Design Thinking: More Usability and Better Medical Devices

Who wouldn’t want to have the best device on the market, the one that is exactly what users want? “Design thinking” can help you develop such devices. It is an approach to innovation that focuses on users’ needs and aims to find the right solutions to their problems. 

That’s why the concept is a perfect fit for medical technology, an industry that affects the lives of people more than almost any other but one that all too often pushes users’ needs into the background. This can lead to medical devices that are difficult to use, impractical or even unsafe, as well as missed opportunities – if a new need is identified, then there is an opening for an exciting new invention. And the financially powerful competition in the consumer sector, which is already user focused, is not resting on its laurels.

In this article, we will introduce the user-centered design thinkingapproach and explain what manufacturers should pay attention to in particular when developing medical devices.

1. Design thinking – the concept

a) Definition

b) The process 

1. Empathizing: understanding people's needs

The first phase starts with gathering information about the users. This means for example:

• Talking to experts
• Looking at existing user data and collecting new data
• Gaining an understanding of the users, for example, through interviews, role plays and observation

In this phase, teams can also draw on standard market research processes and marketing tools, such as the customer journey.

The most important thing is empathy. This means:

• Putting yourself in an individual user's shoes and
• Forgetting your personal assumptions

The most important thing is what the users actually think and want, not what the designers think users think and want.

Gaining insights for the medtech industry

When developing or improving medical devices, a lot of data is often required in the first phase of the design thinking process. For example, the patient experience as a whole and the extent of suffering is relevant, not just the immediate symptoms. 

This means that the patient's complete daily routine must be considered, as well as all the burdens and frustrations an illness can entail. All stakeholders must be taken into account: patients, physicians, nursing staff, family members.

This often requires:

• Home visits
• Family interviews
• Focus groups
• Sifting through and collecting clinical information about the illness

Because of the large amount of information required, this first phase is often associated with research projects.

2. Defining: person-centered reframing and definition of the problem

The second phase builds on the information collected in the previous phase. This is where the specific question is defined. 

User groups are usually also defined at this point. In marketing, these are known as “personas.” In design thinking, we generally use the term “points of view.”

This involves:

• Formulating these groups’ specific needs
• Setting specific goals
• Defining the core problem.

In the medtech sector, this also involves thinking about:

• The intended purpose
• The user groups
• Patient group indications and contraindications

Define the core problem from the user's point of view, not from the company's point of view!

3. Ideating: generating lots of ideas in brainstorming sessions

The third phase is the idea generation phase. This is the time for the diverse teams with their different perspectives to shine. Their task is to compile a lot of creative ideas. For this to work, you need to remember the following:

• This phase is initially about quantity, not quality.
• Value judgments are a no-no when brainstorming.
• Delete the word “but” from your vocabulary. Replace it with “and.”

Avoid setting any rules or imposing any limits in your brainstorming sessions. They have a negative impact on creativity. Let your creativity run wild, no matter how sensible or helpful the proposals seem initially. Many a crazy idea has later turned out to be a stroke of genius.

The ideating phase concludes with an evaluation of the ideas. This is when the ideas are sorted and condensed. The most promising ideas are selected and evaluated with respect to the goals of design thinking:

• Desirability (by the users)
• Feasibility
• Economic viability

4. Prototyping: the simpler, the better

In “rapid prototyping,” prototypes are created as simply as possible. The general rule is the faster, the better. These prototypes are used as visual aids and should be easy to modify. Destroying them should not be a big waste of resources.

Ways of making these prototypes include: 

• Sketches
• Post-its
• Storyboards
• Mock-ups
• Wireframes
• Lego figures

Nevertheless, a user should be able to imagine from the prototype what the solution to their problem might look like.

5. Testing: testing the prototype and solving any problems

In the fifth phase, the prototypes are tested and improved. The result of this phase should be a solution to the problem. 

Don’t stick with prototypes and ideas that obviously do not achieve the desired effect. As in all the other phases, the team should remember that it is the users’ perception that is key, not the company's.

Useful methods in this phase include:

• Focus groups
• Interviews
• Cognitive walkthroughs 
• Usability testing

This phase is related to the first phase and uses a lot of methods already used for empathizing.

c) Design thinking as a non-linear process

Even though each of the five phases of design thinking builds on the previous phases, the process is not completely linear. In fact, each phase is worked through several times. In some cases, teams work on several phases simultaneously. 

For example, in the test phase, a team might gather new insights into the users. These, in turn, lead to new brainstorming sessions and to new prototypes. 

As a result, design thinking requires flexibility in many respects.

3. Three reasons why medtech manufacturers should embrace design thinking

Design thinking is becoming increasingly popular in all industries. But medtech manufacturers in particular should take a closer look at its principles. Why?

1^st reason: made to measure products

Design thinking has huge amount of potential for the medical industry – after all, people are the focus in both. Just like human-centered design, design thinking should be a common tool for manufacturers but too often patients are not seen as consumers or customers. Needs-based product development can increase the success of a treatment and patients’ general quality of life enormously. What’s more a cleverly designed device can make life much easier for medical staff.

