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Usability standards herald new era for medical devices

This article has been taken from The Gen newsletter - Autumn 2010.

It has been reported that more than a third of medical device incidents involve usability issues* and that on average 195,000 people die in American hospitals annually due to medical errors**. While the former figure gives no indication of the severity of the incident, and the latter includes all errors, not just those attributed to devices, the figures are sobering nonetheless. Statistics like these, and others like them, have driven the FDA and other regulatory bodies to issue new standards that require usability studies to be incorporated into medical device product design and development.

While the importance of human factors research has never been in doubt, particularly amongst companies where good design practice prevails, its adoption has varied substantially from one device manufacturer to another. The integration and documentation of usability studies into the device design and development process, as called for by the new standards, requires specific skills and approaches, many of which do not currently exist in-house.

There is also the matter of a pressing timeframe: HE75, the new ANSI/AAMI standard, is live already while IEC62366 will be enforced at the end of 2010. While subtle differences lie between the two standards, they are closely aligned. Device manufacturers that wish to sell in the US or EU will need to demonstrate full compliance with one or the other by the end of the year.

The standards are pushing manufacturers to consider the broader applications for their products even if they only intend the product to be used in a clinical environment. The point here is that devices that have been designed primarily for hospital use are increasingly being used in the home and this is causing significant safety risks from the perspective of usability. The introduction of the two standards is forcing manufacturers to think about the wider design considerations, not just those devices that are intended for specialist use but now also those that will be used by patients and their carers.

What we are looking at here is a fundamental shift in the way in which usability is dealt with. At pre-licence review, the FDA is now looking for Design File documented evidence that usability testing has been undertaken throughout the product development process. Secondly, whereas previously a design goal may have been ‘80 per cent of users can switch the device on first time’, the FDA will now want to know more about the 20 per cent that couldn’t – what they did, why and what the resultant safety risk is. A plan to mitigate or control expected or actual use errors is needed. This plan may include, for example, a product modification, changes to the user training manual or printed warnings on packaging. While there is nothing surprising here, the crucial point is that all must now be justified, tested and documented.

At the present time many device manufacturers are trying to determine how best they are going to meet these standards. While usability isn’t a new area, many companies will lack the appropriate specialist skills to unravel and negotiate the complexities of the newly introduced, and more demanding, standards.

For many, usability assessment is a discipline that falls between two functions within an organisation: the marketing department is strongly focused on desirability and fit, but not necessarily usability. Product development meanwhile, will undertake product validation, but often too late in the process for changes to be implemented. And where change is essential, the cost of change could be very high indeed. What we are finding with the device manufacturers that we have spoken to is that there is a significant culture and skill set shift – one that can only be addressed through serious usability design considerations and ‘good’ design practice as a whole.

Over time, as human factors engineering becomes embedded into the product development and design process, current anxieties in the marketplace will diminish. Meanwhile, we believe there are many device manufacturers who can benefit from the expertise we have built up in this area at Sagentia over many years.

A track record in desk based assessment (task analysis, use scenarios, hazard analysis, use error assessment) is complemented by formative and summative study design and implementation (expert capability assessment, user observations, diaries, interviews and focus groups). We can also assist clients in the preparation of documentation for the new product’s Design History File (application specification, usability action log, usability specification, risk assessment).

With established in-house design and engineering groups, we can ensure that human factors research is integrated into the wider design process to ensure the impact of these standards is taken into account across all areas. Our focus on holistic design also means that we can explore the user experience referencing usability, desirability, performance and overall product satisfaction.

The introduction of the new standards has been driven by the desire for improved safety. However, by complying with them, device manufacturers will also benefit from significant commercial advantages. In the case of devices that are specifically designed for consumers or those that consumers will have access to, the internet has allowed greater sharing of information by way of patient forum groups. Bad reviews for a poorly designed product with questionable usability can dramatically and negatively influence sales. The converse, of course, is true for a well received device.

Among the many benefits that will arise from standards compliance are:

Increased customer loyalty and hence sales(due to increased customer satisfaction)
Reduced usability errors which can result in costly product recalls and post market surveillance activities, leading to a faster time to market
Reduction in usability errors that allows devices to be self used in a non clinical environment, hence reducing medical staff time and also potentially improving compliance through better convenience
Improved customer support in terms of simpler user manuals and related learning tools, leading to reduced training and after sales support requirements
Reduced customer complaints and negative comments in internet user forums
Reduced exposure to liability claims

There is little doubt that over the coming months, there will be anxiety and some confusion, as device manufacturers get to grips with the new usability standards. No one, however, is in any doubt that the standards are a significant move in the right direction. For the clinician and patient alike, they will drive forward the user experience and limit user risks. For the manufacturer, the competitive and commercial benefits of a device that incorporates good design, technical innovation and usability, are all too clear.

Usability standards article (PDF)