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How Design for Reliability Can Help Mitigate Medical Device Failure Risk

Posted by Dock Brown on Jun 13, 2017 9:20:00 AM

Design-for-Reliability-Medical-Device.jpgAccording to recent reports, the global medical device market is expected to reach $398 billion in 2017, and continue with strong revenue growth through 2023. However, with increased demand comes increased responsibility, and it will be up to medical device OEMs to maintain product quality standards and provide reliable products that can be counted on in life-saving situations. High profile recalls in recent years have given medical device OEMs a reason to be more diligent, but there are many improvements companies can still make to their testing standards.

One way that medical device OEMs can improve predicted product reliability, while improving speed-to-market and lowering costs, is by using the Design for Reliability (DfR) process to identify potential problems during product development. To help show you how this can be done, I’ve outlined two key best practices below.

Best Practices for Implementing Design for Reliability (DfR) for Medical Devices

Implement Early in the Design Process

The sooner you introduce DfR into your design process, the better. The longer you wait, the more you may have to backtrack if a potential failure is uncovered. When implemented early in the design process, DfR, combined with Physics of Failure (PoF) analysis, can help ensure your products will perform as predicted—without lengthy physical usage testing. This is crucial for helping mitigate issues, saving time and reducing cost. You can use PoF analysis software to calculate how part wearout will impact your product design, as well as providing crucial information on the average and worst-case usage scenarios, identifying failure-inducing threats and determining response in multiple environments. For medical devices especially, it’s critical to consider the different transportation and storage conditions your product will be subjected to in your overall testing plan. Often times, these overlooked environments turn out to be much more challenging for a product than the most frequent use environment.

Use PoF-Based Reliability Modeling Software

As mentioned above, using PoF analysis software, like Sherlock Automated Design Analysis™ Software, in combination with DfR offers many benefits for medical device OEMs. Utilizing Sherlock can help determine how your design will be impacted by desired lifetime and use environments before ever creating a physical prototype. Design weaknesses and potential failures are identified early on, allowing you to make improvements and remain on schedule. You can also compare different design choices quickly to help ensure you choose the best possible design for long-term use and low cost of ownership.

By implementing DfR practices and incorporating a PoF approach, companies can stay competitive in the growing medical device market. Using reliability modeling software, like Sherlock, can help you streamline new product development even further. To learn more about how PoF reliability methods can benefit your project, download our free guide below.

Introduction to Physics of Failure Reliability Methods

Topics: Design for Reliability, Physics of Failure