Industrial Design For Medical Devices

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We create intuitive, meaningful medical device experiences that optimize usability, performance, and marketability to advance our clients’ vision.

INDUSTRIAL DESIGN

Human-Centered Approach

Engenious focuses on keeping users at the heart of the design process. Technology is important, and we work to use technology in a way that it supports user needs first.

User-centric design has been a deeply held value at Engenious Design from our inception. Our team of Industrial Designers and engineers humanize advanced technology to deliver market-ready solutions that improve the lives of patients and clinicians. The systems we bring to market are used by healthcare professionals, patients, caregivers, and others. We strive to create intuitive, meaningful medical device experiences that optimize usability, performance, and marketability to advance our clients’ vision. We quickly validate concepts through creative problem solving, multidisciplinary design, concept development, fast visualization, rapid prototyping and design refinement.

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INDUSTRIAL DESIGN & HUMAN FACTORS CAPABILITIES

Research

RESEARCH

Clinical Insights Research Program

Clinical Observation Field Research

Product Positioning/Market Analysis

Anthropometric Data Insights

User Related Risk Management

Formative (Verification) Testing

Strategy

STRATEGY

Clinician Workflow Analysis

Usability Engineering Requirements

Human Factors & Ergonomics

User Interface Design

Concept Ideation

Instructions for Use (IFU) Design

Design

DESIGN

Form Development

Form Study Models

Product Aesthetics

Visual Brand Language Design

2D Concept Rendering

Regulatory Labeling Design

Develop

DEVELOP

Rapid Prototyping

3D CAD Modeling

Color, Material & Finish (CMF) Design

Appearance Models

Photo-realistic Rendering

Validate

VALIDATE

Summative (Validation) Testing

Observational Evaluations

Workflow Evaluation

Clinical Study Support

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Human Factors

Human Factors and Usability Engineering considerations are vital in medical device product development. Engenious Design Industrial Designers review concepts and prototypes early and often with our on-staff clinical professionals through a Human Factors lens. This continuous feedback efficiently provides critical insight for our industrial designers on topics such as intended users, critical tasks, and user environments. Our methodology results in products equipped to fuel overall user satisfaction – optimizing comfort, usability, and function.

Engenious follows defined HF/UE processes to uncover valuable metrics and insights. 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.

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Clinical Insights

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 also helps meet FDA medical device development requirements. Our team visits hospitals, clinics and procedure labs to observe our prototypes in action and learn directly from healthcare professionals and patients. By conducting research, we are able to make our clients’ medical devices safer, easier to use correctly, and designed to require less cognitive and physical burden on users.

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Document Discoveries

Our team creates detailed Workflow Analysis including sketches to tell the story of user discoveries and insights for all product stakeholders. We identify potential use errors and severity levels that highlight critical tasks for further review during summative usability testing. We leverage anthropometric data to ensure the product is adaptable to a wide audience or a specific niche of users to ensure client products become market successes.

Let's Talk Industrial Design

Great teamwork starts with a conversation!

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