Putting the user at the center of your thoughts is also simply good business sense: users have more say and choice than ever before when it comes to medical devices. They also have increasing demands. If they are undecided, customers will choose the devices that solve their problems the best.

Using design thinking can help manufacturers create the medical devices that users desperately need: 

• Medical devices usable at home
• Telemedicine
• Devices that focus on caregivers rather than physicians

Design thinking can be applied in many ways in medical technology. For example:

• To develop more effective and easier-to-use medical devices
• To find better treatment options
• To identify the needs of society as a whole
• To exploit untapped market potentials

2^nd reason: better and safer devices

Well thought-out devices tailored to users’ needs don’t just make life easier for patients and medical staff. In medicine, an awkwardly placed button or complicated software can waste precious time and endanger lives. That's why there are global regulations and standards governing the usability of medical devices.

So, design thinking is not just a gimmick in the medtech industry: it helps improve device safety and performance.

3^rd reason: better competitiveness

Apple, Amazon, Google and Co. discovered the medical sector a long time ago and are developing their own products. These are companies that have clearly been successful by solving people's problems as efficiently as possible. Customers use their products because they are practical and make their lives easier. 

The boundaries between classic consumer products and medtech are becoming increasingly blurred: smartwatches that detect cardiac arrhythmias are now accepted even by cardiologists. Headphones that measure fever could provide serious competition for the time-honored thermometer. With so much choice, who wouldn't choose the product that best meets their needs? 

For manufacturers of medical devices, this means: 

• They have new competition that they can’t afford to be left behind by
• They should learn from the consumer giants because their products are in demand

4. What medical device manufacturers need to keep in mind

Medical device manufacturers must pay attention to some specific features when using design thinking to develop their devices and services.

a) Follow the development process requirements

Manufacturers must comply with the legal requirements and their own specifications for development processes. Design thinking is considered part of the development process. Examples of these specifications are:

• Manufacturers must establish and ensure that the people involved in design thinking are competent.
• Design thinking generates a design input, such as the identification or specification of the context of use in the empathizing phase or of the user groups in the defining phase. Manufacturers must use the design input documents as a guide.
• Prototypes are created in the design thinking process. These “artifacts” must not become a design output without further evaluation. For example, transferring a prototype's software code directly into the resulting medical device without having first performed the required checks (e.g., in the form of tests or reviews) would breach the legal requirements.

b) Don’t “suffocate” design thinking with overbearing processes

Conversely, a development process should not prevent or hinder design thinking. 

A streamlined development process not only ensures the conformity of the development results, it also enables the process to be fast and iterative, as it has to be in design thinking.

In most cases, it is better to specify design thinking in the development plan rather than in the development process. This plan should describe or reference the design thinking method.

c) Map the design thinking methods to regulatory requirements

Manufacturers should also make sure that they can demonstrate to auditors and reviewers how they are using design thinking to meet regulatory requirements.

For example, IEC 62366-1 requires formative evaluation of the usability of user interfaces. In design thinking, devices and thus user interfaces are developed and tested in the ideating and prototyping phases. 

Manufacturers should describe this process, either in the development plan or in the formative evaluation plan. However, according to IEC 62366-1, this plan must include the following elements:

• Method (e.g., cognitive walkthrough)
• Part of the user interface to be evaluated
• Point in the development process where this should take place

Nevertheless, planning these points takes little effort and does not stop design thinking being lean.

d) No trial and error on or with patients

The combined prototype developing and testing process may and should involve future users. But, under no circumstances, should these users also be patients and there should be absolutely no trial and error on patients. Otherwise, the manufacturer runs the risk of performing a clinical investigation without realizing it and without complying with the regulatory requirements.

Starting a clinical investigation requires all risks to have been controlled as well as possible and all general safety and performance requirements that can be demonstrated without a clinical investigation to have been demonstrated. This implies that all risks due to lack of usability have been controlled.

In other words: design thinking’s iterative approach must not extend to testing on humans.

e) Systematically record stakeholder requirements

Manufacturers should not use design thinking (just) because they see it as a modern way of sticking Post-its on a wall. Instead, they should use the design thinking method precisely. Just like other methods, this requires competencies that are acquired through training and practice.

In the defining phase, in particular, the context method according to ISO 9241-110 helps you to identify requirements and to systematically work out stakeholder requirements.

5. Conclusion

Medical device manufacturers should definitely explore design thinking and/or human-centered design. Ultimately, it's people who use their devices and people who benefit from them. So, tailoring devices to meet users’ actual needs should be an obvious course of action. 

However, in the medtech industry, this aspect still takes a back seat far too often. This is a mistake, because without sufficient information, actual needs cannot be recorded, and problems cannot be identified and, therefore, cannot be solved.

Patients, medical staff and, ultimately, the manufacturers themselves benefit from a human-centered approach to problem-solving and development such as design thinking. Because solving people's problems has never been a bad business idea.