News: Medical device design webinar


The CIEHF hosted a unique, six hour joint webinar with the Human Factors & Ergonomics Society (HFES) of the United States. The programme involved speakers from both sides of the Atlantic commenting on regulatory issues, design challenges and human factors developments and applications in medical device design. The recordings from all but one of the hour long presentations, are now freely available.

‘A trio of thoughts: lessons from a successful combination product submission, simplifying use related risk assessment and expanding PCA’ by Richard Simcock of Ergonomic Systems Ltd

  • Key aspects of a successful medical device development project from project specification through to submission, from specification of user groups, clearly communicating use-related risk assessment, through usability testing of the device and the all-important HF Summary Report.
  • Thoughts on simplifying use related risk assessment and strictly controlling how it is conducted to ensure that use related risks are thoroughly analysed and not underestimated, but equally, not unnecessarily over-analysed with respect to such things as probability/ likelihood.
  • Thoughts on expanding how we consider PCA analysis within the medical device development process, in a way that provides additional support to people analysing the role of device use, than is currently within the related human factors standards.

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‘Making Contextual Inquiry Really Effective’ by Stephen Wilcox of Design Science (Philadelphia)

To be effectively used, contextual inquiry must be accurate and thorough, and the results must be presented comprehensibly, despite their inherent complexity. Here are some new ideas to address each of these issues - new ideas for gathering information and new ideas for presenting it. Regarding gathering information, two ways of supplementing direct observation and basic video are to apply new, more sophisticated video techniques and to use measurement tools to obtain additional objective data. Regarding the presenting of information, important tools include new types of information graphics and new ways of presenting video. The goal is to provide a body of information that product-development teams can use to create superior devices and systems.

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‘Usability study for an intraoperative probe’ by Miranda Newbery of Inspired Usability Ltd

Radio guided surgery is a growing field that potentially allows surgeons to identify and remove cancerous cells during surgery. But how do you help inform the design and assess the usability of such a device before you have access to working detectors and radiopharmaceuticals? This talk describes the process and challenges during the development of a laparoscopic gamma probe for radio guided surgery in prostate cancer.

‘Getting to the bottom of use error: Approaches to root cause analysis’ by Michael Wiklund of Emergo by UL

Human factors specialists employ the term use error to describe mistakes that people make when interacting with products. The term recognises that a mistake may be due to blunder or induced by poor user interface design. Learn how to take a structured approach to determine the likely root causes of use errors that occur in real and simulated use scenarios: 1) develop a hypothesis, 2) examine user’s opinions about an error, 3) inspect the device’s user interface for deficiencies, 4) evaluate the use environment’s influence, and 5) form a final hypothesis or factual finding.

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‘Medical Human Factors Network and framework for ethical standards in medical human factors studies’ by Miranda Newbery & Louisa Harvey of  the Medical Human Factors Network UK

The Medical Human Factors Network UK was set up in 2018 by Miranda Newbery and Louisa Harvey to help develop human factors practitioners in the UK. The network aims to give the UK HF community more of a voice when discussing key HF topics globally and to keep our community growing. Their initial focus has been on ethics in HF research. This presentation introduces the network, an overview of current HF study trends from an ethical perspective, ethical considerations of HF studies and a proposed consideration for ethical code of conduct for medical human factors research.

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‘Common shortcomings in new device and combination product submissions to FDA’ by Ronald Kaye of Human Factors Focus

Submission of HF materials for new devices and combination products to FDA are too often, and unnecessarily, fraught with shortcomings that result in requests for additional information, including partial or complete re-testing. This webinar covers the major shortcomings observed when reviewing HF at the FDA and why these persist. Incomplete identification of critical user tasks are discussed with unacceptable HF test methods, incomplete (or meaningless) HF data, inadequate analysis of data, unsupported conclusions regarding medical device or combination product safety and effectiveness of use, and (use-related) residual risk.

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