COMPANY INSIGHT

We are User Experience and Human Factors experts

We have been applying HF/UE to medical device development longer than the FDA has been regulating it!

e are working as Human Factors and User Experience Consultants since 2000. We support our clients in developing safe and effective medical devices according to ISO 62366, FDA guidance and the EU Medical Device Regulation (MDR).

What we do

PLANNING & EXPLORATION

Are you about to get started and want to know more about your customers and what really moves them? Make sure you have all pieces in place by doing explorative research and fully understand your users needs and goals.

MEASURE & VALIDATE

If you want to measure your success or are under regulatory requirements, our validated measurement approaches are designed exactly for you.

DESIGN & ITERATE

Do you want to create a new and innovative service from scratch? Have you already built prototypes and just want to kink out usability flaws? Enter the cycle of ideation, design and testing to iteratively move from your first idea to a test-proven product!

MANAGEMENT & STRATEGY

Lift UX to the next level and systematically integrate it into your development process using our tools and experience.

About us

Our team includes industry pioneers with more than 20 years of experience in UX as well as young professionals from the fields of research and design. We have worked in large organizations as well as in start-ups and are happy to share our experience with you!

Our additional motivation kick: uintent is employee-owned. Researchers and designers are also our decision makers!

Your benefits:

Agility | No overhead | Flexibility | Professionalism | Creativity

We are uintent

uintent has offices in Hamburg, Basel and Munich. We operate in other German cities as needed.

We have sibling companies in the USA, Japan and China and mutually own each other.

These have a similar philosophy and organization and are closely linked to us - in these markets we operate as one company.

Our commitment to quality is part of our DNA

HF/UE best practices and industry standards are part of our DNA. Our research is conducted according to the guidelines found in IEC 62366-1, TR 62366-2, FDA guidance on applying HF/UE to medical device development, AAMI HE75, and other standards wherever appropriate.

We don’t just adhere to best practices; we work with other industry thought leaders to define them through our corporate memberships with AAMI and other organizations.

Contact information

uintent

Web: www.uintent.com
Email: hello@uintent.com

05/22/2024 21:23:31

Applying human factors best practices to product development is much more than executing a validation study

Creating safer, more effective and engaging experiences for your customers starts much earlier.

The foundation for great products begins with exploratory research and spans the entire development process.

Explore & understand

Understand the challenges faced by patients, caregivers, and healthcare professionals when interacting with similar products already on the market.

We observe intended users of your product in their natural use environments. This helps inform definitions of critical tasks, as well as, provide a better understanding early on for which use-related challenges and risks your product should account.
We analyze behavioral data, qualitative feedback, and existing post-market surveillance data to get a comprehensive understanding of barriers to safe and effective use.
We inform the development of a robust human factors plan that will minimize the amount of time and effort required to validate your product.

Design & iterate

Get feedback early and often to fix use-related risks while it’s still easy to do so.

Rapidly test early design iterations in small sample formative usability tests to mitigate use-related risks.
Document updates to the use-related risk analysis (URRA) and progress the HFE report to reflect the evolution of your product’s design as a result of formative evaluations.
Refine and finalize definitions for intended users, use environments, and (critical) tasks.
As product design approaches production equivalence, shift focus to refinement of research protocols and simulation of use environments in preparation for human factors validation.

Measure & validate

Know where you stand and get the insight you need to focus future development efforts or to document the achievement of objectives.

Ensure that intended users, critical tasks, and elements of simulated use are appropriately defined.
Conduct thorough root cause analysis of all observed use errors, close calls and operational difficulties to determine if residual use-related risk is acceptable.
Validate that your product can be used safely and effectively by its intended users, in its intended use environments, for its intended uses

Management & strategy

It happens that organizations do not have proper medical device development processes in place (because there is rarely need for it) or the organization is large and processes vary from department to department. We support you in getting the task done.

We provide consulting and interim management to set up one-time medical device developments according to regulatory needs.
We analyze existing processes (or create them). We align them to be more efficient and at the same time fulfill all regulatory requirements.
We connect you to international partners worldwide and execute your studies where you don’t have boots on the ground.