Human factors in the medical device industry

There has been a growing emphasis on human factors as a part of the product development process in the medical device industry, in the past few years. In fact, the human factors and ergonomics society even conducted a special symposium on human factors and health care, wherein medical device design was a special track. So, why the sudden demand for human factors in the medical device industry? A lot of this demand is driven by regulatory requirements and I attempt to describe some of this in this blog.

Several medical device directive (MDD) and active implantable medical device (AIMD) changes took place in 2010. This impacted multiple functions (e.g., Regulatory, risk management, technical communications) and had an effect on legacy, ongoing, and future products. For example, the crux of the MDD changes included:

• Designing and manufacturing medical devices in such a way that when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users.
• Reducing the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used.
• Considering the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users.

In summary, essential requirements related to human factors and ergonomics was added to MDD and AIMD.  As part of the MDD/AIMD work, two human factors engineering standards, EN 60601-1-6:2007 and EN 62366:2008 were harmonized and was in effect.

 So, what is EN 62366? 

• This is a ‘process standard’, that tells a manufacturer the process to  analyze, specify, design, verify and validate usability, as it relates to the safety of a medical device.
• The standard focuses on the need to provide adequate usability such that the “risks resulting from normal use and use error are acceptable”.
• The standard focuses on identifying and mitigating design-induced use error.
• The standard discusses the need to validate primary operating functions.
• Overall, this standard emphasizes a more formal human factors process that combines analytical and empirical methods to detect as well as mitigate use error.
• The standard also requires the maintenance of a usability engineering file and associated documentation that human factors work was done. However, the process is scalable.

In 2011, FDA published a draft guidance on “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” for comment purposes. The comment period is complete but the effectivity date for the guidance is still TBD. Overall the FDA draft guidance is very similar to EN62366.  However, some key differences exist:

• The FDA draft guidance focuses on using analytical and empirical methods very early in the project lifecycle to identify and mitigate sources of use error.
• There are clear expectations for handling, documenting, and resolving use errors.
• The guidance discusses a human factors engineering summary report, which is very elaborate and prescriptive.

As a human factors advocate, I believe that irrespective of the regulatory driven requirements, human factors should be an integral part of the product development lifecycle in medical device industries (or any industry) so as to create products that are not only safe but also improve user workflow and efficiency.  

Is pessimism good for older adults?

According to this article published in the Journal of ‘Psychology and Aging’, pessimism about the future can make older adults live more healthier and longer lives. The key excerpt from this article is summarized below:

• An extensive longitudinal study was conducted with individuals aged 18 to 39 years old, 40 to 64 years old, and 65 years old and above, from 1993-2003. The individuals were asked to rate how satisfied they were with their lives and how satisfied they thought they would be in five years, using a 0-10 scale. This data was collected via in-person interviews.
• There were interesting age related differences. Younger adults had more optimistic expectations about the future, middle aged adults had more stable expectations, and older adults had more pessimistic expectations about the future. Younger adults do not have much experience with life and therefore have a positive outlook, which helps them to pursue their goals. At middle-age, adults form a more realistic outlook of what to expect from life. Older adults perhaps have a more pessimistic attitude towards life compared to middle-aged and younger adults because they know that their time is limited and want to enjoy their present rather than expecting things to change in the future.
• Interestingly, pessimism about the future among older adults was associated with a lower decline of health. In other words, a darker outlook on the future makes older adults live a more cautious life, contributing to better health outcomes.

Photo credit: Rhoda Baer, via Wikimedia Commons. 

Responsive design

Mashable has termed 2013 as the year of responsive web design. According to this article:

• We are in the post-PC era, where PC sales are falling while tablets and smartphones are in popular demand.
• Supporting mobile web is very important because majority of the users prefer reading content in mobile web versus having a specific app.
• With the plethora of devices that technology consumers interact with today, it is important to design a website in such a way that it is supported in multiple devices. The solution to this is responsive design.
• In short, responsive web design is a term that is used to denote a design approach that aims at designing websites that provides an optimal reading experience across a range of devices, from desktop monitors to mobile phones to tablets, and a range of browsers.
• So, how is this done? Responsive design uses media queries to determine the resolution of the device in which the website is being run and based on that resizes the image and the content.
• The obvious advantage of the responsive design technique is that you need to create the website only once and it works on different devices. This does require planning ahead of time. Understanding the organizational layout, navigation and searching methods across the various device platforms helps to create web designs with the appropriate content and layout that will provide a good user experience across platforms.

