Nissha Medical Technologies has a wealth of use results and experience in the development of medical devices for the U.S. and European markets. It is required, especially for development of medical devices for the U.S. market, to comply with the guideline for the development of medical devices recommended by the FDA (FDA 21 CFR 820.30). One of the guidelines is a waterfall development process, and a brief description of key points is provided later.
Roles of the FDA in the U. S. market of medical devices
Manufacturing and sales of medical devices require certification and approval by public institutions and registered certification institutions.
In Japan, the “PMDA: Pharmaceuticals and Medical Devices Agency” conducts approval reviews of pharmaceuticals and medical devices.
In the U.S., the “FDA (Food and Drug Administration)” takes on this role.
The FDA is a (public) agency of HHS (United States Department of Health and Human Services), and is the counterpart of the Ministry of Health, Labour and Welfare in Japan. The agency conducts tests, approval reviews and supervision to secure the safety and efficacy of foods, drugs, animal drugs, cosmetics, medical devices and toys, etc.
Registration with/notification of the FDA and approval by the FDA are required to export medical devices manufactured in Japan to the U.S.
| ClassⅠ | |
|---|---|
| Extremely low risk of causing damage to the body | Compliance with quality control regulations, registration of site, registration of product |
| ClassⅡ | |
| Poses a risk of injury | Compliance with quality control regulations, premarket notification (510K), GMP review |
| ClassⅢ | |
| Causes serious disorders or results in death | Clinical Trial (IDE), marketing authorization (PMA), GMP Review |
In Japan, devices are classified into three categories (i.e., general medical devices, controlled medical devices, highly controlled medical devices) according to the risk to human body; they require notification, third-party certification and approval by the Minister (reviewed by PMDA). There is no system of third-party certification in the U.S., and it is necessary to confirm whether a medical device of the same class is classified into the same class in the U.S.
Development of medical devices by the waterfall process
Medical devices are required to comply with the quality control regulations (QSR: Quality System Regulation) by the FDA.
The quality control regulations require that medical devices be developed, designed, and manufactured in accordance with appropriate specifications and controls.
Accordingly, the manufacturers of medical devices must establish and maintain a quality control system for each product.
Concerning the development and design of medical devices, the FDA recommends a waterfall process to medical device manufacturers. The guideline for the development of medical devices (FDA 21 CFR 820.30) specifies the design control of Class Ⅱ or higher devices (including some of ClassⅠ) in the U.S.。
For development and design in general manufacturing industries including medical devices, a “spiral” process is often adopted; with this process, specifications are finalized when requested by users, and then prototyping and evaluation are repeated to achieve the finished product.
The waterfall process first determines the “request of the user” and “intended use” as the definition of requirements.
We proceed with design and development by taking the qualitative requirements of healthcare professionals and patients as the starting point, conducting review at the respective stages of design input of quantitative defining as well as of design output through the design process of realizing the definitions, while leaving written documentation of the association of the different elements as results as we move forward to achieve the finished product as the end point.
Since each stage can definitely be implemented and it is not allowed to go back later, design mistakes as a result of going back many times can be prevented. Even a slight mistake in a medical device is not allowed since it may have life-threatening, consequences, and the FDA recommends waterfall-type and not spiral-type process of design and development.
Distinction between validation and verification
Waterfall process includes verification and validation.
Verification checks that the design output is completed according to the design input. As an example, if a requirement of the user is that “it must be light enough to hold with one hand,” it is defined by the design input of “keep weight at a maximum of 〇〇,” and the target becomes to follow a design process that meets the set specifications.
It is verified that design input is designed as planned and a written trail is kept to guarantee accurate procedure of development and design.
Nissha system of medical device development
Nissha Medical Technologies has long operated contract design/manufacturing of medical devices covering from highly controlled medical devices to medical cables, including wearables/biosensors for medical use that attract much attention in the U.S.
The Design Team of Nissha Medical Technologies is working to establish and maintain a design control and quality control system, and perform development according to the FDA guidelines on a daily basis.
Since we are handling various cases of design/development for customers, we have accumulated knowledge in a wide range of clinical fields. Furthermore, by using front loading development that includes 3D simulation tools and verification methods to solve issues and address risks at an early stage, we complete our products with high design quality from the initial to the final stages of development.
Nissha Medical Technologies, with its abundant knowledge and experience in the development and manufacturing of medical devices, not only in Japan but also overseas, provides support in a wide range of businesses as a development/manufacturing partner of medical devices.
