Accessibility

Accessibility is an essential aspect of digital product design. It is important that digital products are designed so that all users, including people with disabilities or limitations, can use them. This can be achieved through the use of fonts, colors, contrasts, sizes, and read-aloud features.

Design and development teams must ensure that their products comply with applicable accessibility standards. These standards ensure that digital products can be used by any user, regardless of their abilities or limitations.

Creating accessible digital products requires careful planning and implementation. It is important to consider the needs of all users and ensure that they are able to use all the features of the application. Making digital products accessible is not only an ethical responsibility, but also helps to reach a wider audience and improve the overall user experience.

Design System

A design system combines various design elements such as branding, colors, tonality, typography, animations and data visualization. It provides a structure with clear rules, principles and reusable components like forms, tables or buttons to avoid inconsistencies and contradictions in the design. To ensure that all parties involved – such as design, project / product management, UX, development etc. – can access it, it should be available online.

There is now a wide range of design systems available. If no particular system has been specified by the company or management, the areas involved can jointly define a design system and exchange information about it. In this way, everyone involved can make the best use of the system and thus contribute to a uniform and consistent design.

Health Tech
The Academy Technikum Wien (GER) sums up the definition nicely:

“Health Tech (Health Technology) is an approach that links medicine as well as health care with innovative technologies. Digital products and services are designed to promote, maintain or cure human health. The Health Technology Assessment process is used to evaluate these health technologies, services and tools.
The development of health tech must be understood against the background that in medicine and healthcare, curative treatment of patients was predominant for a long time. In recent decades, the need for preventive and holistic treatments changed. The health tech approach aims to meet these needs with new technological tools.
Technology companies are working with medicine and the healthcare system to do this.”

IEC 62366-1
Because we are experts in user experience and usability engineering and deal primarily with medical devices, ISO 13485 is often not detailed enough. IEC 62366-1:2015 is a standard that provides guidance on applying usability engineering to medical devices.

The aim is to ensure that products can be used safely and effectively by their intended users. The standard covers the entire product life cycle and requires manufacturers to conduct risk management and usability testing. Among the usability tests are formative assessment and summative evaluation. In both processes, usability is tested using various methods in order to detect faults early on and solve them in a sustainable way. Compliance with the standard can help reduce use errors, increase user satisfaction, and ensure regulatory compliance.

We are not certified, we have spent a long time studying the standard and know what is relevant for your medical device.

ISO 13485

ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for medical devices. The standard specifies the guidelines for designing, developing, manufacturing, and distributing medical devices that meet regulatory requirements and ensure customer satisfaction.

ISO 13485 is applicable to all organizations involved in the medical device industry, regardless of their size or type. Compliance with the standard demonstrates that an organization has implemented a QMS that meets the requirements of regulatory bodies and has the necessary controls in place to ensure product safety and effectiveness.

The implementation of ISO 13485 can improve an organization’s operational efficiency, reduce costs associated with compliance, and enhance customer satisfaction. It is a valuable tool for organizations that want to demonstrate their commitment to quality and regulatory compliance in the medical device industry.

Here too, although we are not certified, but we know what’s important.

Medical product/device

…or not!?
Applications that calculate and display a diagnostic suggestion or a progression prediction are medical devices. These are also defined in different classes depending on their content and scope – from I, IIa over IIb up to III.

NOT medical devices are apps/products that are used to merely record, archive, search or communicate data. Apps or software that serve, for example, billing, bed organization of a clinic or epidemiological research are also not medical devices. As a manufacturer, you should be clear from the outset whether your own product or application is a medical device or not.

An internal view is often not entirely objective. Let us advise you. We have a neutral eye on your product and can help you with the classification and further development of your digital product. Contact us

Patient safety
According to the DiGA guide (GER), the manufacturer of a DiGA must take appropriate organizational and technical measures to ensure that the risks in the use of the application are as low as possible. While the CE marking ensures the basic technical safety of the DiGA, the measures required here are aimed at consciously dealing with existing residual risks for the insured persons.

We are aware of this requirement and can work out the residual risks together with the project requirements and perhaps further minimize or even eliminate them.

PDCA cycle

The PDCA cycle, also known as the Deming cycle, is a four-phase process that originated in the field of quality assurance and management. The American physicist William Edwards Deming developed this process to promote “learning and improvement”. The abbreviation PDCA stands for Plan – Do – Check – Act.

Deming placed particular emphasis on the work system, stressing that one should go “to the scene” to put the employees on the spot, with their exact knowledge of the situation at the workplace, at the center of planning.

The PDCA cycle begins with the planning process, where goals and processes are established. Then the plan is implemented and the results are reviewed and measured. Based on the results, action is finally taken to make corrections and improvements to optimize the process. The cycle then starts all over again with renewed planning.

The PDCA cycle is an important process in quality improvement and is used in many industries and companies to achieve continuous improvements in their processes and products.

