Kim Wakeman, EtQ

Balancing Compliance and Quality in Medical Device Manufacturing

By Kim Wakeman
Kim Wakeman, EtQ

As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough.

The medical device industry is one of the most highly regulated sectors in the world, and with good reason. From stethoscopes and syringes to the most sophisticated radiotherapy equipment and AI-based monitoring systems, medical devices play a crucial role in the health of those whose lives depend on the quality, consistency and safety of those products.

The FDA authorized a record high 132 novel medical devices in 2020 driven primarily by a surge in innovation and the need for new diagnostic and therapeutic solutions. These innovations include breakthroughs such as an anterior cruciate ligament (ACL) implant that can be used as an alternative to reconstruction, the first cardiac ultrasound software that uses artificial intelligence to help the user capture images of a patient’s heart, and the first game-based digital therapeutic to improve attention function in children with attention deficit hyperactivity disorder (ADHD). While the pace of innovation in 2020 accelerated across all medical technology sectors, the COVID-19 pandemic was only partially responsible. As the FDA worked to fulfill its core responsibilities of ensuring compliance and helping to bring new products to market safely, medical device companies navigated unchartered territory as they sought to expand the availability and capability of various diagnostic, therapeutic, and protective devices in high demand during the pandemic, while also ensuring increasingly stringent safety protocols were met. This was further complicated by the challenges of having a predominantly remote workforce.

The medical device industry represents a marriage of medicine and technology that has the possibility to change (and save) countless lives. Yet, there is also the possibility of doing harm. That is why we have regulations like those from the FDA as well as ISO standards, specifically ISO 13485. While they make the journey to market more challenging, the need for regulation is obvious.

Medical device product development is a clearly defined process established and monitored by the FDA. Once a device is on the market, the FDA monitors reports of adverse events and notifies health professionals, manufacturers, and consumers to ensure proper use of the device and safety of consumers. In fact, the FDA sends hundreds of warning notices each day to medical device manufacturers that are not meeting the agency’s strict safety and compliance standards, and, in total, these warnings paint a clear picture of the most common regulatory challenges.

As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough. While a compliance audit tells a manufacturer whether a product is compliant with current FDA and ISO regulations, it offers no insight into how that company can improve its development and manufacturing processes, manage workflows, optimize collaboration, anticipate and mitigate supply chain issues, minimize risk, optimize storage and distribution, and provide a positive customer experience. That is where proactive quality management strategies come into play.

A Proactive Approach to Quality Management

Taking proactive measures to improve quality can have far-reaching effects—from more efficient resource allocation, workflow automation and document control to decreased probability of a recall. Conversely, manufacturers that meet all the FDA’s compliance requirements yet fail to strategically implement quality objectives put the future of their companies at risk, through cost-overruns, resource overload, lawsuits, or negative brand image.

The following are key considerations to ensure effective quality programs move beyond compliance requirements and into proactive practice.

Encourage enterprise-wide collaboration. To ensure quality across the organization, as well as with suppliers, it is important to remove functional siloes and ensure effective collaboration—with everyone from the vendors who supply the raw materials to the people who check quality on the plant floor. If there is a nonconformance issue, a workflow automation solution can notify everyone involved that there is a problem to address it. Actionable trends can be identified by analyzing large and diverse sets of data to ensure quality decision making and continuous improvement.

Establish effective document control processes. Documentation is essential to the safe use of every type of medical device, yet ineffective document management is often a key reason errors appear in documentation. Documents must be reviewed and approved to reduce errors and incorporate training. An automated system can ensure that all documents related to specific products are organized in a way that everyone who needs them can quickly access to them at any time.

Implement a strategic Correction Action Plan. When it comes to addressing problems that arise in production, identifying the issue is the priority. Corrective actions do not exist in a vacuum—they need to connect to relevant areas of the compliance record to communicate the full context of the problem, and each corrective action should be linked to the appropriate source, whether that is audit results, nonconforming materials, or customer complaints. Once you have identified the root cause of the issue, the corrective action plan needs to be defined, approved, and implemented. Once the correction action plan has been implemented, the effectiveness check will help ensure the corrective action put in place eliminated the problem. Risk assessment is an essential element of any corrective action plan to determine if the actions performed mitigated any risk.

Changing a corporate mindset to prioritize quality is not an overnight process. The champions of quality within an organization must first educate management that the value of quality, including the cost of poor quality, is real, measurable, and in the case of medical technologies, a potentially life-altering calculation. The winners in the medical device industry will be those who get to market first with products that are safe, effective and achieve the desired results for their patient populations.

About The Author

Kim Wakeman, EtQ