Strategize, research, build, test, learn. Our capabilities and process reflect the breadth of talent our team has to offer.

  • Sketching in the early stages of the design process helps us quickly develop a range of designs. This is the jumping off point for all design projects.

  • The packaging is the user’s first impression of the project. We take the structure, graphics, product, and branding all into account during a packaging project to create the optimal user experience.

  • We make physical models to evaluate aspects of the design. From quick turnaround foam core models to works-like prototypes and final looks-like models.

  • We offer customized CMF design strategies to elevate the aesthetics and performance of your product, creating a compelling emotional response. 

  • Identifying an appropriate supplier to manufacture a product is crucial to a company's success. We have a vast network of recommended manufacturers and will be there to support you along the way.

Industrial Design

Human Factors & Usability Testing for Medical Devices

  • Early use testing to discover what users want and rapidly improve the product’s usability, safety and performance. Qualitative and quantitative analysis help us turn data into actionable insights for iterative design improvements.

  • Use Failure Modes and Effects Analysis (UFMEA) and gap analysis to reduce risk and inform design input requirements.

  • Using anthropometric data, task analysis, and observational studies with real users to improve physical and cognitive ergonomics for better usability.

  • A critical component of FDA medical device applications, we run Usability Validation studies to verify that a device will be safe and effective for the intended users, uses and use environments.

  • Manage application, communication, and study close-out with Institutional Review Boards.

    Human Factors Engineering / Usability Engineering plan and report for regulatory submission and compliance with international standards such as IEC 62366-1 and IEC 60601-1-6, as well as meeting current FDA expectations for human factors engineering.

  • From concept to CAD, we preserve design intent while developing mechanisms, refining the assembly strategy, and selecting materials to give the best performance.

  • Design for Manufacturing is in our DNA - we consider it at all points of the design process, from early concepts through engineering. This means that we consider materials, constraints of various manufacturing methods from machining to molding, and assembly strategies.

  • We create functioning bench-top prototypes to prove functionality quickly. From there, we can create a custom PCB (Printed Circuit Board) to fit your product purposes.

    We partner with a range of electrical, firmware, and software partners to keep these functions aligned with project goals throughout the development process.

  • From bench-top proof-of-concept prototypes, 3D prints, and works-like models to cosmetic looks-like models and form factor prototyping, we have the capability to turn concepts into reality and put them to the test.

  • To produce engineered designs with the rigor to stand up to their environment and intended use, we routinely analyze risks and implement mitigation strategies.

    Testing early and often, we provide root cause analysis and solutions to reduce risk in the future.

Mechanical Engineering

  • Before diving into any visual design, developing a holistic overview of an experience helps us to identify key user workflows, alternative pathways and errors that the user may encounter.

  • Information architecture focuses on organizing and structuring content on a screen or page based on importance and priority.

  • Creating clickable prototypes help us test concept workflows and legibility amongst our team, or with clients and potential stakeholders. These prototypes give us a realistic sense of what the app may look and feel like.

  • Developing a visual language for an experience is essential to creating and maintaining a consistent look and feel for your brand.

    Visualizing complex datasets helps user to digest important information without feeling overwhelmed.

  • When a design moves into the development phase, our team will work with your development team to support any questions or additional adjustments that the implemented design requires.

User Experience Design

  • Developing persona profiles help us understand the key traits, behavioral patterns, goals, responsibilities and needs of particular users, or user groups.

  • A user journey map is a visual tool that helps us understand how a product will fit into a user’s daily life, and helps us identify user touchpoints.

  • User testing enables us to evaluate a product or service with real users, keeping the human at the center of the experience.

  • A competitive analysis is the process of identifying competitors or adjacent products in a given industry in order to better understand how to position a product in its market.

  • Taking the time to observe and interview users within a given industry provides our team with valuable insights to user pain-points and opportunities for improvement.

Research

  • Crafting an approach to ensure that a client's device meets regulatory FDA requirements and in-line with the device's desired intended uses and indications for use. The strategy typically addresses regulatory landscape assessment, class and classification of the device, regulatory and quality management system (QMS) requirements, preclinical and clinical studies, regulatory submissions, engaging with FDA officials, and managing post-approval obligations to ensure product safety, efficacy, and compliance throughout the product lifecycle.

  • Researching options to assign a specific regulatory category or class to a product based on its intended use, indications for use, technology, and potential risks. This determination is crucial for regulatory compliance and ensures that products are appropriately regulated and marketed.

  • Supporting clients seeking regulatory feedback and guidance from the FDA during the development process, such as feedback on specific questions related to product classification, regulatory submissions, clinical study design, and other regulatory requirements and inquiries. This includes compiling data such as preclinical and clinical study plans, product descriptions, proposed indications for use, and manufacturing details, and crafting a clear and concise submission package with the specific feedback being requested.

  • Following a regulatory compliant and systematic process for the development and manufacture of medical devices to ensure they meet specified requirements and are safe and effective for their intended use. Risk Management identifies, assesses, and mitigates risks associated with devices throughout their lifecycle. It aims to ensure that risks are understood, managed, and minimized to an acceptable level to enhance the safety and effectiveness of the device.

  • Implementing a structured framework of policies, processes, and procedures to ensure consistent quality and compliance with regulatory requirements throughout an organization. Includes Standard Operating Procedures (SOP's) and, for regulated medical device development, is required and auditable if you are certified

Regulatory and Quality

Contact