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Mitigating Usability Risks in Medical Device Development, in the light of the upcoming National Medical Product Administration (NMPA) guidelines in China.

Over recent years, healthcare innovation in China has accelerated massively. From AI-empowered solutions and innovative devices and tools, to increasing connectivity and digitalisation, technology and design are transforming the experience of patients, carers and healthcare professionals for the better.

A crucial milestone in that journey will be the upcoming application of the NMPA’s ‘Guidelines for Technical Review of Human Factors Design of Medical Devices’, published in draft form two years ago. The acceptance of this guidance is now imminent, with significant consequences for how medical devices in China are designed and validated.

Once officially issued, this new guidance will place an obligation on medical device companies to recognise the potential impact of usability risks and conduct their design and development process accordingly. Any medical device product launching in China in the near future needs to consider this guidance so companies need to adopt the guidelines without delay, even for ongoing projects. This is because, inevitably, adopting to this approach will take some time, not only in terms of team mindset but also in terms of the transition required around process and resourcing. In this context, time is of essence.

How to mitigate the risks of summative usability tests?

As a critical part of usability validation, summative usability tests have been conducted in international markets for some time – following the recommendations of the US Food and Drug Administration (FDA) and the European Union Medical Device Regulations (MDR). For the majority of medical device companies in China however, they are still a relatively new tool in the design validation process and there is still a degree of hesitation when it comes to running these validation tests for new products.

Reluctance is partly driven by the fear of “failing” a summative test – i.e. the fear that the new process will lead to a design refinement or a redesign, with potentially huge commercial impact and a disrupted launch schedule. In reality, of course, it is impossible to “fail” a summative test as any learning is beneficial.

Although hesitancy is understandable, it is also misplaced. To adopt this process, medical device companies need to test more, not less, and run earlier and more frequent formative evaluations that can de-risk subsequent stages. Finding potential for improvement during development is a win-win, as fixing problems early saves money (recalls can be costly) and creates a better product – which in turn is likely to underpin a commercial advantage.

The main purpose of adopting a Human Factors Engineering (HFE) process for new product development is to mitigate risks relating to usability. So, how can we avoid finding issues at a point where they are difficult to fix (either just before a product release or post release)? The answer is simple – by engaging users more frequently, at the earlier stages of the design and development process. Formative evaluations can in fact identify ‘bumps in the road’ early, ahead of the summative evaluation. After that, there may be new learnings at summative / validation testing stage, but there will already be an established rationale around the design to work from.

Embracing imperfection in formative evaluations

Some manufacturers already carry out different kinds of formative evaluation, taking prototypes to the intended users to collect feedback and comments. These activities are typically associated with Usability Engineering (UE), and the information collected helps inform design iterations.

However, these formative activities could happen more frequently through the design and development process, with different fidelity of mock-ups or prototypes. Although it might feel uncomfortable or counterintuitive to present unfinished or partially functional prototypes to users, these are actually very useful to spark interactive discussions and co-creation. They are often a source of meaningful inspiration and provide a safe space to navigate and modify solutions before the design is frozen.

Crucially, any evaluation needs to encourage honest feedback.  Design and innovation always benefits from multidisciplinary contributions and the involvement of marketing and sales teams is important. This can be reflected in terms of the fidelity of the test setup (e.g. the extent to which a real-world context is simulated) and also the objectivity of the feedback (avoidance of bias). This also means that the purpose of the test has to be clearly communicated to participants, whether they are KOLs, leading surgeons, busy practitioners or patients, to ensure that quality is maintained. Even if usability testing sounds unfamiliar to some stakeholders, from our experience most people are willing to share their personal experience and feedback to contribute and improve products and therapies – i.e. for the greater good.

Never isolate a product from context during design and development

No medical device can be used in isolation. That’s why the clinical or home care context must always be taken into consideration in product development. R&D teams will always focus on the product itself and do their best to develop functionalities that meet product and system requirement specifications. But clinical practices can’t be neglected since they often determine the interface between the user and the product.

At PDD, we have often seen how products that worked well in a lab end up presenting significant issues when used in a clinical environment. It could be, for example, that the usage of a product might violate sterilisation rules, or that some tasks in the clinical setting might require collaborations between people that weren’t originally considered. Identifying and foreseeing these important influential factors is the beauty of early-stage user research, either through voice-of-customer interviews, ethnographic research and contextual inquires or expert reviews.

