Inter-relationship between Medical Device Design and Risk Based Control Systems

New realities have presented the medical device manufacturers with favorable circumstances and some challenges. Medical devices are more integrated into outpatient, inpatient, and home care. Medical device design and manufacturing have been evolving with technological advances. However, an increase in modern health reforms has increased patient connectivity and media scrutiny, which has left manufacturers with little margin for error.

Design controls play an important regulatory role for medical devices. Typically, medical devices are made up of multiple components, some of which are developed in-house, and the rest are procured from vendors. To produce a finished medical device, the manufacturer has to assemble all the parts together. Lack of proper communication, planning, and program control, make it difficult to develop an error-free medical device. To meet up with the regulatory requirements and applicable international or domestic standards, regulatory strategy needs to be developed early in design and development phase.

Risk management has become a competitive tool to gain access to foreign and global markets. The process is necessary to ensure device safety, usability, and regulatory compliance. Manufacturers are required to identify possible hazards that are associated with the design of the medical device in both normal and fault conditions. Any risk that is judged unacceptable, must be reduced to acceptable levels by appropriate means.

Components of Device Design Control

Design control components establish and maintain procedures that help in controlling the device design. The components help in maintaining the intrinsic quality of the device to ensure that specified design requirements will meet the needs of users and the intended specifications, uses, effectiveness, and safety of the device; and reduction in recalls. The essential design control components include:

1. Design and development planning

The design control regulations of the U.S. Food and Drug Administration (FDA) require that the manufacturers of medical devices establish a design and develop a plan to describe the activities that are required for the specific device design. The design records should be timely reviewed and updated in the Design History File (DHF). The design control records and procedures play a crucial role during FDA inspections.

2. Design Input

All manufacturers are required to establish and maintain procedures that help in ensuring that the design requirements of a device are appropriate. The requirements of design input must be documented and must be reviewed and approved by the designated person(s). The date and signature of the person(s) approving the requirements, must be documented.

3. Design Output

All manufacturers are required to establish and maintain procedures that help to define and document design output in terms that allow an evaluation of conformance to design input requirements. The procedures for design output must make a reference to the acceptance criteria and must ensure the identification of the design outputs that are important for the proper functioning of the device.

4. Design Review

All manufacturers are required to establish and maintain procedures that help to ensure proper planning and conducting the formal documented reviews of the design results at appropriate stages of the device’s design development. Design review results, including the date, design identification, and the individual(s) performing the review, must always be documented in the DHF.

5. Design Verification

All manufacturers are required to establish and maintain procedures that verify the design of a device. Design verification must also confirm that the requirements of the design output meets those of the design input. Design verification results, including the date, design identification, and the individual(s) performing the review, must always be documented in the DHF.

6. Design Validation

All manufacturers are required to establish and maintain procedures that help to validate the device design. Design validation must ensure that devices conform to user-defined needs and intended uses. The production units must be tested under actual or simulated use conditions. Design validation results, including the date, design identification, and the individual(s) performing the review, must always be documented in the DHF.

7. Design Transfer

All manufacturers are required to establish and maintain procedures that help to ensure that the design of a device is correctly translated into production specifications.

8. Design Changes

All manufacturers are required to establish and maintain procedures that help in identifying, documenting, validating or verifying, reviewing, and approving design changes before they are implemented.

9. Design History File (DHF)

All manufacturers are required to establish and maintain a DHF for each type of device. The DHF must reference or contain the records that are necessary for demonstrating that the design was developed according to the approved design plan.

Design control regulations provide a systematic and comprehensive framework for the development of medical devices. Periodic regular design reviews help to confirm that device development continues to meet market and clinical needs. Confirming the alignment of design inputs with design outputs reduces the risk of omitting an important feature in designing the device. The design control process is iterative. The regulations require that prior documents should be reviewed and revised as necessary when new information comes up with the progress of the project. Redesigning the device after considerable effort and time are spent on it is a costly exercise. Therefore, design control regulations are a regulatory requirement, and serve as a good business practice when used properly.

For more insights on how risk management fits into design control, attend this Webinar by expert speaker Edwin Waldbusser, who is a consultant retired from industry after 20 years in management of development of medical devices, with 5 patents. Also, get familiar with the interrelationship between ongoing risk analysis and the design process.

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