Cambridge Design Partnership hears that consultation on the document ‘Applying Human Factors and Usability Engineering to Optimize Medical Device Design’ (1), has nearly completed. This regulation will mean that all devices submitted to the FDA will need to include a Human Factors Report.
The consultation process began when the document was first issued in June 2011 and industry has been responding in droves ever since. The guidance document helpfully provides a detailed template, so it’s quite clear what is expected. But while the FDA is nearly ready, the question is, are you?
The FDA has been developing its HF strategy over the last 18 years (2) because it recognises the important role it plays in improving patient safety. In 1999 it was found that up to 98,000 deaths in US hospitals were due to medical errors (3), and that human factors were an important contributory factor. With this type of insight driving them, the FDA’s Human Factor team published a significant guidance document in 2000 (4) which the new guidance will supersede.
There will undoubtedly be shockwaves the first time the FDA rejects a submission on usability grounds. In order to avoid nasty surprises, it’s well worth looking at how you currently develop medical devices and ways in which you can put the right processes in place to address any gaps. The guidance defines the 7 chapters required for the report, and points to how each chapter of work might be completed.
FDA Human Factor Engineering Report, prescribed chapters (1)
1. Intended device users, uses, environments
2. Description and images of device user interface
3. Summary of known use problems
4. Use tasks: descriptions, risk priorities, success criteria
5. Summary of preliminary evaluations
6. Validation study protocol and results
7. Conclusion
Does this sound like lots of work and a bit of a headache?! Well, it’s true that changing design processes can be challenging, but the rewards should be worth the effort. By ensuring that usability is considered early in a development programme, a device company can ensure a less stressful submission, but more importantly stands to uncover insights into their users lives and usage experiences that enable the development of standout devices.
The deep understanding gained from usability engineering when integrated with the design process can please and surprise the user with the elegance of the device delivered. And, to cap that off, the device risk profile will be robustly reduced, through the sound understanding of potential use risk issues.
So if you are prepared, the new FDA guidance should offer nothing to fear and adopting the practices described should ensure your devices are a delight to use.
Cambridge Design Partnership provides Usability Engineering solutions to a wide range of product sectors including drug delivery, medical diagnostics, consumer and industrial. We can offer modular research activities to provide early understanding of your customer needs, through to a holistic and integrated user centric development programme compliant with global usability standards. For further information about our Human Factors engineering capabilities and how we can help you to navigate the changing regulatory landscape, please email Ian Scrimgeour and the team on [email protected].
Look out for a further blog with an analysis of the 7 report chapters required by the guidance document and an overview of the tasks required to complete them.
1. FDA HF Draft Guidance Doc. US FDA website. [Online]
2. Human Factors/Usability for Medical Devices: An Historical Perspective. FDA CDRH website. [Online] Cited
3. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors and Committee on Quality of Health Care in America, Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC : The National Academies Press, 2000.
4. Kay, Ron and Crowley, Jay. Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. FDA guidance documents. [Online] 18 July 2000. Cited
About Cambridge Design Partnership
Cambridge Design Partnership is a consulting company that develops 'first of a kind' products in the medical, consumer and cleantech sectors. We combine leading engineering talent with business acumen and a deep understanding of the technical and human needs that drive innovation.
Cambridge Design Partnership’s multi-disciplined experts and proven process will benefit any multinational or ambitious company aiming to maximise their return on investment in innovation.
Working as an integrated team, the company creates new products with a dynamic, flexible approach that leads to enduring client relationships, anchored by high quality work and excellent customer service. Our diverse team of engineers, scientists and designers has grown rapidly to establish a world-leading reputation for technical excellence, astute project management and, above all, thinking differently.
__________________________________________________