Don’t leave it all until the summative usability test

Of course, project teams might be tempted to stick to the project schedule and avoid what may be seen as time-consuming activities associated with user research. However, from our experience, running formative evaluations does not take long. The concern sometimes is about design iterations – if any risks are identified they might challenge an already tight development timeline and require work to be undone. No doubt, a cross-functional review of the risks and associated design refinements needs to be conducted following any form of user testing, but skipping formative evaluations inevitably leaves those risks hidden until they emerge at a later point. By then, it’s often too late and too costly to revise the design.

Safety is the baseline; a well-considered user experience is what makes the product outstanding

Although the regulatory requirements on HFE focuses on safety, user experience is what will make the product stand out. Well-considered human factors work contributes to user experience, will bring extra satisfaction to users and allow for differentiation.  During our work in clinical environments, we often see how users might not remember a product’s brand name but they clearly know which one is their favourite due to well-designed features or small usability details – like how easy the cap or packaging can be opened, given that they have to do the same thing numerous times every day. All these details are not invented in R&D’s labs, they are a direct result of the empathy with which we build the products and a human-centred approach to design

Conclusion

Whether it is FDA, MDR or NMPA, ultimately the goal of Human Factors Engineering is to support medical device companies in improving the design of devices to minimise potential use errors and resulting harm. Continuous efforts invested in HFE, from user requirement identification and generation, user interface design and formative evaluations will pave the way to alignment with the upcoming NMPA HFE guidance. This will help companies in China design medical devices that respond to the needs of patients and healthcare professionals, with an outstanding product experience to underpin their commercial success in domestic as well as international markets.

We are pleased to let you know that this autumn we will be present at some of the most prestigious medical conferences in China.

CMEF (China International Medical Equipment Fair): 29th – 30th Oct. 2018, Shenzhen

Join Vassilios Kanellopoulos (Global Business Development Director) and Vicky Hong (Principal – Business Development) at the fair and if you would like to get in touch or to make an appointment at CMEF, please contact Vicky Hong on:
e: vickyhong@pddenglish.wpenginepowered.com
t:+86 13386037276

CMP (China Medtech Partnering): 2nd Nov. 2018, Suzhou

We are pleased to announce that Vassilios Kanellopoulos, Global Business Development Director at PDD will be joining a panel discussion on the topic of ‘Safety design of medical devices driven by clinical needs’from 15:30 to 16:10 on 2nd November. For more information on this event, visit China Medtech Partnering
Venue: Nikko Hotel, Suzhou, China
Looking forward to seeing you at the conference!

Over the past few decades, Chinese consumers’ perception of international brands and products was that they were ‘the best quality and most reliable’. But, with home-grown brands providing more choice and improved reliability, western brands are losing market share as it’s become harder to win trust and revenue, even for well-established brands like Siemens.

At the Consumer Electronics Show (CES) earlier this year and AWE in Shanghai, the home appliance giants Samsung, LG and Haier (Casarte) simultaneously launched new washing machines. Being a Chinese consumer myself, and having spoken to housewives in China in-depth about their attitudes and behaviours towards laundry—which are very different to western cultures—it was clear that these new products were designed specifically for the Chinese market.

Chinese attitudes and behaviours towards laundry

• Targeted wash. Due to poor air quality, to remove dirt from a shirt collar or cuff, Chinese consumers spend more time on pre-wash activities, such a hand-washing in the sink, because they’re concerned that the general washing program on washing machines may not be efficient enough to remove this type of stain.
• Separate wash. For hygiene reasons, they always prefer to wash outerwear and innerwear separately, especially when there is a baby at home. Chinese mums always hand wash their baby’s clothes.
• Efficient wash. The separate wash doubles the time Chinese consumers spend on laundry. A longer wash program is associated with consuming more water and energy, which does meet the need for an efficient wash cycle.

Washing machines aimed at the Chinese market

LG TWIN WASH
The TWIN combines a standard front-load space for a regular wash and a drawer-structure top-load small space for a specific wash like innerwear or baby clothes. The two cabinets work individually, which makes it possible to wash separately and simultaneously.

Casarte (premium brand of Haier) Twin Wash
The Casarte machine shares the same principle as the LG Twin Wash but Casarte has increased the height of the machine to 1280mm and has an enlarged second cabinet. Considering the limited space in the homes of most urban families in China (wash machines are usually set in the bathroom or balcony of city apartments), a taller machine does not sacrifice valuable space when compared to a wider machine.

