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Pharmaceutical Manufacturing and Packing Sourcer

The Human Factor

Pharmaceutical companies are increasingly using delivery devices as a primary differentiator in a market that is becoming more and more competitive. At the same time, regulators have adopted new human standards, introduced over the past few years, which means that all devices now need to undergo rigorous usability evaluation at every stage of development. This is increasingly important as it is becoming more common for devices to be used by a patient population that has less experience and training than healthcare professionals.

In recent years, several new standards covering human factors engineering have been developed, notably HE74, HE75 and IEC62366. In the last two years the FDA first adopted IEC62366, which focuses on the human factors process employed in device development (this standard essentially replaces HE74 and may well replace ISO60601-1-6 in the longer term). More recently, the FDA has also adopted HE75, which provides a reference on key human factors topics, such as visual displays, packaging design and general design principles. The FDA now expects companies developing drug delivery devices to follow these standards, or at least demonstrate an equivalent approach. Furthermore, their uptake will have a significant effect on the design and engineering process, hopefully bringing benefits in terms of reduction of use errors for a wide range of medical devices.

Human factors play an important role in regulatory compliance (which demands safety and mitigation of risk), market differentiation (which relies on effectiveness), as well as several grey areas in between where factors affecting safety and effectiveness interact and sometimes conflict with one another. The new standards provide sensible guidance on how to incorporate human factors research throughout the development process, and will hopefully reduce the number of design iterations required to develop devices that better meet patient needs alongside those of other key stakeholders, such as prescribers and payers.

Ensuring the usability of a drug delivery device is important on three levels: first, it should be safe for use and pose no risk to the user; second, it should be designed in such a way that the intended user can and will use it in the way it is meant to be used; and finally it should be designed in a way that makes the user want to use it. While the first of these is arguably the most crucial, the second and third will also have an important impact on patient compliance and, therefore, clinical outcomes.Whatís more, consideration (or lack thereof) for the second and third can have an undesirable impact on the first. Ultimately, the emphasis put on each stage will depend largely on the stage of maturity of the device in question, as well as the competitive landscape, reimbursement, regulation and time in the market. For example, in the diabetic market, insulin pens have been available since the early 1980s and have evolved through a number of design generations which have successfully improved usability and patient appeal. In contrast, single use auto-injector devices used in the treatment of rheumatoid arthritis are relatively new to the market, and the designs are less mature, so there is still an opportunity to create differentiation and improve usability. More complex devices emerging today, such as wearable pumps and other electronic delivery systems, present more opportunities for usage error, which was a key driver for the introduction of new regulations.




ďDonít Hurt MeĒ

By requiring companies to track user feedback and justify proposed error mitigation approaches, the new standards emphasise the important role that usability plays in product safety. Device manufacturers must apply human factors research at all stages of a productís development in order to prevent risk of injury and minimise the potential for user error. Whatís more, they are required to prove how this has been done. This calls for rigorous processes that identify potential hazardous scenarios, assess the likelihood and severity of these cases and put mechanisms in place to prevent accidents and minimise their impact. None of this can be done effectively without a thorough understanding of the target userís traits, characteristics and behaviours.While this is a challenge, the good news is that there are wellestablished tools to help device developers do this.

Context Exploration

Context exploration tools help define and understand the target user(s) and their environments. This will involve task analysis and the exploration of use scenarios, potential user errors and hazards. Exploring capability, including the physical, cognitive and sensory boundaries of each user profile, should also be a key part of human factors testing.

User Perspective Exploration

User study tools come in a number of different forms, but the aim is to explore potential use errors and hazards, user preference and instinct, physical and cognitive demand, user performance and capability boundaries, and so on. This should include a cross section of all potential user types, including patients, care givers and healthcare professionals. As illustrated in Figure 2, capability is measured on seven different levels: vision, hearing, thinking, communication, locomotion, reach and stretch, and dexterity. While one personís sensory and communications capabilities may be considered high, their physical capabilities may be low.The importance of each level of capability will depend on the device that person is expected to use.

Justification and Documentation

All FDA documentation now needs to include an explanation of the companyís plan for managing and mitigating possible risks. There are many tools that can be used to address this requirement. A single document approach to tag and trace all potential usability issues is perhaps among the best. Regardless of format, companies will need to justify their device Source: www.inclusivedesigntoolkit.com decisions from the perspective of the user. In the past, the FDA may have accepted a design goal that Ď80 per cent of users must be able to open the device first timeí, they now want to know more about the 20 per cent that couldnít Ė what they did, why they did it, and what is the resulting safety risk. A plan to mitigate or control expected or actual usage error will also be required.



ďI Can (and Will) Use ItĒ

Product safety is a minimum requirement for any medical device, but even a safe product will be rendered ineffective if the intended users canít operate it properly or choose not to use it. If the effective delivery of the drug depends on the proper (not just safe) use of the device, then device developers must adopt inclusive design principles in order to gain a thorough understanding of the usage drivers and barriers. To do this, itís important not to make assumptions about large patient groups. For example, while diabetes does affect a patientís eyesight, which should be taken into account when designing an insulin pen that requires the user to read a display, itís also important to recognise that diabetes affects a broad range of the population (young and old, active and fragile, and so on) Ė subsets of which will display different capabilities and behaviours.

A personís ability to operate a device will depend on his or her cognitive, sensory and motor skills. If a device intended for use by a patient population is known to have poor grip but requires a sharp twist to function and deliver the drug, it is unlikely to be effective.

