Successful products must solve both real business needs and real user problems to deliver value to our clients and their customers.

Before the start of a project, we work closely with clients to fully understand their business needs and goals. With those upfront insights plus our deep understanding of the IVD market, we initiate the process of discovering the needs and goals of users.

To identify and understand the problems a product must address for the user, our experience design and engineering teams immerse themselves with the people, challenges and user environment to discover the user’s true goals and pain points at the start of the product development process.

This front-end design research involves observing users in context to develop a view of their end-to-end workflow with a product or system at the point of use, including digital, physical and human interactions. These research insights are then analyzed and synthesized into actionable findings and clear objectives that serve as a guide throughout the medical device development process.

Through our rigorous systems engineering and solution architecting processes, we take the problems identified and create product solutions that are customized to deliver on all stakeholders’ needs.

We explore candidate solutions by building, evaluating and testing multiple product concepts at the user and subsystem level using a “design, build, test, iterate” approach. As we move from lower to higher fidelity prototypes, we work to deliver on user needs, usability, and IVD manufacturer requirements such as performance, manufacturability, cost and risk. We take early concepts into the field and test them with real users.

This allows us to quickly check key assumptions and identify improvements by observing what works well and where friction or risks exist in the interactions. Through multiple iterations, features and functionality can be prioritized or improved to ensure that the needs of both users and the manufacturer are being met.

By the end of this phase, a product concept and architecture are established with a high degree of confidence that they will deliver both market value and technical feasibility.

Based on concept testing and review, we create the detailed product design and build representative Alpha prototypes. Our focus is to confirm that all product functionality and requirements are fully addressed, including all key performance metrics, product safety, reliability, cost and manufacturability. At this stage, we also prove fully featured software and firmware.

We continue to learn from and refine the product designs as the prototypes move through usability testing and field evaluation trials, identifying any performance or reliability issues and assessing any risk associated with normal use of the device, maturing the design to product ready Beta maturity.

Beta prototypes are built using fully representative manufacturing and assembly methods, proving both the design suitability and the production processes. These are full functionality production representative units, including all physical and digital user interface features of the final design. These Beta prototypes are the basis for our formal Verification of the design Validation in real use environments by our clients.

Even after formal transfer of the design to our (or your) manufacturing facility, we continue to provide support during manufacturing process Validation and scale-up. We also provide troubleshooting support of manufacturing, assembly and testing. Depending on client needs, partnering on contract manufacturing provides a seamless internal transition for the final product.