The ultimate guide on usability in medical technology development

7 tips to improve the usability process of your medical device

U sability is of great importance in medical technology development because of the regulatory requirements, but also because it’s the key to a successful product. A good usability process will not only lead to efficient approval and rapid market entry, but it will also make your product stand out compared with competitors and help you to create a great marketing strategy.

“A good medical device does not only solve a real problem, but it is also easy to use. The nicest solution to a problem doesn’t solve anything if you can’t use it safely and easily”, according to Dr. Simon Weidert, orthopaedic surgeon and co-managing director of M3i. He also points out how important it is that the product does not only work by itself, but also in the existing clinical workflow. “The use of robotics, for example, leads to much longer surgeries, because of all the time needed to set it up. The original surgery would be long completed by the time the robotic surgery can start. The solution itself is good, but it disrupts the existing workflow.”

In this guide you will learn:

  • What usability is and which requirements there are
  • Why usability is the key to success in medical technology development
  • 7 tips to improve the usability of your medical device
  • How investing in a good usability process pays off in the end

The basics of usability

Before we get into why usability is so important in medical technology development and how it can significantly improve your final product, we will first cover the basics of usability: what it is, what the regulatory requirements are and how these are measured.

What is usability?

To understand the importance of usability, you need to know what usability in medical technology development means. For us in our medical context, usability is the quality of use that a user experiences when interacting with technical systems and devices or products. When it comes to the treatment of patients, usability means that a product is safe and effective to use. The learning curve of the product should be short, so that medical professionals can use the product safely without needing a lot of training. The easier it is for a user to complete their goal with a product, the higher the usability of the product and thus the higher the customer satisfaction.

Usability as a requirement for medical devices

Since the Medical Device Regulation (MDR) started to apply in May 2021 after a four-year transition period, the proof of usability has become a bigger point of attention for manufacturers of medical technology. According to this MDR that applies throughout Europe, manufacturers of medical devices should reduce risks and design products in accordance with ergonomic principles. Part of this is the internationally recognized IEC 62366 that focuses on minimising the risks from poor usability and requires specific evaluations. In addition, ISO 9241 deals specifically with software products and IEC 60601 specifically with medical electrical equipment.
In short: without good and measurable usability hardly any product will be able to enter the market.

How usability is measured to comply with regulations

We know that usability is of great importance to get a medical device approved, but how is usability measured? In the development of a medical device, there are two essential and mandatory steps for approval related to usability:

1. The formative evaluation. The formative evaluation takes place during the early development stages and already provides potential improvements of the product. A formative evaluation can be done by a clinical end user or a key opinion leader in the field, but there are also ways to do it without involving clinical end users. The goal is to get answers to specific questions related to the design, such as “is the instruction guide clear” or “is the product comfortable to use”. The formative evaluation has relatively low requirements and is therefore often carried out in a very simplistic way.


2. The summative evaluation. The summative evaluation takes place after the completion of the final prototype. During this evaluation all (security-related) usage scenarios are tested by clinical end users to figure out if the device is safe to use. There are high regulatory requirements for this final evaluation of the product, which makes it both time-consuming and expensive.


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Usability as the key to success in medical technology development

It is safe to say that usability is important, because it is a regulatory requirement. If your medical device doesn’t meet the basic requirements, it will not be able to enter the market. However, usability is not only important because of the regulations, but also because it’s the key to a successful product.

Challenges with usability testing

Formative and summative usability testing is a time-consuming and cost-intensive process, because you need access to different types of clinical end users – from doctors and nurses to cleaning staff and IT administrators. This is a real challenge for medical device manufacturers due to the lack of time of the clinical staff, compliance issues and finding the right contact persons in clinics. Therefore, it is tempting to stick to the basic regulatory requirements and do no testing beyond that. However, it is important to note that just passing the regulatory requirements to enter the market doesn’t necessarily mean that the product will sell well.

How you benefit from a good usability process

By incorporating some extra steps into the usability process, you can make sure that your medical device will be effective and successful. By involving the right clinical end users early on in the development process, you make sure that your product meets their needs and adds value compared to alternative products. Furthermore, the close cooperation with a large number of clinical experts helps you to find early adopters and convince key opinion leaders of your product. Their opinions and suggestions will significantly improve your product and their positive feedback will serve as a great marketing tool once the product is on the market.

