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Designing Medical Devices for Humans

29/02/2012


Steve May-Russell of Smallfry looks at why medical devices that have been 
designed around user needs will result in better compliance.

Noncompliance is a major obstacle to the effective delivery of healthcare. More people are regularly relying on prescribed medication, but many are failing to take it as directed. According to the World Health Organisation, only approximately 50% of patients with chronic illnesses living in developed countries take life-saving medication as prescribed.1 A number of factors contribute to noncompliance including lack of education about the treatment, cost, poor communication and the actual experience of using the medical device itself.

Failure to follow treatment regimes as directed leads to a significant drain on healthcare resources. For example, noncompliance of diabetes treatment could result in a patient being hospitalised for nerve damage or kidney failure. Recent estimates from Diabetes UK (www.diabetes.org.uk) show that 10% of NHS spending goes on diabetes, that is £9 billion a year. This can be improved if diabetes medication is taken as directed.
Evidence of noncompliance is shown in the adherence dashboard analysis based on patient-level data from National Data Corp. (www.mekesson.com) (Figure 1).2 It shows that compliance rates vary by therapy, but generally follow a similar pattern. The findings demonstrate that the most dramatic adherence declines occur within the first four months of the prescription being written. At the end of 24 months less than 50% of patients are still taking the drug, even in disease areas such as cancer.

When will the medical industry wake up to the fact that patients do not always do what they are told to do and instead do what they want? The issue is that many medical devices have not been designed with patients in mind; often the devices do not fit into their lifestyles, they have a stigma attached to them and are not easy to use.


   Figure 1: Evidence of noncompliance

 for various therapies

There are many stakeholders involved in getting a medical device to the patient. It has to be approved by the physician, then explained by an educator, accepted by the caregiver, well received by the pharmacist, compliant with the NHS procurement procedures and reimbursable by the insurance company (in the case of private healthcare). However, with point-of-care moving from the doctor’s offices to the home, power is shifting to the patients. Patients will now have more of a say in where their money is spent and as a result will have a greater choice of medical devices. No longer will they rely on the doctor to tell them which device to use, they will do their own research and select the one that best suits their lifestyle and meets their needs.

The answer to noncompliance
It seems obvious that if a device is easy to use it will have a huge impact on patient acceptance, dosage compliance and ultimately health outcomes. This means that patient experience should be a primary focus in the development of devices. As with consumer products, we do not merely buy things for what they are, we buy them for what they do for us on an emotional level.

To have a more user focused approach med-tech companies and device manufacturers need to move away from the traditional way of developing devices, which is essentially based on "inside-out thinking.” This engineering-focused mindset involves developing new products based around technology and resources. The ultimate outcome is to gain profits through sales volume.

But, being technology driven will not always lead to success in the marketplace. True innovation comes from "outside-in thinking.” Here, the starting point is the target customer, not technology and resources. Focusing on user needs throughout the product development process and considering how the end user will interact and emotionally relate to the end product will result in increased profits through customer satisfaction.

An important motivator to improve the usability of medical devices is evident in the latest revisions to the Medical Device Directive (93/42/EEC), which was amended by Directive 2007/47/EC. The revisions highlight the need to consider ergonomic design. This is not mandatory and alternate methods for meeting the Essential Requirements of the Directive are possible, however manufacturers have an obligation to prove their products conform.

Another incentive to change the way products are designed and make them more appealing to the end user is the fact that many drugs will reach the end of their patent lives in the next five years. According to a report from market analyst Datamonitor (www.datamonitor.com), drug makers are facing "unrelenting generic competition” with medicines worth nearly $140 billion in sales due to lose patent protection by 2016.3 Financial analysts have been cautioning for some time about the patent "cliff” that many large pharmaceutical companies are facing. Until now one patented medication has monopolised the market. The medication has been the same for everyone and is delivered in the same universally generic medical device. But soon generic drug companies will be fiercely competing with large pharmaceutical companies for their market share, armed with identical formulations. The only way to compete is through differentiation.

Building-in differentiation
A means of gaining a competitive edge in this tough marketplace and ensuring that devices are user friendly is through design. Many pharmaceutical companies and medical device manufacturers employ industrial design consultancies to help them develop innovative new devices. Although it is an investment and some members of the board may need persuading that it will be a worthwhile endeavour, in most cases the rewards are substantial and can have a massive impact on a company’s bottom line.

Contrary to belief, industrial design involves far more than mere styling. Many companies are only now waking up to the strategic importance of using design and the fact that it is not just a case of "slapping lipstick on a pig.” Industrial designers can often get involved in part of the design process or in its entirety from market research all the way through to production. They can advise on a variety of aspects such as materials, suppliers, legislation, moulding, tooling, production processes and manufacturing. Most have the facilities and technologies in-house to see a product through from concept, computer models, prototypes to finished item.

