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By Karl Hewson
We recently brought the highly regarded AAMI (Association for the Advancement of Medical Instrumentation) Human Factors for Medical Devices course to Europe for the first time. Well established in the US, the three day course was held in London last week – with over 60 delegates from world leading medical device development companies attending, representing a wide range of disciplines including engineering, human factors/usability, project management quality systems and regulatory planning.
The course delivers practical usability engineering techniques that can be implemented in any medical device development programme, and gives insights into creating usability submissions for both the USA and EU regulatory regimes. It is aimed at helping companies plan projects and activities to ensure that sufficient human factors understanding is gained to demonstrate to the FDA that the product is both safe and usable.
Such was the demand for the course that it was over-subscribed and registration is now already underway for future classes, scheduled for 2015.
Our usability team were there to meet delegates and to discuss the challenges they face taking new devices to market.
Course leaders Bob North and Ed Israelski drew upon their combined 80 years of human factors experience to deliver the course, informing delegates of the requirements expected for submissions to the FDA. As a valuable addition to the course content, we were joined via teleconference by Ron Kaye who leads the Human Factors pre-market approval (PMA) team at the FDA and is the leading author for their guidance document’Applying Human Factors and Usability Engineering to Optimize Medical Device Design’. Whilst this document has been in draft guidance for a number of years, its principles are considered by the FDA to be a prerequisite for any PMA and 510(k) submission.
Ed and Bob’s risk centred approach demonstrated how many of the common user research methodologies including contextual inquiry, heuristic evaluation and task analysis can be combined with Quality Systems Post Market and Corrective and Preventative Action (CAPA) insight to feed in to use risk analysis activities (uFMEA). The primary focus of these activities is to identify and establish risk mitigation for use error as an independent element to device reliability. Whilst these Formative activities are not the final measurable element within the 7 point HF/Usability Report they form the backbone of the submission and go a long way to establish the credibility and robustness of the application that Ron and his team are looking for. The main demonstrable activity expected by the FDA is a Summative or Validation Test which, through real world simulation, proves that no residual critical use errors, which cannot be reasonably explained, remain within the products intended use.
As well as valuable insight in to the FDA’s Human Factors and Usability expectations, Ed and Bob provided updates on many of the international standards required internationally. Leading the way is the update to AAMI/IEC 62366 which through a number of name changes and omissions moves closer to the FDA draft guidance. This update is currently in final review and is expected to release towards the end of 2014. Interestingly new HF/UE requirements for CE marking and renewal were discussed emphasising the need for companies to now have robust procedures in place to produce product use specifications and evidence of Post Market and CAPA activities as part of their application.
Cambridge Design Partnership is sponsoring the Human Factors for Medical Devices course again in 2015, along with our partners Pure Insight, who helped to organise and plan this course. Reserve your space now to avoid disappointment – as this one was over-subscribed, and bookings have already started!
If you’d like to talk to us about human factors for medical devices please contact our human factors specialists or our medical device team: firstname.lastname@example.org or call 01223 264428.
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