White Paper: Design
Strategies to Prevent Costly Medical Device Recalls
SPONSORED BY: ![]()
Medical device recalls are increasing, creating serious risks for patients and manufacturers.
Explore the leading causes, including design flaws and technology failures, and discover practical strategies to reduce risk during development.
Formerra’s guide shares best practices for design, material selection, testing, and documentation to ensure compliance and product integrity.
Protect your customers, your brand, and your bottom line.
Don't have an account?
Overview
The document outlines critical considerations for minimizing the risk of medical device recalls, emphasizing the importance of quality control, security, and clear documentation in the design and manufacturing processes. It highlights that both short- and long-term consequences can arise from recalls, affecting manufacturers and the public.
One significant concern is the vulnerability of connected medical devices to cyber threats. The document cites a 2019 recall of an insulin pump due to software vulnerabilities that allowed hackers to remotely alter device settings. This underscores the necessity for manufacturers to incorporate robust security measures during the software development phase to protect against potential cyberattacks.
Quality control (QC) is another focal point. Insufficient QC in software and firmware can lead to unexpected device performance issues, data integrity problems, or component failures. The document stresses that while testing under ideal conditions can reveal many failure causes, real-world usage often presents unforeseen challenges. Therefore, manufacturers must ensure that installation documents and user manuals are clear and concise, particularly for home healthcare devices, which are often used without professional supervision.
The document also advocates for investing in component monitoring technologies, which can provide real-time diagnostic data and prevent misuse that could lead to device failures. This proactive approach is essential for manufacturers aiming to avoid adverse patient events.
Furthermore, the text emphasizes the importance of balancing budget constraints with functionality. Cost-cutting measures should not compromise the device's integrity or performance. For instance, reducing the thickness of a device's casing to save on material costs could make it more susceptible to physical stressors, increasing the risk of failure.
Lastly, the document includes a disclaimer from Formerra, the distributor, stating that they make no warranties regarding the information provided and that users assume all risks associated with the use of the information or products.
In summary, the document serves as a guide for manufacturers to navigate the complexities of medical device production, focusing on quality, security, and clear communication to minimize recall risks and enhance patient safety.