CDMO(Contract Development and Manufacturing Organization) of
medical devices organization

Customer needs of CDMO

When selecting CDMO (contract development and manufacturing organization of medical devices), it is important to keep in mind that companies that not only possess the necessary technical capabilities, but also keep to the costs and schedule are desirable.
Kyoto Factory implements product design/manufacturing design/manufacturing in a one-stop manner, thus achieving a schedule that takes points involved in regulatory approval, etc. into account to achieve production without any waste of time.

We look ahead towards the future to accommodate such regulatory approval needs as “it is not a medical device now, but in the future we wish to obtain approval as a medical device” and “we hope to achieve global expansion of our business in the future.” We can namely propose designs that will not only achieve regulatory approval in Japan, but also in other countries in the Asia region such as Korea and Malaysia.

Requirement for CDMO

1. Point

   Accurate designs for regulatory approval

   Medical devices must be approved by the regulatory authorities. We can provide design support for regulatory approval based on the experience of our human resources including knowledge of the U.S. system.
   If the key points and ISO standard guidelines are not complied with, the amount of rework will increase with a resulting in an increase in man-hours and costs.
   We proceed by reflecting customers' wishes in designs that secure the quality specifications and take safety into consideration.

2. Point

   Certified ISO 13485

   We have obtained ISO 13485 international standard (Medical Device Quality Management System) certification, we design in compliance with the guidelines, and have a QMS (Quality Management System) to manage the quality and production pf medical devices, which comprise the requirements to secure the quality, efficacy and safety of medical devices.
   It is possible to achieve a design that can easily obtain regulatory approval in any country.

3. Point

   Design for the global market

   High quality, fast speed, and accurate design are achieved based on human resources with abundant experience including knowledge of the U.S.
   We have particular skill with mechanical and structural designs, especially treatment tools requiring handle operations.

Importance of CDMO

For products to pass regulatory approval, quality specifications/performance must be guaranteed taking safety into consideration. Design is the starting point of development and the initial foundation on which to build technical capabilities. Not only does inaccurate designs cause defective products, but they may require rework of manufacturing stages. We also cannot obtain regulatory approval without a design that takes the key points for approval of the finished products into consideration, which would result in increased man-hours and costs.

NISSHA reflects customers' wishes on design and development based on the experiences of our human resources, including knowledge of the U.S., and can therefore provide full support for regulatory approval with our ability to accommodate customers' needs and our proven technical capabilities.

Advantages for CDMO

• Design of medical devices

  A team with a high level of expertise and diverse experiences builds projects to solve clinical issues with proven development processes.
  Verification and validation are conducted in the early development stages, and an approach of DFMA (Design for Manufacture and Assembly) is adopted to proceed consistently up to mass production, while saving on total cost resources such as the development period.

  Not all concepts can be commercialized just because they are for medical devices.
  Nevertheless, we will visualize design/evaluation processes to use for subsequent projects, and provide all data and knowledge obtained as deliverables.

• Wearables Lab^™(US)

  NISSHA's unique service to accelerate design/development of wearable biosensors.
  There are many challenges in the development of wearable devices, including signal noise, burden on the skin and available time. To solve these issues, our experienced team reduces the development period by realizing the selection of materials/prototyping/evaluation in a short period of time.

• Cross-functional development system

  NISSHA Innovation Center has built a development system that can quickly support development by customers.
  Development is implemented cross-sectionally by functional departments (design/manufacturing technology) and various technology fields (e.g., sensors, roll-to-roll manufacturing, molding), and the Center also has a clean room for possible mass production.

• Development for global markets

  Support for speedy global operations in collaboration with development/manufacturing sites of medical devices in Europe and the U.S.
  We have a network to back up global operations by customers, including responses to overseas regulatory affairs, and support for the supply chain to back up stable supply of products.