Quality Challenges Facing the Medical Device Industry 

Sparta Systems

Medical device challenges don’t just affect compliance. They affect patient safety, pose a recall risk, affect the total cost of quality and more. Often, the impact of these quality challenges isn’t realized until the business is affected.  

Challenges related to supplier management, quality-related risk and complaint handling and reporting are some of these key areas. These challenges can increase the risk of patient harm and significantly impact a company’s competitive edge and bottom line.  

Here’s why.  

Lack of Supplier Visibility and Traceability  

Many medical device manufacturers still rely on manual communication methods for supplier quality management processes. This results in siloed information streams, lack of management oversight and poor visibility into supply chain quality-related issues.  

Manual processes can result in communications delays between the supplier and medical device company or even across divisions within the company such as between procurement and quality. This results in limited ability to trace, control and report supplier related quality issues. In addition to compliance risks, inadequate supply chain management can also negatively impact the business.  

Inefficient Complaint Handling Process 

The increased complexity of medical device companies can lead to a high volume of complaints. This, with stagnant budgets, can lead to longer resolution times for investigations and poor regulatory compliance.  

In addition, greater volume of complaints require a large number of resources to process the records quickly. When rushing to process complaints companies often lose the opportunity to gain actionable insights that can improve product quality. The result is slow response and reporting times as well as the potential for higher risk issues going unrecognized and, ultimately, unresolved.  

On top of this, variability in root causes of similar complaints, duplicate efforts, and lack of signal detection and trending result from poor complaint handling and reporting. The result is the inability to gather insights, react, and continuously improve products. Organizations must focus on shifting away from processing records, and toward identifying signals, identifying trends, and supporting fast and data-driven decision making.  

No Oversight into Quality-Related Risks 

Even with increasing regulatory focus, risk management has continued to be one of the most overlooked challenges facing medical device quality.  

Successful risk management requires a strong link between data and information that goes beyond checking-the-box. Effective risk management is challenging as risk management information and data exists across the enterprise, in different data structures, and with different key personnel.  

Different teams across the enterprise may be using alternative naming conventions for the same patient harm or occurrence level, challenging the ability to aggregate that data. This puts a strain on resources and manual risk management and post-market processes that are ad-hoc or periodically done.  

It also increases the chance of human error and impacts the ability to identify and act on adverse trends. This can have a significant effect on understanding the evolving product risk profile as a result of a lack of production and postproduction data being fed back into the development process.  

Mitigating these Challenges with the Digital Quality Management System  

Medical device companies need a solution that mitigates these three critical challenges and improves supply chain quality management, complaint handling and reporting processes and provides insight into quality-related risk.  

A digital Quality Management System (QMS) can address and alleviate these quality challenges. Download the white paper to find out how.