{"id":2860,"date":"2021-09-02T09:05:22","date_gmt":"2021-09-02T06:05:22","guid":{"rendered":"https:\/\/vyp4g2zxbcr.c.updraftclone.com\/kaytettavyys-ja-palvelumuotoilu\/"},"modified":"2024-06-03T09:14:49","modified_gmt":"2024-06-03T06:14:49","slug":"usability-and-service-design","status":"publish","type":"page","link":"https:\/\/www.clinipower.fi\/en\/services\/usability-and-service-design\/","title":{"rendered":"Usability and service design"},"content":{"rendered":"\n
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A successful product or service solution corresponds to needs of users, customers, and other stakeholder groups, and its design acknowledges business objectives. The solutions need to meet use safety requirements in the health tech field. The aim of product and service design is an effective, safe, and pleasant outcome.<\/p>\n<\/div><\/div>\n\n\n\n

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Clinipower offers usability and service design services as a part of your own product development and innovation activities. You can contact us already when your product is on idea or concept level! <\/strong><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Concept design and testing<\/h2>\n\n\n\n
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Understand need and magnitude of a problem before creating a solution <\/p>\n\n\n\n

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To shorten product development time and enable success of your solution, we encourage you to understand and validate demand and the problem of your customers, define criteria for success, and iterate various solution concepts.<\/p>\n\n\n\n

Clinipower assists in user and market research and utilizes service design methods to build a prototype and business model for a product idea.<\/strong><\/p>\n\n\n\n

We have developed a Medical Device Scoping Canvas<\/strong> which helps recognize uncertain areas in the beginning of a development project. Documentation from early concept testing functions as a basis for actual product documentation to ensure regulatory compliance.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Design sprint<\/h2>\n\n\n\n
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From an idea to a usability tested product concept in four days? It is possible<\/p>\n\n\n\n

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In a design sprint, an ideation phase that might take months is compressed to a single week<\/strong>. This saves time and ensures seamless information sharing within your team.

The design sprint consists of a problem framing meeting, and four day long design sprint workshop. Depending on the phase of your project, for example a research phase can be implemented between the problem framing and the sprint to specify user needs.

At Clinipower, the design sprint version 3.0<\/a> developed by Design Sprint Academy is followed: we have a Certified Design Sprint Facilitator<\/strong>.

We have customized the sprint for medical devices by including aspects that affect launch of a first MVP-product version:<\/strong> e.g. defining intended purpose, product classification, and planning regulatory strategy as a part of designing the concept.

The Innovation voucher of Business Finland<\/a> is a great funding instrument for the design sprint.<\/p>\n<\/div><\/div>\n\n\n\n

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UX design<\/h2>\n\n\n\n
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Increase safety, fluency, and delight with user experience design<\/p>\n\n\n\n

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Clinipower offers user experience design as a part of product development and innovation activities of your organization.<\/strong> Our expertise in this area comes from years of experience in for example information system development, in tight co-operation with end users, management, and product development and quality experts.<\/p>\n\n\n\n

The UX design is based on defining user journeys, personas, and understanding potential use risks.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Formative evaluation<\/h2>\n\n\n\n
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Evaluate your product from user point of view throughout product design and development<\/p>\n\n\n\n

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Formative evaluation is an assessment which takes place in product design and development phase. By conducting these evaluations, you can ensure that customer value recognized in concept design phase does not get lost in product development. You will also identify possible use-related risks and opportunities for improvement.<\/p>\n\n\n\n

We have developed a UX checklist for medical software<\/strong> which considers typical usability issues and use-related risks of software products.<\/p>\n\n\n\n

Clinipower offers formative evaluations for each phase of a project, with help of our own experts and end users.<\/strong> We recommend UX expert\u2019s evaluation for assessing basics of a user interface. For clinical job description and use-related risk evaluation, we recommend clinical assessment, which can be for example the viewpoint of a clinical opinion leader or an end user.<\/p>\n<\/div><\/div>\n\n\n\n