Using this website, you can check out how your website would look in an iPhone, iPad, a small tablet, and a small phone.

Photo credit: Muhammad Rafizeldi, via Wikimedia Commons.

Uncovering drug interactions from search queries

In this video, Dr. Eric Horvitz, Distinguished Scientist at Microsoft Research, discusses how search queries in the web can give doctors and drug companies information on the side effects of drugs or even the interaction between different drugs that has been overlooked during clinical trials. The summary from this talk:

• Nearly two-thirds of the people in the web are looking for health care information and to do self-diagnosis.
• Dr. Horvitz and his collaborators used this search information to determine potential drug interactions from 82 million search queries on Bing, Google, and Yahoo.
• They found that if a popular anti-depressant and a popular cholesterol-lowering drug are both taken by the same individual could cause a rise in blood sugar. 
• Dr. Horvitz believes that this technique can be used to detect dangerous drug interactions earlier than the FDA's adverse event reporting system.
•  The same line of reasoning can be applied beyond drugs to medical devices. For example, medical device companies can use this method for post-market surveillance, to understand the impact of medical devices on users and/or patients.
• In short, the world wide web becomes a hub for health care.

Photo credit: J. Troha, via Wikimedia Commons.

Too hot, too cold?

This is an interesting article by an environmental psychologist, discussing the role of temperature on knowledge work. Research has indicated that the most optimal temperature for doing office work is around 72 degree Fahrenheit. Besides the actual temperature, human perceptions of temperature are also influenced by environmental design characteristics such as the colors of the walls, with rooms painted with warmer colors perceived as being warmer. Value systems also play a role in the perception of temperature. For example, if you are a conservationist, you may perceive the room to be much warmer compared to others.  

Seems like it is not such a good idea to keep the conference rooms so cold if you want your meetings to be productive!

Photo credit: Andy Butkaj (Flickr), via Wikimedia Commons.

Reducing the fear factor during medical procedures

This article in this month’s issue of ‘Monitor on Psychology’ describes how strategies such as distraction and exposure therapy can be employed to reduce anxiety among patients, specifically children, who face medical procedures.

The article talks about how anaesthesiologists are using cartoons help children stay calm in operating rooms.  Researchers are also exploring the usefulness of video games to reduce anxiety. In one study, researchers had one group of healthy children watch footage of the game ‘Finding Nemo’ while another group played the game. One hand of the children in both groups was immersed in ice-cold water. The study showed that the children who were actively engaged in the game showed more tolerance to the pain, compared to the children who only watched the video footage. Why is this the case? This is because actively playing the game requires the use of executive cognitive processes that reduce the perception of pain. Research is also underway to determine the type of games (e.g., action games, mellow games) that are most beneficial in reducing anxiety and manage painful medical procedures among children (and clearly, there will be individual differences).

Exposure therapy is also another technique that is used to lower anxiety levels. For example, simulated medical procedures are used to expose children to sights, sounds, and smells associated with the procedure as well as the equipment that will be used during a procedure. 

These techniques should be kept in mind when designing workflows and systems to create an optimal user experience for patients.

Photo credit: Danielle Grannan, via Wikimedia Commons.

Warning Labels

This Forbes article provides a list of really amusing warning labels.  From a label on an egg carton stating that the product may contain eggs to the label on a vanishing marker stating that it is advisable not to sign legal documents with the marker, these labels are really entertaining!

So, what can practitioners do to develop meaningful warning messages? This paper provides guidelines for developing warning messages for products. The highlights include: 

• Use less text
• Explicitly tell users what to do
• Use simple words and not technical jargon
• Use words such as ‘danger’, ‘warning’, and ‘caution’ to signify the hazard level
• Avoid abbreviations
• Bullet the steps
• Use active voice 
• Use mixed case and not all CAPS
• Left justify text
• Orient messages to facilitate reading from left to right