HUMAN FACTORS / USABILITY ENGINEERING AND HEALTHCARE
Your Partner for Human Factors / Usability Engineering and Medical Device Research
OUR FULL-SERVICE OFFERING
Create Safe and Effective Medical Devices
Applying human factors best practices to medical product development is much more than executing a validation study. Starting from exploratory research to your final validation study, we help you to create safe, effective, and engaging experiences for your customers. We put together a package that is tailored to your needs. Our services include:
EARLY USER RESEARCH
Get to know your users and uncover their needs, behaviors and pain points to help inform the design of your device early.
CONSULTING
Leverage our usability engineering expertise. We provide consulting services along the entire development cycle of your product.
FORMATIVE EVALUATIONS
Uncover issues, improve your product and assess the effectiveness of risk mitigation strategies.
RECRUITMENT OF USERS
Use our extensive recruitment network to test with the actual users of your product: patients, caregivers, healthcare professionals of all kinds and more.
SUMMATIVE EVALUATIONS
Validate that your final product can be used safely and effectively by its intended users in its intended use environments.
MEDICAL APPS & SOFTWARE
Facilitate the development of your digital health assets with our expertise with user-centered software development in healthcare.
PACKAGING, LABELING & IFUS
Develop, test and improve your instructions for use, packaging labels or packaging concepts with your intended users.
AND MUCH MORE...
Use-related risk analysis, market research activities (e.g. landscaping research, competitor analysis, ...), ethics committee approval (IRB), etc.
We help you to comply with IEC 62366, AAMI HE75, MDR and the FDA guidance on applying HF/UE to medical device development.
OUR HEALTHCARE CASE STUDIES
Unifying HF Usability: Streamlining Processes Inside Departments
Industry
Healthcare
Method
Consulting, IDIs, Co-creation workshop
Duration
1.5 Years
Background
A large medical systems manufacturer with 5 different departments, all following different usability processes, wanted to streamline its usability processes. Historically, the different departments had been developing their usability processes in silos. Our task was to help our client build one usability process for all departments, based on the feedback and needs of each department.
Approach
We interviewed different types of stakeholders (UX/usability engineers, risk managers, developers, managers, etc.) to map out each departments' usability processes.
Afterwards, we facilitated several rounds of iteration workshops with stakeholders to refine early designs of a unified process for all departments and select the best approach.
Outcome
A final common usability process could be established, taking into account the requirements of all departments' stakeholders and the guidelines and regulations (FDA/IEC)
The common usability process was tested successfully during a pilot roject and the client decided to move forward and implement it across all departments.
Validating a Digital Biomarker App for Clinical Trials
Industry
Healthcare
Method
Formative usability test, Health app testing
Duration
3 months
Background
A pharmaceutical manufacturer was planning to use a smartphone app in a clinical trial. The app consisted of several tests to assess specific disease symptoms.
The data captured via the app would help assess changes of patients’ abilities and therefore potentially assess the effectiveness of the treatment.
To ensure usability of the app and if it would capture appropriate data , it had to be tested with patients prior to launch.
Approach
We recruited 20 patients diagnosed with different stages of a neurodegenerative disease.
During face-to-face interviews, patients were asked to use the smartphone app and its “games”.
For some sessions, alternative versions (e.g., with several difficulty levels, or different parameters) were tested to identify the best design and/or baseline settings.
Outcome
The research revealed several usability issues with the app. Additionally, we showed that some of the instructions were not understood by all participants and could be a source of confusion.
Based on these results, uintent provided recommendations for the manufacturer to address before the app’s launch in the clinical trial.
Unifying HF Usability: Streamlining Processes Across Departments
Industry
Healthcare
Method
Consulting, IDIs, Co-creation workshop
Duration
1.5 years
Background
A large medical device manufacturer with 5 different departments, wanted to streamline its usability processes. Historically, the different departments had been developing their usability processes in silos. There was a need to have one usability process for all departments.
Our task was to help our client build one usability process for all departments, based on the feedback and needs of each department.