There are some recent examples of manufacturers who have worked with design consultancies to develop innovative medical devices that have been successful due to the fact that they are centred around user needs. For example, hearing aid manufacturer Starkey Laboratories (www.starkey.com) worked with US-based product innovation consultancy Stuart Karten Design on the creation of a new range of hearing aids called Zon (Figure 2). Hearing aids have a stigma attached to them, but by understanding the physical and emotional needs of users with hearing impairment the designers were able to create a product that better met their needs. Small and discreet, the device has won numerous design awards and has been heralded as an object of beauty.
                                    
 Figure 2: The Zon hearing aid is described as an object of beauty

 
Another example includes transforming the design of insulin pens. Ypsomed (www.ypsomed.com), an international independent manufacturer of injection systems, worked with Swiss design consultancy Process Design on the ServoPen Insulinpen injection device (Figure 3). The pen stands out due to its user-oriented design and improved functionality. Technical advantages such as spring-assisted delivery, trouble-free cartridge exchange through a bayonet closure, a comfortable push-back thread rod, as well as durability and scratch resistance all simplify daily usage. Moreover, the favourable ergonomics of the dosage knob and the resulting ease with which the dosage can be adjusted, together with the exchangeable coloured rings, are additional features that contribute towards user-friendliness in usage and give customers the necessary assurance of safety.







Figure 3: Insulin pen
 with spring assisted delivery








Design consultancy Smallfry has worked on numerous products in the healthcare sector including an ear thermometer for Nurofen (www.nurofen.co.uk) (Figure 4) and a range of medical products for Lloyds pharmacy, which include a body fat monitor and a forehead thermometer. More recently it has designed the Powerbreathe (Figure 5), the world’s first portable precision electronic inspiratory-muscle training system for HaB International (www.habinternational.co.uk). Described as a "gym for your lungs” this device helps to strengthen the breathing muscles, reduce breathlessness and improve stamina. It can be used by athletes, but is also of great benefit to those with conditions such as asthma, chronic obstructive pulmonary disease and emphysema. Patented auto-optimising inspiratory muscle training technology automatically selects the most effective training load based on respiratory muscle strength. Training results, progress and physiological respiratory measurements are continuously monitored and displayed on the high contrast LCD display. 



          Figure 4: An ear thermometer                      Figure 5: Powerbreathe gym for the lungs 

The company worked with the client from the early prototype stage all the way through to manufacture. The challenge was how to integrate complex technology and mechanical requirements into a design that was appealing and user-friendly. When launched, not only did the product receive excellent reviews from users it also resulted in commercial success for the client. It has since gone on to win a number of awards including the Design Week Award 2010 and the 2010 Consumer Product Design of the Year at the Plastics Industry Awards.

Other medical devices currently in development at Smallfry include an innovative device for those living with Parkinson’s disease. Designed with the user in mind, this drug delivery system helps de-stigmatise the disease because it looks more like a consumer product than a medical device. This means that patients will be more likely to use it and keep using it.

Seven steps to innovative design
To develop innovative and practical products that can become real market leaders, Smallfry utilises a seven-stage innovation process. This begins by looking at the user and the market context. Design is not all about the technology. To be innovative you have to be focused on the market and discover what the users need. Before pen is even put to sketchpad, time is spent with the client discussing the marketplace, what customer needs the new product will address, the strategy and what the brand objectives are. Once the concept for the product has been finalised, the design team will then bring it to life and throughout the development process, ensure that the design intent is maintained.

This market driven or user centred approach has proven extremely successful for design consultancies. If device manufacturers want to enhance the compliance of their devices, they must begin the design process by looking at the user: the patient. Essentially, if the device enhances the user’s experience, fits better into the patient’s life and has less of stigma attached to it, there is a greater chance it will be used. The end result will mean happy customers and a manufacturer who has gained a competitive edge in the marketplace.
 
References
1. www.who.int/chp/knowledge/publications/adherence_full_report.pdf
2. National Data Corp. was acquired by Per-Se Technologies, which is now owned by McKesson, www.mckesson.com.
3. www.reuters.com/article/2007/05/02/idUSL0112153120070502

Steve May-Russell is Chief Executive Officer of Smallfry,
School Street, Wolston, Coventry CV8 3HG, UK,
tel. +44 (0)24 7654 5678,
e-mail: steve@smallfry.com,
www.smallfry.com


See Med-Tech Innovation TV for an interesting panel debate including Steve May-Russell on
Medical Device Design: Which Comes first, form or function?



   

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