7 tips to improve the usability of your medical device

By now it should be clear that usability is not only a regulatory necessity, but it is also a part of the development process that can really add value to your final product. By extending the usability process with some extra steps and by skillfully using your time, you can significantly improve your product and adapt it to the needs of the end users. With the seven tips below, you will be able to develop more effective and successful medical technology.

Tip 1:

Clinical experts can be real innovation incubators and should be involved early on

Most of the time, clinical experts are involved in the last stages of the development of medical technology. Their involvement consists of testing the developed software or device and giving feedback on the usability of the tool. However, it’s much better to involve the clinical experts as early on as possible in the development process. Some clinical experts are real innovation incubators and can help you to increase the usability of your tool. They have a broad overview over the clinical needs and the competing products, which is a big advantage. This way, you can take their ideas and needs into the development and deliver a final product that is more user-friendly.

Tip 2:

A formative evaluation can significantly improve your product

The fact that the formative evaluation has lower regulatory requirements often means that this part is neglected or carried out very sparsely. This is very unfortunate, as the formative evaluation has a lot of potential to significantly influence the development process and therefore to significantly improve the product. By surveying key opinion leaders and lead users in the early stages, potential improvements and unused market potential can be revealed. It is important to have this information as early as possible, as it will be a lot easier to incorporate it into the final product.

Tip 3:

Continuous involvement of end users leads to constant feedback and improvements

Key opinion leaders and end users should not only be surveyed in the early stages of the development, but they should be continuously involved in the process. There are several ways to get feedback at different points in the development process. You can do expert interviews, host workshops or organize user tests throughout the process. In each session the end users will be able to point out new things that will lead you to improve your product along the way.

Tip 4:

You can only get realistic results from testing in a realistic environment

Products are often tested in unrealistic environments, which automatically leads to unrealistic results. For example, a bed is placed in an office to simulate a patient’s room, but this doesn’t represent the real clinical conditions. Besides that, clinical users often act differently in everyday clinical practice than expected by the manufacturers. This can be due to stressful situations, certain clothing or spatial conditions. Therefore it is essential to simulate the environment as accurately as possible to get realistic results. This doesn’t only mean accurately recreating the patient’s room, but also deliberately triggering stressful situations to observe the end users in these special conditions.

Tip 5:

Being well-prepared for the summative evaluation will save you a lot of time

During the summative evaluation different usage scenarios are carried out to test the safety and usability of the product. This evaluation is linked to high regulatory requirements and is therefore the evaluation requiring the most attention. To save considerable effort and resources, you want this evaluation to go smoothly and you want to avoid having to make changes to your product afterwards. The best way to ensure this is strong end-user involvement during the development process. This way you already know that your product is safe and user-friendly before the summative evaluation and this evaluation merely serves to comply with the regulations.

Tip 6:

Use the usability testing also for regulatory requirements and marketing

When planning the usability testing skillfully, you can deal with several regulatory requirements at the same time. The usability testing can, for example, be combined with the completion of the risk management file and the verification of the ergonomics of the product. With permission of the clinical experts, you can also use the positive opinions from the evaluations for marketing purposes. This way you’re already collecting testimonials along the way. By planning your usability testing efficiently, you can save both money and time along the way.

Tip 7:

Find the unique selling points of your product through a benchmarking study

Getting your product approved can seem like the finish line of your project, but there’s a very important step left: selling your product on the market. A benchmarking study can help you to find the right marketing strategy to sell your product successfully. In a benchmarking study your product is compared with competing products to measure the performance gap. Clinical experts evaluate the advantages and disadvantages of the competing products and start to develop medical claims about your product. These claims are proven with reproducible measurement methods and can subsequently be used for marketing purposes.

How investing in a good usability process pays off

A good usability process requires a financial investment and a significant amount of effort in the early development stages, but it will definitely pay off in the end. Look at the increased requirements for proving usability as an opportunity to benefit from:

  • An efficient innovation process with low error potential
  • Secure and efficient approval and rapid market entry
  • Early adoption of the device by the clinical experts involved in the usability process
  • Positive feedback from key opinion leaders to gain credibility
  • Effective and well-founded marketing
  • Added value of your product in comparison with competing products

Improve your usability process now

Improving your usability process can be difficult when you lack time or you don’t have access to the right clinical experts. At M3i, we have a lot of experience with formative and summative evaluations, realistic testing environments and we have access to a wide range of clinical experts and key opinion leaders.

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