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BERGO is developing a software tool called usepaq

Posted on 19 June 2017

Usepaq, which is being developed by BERGO, is a software service for medical device companies. The service provides a 'paq' of industry-recognised tools for performing usability analysis and evaluation.

We anticipate a first release of the service in early 2018. If you'd like more information, please get in touch.

 

Human Factors/Usability Engineering Report for the FDA - Issued 3 Feb 2016

Posted on 17 February 2016

The FDA has recently released updated their human factors guidance document, titled 'Applying Human Factors and Usability Engineering to Medical Devices' to reflect their thinking on human factors.

The purpose of this document is to assist industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle. The recommendations are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls.

A HFE report is described for inclusion in Pre-Market Applications (PMA) or as requested by the FDA. The key sections are:

  • Conclusion
  • Descriptions of intended device users, uses, use environments, and training
  • Description of device user interface
  • Summary of known use problems
  • Analysis of hazards and risks associated with use of the device
  • Summary of preliminary analyses and evaluations
  • Description and categorization of critical tasks
  • Details of human factors validation testing

The FDA has provided details on when this report is expected. For instance, if risks of use-error are between moderate-high or if a manufacturer makes a design modification to a marketed device due to use-related problems.

 

BERGO gets a Journal Paper Published

Posted on 13 June 2014

In collaboration with one our clients, Ypsomed, we recently had a paper published in the Journal of Medical Devices: Evidence and Research.

The article presents a late-stage formative usability study, carried out by BERGO, of a pen-injector platform device.

View paper

 

BERGO in Southeast Asia

Posted on 9 June 2014

Organised by the Association of Malaysian Medical Industries (AMMI), BERGO recently delivered training courses in usability engineering in Penang and Kuala Lumpur.

Attendees consisted of industry professionals from manufacturers and the Medical Device Authority, Ministry of Health Malaysia. Given the recent implementation of a regulatory framework in Malaysia (Medical Device Act 2012), coupled with the heightened recognition of the industry by governmental agencies, this was an exciting time for BERGO to work within this market.

View our next courses

 

Human Factors Validation test of Infusion Set in United States

Posted on 2 February 2013

Validation Testing in US

Last month, BERGO was in the United States facilitating a human factors validation test of a subcutaneous infusion set for a Danish manufacturer.

Partnering with a local market research agency, nurses and lay users were recruited for the test, which was conducted at Maimonides Medical Center in New York.

View more projects

 

FDA Draft Guidance on Devices for Home Use - Issued 12 Dec 2012

Posted on 4 January 2013

This draft guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements.

Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.

 

Medtechinfo Interview with Dr Nick Bradley, Manager at BERGO

Posted on 30 September 2012

Medtechinfo Article

In the September edition of the Medtechinfo magazine, an article was published on an interview with Dr Nick Bradley, the manager at BERGO.

Nick responded to questions about the the current climate of usability engineering in the medical device industry, the challenges faced by manufacturers in meeting the requirements in Europe and United States, the future direction of the usability profession and possible revisions to standards.

Download this article (in Swedish)