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If You Think HFE is Just About Regulatory, You’re Missing the Point
Eugene Canavan
Healthcare Design Director
Eugene Canavan is an industrial designer and HFE specialist who has worked in consumer and medical product development for 23 years. He is the director of the Healthcare team at Design Partners, a strategic product & interaction design consultancy. Eugene is a visiting lecturer for the medical device design course at the National College of Ireland, Dublin University Bio-engineering and external examiner at CIT design-core, Ireland. Eugene is currently mentoring a PhD in Human Factors Engineering of surgical devices at University of Limerick.
If you think that the Human Factors Engineering (HFE) process is just to answer a regulatory requirement, then you’re missing point. Design Partners have over 35 years of product design and development experience and we have seen first-hand where the HFE process correctly applied provides a significant commercial advantage with significantly superior user experiences and end -product solutions. HFE is a regulatory requirement, but it is also a cost reduction and strategic product development tool.
The Challenge
In the sphere of modern healthcare, patient engagement, education and independence are recognised as critically important in returning patients to full health. More and more healthcare treatment approaches recognise that the patient is a key stakeholder in defining the appropriate therapeutic approach and subsequent treatment course of action.
The earlier HFE is applied in design, the cheaper the cost and the greater the benefit. The cost of catching and solving usability design problems early in the design process costs about one-fourth of what the same changes made late would cost
M. Mantei and TJ. Teorey, 1988
A combination for change
This ‘therapeutic alliance ‘where healthcare professional and patient combine, places end users, patients or healthcare consumers at the centre of healthcare solutions like never before. Increasingly the home is recognised as a medical care environment. In this context, the healthcare consumer is the primary user, rather than the healthcare professional. In this situation, as the end user is not a clinical professional, the bar for good usability, risk reduction and solution optimisation is extremely high.
In the professional healthcare environment, the safety and performance of medical equipment and devices are paramount to effective care delivery and outcomes. The requirement for manufacturers to deliver both safety and performance can be a challenge given the context of use and the use environment.
HFE Can Help
So, have you ever wondered how you know that you’re doing the right thing? That your project is going in the right direction? That the right questions are being asked of the right people? That the solutions answering those questions are appropriate and are being tested? Have you ever wished that you had user-focused data to support product requirement and project direction decisions?
The HFE process has been developed to answer these questions, to provide the data required to support decisions and reduce risk. This also ensures that the end user and their needs remain present throughout a development life cycle. The correct application of a HFE program and process is a strategic product development tool, cost containment and cost reduction tool as well as a regulatory requirement.
HFE as a strategic Tool
User-centred design enhances brand perception, while user-focused research and testing provide insight and market intelligence to inform solution optimisation. The process maintains an end user perspective through the development cycle and ensures that the right decisions are made for the right reasons.
Usability is a de facto requirement, if not an explicit law. Moreover, medical device manufactures are practically required to conduct usability tests as a matter of due diligence
M. Wikund,2011
Cost containment and reduction
Integrating the HFE process into the product development cycle can also reduce cost and time to market as user needs are defined early and tested throughout the design process, providing data-based design guidance to support decisions and validation planning.
Regulatory Compliance
Of the world’s leading medical device providers, over 30% have experienced device recalls due to human factor problems. Medical solutions have an increasingly direct impact on the health and welfare of millions daily. Recent changes to Medical Device Regulations have seen a reassessment of the importance of human factors relating to device success, risk and safety. For this reason, HFE processes must be adapted and incorporated into risk management.
It would be unheard of to put a mechanical design into production without extensive prototyping, verification and validation. However, the human element providing the intelligence is often left to chance. HFE is a regulatory requirement but, applied well, it is also a strategic product development and cost containment tool essential to commercial success.
We are proud sponsors of The 4th Annual Human Factors Engineering & Usability Studies Summit
February 4-5, 2019 | Hyatt Centric Fisherman’s Wharf, San Francisco, CA
If you would like to arrange to meet with our team at the event you can mail us at hello@designpartners.com or connect with us via our LinkedIn page.
The 4th Human Factors Engineering & Usability Studies Summit provides in-depth insight on working with multiple user groups, improving the user interface of medical device software and apps, and properly siting human factors engineering into device life cycles to avoid wasted time, money, and reputational damage. No other West Coast conference offers such a specific focus on the usability needs of the life science industry.
