This article describes the design process during the product development of a new medical device. For information on the product development lifecycle for a new drug or biologic, please see Product development lifecycle: New drug development.
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After conceptualizing a new medical device, the next step in its product development is the design. This is the most important stage in the development of a medical device since a flawed design may lead to it being ineffective or unsafe (that is, not approved or cleared by the regulatory agency).1 At the design stage, a design control process needs to be initiated and implemented as part of the quality system requirement.* In essence, design controls are simple and logical steps to ensure that what you develop is what you meant to develop, and that the final product meets your customer’s needs and expectations.2,3
The design control process includes a set of interrelated practices and procedures that are documented and incorporated during the medical device design and development. Through design control activities, a company can:
The US 21 CFR 820.30 design control requirements are outlined below:1-5
Establish and maintain a plan that describes the design and development activities and allocates the individual responsibilities for each activity. Ensure you review, update and approve the plan until the device design is completed, verified and validated.
Use performance, safety, business economics, outputs of risk management and regulatory requirements as a basis to design the device so that its purpose and the intended use are clear. Input may also come from surveying your customers (for example, clinicians, nurses, patients). Review and address information gathered as you develop the product specifications.
Design output procedures or specifications need to stipulate or refer to the design input document developed by the team and need to identify the critical measures/outputs for the proper function of the device. These include the tests and procedures that may have been developed, adapted or used to show conformance with the defined design inputs. Examples of design outputs may include:
Confirm the design, or detect early on and correct any deficiencies identified at other design and development phases. Two common types of review are hazard analysis, and failure mode and effect analysis. Ensure the design is reviewed by personnel from all areas involved with this stage as well as by someone who does not have direct responsibility for this design stage. Document the design review results (for example, the design identification, date and individual[s] performing the review) in the design history file (DHF).
Confirm the device design via examination and objective evidence, verify that the design outputs meet the design inputs. Design verification activities must be planned and routinely examined and the results must be documented. Most design verification activities become DHF records that support the effectiveness of design outputs (for example, risk analysis and management results, test method validations, software verification, biocompatibility results, transit test, and third-party certifications).
Validate the device design via examination and objective evidence, confirm that the final design output consistently meets the specific intended use. Design validation should follow successful design verification. Because design verification is conducted while the design work is being performed, design validation confirms that the medical device meets its intended use. Usually this is established through in vitro performance, functional testing, animal testing and/or in vivo clinical evaluations and trials.
Ensure that all design changes are identified, documented, validated, verified, reviewed and approved prior to implementation.
Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing).
The design history file (DHF) compiles evidence (that is, the history of the design) that shows that the design was developed in accordance with design controls―specifically, the design and development plan, or the design-change plan.
*This article discusses the design control process based on the requirements outlined in Title 21, Section 820.30 of US Code of Federal Regulations. This is very similar to the design control elements of ISO 13485. A table comparing the two approaches is presented in the article Healthcare product development―Step 6: Execute your healthcare product development plan. Additionally, refer to Table 1 in the article Quality system: Medical device product development for information on whether it is mandatory for you to meet design control requirements as part of your quality system requirements.
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.