CONDUCTING FIELD RELIABILITY TESTS FOR MEDICAL DEVICE QUALITY MANAGEMENT IS AN IMPORTANT ELEMENT IN YOUR TOTAL QUALITY STRATEGY
Field reliability tests provide deep insights into how new medical devices are performing for those who use them. Combined with legacy device field data, new information can drive reliability growth. Device manufacturers then incorporate this data into future versions of products to continuously improve clinical performance. Enhanced reliability is essential for offering the highest-quality medical devices to healthcare professionals and patients.
How is your company currently using field testing and statistical analysis? Field testing could be under-resourced, or it could exist with limited time and resources available to fully analyze it. The actionable recommendations to management are dependent on how well this data is analyzed and presented.
It’s important to review your procedures and ensure you’re using best-in-class quality management practices, including performing effective field reliability tests. For instance, there needs to be management consensus on what field testing is and what are marketing trials. Do you want to do design testing at your largest customer or somewhere else?
DEFINING AND ANALYZING THE ELEMENTS OF FIELD RELIABILITY
Every released medical device has a lifetime reliability curve. The population of these medical devices being used and then retired in the field have a combined reliability distribution. Device manufacturers should relate reliability to warranty period and labeled duration of use. Often, we need to predict what the ‘L5 Life’ is; for example – the time at which 5% of the population will likely fail.
There are different curves that are typically used and each can help you define certain device reliability outcomes.
A Weibull Analysis, often called a Life Data Analysis, is an example of how field reliability can be predicted. The life of a product is predicted through statistical distribution. A set of ‘good’ reliability data can show several results including probability, survival, instantaneous failure rate, cumulative failure rate and more! Source: https://www.weibull.com/basics/lifedata.htm
To predict field reliability, multiple device reliability results are combined. This provides a more thorough look at field performance. When individual data is properly pooled together, we can move toward statistically significant conclusions and predictions.
Determining the reliability impact of a medical device involves tracking and recording a combination of important factors related to both end-of-life and costs.
Average reliability includes:
- Reliability specification claims
- Mean time to failure, L5 or L1 Life, hazard rate, availability metrics, etc.
- Annual warranty costs
- Annual cost of complaints and failure analyses
- Annual cost of service
- Annual cost of spare parts/replacements
- Annual cost of parts tracking
A combination of reliability metrics and reliability costs provide quality management with facts to make informed decisions. Both statistical and business confidence can help make design optimization and product release decisions.
LEVERAGE OUR EXPERTISE TO BOOST RELIABILITY
Inadequate field reliability testing and analysis can lead to immense financial and reputational damage. It could even hamper your ability to legally operate in the medical device space.
Our Network Partners reliability engineers are:
- Subject matter experts
- ASQ certified
- Experienced practitioners with overall quality and specifically reliability assurance
- Dedicated to the principles, practices, and procedures of reliability engineering
- Provide a minimum of 10 years of medical device quality engineering expertise
- Bring an outside perspective to your team’s reliability efforts
The earlier Network Partners is involved, the more effective and efficient your quality management process will be. With the use of a comprehensive reliability program management methods and advanced data analysis techniques to provide deep insights into your medical device designs, our team is well-equipped to successfully guide you.
Let Network Partners help you manage field reliability by engaging with us early in your product’s lifecycle. Contact a Partner today to create a quality management plan for tomorrow and launch your product with confidence!