Even if physiological factors donít prevent a patient from being capable of using a device, they may affect the performance of that device or the patientís motivation to use it. For example, dry powder inhalers for the treatment of asthma and chronic obstructive pulmonary disease rely on the userís lung capability to disperse and aerosolise the drug and transport it to the lungs. Research has shown that even a healthy personís lung characteristics vary greatly with age and height, meaning that an inhaler designed for adults will not be as effective or as comfortable to use for children. If a device is uncomfortable or unnatural to use, it will be difficult to ensure compliance.

A personís ability to remember to administer his or her drug is also an important factor to consider when designing a drug delivery device. With this in mind, continuous infusion devices are being developed that reduce the frequency with which the patient needs to administer their own treatment. In this case itís crucial to find the right balance between reducing the burden on a patientís day-to-day life and making the treatment so unobtrusive that the patient could forget altogether. Reminder mechanisms can also be built into devices, but can actually have a demotivating effect as they serve to remind the patient about their disease. One solution is to integrate reminders into the userís normal day-to-day environment. For example, if a person is accustomed to receiving reminders for other day-to-day tasks via his or her smartphone, the addition of a reminder to administer the treatment is less likely to feel Ďabnormalí. Similarly, technology can also be used to monitor a patientís use of a device, assisting with feedback and ensuring compliant use. However, the level of technology integrated into a device should depend on the capabilities and attitudes of the intended user base: while technology may encourage younger patients to comply, it may actually discourage older generations who are less comfortable using technology and wary of relying on it. Due consideration should be given to how much of the deviceís operation and feedback mechanisms are dependent on technology versus user input.



ďI Want to Use ItĒ

Being willing and able to use a drug delivery device effectively is one thing, but wanting to do so is another matter. The powerful combination of good usability and design of a device can have an important impact on consumer motivation and can be a key market differentiator for drugs in mature markets where the drug and formulation patents have expired. Not only can it impart brand loyalty among patients and subscribers, but most importantly, it can have a major impact on user compliance and, therefore, clinical outcomes.

Rather than focusing on their own brand identity as a means to maintain consumer loyalty, device manufacturers would do well to remove barriers to use by focusing on the lifestyles and preferences of their target users. By designing devices that blend in with a personís lifestyle and daily routine, the patient is less likely to be embarrassed or reluctant to use it.Market segmentation is therefore crucial: a diabetic who needs to take their medication while at a restaurant might want something that is discreet, fast and can be done one-handed without looking; other users may want a rugged, sporty device or one that is business-like or more style conscious; others may have no regard for style and prefer a device that is solely easy for them to use. Children are an important market segment too, particularly for conditions such as asthma and diabetes. For this group, motivation to use a device can be encouraged by introducing an element of fun or reward. For example, an inhaler device may be configured to make a fun noise when the child inhales correctly or, distinct from the device itself, the child could be rewarded with an electronic game to play each time a dose is correctly administered at the right time.

Medical device manufacturers can learn a thing or two from the consumer industry in this regard, but must also pay due consideration to the impact that style and discretion could have on practicality. For example, with some auto-injectors it can be hard for a user to distinguish the needleshield at one end of the device from the actuation button at the other. This has been known to cause some patients to inject into their thumb because they hold the device the wrong way around.

Sensible cues are crucial; while there may be a desire to hide the fact thereís a needle for aesthetic and social reasons, there are ways of doing so that will maintain the safety of the device. It is important to make sure that people are aware of the presence of a needle, so that due steps can be taken to ensure the safety of the user and those around them.

Seizing the Opportunity

The importance of human factors is clear to see; not only is consideration at every stage of the product life cycle now a regulatory requirement, but it is also good design practice. Ensuring a productís usability can be challenging because so many human factors interact and conflict with one another, but it should also be viewed as an opportunity for pharmaceutical companies striving to prove comparative effectiveness.

Emerging technologies will have an important role to play as pharmaceutical and medical device companies seek to improve the usability of their products. Innovating around the improved use of existing drugs carries much lower R&D costs than developing new molecules and also eliminates the commercial and patient risks associated with bringing a brand new drug to market. Advances in technology are already leading to the development of new delivery approaches and technology-driven improvement of existing drug delivery devices, such as the ability to develop smaller and more discreet products. The technology that more and more of us already have in our pockets is also an opportunity for pharmaceutical companies to seize; for example, smartphone apps can be developed to help patients manage their conditions and improve compliance.

While the most important consideration for any pharmaceutical company developing a drug delivery device is ďdonít hurt meĒ, the new standards also bring with them a requirement to understand users and user scenarios. Although this is a challenge, itís also a huge opportunity to improve user compliance and reduce the total cost of treatment for many chronic conditions through a reduction in wasted drugs and missed opportunities to prevent a patientís condition from deteriorating.

Time will tell if the new standards can really support a drive to improve usability and compliance, but they do offer a positive step in the right direction. They should be embedded in pharma companiesí development processes in order to, at the very least, meet mandatory requirements. However, ideally companies will see the benefits in going beyond this basic regulatory need and will strive to develop devices that can appeal to the user on all three usability levels outlined in this article.


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Iain Simpson is a Principal Consultant in Drug Delivery at Sagentia, and has more than 10 years of experience in drug delivery including technical due diligence and project management on inhaled and injectable delivery technology development programmes. He has a degree and PhD in Physics as well as an MBA in Technology Management. Outside drug delivery, Iain maintains a broad interest in R&D and the uptake of new technologies, and is a past chairman of the R&D Society. Email: iain.simpson@sagentia.com

Kay Sinclair is a human factors and usability expert at Sagentia and has more than 15 years of experience focusing on early stage product and service development. Her expertise range from the diversity of customer understanding approaches and inclusive design to large scale advisory project management. She has a degree in Product Design Engineering from the University of Glasgow & Glasgow School of Art, and a Masters in Design, Manufacture and Management from Cambridge University. Email: kay.sinclair@sagentia.com

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