Approach
1. Phase: establish what the usability process looked like for each department via stakeholder interviews.
2. Phase: presentation of the findings, and several rounds of iteration workshops to refine the unified process for all departments.
3. Phase: assess whether the proposed approaches would be usable for all departments’ stakeholders, and ultimately the selection of the best approach.
Outcome
A final common usability process could be established, taking into account the requirements of all departments’ stakeholders and the guidelines and regulations (FDA/IEC).
The common usability process was tested successfully during a pilot project and the client decided to move forward and implement it across all departments.
Validating Safety & Effectiveness of a New Angiography System
Industry
Healthcare
Method
Summative usability test
Duration
4 months
Background
A medical device manufacturer was devel-oping a new angiography system, which included a hard- and software update of the previous version.
The study intended to demonstrate that critical use tasks could be performed safely and effectively by the intended users in the intended use environment.
Approach
A summative evaluation was carried out with n=15 intended users in a market research facility, on a partial angiography system.
Use tasks were assessed via simulated use, and warnings in the instruction manual were assessed via a comprehension assessment.
Outcome
Results for the simulated use tasks were categorized and a detailed root causes analysis was performed for non-successful tasks. A residual risk analysis was conducted.
Comprehension of the warnings was also assessed, results were categorized, and a root cause analysis was performed. The final HFE report was used for FDA submission.
Evaluating Safety & Usability: Validation of a Patient Supply Unit Interface for HCPs
Industry
Healthcare
Method
Summative usability test
Duration
2 months
Background
A medical device company required a validation study to determine if the use of a patient supply unit was safe and effective.
Our task was to determine if nurses and physicians can operate the height adjustment and mobility features of the unit, considering the interface modifications from the previous model. We also examined the capability of service technicians to execute specific maintenance tasks associated with the device.
Approach
N=20 face-to-face usability test sessions were conducted with the intended user groups - nurses, physicians and hospital technicians.
The interviews took place directly at the client’s premises due to the technical setup restrictions of the supply units.
Outcome
Participants successfully executed usage and maintenance tasks for the patient supply units.
Nonetheless, the study revealed new technical issues with the supply unit.
Subsequently, the manufacturer utilized the study findings to proactively address and resolve these identified issues.
Color Preference Study
Industry
Healthcare
Method
Usability test, Online survey
Duration
3 months
Background
Client is developing new growth hormone pen-injectors for weekly injections of Human Growth Hormone (HgH). The pen will be available in 3 different drug strengths – each represented by a colour. It should be easy to differentiate the 3 colours from each other and from other pens on the market in three different markets. (US, Germany & Japan)
Approach
F2F interviews at conference and online survey. The F2F interviews delivered possibility of in-depth exploration. The online survey delivered statistical data for three different countries. To make sure the correct colors were rated each participant of the online survey got a print of each pencolor send by snailmail as colors on the screen may differ depending on the screen.
Outcome
Clear suggestion which color should be used for which dose in which country. Furthermore the data gave insight about the preferences of colors for age, gender, country and the look and feel of the pen itself. The client had a clear recommendation which colors should be used.
Service Conceptualization and Visualization in Healthcare
Industry
Healthcare
Method
Co-creation workshop, Focus Groups
Duration
1.5 months
Background
A medical device manufacturer had a rough idea of new product lines and corresponding services.
Our task was to support in defining the new concepts, visualizing them and presenting them to the target group as well as key stakeholders within the company.
Approach
We conducted a co-creation workshop with the client in a stimulating atmosphere out of the office context. During the full day workshop, a live scribbler sketched first ideas.
After that, our designers fully visualized the concepts to further evaluate them in focus groups with the target audience.
Outcome
The focus groups clearly showed strengths and weaknesses of the concept, which was then re-worked and re-evaluated with the target group. The results were used by our client to further refine the concept and discuss it with internal stakeholders.
