Feature Article

Designing a great medical product means that it has to be safe. Designing a great consumer product means that people have to love it. The medical experience and the consumer experience are generally seen to be poles apart—medical is something that is imposed on you and consumer is something that you seek out. A medical device is tolerated while a consumer product is enjoyed. These conceptions are reflected in the design: medical products generally look serious and functional, while consumer products are meant to evoke a delightful feeling from users.

Historically, the target user groups for medical and consumer products have been considered to be very different from one another. In reality, these two groups are one and the same – they are people. So how do we approach the patient/consumer (i.e. person) to incorporate his or her needs into medical device design?

We are seeing a growing overlap between the medical space and the consumer world. There is a shift both in people’s attitudes and in healthcare agendas from disease management towards wellness maintenance. We are seeing this in emerging areas such as connected health and consumer wellness, but also in more traditional areas, including drug delivery.

Placating the worried well
Connected health and health monitoring solutions, such as telemedicine products and other connected devices, need to become a constant in people’s lives because adoption is key to the success of these products. Adoption hinges on ensuring seamless integration into people’s everyday lives. Consumer wellness products—which are not medical devices, per se, but items that support a healthy lifestyle such as heart-rate monitors, pedometers and the like—face the same challenge. Both product categories are tangential to medical products in that they may be regulated but are not prescribed. As such, they typically are not reimbursed, so people must feel compelled to spend their own money to buy them. These are products that must speak to the so-called worried well or to caregivers concerned about ageing parents, for example.

Even in the traditional drug-delivery space, we are seeing a shift towards a consumer-style approach. For the management of conditions such as diabetes, where there is more choice in therapies, there is also greater brand differentiation among products and a move towards a more consumer feel for items such as injection pens. Also, with the proliferation of biologics, the advent of new drug-delivery technologies, and a shift from inpatient hospital care to outpatient and home care, acute recovery and chronic conditions alike are increasingly being managed at home, and many of them require the delivery of complex drug regimens. These trends are driving the need for easy-to-use self-administered delivery systems that can be used either in the home or clinical setting.

Survey on combination products
Drug-delivery devices intended to be used by patients or lay caregivers are classified as combination products by US FDA. A combination product is a product composed of any combination of a drug, device, and/or biological product (i.e. two or more regulated components). Prefilled syringes, insulin injector pens, metered dose inhalers, transdermal patches, drug-eluting stents, and catheters with an antimicrobial coating fall into this category. Cambridge Consultants, in conjunction with MassMEDIC, recently conducted quantitative research on the patient-related drivers around these types of drug-delivery combination products. We surveyed patients about their experiences and priorities in selecting drug-delivery devices, and we also interviewed healthcare providers about the role of the drug-delivery device in treatment decisions and in patient medication compliance.

The patient surveys were conducted with more than 240 diabetes patients, all of whom use a combination product (such as a vial and syringe, prefilled syringe, injection pen or insulin pump) to administer their medication. This research showed that patients are aware of their options and are driven, to a certain extent, by lifestyle factors such as discretion, portability and feature sets. The study also demonstrated that there is some willingness among patients to pay more in order to get the features and convenience that they feel are important.

When patients were asked if they were offered a choice of devices to use when their medication was prescribed, 75% responded yes. And when we asked patients who had been given a choice how they selected their drug-delivery device, predictably, the largest percentage said that they just took their doctor’s recommendation. Running a close second, however, a substantial number of patients said that they did their own research and even tried out different devices before making a selection.

We also asked patients if they had ever asked their doctors if they could change the drug-delivery device they were using. More than one-third of them indicated that they had. The primary reasons cited for requesting a change were lifestyle factors such as discretion or device portability, as well as the advent of newer technologies.

When asked, most people will say that they want newer technology and/or better features, but there is typically scepticism about people’s willingness to pay extra for those things—particularly around medical devices. To address this discrepancy, we asked patients the following question: “If a device was available that was easier to use than your current device, but it cost slightly more (approximately US$5) than your current device, how likely would you be to pay more out-of-pocket for the easier device?” Even with the increased out-of-pocket cost, more than three-quarters of patients indicated that they would be either “somewhat” or “very likely” to change devices.

These overall findings indicate that patients are aware of their options and are driven, to a certain extent, by lifestyle factors such as discretion, portability and feature sets, and there is some willingness to pay slightly more to get the features and convenience that they think are important. In other words, patients are behaving more like consumers in their approach to drug-delivery systems.

