Medical Product Design & Development: Code of Federal Regulations

Once a new medical device is conceptualized, the next step in its product development is its design. Designing is the most important stage in medical product development as the flawed design may lead to an unsafe or ineffective product. A design control process has to be initiated and implemented as a part of the quality system requirement. The design controls are indeed simple and logical steps to make sure that you develop what you are meant to develop and final product meets your customer’s requirements and expectations.

Design control process

The design control process includes a set of interrelated procedures and practices which are documented and incorporated while developing a medical device. The design control activities can enable a company to:

• Identify its customers’ requirements and understand competitor’s product.
• Meet the regulatory requirements to develop a high-quality product right from inception till production.
• Identifying the discrepancies and inconsistencies in the design early on thereby reducing the rework and redesign getting it right the first time.
• Establish consistent process
• Be sure that the end product meets the customers’ needs.

Code of Federal Regulations (CFR) Title 21

We have outlined below the US 21 CFR 820.30 design control requirements.

1) General: Class I devices such as catherater, applicator, radionuclide, protective, surgeon’s, etc. and devices automated with computer software are subject to design controls. For class II and class III devices procedures need to be established and maintained to control the device design to make sure the specified design requirements are met.

2) Design and development planning: Establish and maintain plans which describe the design and development activities and define the responsibility for implementation. The plans need to be reviewed, updated, approved and validated on regular basis.

3) Design input: Make sure the design requirements address the intended use of the device, which includes the user and patient needs. There should be a mechanism in place that addresses ambiguous, incomplete or conflicting requirements.

4) Design output: Define and document design output in terms that allow evaluation of conformance to design input requirements. The acceptance criteria must be included in design output procedures. You may need to identify the design outputs which are essential for proper functioning of the device.

5) Design review: The design must be confirmed to correct any deficiencies in the design. The common review types are hazard analysis and failure mode and effect analysis. The design must be reviewed by the personnel from all areas in the specific stage as well as by someone who does not have direct responsibility for this design stage. The design review results have to be documented in the design history file.

6) Design verification: The device design needs to be verified to confirm if the design output meets the design input requirements. The design verification results which include design identification, methods, date and verifying personnel must be documented in DHF.

7) Design validation: The design has to be validated via objective evidence and examination. The final design output must meet the specific intended use. Design validation ensures that the device conforms to the intended use and defined user needs. The design validation may include risk analysis and software validation.

8) Design transfer: Make sure that device design correctly translates into production specifications.

9) Design changes: Ensure design changes are identified, documented, validated, verified, reviewed and approved before their implementation.

10) Design history file: DHF compiles evidence to demonstrate that design was developed in accordance with the approved design plan and specific requirements.

The design stage is critical in the medical device product development to ensure you build a safe and effective device. It is essential to implement a design control process to conform to the regulatory requirements.