As we are aware, medical device development is a long and in depth process from early prototyping, to clinical trials, and evaluations before its eventual release to market. Within every stage of development, there are quality assurance systems that are in place to ensure that the processes at that level are standardized and being executed properly. This is of course to ensure the device is compliant with regulatory requirements and is capable of being reproduced safely and efficiently.
However, even with these systems in place, issues may arise when real world use of the devices unveils problems with the device that were not previously identified during testing or inspection. How do you think medical device companies should adapt their QC and QA strategies to account for post market surveillance data and adverse events? In addition to this, how should companies utilize feedback from clinicians and patients to improve these systems after device approval?
QA should conduct an investigation if an adverse event occurs or if post surveillance data detects an issue with the medical device. As per most quality management systems, a complaint should be opened to handle an adverse event experienced by the customer. A CAPA can be opened in response to a complaint or can be issued to correct or prevent deviations identified by the company’s staff. Furthermore, all staff including operators or clerks need to have a “see something, say something” mindset, that can mean reporting on a nonconformity similar to a QC role. If a company wants to modify and improve a product and its processes or design, then an engineering change request can be submitted. These changes could have likely started from customer or employee feedback after device approval. As a result, this may initiate the QA team to submit to the FDA, revise their procedures & forms, or retrain. This may also improve the company’s risk assessments in the future for new projects.
If enough complaints or report of a single issue arise then that would mean there was either a deficiency in the inspection and testing process, or there was an issue with the shipping or storage of the device if that was handled by another company. Either way and investigation must be launched in order to determine the root cause of the complaints. If the root cause lies with the manufacturing site, then the QC testing process must be improved to prevent defective products from leaving the site, and QA should change the process to prevent the error in either manufacturing, or storage that led to this. However, if the issue lies with separate distribution companies than switching to keep as much of the distribution process in house where quality can be more tightly controlled can be a solution. Also conducting audits of the distribution companies to ensure they follow validated shipping and storage parameters can also help ensure quality. QA and QC both have their roles to play following customer complaints, but QA should be the ones receiving the complaints and acting first to determine root cause.
Within post-market surveillance, both Quality Control (QC) and Quality Assurance (QA) play vital roles in monitoring medical devices after they've been released to the market. Quality Control is reactive, focusing on collecting and analyzing data from sources like customer complaints and adverse event reports to detect and investigate product failures. Quality Assurance, on the other hand, is proactive and uses the data gathered by QC to identify systemic issues and drive continuous improvement within the Quality Management System (QMS). This includes implementing corrective and preventive actions (CAPA) to address the root causes of problems and prevent them from happening again. Together, QC's detection and QA's prevention ensure ongoing product safety and regulatory compliance.
Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their strategies in a way which makes the process quicker without sacrificing effectiveness. The QA/QC in the development stages tend to be more involved and "planned" in order to properly validate the device, but in post-market surveillance this is more unpredictable. As mentioned, when something goes wrong, a CAPA is needed. This process usually takes a bit of time which can be less than ideal if a critical flaw is identified. What I am suggesting is that the CAPA process should be done in parallel with QC inspections on existing inventory while a root cause analysis is completed. In the development phases, a parallel approach is usually not ideal since it can cause questions on the quality of validation, but in post-market surveillance the response time to a problem is critical. Should companies utilize a parallel approach to CAPAs, or does this interfere with product quality?