As part of this same survey we also conducted interviews with physicians and nurse educators who either prescribe these types of devices or train patients how to use combination products. These professionals came from several specialties including paediatrics, orthopaedics, internal medicine, gastroenterology, and diabetes education. The feedback received from healthcare providers provided further validation of the idea that there is a patient-driven component to the selection and commercial success of drug-delivery devices.

All of the healthcare providers questioned stated that they believe the usability of the delivery device has an impact on patient compliance with the medication therapy. They indicated that efficacy of the medication is a primary concern in making treatment decisions, but that they may not prescribe a medication if they don’t believe that the patient can be successful with the dosing requirements. One diabetes educator expressed the idea of matching the drug to the patient and that, in doing so, “[the delivery device] is a piece of the puzzle—a piece that you can’t ignore.”

This research underscores the fact that the least effective treatment is one that is not taken. And the efficacy of any particular drug therapy is determined by a combination of both drug efficacy and compliance with the dosing regimen.

The five dimensions of patient compliance
The World Health Organization model describes five dimensions that affect medication adherence, including social and economic factors, condition-related factors, therapy-related factors, healthcare team factors and patient-related factors. A well-designed drug-delivery device has the potential to have a positive impact on three of these five dimensions by:

• being simple and easy to use, thus increasing the patient’s confidence in his or her ability to follow the treatment regimen (therapy-related factor);
• using appropriate levels of force and manual manipulation to accommodate a patient’s physical limitations (patient-related factors);
• including appropriately designed and targeted support material to help compensate for the capacity, or lack thereof, of the healthcare system to thoroughly educate patients and provide consistent follow-up (healthcare team).

So how can we maximise this potential and produce drug-delivery devices that best support compliance and ultimately health outcomes?

Human factors engineering (HF) incorporates user considerations into medical device development. It is the study of how people use technology—the interaction of human abilities, expectations and limitations with work environments and system design, as defined by US FDA. HF is integrated into the development process in an iterative manner, typically focused on user research into the safe interaction between people and the medical device under development. But HF also has something it can learn from its cousin—user experience design (UX)—the approach that incorporates user considerations into commercial product development. UX considers all aspects of end-user interactions, not just with a specific product, but with the company, its services and its range of products. UX starts with the intended user experience and builds the product and all of the components surrounding it to support that intended experience to create “a seamless merging of the services of multiple disciplines, including engineering, marketing, graphical and industrial design and user interface design,” as described by the user-centred design consultancy, Nielsen Norman Group.

So if we take the best of HF for medical devices and UX for consumer products and leverage the commonality of tools and methods, we have articulated a new approach to medical device design: Px, or Patient Experience design. Px combines the safety and rigour of HF with the broader lens of a user experience approach to create safe solutions that patients accept more willingly.

Safety, simplicity and ease of use are all of paramount importance for a medical device, but Px means taking a step beyond that to also consider factors such as acquisition, storage and transport of the device. Does the device allow people to store and use it where they want to in their home? Does the device allow people to travel? Does it provide privacy and discretion? Instead of forcing people to adjust their lives to accommodate management of their disease, Px-driven design results in delivery devices that support people’s mobile and active lifestyles.

Beyond the device itself, one must consider how it is packaged, which is often people’s first interaction with a product, and the instructions for use, which are often kept and referred to again and again. There are also starter kit materials, and making sure that they support proper use of the device and reinforce the initial training lessons. These items are all typically designed as afterthoughts to a drug-delivery device, and are not necessarily considered part of the device system or experience.

Broadening the lens even further, there is the device community, which is typically the online presence of the therapy the device is delivering. Providing services such as online troubleshooting or instructions, user interaction groups, tracking applications, or online patient diaries can all support proper use and compliance with the delivery system, and also reinforce the therapy’s overall patient experience.

Improving health outcomes
While medication compliance is a complex topic, an appropriately designed drug-delivery device can go a long way towards maximising patient compliance. Compliance, in turn, is a critical component to the overall efficacy of the treatment itself and, ultimately, to improved health outcomes. The objective is to strike a balance between safety, usability and preference. Companies that start to take a broader view of device development, beyond just safety, and start to address the overall patient experience will be able to realise the potential for better patient outcomes and improved product adoption. Given changes in the broader healthcare landscape, ensuring improved health outcomes is becoming increasingly critical to the financial success of companies providing treatment therapies.
Melanie Turieo
is Group Leader/Principal - Human Factors Engineering, Cambridge Consultants,
101 Main Street,
Cambridge, MA 02142, USA
tel. +1 617 532 4700
e-mail: melanie.turieo@cambridgeconsultants.com
www.cambridgeconsultants.com