The Poly Implant Protheses (PIP) breast implant scandal was one of the most notorious patient protection failures to have occurred in clinical research. The implants were made from a cheaper, industrial-grade silicone that was not approved for medical use and ruptured easily, leading to scarring and inflammation. The choice of a poor-quality material was life changing for these patients and it also led to significant regulatory change.
As a quality manager, you are responsible for establishing a company’s quality procedures and standards. You will also make sure that all production processes meet both national and international regulatory standards. When it comes to medical devices, the role of a quality professional involves developing and managing a product’s quality management system (QMS) and driving forward the manufacturer’s regulatory strategy.
In medical device companies, the quality manager is therefore responsible for overseeing compliance with the U.S. Food and Drug Agency (FDA), EU Medical Device Regulation (MDR) and other relevant frameworks. This means providing regulatory support for projects, assisting with product labelling and supporting manufacturers with their applications to the notified body (NB).
Introduction to design controls
Design controls are a set of procedures that manufacturers build into the design and development (D&D) process to ensure the design translates into a device that is appropriate for its intended use. Design controls link the user requirements to the device’s design inputs and outputs. This can help quality managers carry out vital tasks, like investigating complaints, managing technical files like the Design History File (DHF), and coordinating post-market surveillance (PMS) activities before the device is taken to an NB.
When reviewing medical device non-conformance, you will expect to find design controls in place for Class II and Class III devices like endoscopes, because these are deemed to be a higher risk. You will rarely find these controls in Class I devices unless they are being automated with software.
One of the main reasons that NBs recall medical devices is that the manufacturer has failed to update its QMS when a new risk arises. Good communication between quality managers and manufacturers can help quality professionals stay informed about any changes in the design controls so that they can manage the QMS more effectively and incorporate any risks into the relevant documentation.
For quality professionals evaluating medical devices, the priorities are safety and knowing that the product meets the user needs and requirements. One way that quality managers can support regulatory compliance and oversee quality is by following and contributing to the design controls. This includes reviewing complaints and the procedures that the manufacturer has followed to ensure FDA or MDR compliance. Here are some of the ways that quality professionals can use design controls to assess device quality.
Understanding user requirements
The responsibility of a quality manager commonly includes investigating complaints that have been made about the device. From a quality perspective, complaints highlight any historical faults, and it can help you to determine whether the product is now at a standard where an application can be submitted to an NB. Manufacturers will use the design controls to document these complaints alongside the original user requirements. This can help them demonstrate how patient needs have been built into the final design.
The user requirements listed in the design controls are fed into the device’s design inputs, which details the physical and performance requirements of a device. When assessing the quality of an endoscope, scalpel or any other device, there are three requirements to consider. These include functional needs that describe what a device does, interface requirements that detail any characteristics that are critical to patient interface and performance requirements that specify how well it should perform. A thorough assessment means considering all three types.
When analyzing the design controls of a medical device, you want to see as much detail as possible. It is good practice for manufacturers to be comprehensive and unambiguous so that everything can be verified. This will make it easier to determine whether a device is effective in carrying out its intended purpose. For instance, saying that a scalpel “must be sharp” is unclear and cannot be proven with certainty. If the manufacturer specifies that the scalpel must be “sufficient to cut flesh seamlessly,” it can then devise tests to demonstrate whether this has been achieved.
When checking the design controls of a device, you also want to see as many design inputs as possible. This signifies that the manufacturer has covered a broad range of performance criteria and requirements. Having multiple inputs to assess allows you to carry out a more thorough internal audit, strengthening the regulatory strategy that you are managing.
Tracing device quality
Design controls provide an audit trail from the device’s user requirements to the final design output. Robust design controls will tell you whether the device meets the needs of the user and if it is safe to use. A detailed D&D plan also makes it easier to trace quality and monitor the risk management process that the manufacturer has put in place.
Traceability is at the heart of design controls, as they allow you to track the various elements of the device through the supply chain. Traceability is part of ISO 13485 and is key to a strong QMS.
It is good practice for manufacturers to create a traceability matrix—a tabular format that lists the design inputs and outputs as part of the validation and verification process. Manufacturers can use the matrix to specify a corresponding output for every design input. For instance, if the input states that the scalpel must be sharp enough to effortlessly cut through human flesh, the output may be that the device must be sharp enough to pass a verified sharpness test. As a quality professional, you can read through the matrix and determine whether the input requirements and design inputs have been satisfied by the final product.
Manufacturers that do not have in-house experience with regulatory applications may choose to work with a freelance FDA compliance consultant to help them build their design controls. Collaborating across the business with specialists can increase your confidence that you have the expert skills needed to improve your regulatory strategy and streamline the route to market for your products.
The PIP implant scandal is a powerful reminder of what can happen when quality is not a priority. When assessing medical devices for the U.S. market, design controls provide a useful indicator that all user requirements have been taken into account, so you can confidently trace quality from user needs to design outputs.
Close collaboration in medical device projects can help you manage the QA process more effectively. This includes working alongside freelance FDA and medical device experts.