Samsung Dualwash
Different from LG and Casarte, the Samsung solution is based on a top-load platform and focuses on optimizing the laundry process. With a pre-wash sink integrated at the top of the cabinet, the new product reduces concern about stain removal by replacing traditional hand wash with an optimized and automated machine wash program.

What does Premium mean in Chinese culture?

Western brands are also looking to innovate in the premium market in China. With years of experience working with clients targeting the Chinese market, I like to define a Premium product as ‘Respecting local lifestyle and bringing in fresh experience’. The newly-launched washing machines introduced above are good examples of premium products.

Similar to laundry, cooking is another area where culture plays an extremely important role. Frequent stir-frying has meant the extractor hood has become the focus of the kitchen. Started in Ningbo, the manufacturing center for kitchen equipment, Fotile is now the leading Chinese brand in this sector and the only brand in the high-end market. ‘Understanding the consumer’s needs, the Chinese kitchen and presenting an international style’ is the design strategy of Fotile and this aligns well with its brand strategy.

Top Kitchen Experience Hall. Image credit: Fotile

New kitchen set launched at AWE. Image credit: Fotile

Technology by itself cannot be called premium if the user interaction is not considered. The 7-inch touch screen of the new Casarte washing machine fully utilizes screen space by replacing misleading text with easy-to-understand icons. Colour has also been used to differentiate the operation of the two cabinets – with intuitive black and white backgrounds to attract the families that buy these premium products – usually either mature parents or Ayi (maids).

Casarte Twin Wash Interface

Haier – Leading Chinese Brand

Haier, without doubt, is the leading home appliance brand in China. The strategy for setting Casarte as its premium brand within Haier shows its success in challenging well-established international brands in the high-end market.

At AWE, Haier celebrated its transformation from a manufacturing giant to a consumer-driven brand and from a hardware producer to a service provider. Take Haier U+ Smart Home Ecosystem consisting of seven units: air, laundry, food, water, health, security and entertainment. It was first promoted last year and now we can see the development of even more tangible thoughts, concepts and products. Taking advantage of its brand influence in China, Haier has partnered with industry leaders like; Wanke – residential building developer, Intel – smart technology provider, P&G – FMCG, JD – distribution channel, COFCO – agricultural product provider etc. to fully understand and execute all stages of the design cycle.

Haier U+ Smart Ecosystem (Food)

Home appliances like washing machines, refrigerators and kitchen equipment play an important role in people’s daily lives. Meanwhile, the usage of these products is strongly linked with regional culture and lifestyle. As consumers and designers, we are encouraged to see manufacturers starting to pay attention to and meeting the unique needs of local people.  Compared with Asian brands, Western brands seem to be lagging behind in ‘innovating for China’.

Haier Home Farm

Haier refrigerator with separate storage spaces

China has experienced tremendous economic growth over the years. A certain amount of Chinese commercial organisations are exploring Western markets, but what are the challenges they face in trying to go West? Invited by The Huffington Post, Karsten Fischer, CEO at PDD, investigates and analyses different routes of how they can successfully break into these markets. Click here to view Karsten’s blog posts on The Huffington Post.

‘What is Design for China?‘ is a series of three blogs where we will be taking a look at design targeted at the mainland Chinese market. In our first instalment in the series we focus on how some Western brands are creating designs specifically for this increasingly discerning market.

An interesting story occurred when the PDD Hong Kong team, a mixture of German, American and Chinese designers, created a series of water bottle concepts for the China market. PDD designers were invited to create new packaging that incorporated elements of ‘Western style’ into a new bottle design. The drawings created by Western teammates focused on the more ‘outward’ view of Chinese culture, such as dragon and ethnic patterns, derived from historical references. During validation studies of these patterns almost none of the mainland Chinese participants selected the designs by our Western designers. But why

The dragon image has become an overused expression in Chinese design over the years. Very few products can carry a contemporary appearance featuring a dragon image. Chinese users often associate ‘cheap’ quality when traditional elements, such as a dragon, are used without another layer of depth. Even the most traditional type of products we use these days, such as moon cake packaging and New Year cakes, required careful consideration of colour and material design in order to stand out in the crowded market place.

Above image credit: Lamborghini veneno. Featured image: PDD