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Summative evaluation<\/h2>\n\n\n\n
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Make sure that usability requirements and objectives are fulfilled in the end of product development<\/p>\n\n\n\n

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Summative evaluation is a mandatory usability test for medical devices to ensure their safety. We offer summative evaluation as a complete turnkey service.<\/strong> The test plan is always customer specific and based on the risks of your product, business needs, and resources. The summative tests are conducted together with your team – by utilizing our broad experience from over a hundred usability tests.<\/p>\n\n\n\n

Clinipower can offer a simulated hospital environment for usability tests<\/strong> in the facilities of our partner the Microsurgery Center of Eastern Finland<\/a>.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Usability process IEC 62366<\/h2>\n\n\n\n
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Following the usability standard IEC 62366 is an important part of medical device development<\/p>\n\n\n\n

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The usability planning process according to IEC 62366 consists shortly of describing users, use environment, and principles of a user interface. It also includes predicting use-related errors and reducing them by design, and usability testing.<\/p>\n\n\n\n

We help combine usability to project planning, risk management, requirement specification, and planning of clinical evaluation<\/strong>. This ensures that the needs and viewpoints of end users are taken into account throughout development process. In software development, the usability standard can be connected to agile development (as a part of e.g. Scaled Agile Framework<\/a>). By following the standard you will also ensure compliance with the field\u2019s requirements.<\/p>\n<\/div><\/div>\n\n\n\n

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Read more<\/h2>\n\n\n\n
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How to Build a QMS System for Medical Devices?<\/a><\/h3>

Here is the English translation: How to Build a QMS System for Medical Devices? A QMS (Quality Management System) is…<\/p>\n

How to Build a QMS System for Medical Devices?<\/span><\/a><\/p><\/div><\/div><\/article>\n

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What are the most common challenges in auditing a notified body?<\/a><\/h3>

Notified body auditing is an essential process in the health technology field, where a third party evaluates a company’s quality system and documentation for compliance with MDR requirements. The most common challenges relate to documentation management, deficiencies in risk management, and inadequate staff preparation for audit situations. Notified body auditing is a systematic evaluation in which an authorized third-party organization examines a medical device manufacturer’s operational compliance with requirements. The primary purpose of auditing is to ensure that the company complies with the EU Medical Device Regulation (MDR 2017\/745) and is capable of safely producing medical devices. Auditing is a central part of the CE marking approval process. Without successful auditing, a company cannot obtain the necessary certificate that authorizes the placing of products on the market in the European region. Health technology auditing focuses particularly on quality system functionality, risk management processes, and product documentation comprehensiveness. Meeting MDR requirements requires […]<\/p>\n

What are the most common challenges in auditing a notified body?<\/span><\/a><\/p><\/div><\/div><\/article>\n

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Why health technology product development fails – 4 most common pitfalls<\/a><\/h3>

Health technology product development is a complex process where even a single wrong step can lead to significant delays, cost increases, or in the worst case, complete project failure. While the industry’s opportunities are enormous, health technology product development contains specific pitfalls that surprise too many companies. Let’s examine the five most common mistakes and methods to avoid them. One of the most serious errors in health technology product development is underestimating user needs. Too often, development teams focus on technical features while forgetting the everyday reality of actual users, such as nurses, doctors, or patients. This leads to products that may function technically flawlessly but do not integrate smoothly into the usage environment. Neglecting usability testing is particularly risky in health technology, as usage errors can compromise patient safety. The IEC 62366 standard requires systematic usability design and testing, but […]<\/p>\n

Why health technology product development fails – 4 most common pitfalls<\/span><\/a><\/p><\/div><\/div><\/article>\n<\/div><\/section>\n\n\n

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Our experts<\/h2>\n\n\n\n
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Juha Kaasinen<\/h2>

Senior Advisor, Usability and User Experience<\/p>

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