Empirical Data
Creating products that make a difference in people's lives is our passion. We seamlessly blending scientific research with captivating aesthetics which prioritize the user experience above all else.
Balancing User and Market Needs
Concept development for medical devices is an art of the thoughtful transformation of user needs and expectations into precise product designs and specifications. Our evidence-based methods offer solutions to translate your data into key insights to guide you through development decisions, allowing you to proceed to the FDA approval process with unwavering confidence.
By seamlessly integrating human-centered design principles into the initial phases of the medical device development process, you can expedite timelines, enhance usability, safety and effectiveness, and circumvent expensive errors that when identified late in the process often result in regulatory setbacks and/or product recalls.
Informed Ideation
Within our process, user needs are identified via contextual and stakeholder research and transformed into concrete requirements. This approach enables us to proactively identify any potential safety, usability, and/or customer satisfaction issues early in the product development process. Early-stage identification means easier and more cost-effective design changes.
Comprehensive Ideation:
- Thoroughly analyze user needs
- Generate innovative ideas to address those needs
- Gather valuable feedback on designs or prototypes from customers, end users, and other stakeholders
- Continuously refine product designs based on newly acquired information
- Select optimal product design based upon user, engineering, business and risk management requirements
Design Excellence
Prioritizing the needs of your user is the secret to our approach. Our design process is rooted in understanding the tasks your user is expected to accomplish, enabling us to develop innovative solutions that enhance their performance. We can help you:
- Organize and accelerate your medical device design process
- Address usability, safety and/or user acceptance challenges
- Evaluate new feature decisions for next-generation products
- Assess feasibility and usability of potential designs early in the design process
Our Concept Development Expertise
Designing and developing medical devices that change peoples lives by prioritizing the needs of the user, engineering capabilities, and business requirements.
2D Visual Design
- User Interface design
- Web, app and software design
- Instructions for Use (IFU) design
- Data visualization
- User Experience Design
3D Industrial Design
- Concept sketches
- Physical user interface design
- Product design and prototyping
- Structural packaging
- Surface geometry/3D Modeling
Immersive Technology
- Augmented Reality/Virtual Reality (AR/VR)
- Physical user interface design
- Simulated use environments
- Scenario-based user testing
- Generative user testing
View Case Studies
Surgical Helmet System
