So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have been many blog posts published summarising the 10 priorities, as they “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices”.
But why the emphasis?
Why Human Factors matters
Hopefully, as you’re reading this, you’ll already be aware of why Human Factors is integral to safe products. As a refresher, here’s why;
- 80% of medical device errors are due to human error.
- Every year, around 98,000 people die in hospitals in US, 11,859 in England, due to medical errors, many of which are due to Use Errors.
“Many device recalls and adverse event reports reflect underlying human factors engineering problems including usability issues and preventable design problems” (FDA CDRH)
Yet we spend a lot of time during development working to reduce the 20% of errors that are due to device performance, testing our devices to ensure the build quality is robust and that the performance is acceptable.
What about working to reduce the 80%?
CDRH priorities include Human Factors
Well, CDRH included Human Factors in their priorities because it helps;
- Facilitate medical device innovation and bring new technology to market,
- Enhance or expedite the availability of medical devices while maintaining their safety and effectiveness,
- Facilitate rapid identification of problems.
What does all this mean for those medical devices or combination products already in development?
A great emphasis will continue to be placed upon adequate and robust Human Factors programmes during development. Programmes that clearly identify who the product is being build for and their needs, demonstrate the integration of Human Factors throughout design development and culminate in evidence that the product is safe and effective in use (i.e. a robust summative usability study).
It is perhaps not surprising that the focus for 2016 includes HF, as there’s been much dialogue between industry and regulators in recent years on this topic, including the wider implications of devices being used outside the clinical setting (see our post on that topic from January 2015).
Merging of EU and US Human Factors requirements
The playing field between EU and US requirements is being levelled (our September 2015 post discusses this in detail). For the EU, developers now need to provide the same Human Factors programme evidence as for the US. So, consequently, the focus on Human Factors will be higher in the EU too.
You may well be thinking that, if you’re developing a product for several markets, it makes sense to develop to meet US Human Factors requirements, as that will satisfy 99% of the needs of the EU and other major world markets.
What does this mean for your product?
You may be thinking about how you could best ensure your development programme meets the requirements for Human Factors.
Pick up the phone (+44 1270 61 86 93) or click on the “Get in touch” tab to the right of your screen to explore how we can help you ensure your product is “right first time”.
Further reading about Human Factors
Perhaps reading this article has left you wanting to find out more about the world of Human Factors (also known as Usability). There are two things you can do:
1. If you’re new to HF or would appreciate a refresher, you will be interested in reading our book “How Humans Factor (in medical device design)”. Email us to request your free e-copy.
2. Have a read of other recent posts on the topic of Human Factors: