Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.
Judith Antler, Eitan Medical
[Image from Unsplash]
When we consider the current COVID-19 pandemic and the abundance of critical care administered via medical devices, today more than ever, we must aim to ensure our products meet all safety standards and beyond.
Unfortunately, even with the current regulatory policies and systems, there are still recalls and field actions in the medical device industry. Both humans and machines are subject to error, but we must do our utmost to avoid these errors.
As medical device manufacturers, how can we ensure our products not only adhere to all industry standards and regulations — but also ensure patient safety as the ultimate goal?
Back to the beginning: Employee onboarding
To best ensure device quality, manufacturers must understand that the QA process starts at the beginning: employee onboarding. It’s crucial that new hire training regimens highlight the global health impact of the devices manufactured, mainly that patients in need will use these devices—and those people might be the employee themselves or their loved ones.
When employees fully understand the onus of the task at hand, they feel compelled to go above and beyond to ensure they keep regulations to the strictest standards. This sense of urgency, responsibility and genuine care are the fundamental ingredients for better and safer medical devices. With the proper mindset, employees can purposefully tackle the rest of the manufacturing process, starting with device design.
The ins and outs of device design
Device design starts with and revolves around understanding and addressing user needs. Manufacturers must create their own multi-phased design QA control process with users at the focal point, with verification and validation stages. The importance of these control stages is crucial, as they act as a checks and balances system to ensure that the initial device design input and resulting output do not have significant differences, removing the need to conduct major design overhauls down the line. Without these self-checking measures, manufacturers may indeed develop a product that “works” but may not deliver care in a way that also answers patient needs.
Furthermore, the design process should entail cross-team collaboration to ensure the product assessment through multiple lenses. The collaboration helps keep the overall product design on-target and encourages out-of-the-box thinking to resolve relevant issues or concerns.
Crucially, manufacturers must also keep in mind regulatory authority requirements throughout the design and manufacturing process. The FDA, EU MDR and similar organizations provide regulatory processes to ensure devices are kept to the highest safety standards. Acting as a guide, the FDA’s Waterfall Design Process illustrates these steps for device manufacturers, providing simple yet comprehensive instructions for developers to bear in mind.
As the QA process becomes more elaborate and intensive, manufacturers must conduct their own risk analysis to better understand where, if at all, mistakes and errors within the manufacturing and medical device design process may happen. As quality control is always performed on a sample basis, this allows developers to tighten controls where necessary, putting manufacturers in the best position to identify and rectify any issues.
Assuring quality with care and process
The medical device manufacturing process is lengthy and arduous. Manufacturers that have a deep understanding, alignment, and care for the end-user, along with comprehensive processes that comply with regulations, will be in the best position for device quality success. As the world increasingly relies on medical devices, the quality and lasting power of our devices will be more vital for improving patient outcomes than ever before.
Judith Antler is the EVP of quality assurance and regulatory affairs at Eitan Medical. Judith has over a decade of experience in regulatory affairs and quality assurance within the medical device industry. Judith holds a Bachelor of Technology Chemistry & Biotechnology Engineering from Ariel University.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.
