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A nurse in a crowded hospital inadvertently connects an oxygen tube to intravenous access during an emergency procedure because the two pieces neatly slot together. A senior citizen is getting a ureter inserted at home, and the monitor rolls into a mandatory update. A home caregiver is trying to change a breathing aid, but the interface requires a one-time code that can’t be immediately generated.
The outcome of these three problems can be dangerous, if not fatal, for patients. While MedTech aids patient diagnosis, treatment, and recovery, the User Experience (UX) and User Interface (UI) governing these devices continue to cause headaches for the medical community despite significant recent improvements.
Healthcare UI/UX Challenges and Inadequate Quality Assurance
UI and UX healthcare challenges begin by addressing the usability of an electronic medical records system–which houses all patient data in dense, hard-to-operate interfaces. “A doctor typically gets around 90 seconds to review a patient’s records before they see them, and some of these systems require a provider to click through 10-20 data blocks or screens before finding the info they need,” says Marc Caposino, Chief Executive Officer of Fuselab Creative, a US-based design studio.
Healthcare devices are increasingly tasked with monitoring and treating specific conditions, making the need for user-friendly, dependable software architecture and UI design paramount. However, glitchy UI and UX continue to hinder the caregiving process.
The MedTech industry has had a go-to-market challenge since medical devices began to be regulated in the US in 1976. This challenge was further amplified under the Safe Medical Devices Act of 1990. This act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a probability that a medical device has caused or contributed to a death, illness, or injury.
Similar laws were enacted in Europe and around the world. This put pressure on manufacturers to get devices that were safe for the patient to the market, but how “safe” is safe? Driving the GTM business goals to bring products to market rapidly could mean reduced or abbreviated testing and quality assurance, which could risk multi-million-dollar product recalls. The more complex the use and function of a medical device, the increased need for sophisticated, reliable, repeatable QA processes and tools.
“UI and UX are incredibly different in healthcare,” says Chad Holmes, a cybersecurity evangelist at Cynerio. “In the ER or operating room, you can't go through multifactor authentication or wait for a code to hit your phone. You can't be locked out after three tries.”
The MedTech industry has also adapted slowly to software and emerging technologies such as artificial intelligence. According to a report from the UK-based health think tank Nuffield Trust, the healthcare industry is at least a decade behind other sectors, such as consumer technology, in using information technology.
The focus must be on user-centric (doctor and patient) design, with easily navigable labeling and simple functionality, with simple navigation that leans on visual aids and icons and simple text. Manufacturers must rewrite the software to include multiple language options and use simple typography to improve navigability.
Changing Demographics Demand Different User Experience in Healthcare
Traditionally, users have been trained doctors, nurses, and other medical personnel adept at using these machines within the confines of a hospital. The rapid advancement of technology has meant that a chunk of this caregiving has not only moved out to smaller clinics but even into homes and the hands of untrained personnel.
The COVID-19 pandemic accelerated treatment outside of the hospital because you didn’t want to mix severely sick people with those suffering from minor conditions. “The democratization of medical devices is the biggest challenge facing device makers,” says Ben Cyprian Sindram Müller, Founder and Managing Director of Silberpuls, a Berlin-based product design company.
The software has to be rewritten to display blood pressure or sugar clearly, but increasingly, consumers want to know the results of these readings. He adds, “The patient receives the data and doesn’t know what to do with it–this turns the whole pyramid of data upside-down–interpretation of data is the biggest challenge for UI and UX design.”
Consumers are also changing how they interact with medical devices, with a growing emphasis on accessibility for users with disabilities and limited tech skills. In response, the MedTech industry is embracing emerging trends like voice, gesture, and emotion-based user interfaces, ensuring these technologies are more personalized and user-friendly.
Navigating Regulatory Requirements and Ensuring Compliance
Unlike in other sectors that have embraced technology–think of Uber and ride-hailing–healthcare innovation has had to trail regulation. Device makers in this industry need to follow a raft of rules when they design new products or seek to enhance existing ones. For instance, the Medical Devices Regulation (EU MDR 2017/745) in the EU sets high standards for medical device safety and performance. Similarly, in the US, manufacturers must comply with regulations from the Food and Drug Administration (FDA).
Furthermore, EU Directive 2019/882, which focuses on accessibility requirements for products and services, will come into effect in 2025. Software must meet stringent QA standards while being flexible enough to incorporate personalized settings. UI/UX design must not only be aesthetically pleasing but also function flawlessly under different conditions.
In addition, a 2024 study has shown that the implementation of advanced UI/UX design principles can significantly reduce user errors, a common cause of device failures. By focusing on intuitive design and thorough testing, MedTech companies can enhance the reliability of their devices, thereby reducing overall failure rates.
Tools offering testing solutions that can simulate a wide range of user interactions are now available. These tools ensure that the UI meets both functional and regulatory requirements across multiple platforms. By integrating such tools into the development process, companies can identify and rectify issues early, reducing the risk of failure in real-world applications.
As we look towards the future, the integration of advanced UI/UX elements will be vital to developing smarter, more intuitive medical devices that meet the diverse needs of patients worldwide.