Prevention applications and the DiGA directory
The DiGA Directory (Directory of Digital Health Applications) is a platform that lists digital applications that are accepted as medical products. The applications are reimbursed by health insurance companies and are intended to help improve the health of users or treat illnesses.

In addition to applications for therapy, there are also applications for prevention that are listed on the DiGA directory. These applications aim to prevent health problems before they occur. Various prevention approaches can be used for this purpose, such as exercise programs, nutrition tips, stress management or smoking cessation.

To be included in the DiGA directory, applications must meet certain requirements. These include scientific proof of the effectiveness and safety of the application. The applications must also show high quality and be designed to be user-friendly.

Prevention applications can make an important contribution to health promotion by helping to prevent health problems. By being available in the DiGA directory, the applications can be made accessible to a broad public and thereby contribute to improving the health of the population.

Requirementdefinition
Requirement definition for medical products and devices involves identifying and specifying the features, functions, and performance criteria that a product, application or device must meet in order to be safe, effective, and compliant with regulatory requirements.

The process typically begins with a comprehensive assessment of user needs, market trends, and regulatory requirements to determine the product, application or device’s intended use and target market. From there, a set of requirements is defined that outlines the product’s features, functions, and performance criteria, as well as any necessary safety and regulatory requirements.

The requirements definition process is critical to ensuring that the product meets user needs and regulatory requirements, as well as minimizing the risk of errors, failures, or safety issues. It should involve collaboration between various stakeholders, including product designers, engineers, regulatory experts, and quality assurance personnel.

Requirements should be documented in a clear, concise, and unambiguous manner to facilitate communication and ensure that all stakeholders have a clear understanding of what is required. They should also be testable and verifiable, with clear acceptance criteria and validation methods to confirm that they have been met.

In conclusion, requirement definition is an essential component of the product development process for medical products. It ensures that the product meets user needs, regulatory requirements, and safety standards, and minimizes the risk of errors or failures. It should involve collaboration between various stakeholders and be documented clearly and unambiguously to facilitate communication and verification.

Technical documentation
Technical documentation refers to the set of documents that describe a medical device’s design, performance, safety, and effectiveness. The Medical Device Regulation (MDR) in Europe requires manufacturers to provide comprehensive technical documentation to demonstrate device safety and performance, including information on intended purpose, risk management, clinical evaluation, labeling, and instructions for use. The MDR sets out specific requirements for the format, structure, and content of the documentation, which should be kept up to date and readily available for inspection by regulatory authorities. Technical documentation is a crucial component of the conformity assessment process, which ensures medical device compliance with EU regulatory requirements.

Usability
DIN EN ISO 9241-11, entitled “Requirements for usability – Guiding principles”, defines the term usability as follows:

“Usability is the extent to which a product can be used by specific users in a specific context of use to achieve specific goals effectively, efficiently and satisfactorily.”

• For full understanding, the terms need to be explained:
  The product is the app/software/website being developed for which usability is specified and evaluated.
• The users are the people who will install or use the product – effectively, efficiently, and satisfactorily.
• Effectiveness means how completely the result is achieved relative to the desired goal.
• Efficiency, on the other hand, relates the result to the effort expended.
• Satisfaction is defined in the standard as, “Freedom from interference and positive attitude toward the use of the product.”
• The context of use consists of the items users, work tasks, work equipment, and social and physical environments.

Usability Engineering
Usability engineering is a critical process in designing and developing medical devices and products that are safe, effective, and user-friendly. This involves identifying user needs and requirements, defining user interfaces, and testing the usability of the product or system.

Human factors engineering is an important aspect of usability engineering in medical applications, which involves understanding how users interact with the product or system and designing interfaces that are intuitive, efficient, and easy to use. This helps to minimize user errors, improve efficiency, and enhance patient safety.

Compliance with regulatory requirements is also a key consideration in usability engineering for medical applications. Medical devices and products must meet strict regulatory standards for usability and safety, and failure to comply with these standards can result in regulatory action or legal liability.

To ensure that user needs and requirements are incorporated into the design, usability engineering should be integrated into the product development process from the earliest stages. User testing and feedback should also be incorporated throughout the development process to identify and address usability issues early on.

User Interface
A user interface (UI) refers to the visual and interactive components of a software application or system that allow users to interact with it. It includes elements such as buttons, icons, menus, text fields, and graphics that are designed to be easy to use and understand. A well-designed UI can enhance the user experience, improve usability, and increase user satisfaction. It is crucial to consider factors such as user needs, cognitive load, accessibility, and usability testing when designing a UI to ensure it meets the needs of its users.

User Journey
A user journey is the path that a user takes while interacting with a product or service, from initial awareness to the final outcome. It includes all the touchpoints and interactions that the user has with the product or service and encompasses their goals, needs, and emotions. Understanding the user journey is essential for creating a positive user experience and can help identify pain points and areas for improvement. By mapping out the user journey, designers and developers can gain insights into user behavior, preferences, and expectations, and create a more intuitive and seamless experience that meets their needs and exceeds their expectations.