranking among Japanese manufacturers). (Source: "Medium-term forecast of the medical bionics (artificial organ) market and thorough analysis of participant companies in 2014" by Yano Research Institute.)


[Awards and media coverage]
[Awards]
Good Design Award (2006 to 2008 and 2011); Good Design Award 2007, Small and Medium Enterprise Agency Director General's Prize; 100 KANSAI Vibrant Manufacturing Companies (2011); 300 of Japan's Vibrant Monozukuri (Manufacturing) SMEs (2014).

[Media]
DMG MORI Magazine, the only Japanese company listed in both volumes distributed to 110 countries at the European International Machine Tool Trade Fair 2015 (Vols. 1 and 2, 2015).


[Authorization/Certification]
Class 1 Medical Device Manufacturing and Marketing License
Medical Device Manufacturing Notification
Specially Controlled Medical Device Marketing and Rental License
Medical Device Repairing License
ISO 13485
Manufacturer registration with the US Food and Drug Administration


[Joint research and development]
Industrial Research Center of Shiga Prefecture: Development of porous processing on artificial bone surface by combining machining process and electrolysis, under the Strategic Core Technology Advancement Program (since 2010).


[Intellectual property]
Bone fixing tool (Japanese Patent Registration No. 5100357) and three other patents registered, three Japanese laid-open patent application, and one Japanese utility model registration for a bone perforation instrument.


[Main Clients / Business History (domestic)]
Pentax Corporation (medical devices, since 2002); Olympus Terumo Biomaterials Corp. and Kuraray Co., Ltd. (medical devices, since 2009); Japan Medical Dynamic Marketing, Inc. (orthopedic implants, since 2009); Kisco Ltd. (orthopedic implants, since 2014); Hoya Technosurgical Corporation (orthopedic implants, since 2015); Nipro (medical devices, since 2015); and so on.

[Main Clients / Business History (overseas)]
Johnson & Johnson/Zimmer (medical devices, since 2002); Stryker (medical devices, since 2005); Biomet, Smith & Nephew, and Medtronic (since 2006); Aesculap (medical devices, since 2007); Arthrex (medical devices, since 2011).