Now that we’ve finished covering the rudimentary basics of what occurs during the medical device development and manufacturing journey, let’s dive a little deeper to see how we can create a roadmap for design controls that’s transparent, traceable, and seamless for anyone on your team to follow.

First, let’s define what design controls are and why they’re important.

According to the FDA, design controls are practices and procedures that medical device manufacturers must follow during design and development stages. They are governed by the FDA under statute 21 CFR 820, and are used for quality assurance and risk management purposes. Design controls are mandated for Class II and III medical devices, and for a select few of Class I products.

A comprehensive breakdown of the design controls can be viewed in what we call a “traceability matrix.” While this terminology might sound a bit complicated, our team of experts at Pathway NPI can assure you that it’s an easy concept to grasp. In essence, a traceability matrix is a project management tool that helps to ensure a product design is viable, safe, and fulfills its intended purpose. It provides a visual snapshot of the relationships and linkages between various design components (e.g., user needs, design inputs/outputs, etc.) to support validation and verification efforts.

A traceability matrix spells out every step taken to make a medical device design, and can be produced in a spreadsheet-type document such as Microsoft Excel or online with Google Sheets. Like ISO 13485, a traceability matrix is not mandated by the FDA. However, ISO 13485 gives guidance on certain items needed for the traceability matrix, and new requirements are highlighted as they arise. The ability to trace the path between design and manufacturing processes through meticulous documentation supports better project management and the ability to satisfy FDA compliance requirements.

In a nutshell, the benefits of a traceability matrix may include:

  • Transparency: Gives project stakeholders clearer insights on a medical device’s design history.
  • Improved communication: Answers general questions and provides other details such as the cost of items needed for a design and the progression of the project.
  • Enhanced project management: Allows team members to better manage processes related to medical device development and manufacturing.

Key Steps to Creating a Traceability Matrix:

  1. Define the intended use of your medical device. EXAMPLE: A digital fitness band that is intended to record the beats per minute or pulse of end-user X. (You can get more specific by identifying end-user X in terms of age group, fitness level, gender, etc.)
  2. Define the user’s needs. To continue with the digital fitness band example, the user might need a device that’s portable and small enough to fit into a purse or a fanny pack. NOTE: The user’s needs should be aligned with the intended use.
  3. Construct your design inputs. Design inputs are usually technical in nature and created based on the user’s needs, such as weight or length requirements of a medical device. For instance, our digital fitness band might require the material used for its construction to be safe for human skin contact. Also, the material should be lightweight or specifically 2.5 pounds to make it portable and small enough to carry around.
  4. Perform design verification. This process explores if design inputs match the design outputs. In the case of our digital fitness band, this can be done by weighing the device to see if it meets the specifications set by the design inputs.
  5. Perform design validation. We know the intended use of our digital fitness band, but we still need to confirm that it is suitable for the intended user and fulfills the user’s needs. We can test out the product via simulation or AI, or on an actual person, to help validate that the design outputs align with the intended use.

When Should Your Team Create a Traceability Matrix?

A traceability matrix should be created after a medical device concept has been submitted for 501(k) approval (if need be), and also after defining the class in which your product falls under. Once these things are established, your team can create a traceability matrix.

The matrix can be updated in real time as the project progresses. However, having a process in place to communicate when it’s being updated is ideal to mitigating miscommunication and human error.

How Will You Know If Your Traceability Matrix Is Effective?

Bringing a medical device to market is not based on the traceability matrix; rather, the design controls within the matrix play a major role. This project management tool can be an enormous help in confirming if the design inputs for a medical device match the design outputs, and if the design outputs meet the intended use. These enhanced validation/verification efforts help to ensure that new products comply with FDA requirements, and also mitigate potential recalls by ensuring they are high-quality enough to be manufactured reliably and are safe for consumers.

Are you in the design phase of your medical device product, and need assistance with creating a traceability matrix to continue along the path of getting your concept approved by the FDA? Contact us today for an in-depth consultation.