Validating a Mobile Patient Monitoring Solution for HCPs
Industry
Healthcare
Method
Summative usability test
Duration
5 weeks
Background
A medical device manufacturer wanted to conduct a validation study to determine if the use of their mobile patient monitoring solution was safe and effective for the intended users in the intended use environment.
Our task was to evaluate if nurses and physicians of different specialties could operate the interface (desktop & mobile) to locate different parameters and to recognize malfunctions and notifications.
Approach
90-minute face-to-face sessions with n = 15 nurses and n = 15 physicians in a simulated hospital office use environment.
Participants were asked to perform different use scenarios with the software, including knowledge-based tasks.
Performance evaluation based on pre-defined acceptance criteria.
Root cause probing for any observed use difficulties.
Outcome
The mobile patient monitor system could be used safely and effectively by the intended users. Some remaining issues with notifications and alarms were discovered.
uintent delivered a summary report together with the data collection sheet, with recommendations to mitigate the existing risks from the issues encountered.
The writing of the HFE report remained with the client.
GLOBAL COVERAGE
We Consider Our Global Reach One of Our Biggest Assets
We have offices in Hamburg and Munich and we operate wherever you need us. We have sister companies in the USA, UK, China, Japan, India, and Singapore. They have a similar philosophy and organization and are closely linked to us – in these markets we operate as one company: ReSight Global. As a member of the UXalliance, we conduct global studies with our international partner agencies in more than 50 countries across six continents. The UXalliance is a leading UX network, which we co-founded in 2005.
OUR HEALTHCARE EXPERTISE
We Are Experienced With a Wide Variety of Medical Areas
MEDICAL DEVICES
DIGITAL HEALTH SOLUTIONS
PACKAGING, LABELING & INSTRUCTIONS FOR USE
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Needle safety devices
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On-device labeling
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Surgical devices
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Imaging systems
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Clinical diagnostics
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Robotic surgery systems
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Patient & caregiver diagnostics
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Form factor considerations
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Connected devices
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Digital therapeutics
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Patient support applications
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Websites & desktop software
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Clinical decision support systems
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Remote patient monitoring and management
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Mobile health apps
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Software as a medical device
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Clinical applications
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Injection devices
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Infusion pumps
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Oral therapies
VOICES OF OUR CLIENTS
Methods and Approaches That Take Effect
„uintent incorporated its human factors engineering and usability expertise into our project and our drug-device combination product design in a noticeably positive way, so that we ended up with a very good result for our patients. uintent responded very flexibly to input and took it into account in a goal-oriented and effective way when planning the study. The documentation for the HFE study was professional and, in our opinion, fully compliant with regulatory requirements.“
Dr. med. Martin Karjalainen
Human Factors Engineering Specialist,
medac
„I always look back with satisfaction on the collaboration with uintent. We had a successful project in many aspects. The results of the studies we carried out together are a great help in adapting the functions of the products to the actual needs of our customers and putting the users at the center of all activities.”
Andrea Schwendele
Usability Expert,
Dräger medical
We’ve partnered with industry leaders across healthcare, aviation, software, industrial UX, and many more. Our projects have delivered measurable improvements in user satisfaction and productivity.
GUARANTEED QUALITY
We Stand for Quality Management and Information Security
We have a certified Quality Management System in compliance with ISO 9001:2015, which establishes the required quality standards and processes to be followed. This way, we deliver high quality work and continuously improve our processes. For us, confidentiality, availability and integrity of our clients' information and data have great value. Therefore, we implemented an Information Security Management System according to the question catalogue of the German Association of the Automotive Industry (VDA ISA).
MORE HEALTHCARE INSIGHTS ON OUR BLOG
GET IN TOUCH WITH OUR HEALTHCARE TEAM
Combined Medical Expertise for Your Success
Our HF/healthcare team consists of highly skilled consultants who have 10-20+ years of experience in the field of healthcare/usability engineering for medical devices. Our experts are located in Hamburg and Munich and have conducted research around the globe.
WOLFGANG
WAXENBERGER
TABEA DAUNUS