Clinical Field Research

Our team visits hospitals, clinics, procedure labs, and conferences to observe our prototypes in action and learn directly from healthcare professionals and patients. By conducting research, we make our clients’ medical devices safer, easier to use correctly and designed to require less cognitive and physical burden on users. We conduct focus groups within our Clinical Insights Program to document stakeholder insights as one component of formative usability testing. This usability testing is inherently useful and helps meet FDA medical device development requirements.

Human Factors

Our team understands that human factors and usability engineering considerations are vital in medical device product development. We review concepts and prototypes early and often with our on-staff clinical professionals as part of our human factors and usability engineering considerations. Continuous feedback provides critical insight into human behavior, intended use cases, critical tasks, and user environments. We operate under the guidance of both the EU and the FDA’s pre-market human factors approval and compliance requirements described in IEC 62366 and the FDA HF/UE guidance.

Workflow Analysis

Our workflow analyses tell the story of user discoveries and insights, and are brought to life through sketches, user journey mapping, storyboarding user experiences and other visual communication methods. We identify potential use errors and severity levels that highlight critical tasks for further review prior to summative usability evaluations. We leverage anthropometric data and human factors studies to verify the product is adaptable to a wide audience or a specific niche of users to ensure client products become market successes.

Concept Development

Our team solves complex problems in style. Through various visual communication methods, we infuse emotion and value into novel, optimized solutions for our clients’ most pressing problems. We explore form with the right balance of function, ergonomics and aesthetics curated from user research, human factors studies, and the latest product design trends. We help medical device companies visualize opportunities, mitigate potential risk, and identify feature scopes. We ensure proposed design concepts align with your company’s brand voice, or pivot to create a refined brand language designed to last well into the future.

UX/UI Design

We develop medical devices used by an international cross-section of clinicians and patients in situations that can be stressful; a reality that drives our team to create intuitive user experiences. We create systems that have complex multi-lingual graphical user interfaces and simple indicators – and everything in between. We understand the medical device alarms standard (IEC 60601-1-8) and its’ unique requirements for UI design. The user interfaces we design are unique for purpose-built embedded systems, and our team considers direct observation of clinician workflows to create user experiences that work with and not against clinical norms.

Validation

We know the medical device process, including whole-product validation to FDA and ISO standards. Our test group validates that designs (our design or designs originating elsewhere) meet user needs and intended uses. We conduct formative usability engineering/human factors testing on the front end to inform design, then evaluate the design with summative human factors studies according to FDA guidance and IEC 62366. Our Clinical Insights program means that we have practicing clinicians available to help quickly and effectively validate designs.

Clinical Insights

We created the Clinical Insights program to integrate practicing healthcare providers into the design process. This enables us to include real clinicians in the entire design cycle, from formative work and early definition of opportunities, into the preliminary design and through final validation.

Engenious Design’s Clinical Insights Program incorporates regular and meaningful feedback from healthcare professionals into the design of the tools and equipment clinicians use daily. Our team includes highly specialized healthcare professionals who collaborate with our design team through focus groups, surveys, phone conversations, in-person concept or prototype evaluations and interviews.

Rapid Prototyping

Our in-house model shop quickly crafts models and proof-of-concept prototypes so you can get hands-on with physical parts that work – without waiting on third party suppliers. Engenious Design has established in-house prototyping capabilities to fabricate, build and test concepts throughout the development process – far beyond having a few 3D printers. We are able to iterate quickly and inexpensively to get ideas in front of users in record speed.

From non-functional appearance models to functional prototypes to polished production-equivalent systems built under Design Controls, our in-house model shop is equipped to quickly take ideas from concept to reality.