In an increasingly complex environment, both technological advancements and procedural improvements are impacting the way medical device manufacturers are approaching design and development. Minimized time to market for new and refreshed medical device development is more important than ever as the industry undergoes rapid changes in our post-COVID world. By applying enhanced methodologies, development cycles can be compressed to reduce R&D costs, optimize revenue generation, and streamline design validation.
New opportunities lie in filling burgeoning new markets such as patient-operated self-care devices, robot-assisted, interventional, minimally invasive procedures, and connected diagnostic and preventative care technologies. Focusing on preventative healthcare to reduce healthcare costs, increasing distance care capabilities, and tracking mechanisms, mean new approaches to healthcare with quicker and more innovative responses to market demands.
Human Factors Engineering in User-Centred Design
User-centered approaches to device development are essential to creating products that meet real-world market needs to maximize market penetration. But additive usability tasks cannot slow down the time-to-market schedule for these pioneering new devices.
Human factors engineering (HFE) methodologies establish and focus design exploration so that the end product remains market-relevant but that its specification also embodies optimal functions, features, and product workflows to streamline development.
This HFE approach is best initiated at the beginning of the design process, where methodologies like contextual inquiry, virtual reality (VR), and rapid-prototyping techniques are applied that are able to direct subsequent development with near certainty that the device will be highly marketable either in clinical or at-home settings.
Deploying Contextual Inquiry
Sometimes referred to as Design Discovery, Contextual Inquiry (CI) is a valuable tool to determine design parameters as it discovers user behavior patterns, whether in an in-home or clinical environment. Conducted as an in-person process at project initiation, CI doesn’t seek to directly solve user problems. It is used to establish user problems and aspirations as they interact with a prospective device in context with adjacent devices within the intended environment(s). This exercise, undertaken one-on-one with one or more user types, identifies trends and behaviors that will have an impact on the final design.
The fundamental objective of CI involves observation, inquiry, and documentation. Observation allows the researcher to see how users approach typical activities in the context of actual device operability versus simply documenting a remote discussion of how the activity is conducted, which results in a lack of immersion detail. It also gives the researcher, in real-time, the opportunity to log the behavior of the user, comparing and contrasting it with other user behavior to develop repetitive patterns. These patterns then create the proven trends that ultimately impact product design.
Virtual Reality Tools
Virtual Reality (VR) techniques provide an interactive experience and vastly increased stimuli resolution over traditional remote techniques such as questionnaires, 2D visuals, and computer animations. VR technology and real-time global streaming provide cost and time-efficient remote user immersion at critical stages in the development process, enabling development teams to wholly embrace user-centered design methodologies that support fast-tracked design processes.
Evolved from the gaming industry, high-resolution VR technology has finally become an affordable and easy-to-use development tool. Configuration modeling of a prototype device is valuable because it is intended to inform system architecture, especially as it correlates to user interfaces (UI) such as reach, visibility, and overall bulk. Study models mocked up in CAD allow the user to assess any disparate UX configurations before the conceptual design is delivered to systems engineering. These virtual study models are deliberately configured to demonstrate UI features in various ways. For example, the model may be mocked up in landscape and portrait modalities, and operating features may be presented in varying positions and orientations. This allows users with varying demographics to evaluate preferred configurations in 3D space and then report on why certain features or configurations are favored. Information from these studies is then reported to the development teams prior to the final device configuration and subsequent design.
Rapid Prototyping
Rapid prototyping is historically used to refer to computer-simulated finite-element-analysis (FEA) derived from 3D-CAD modeling and “additive” 3D printing manufacture of physical parts. Today’s technologies now offer a wide range of engineering-grade production-simulated materials to support rapid prototyping, pre-packaged computing platforms, and clickable app-based graphical-user interface (GUI) mockups enabling product management and pre-launch teams to closely evaluate and modify semi-functional conceptual designs ahead of intensive engineering phases, enhancing project, timeline, and cost efficiencies.
HFE as a Critical Component of the Design Team
HFE is an integral component of the new-product-design team and thus should be integrated early on and throughout the entire development process. Without a collaborative process, teams often stay siloed, and information-sharing is limited at best, creating unnecessary design and development interruptions and iterations. Creating a foundation that identifies early on how users interact with proposed technology or devices gives proven guidance for the development of a successful and competitive product. Performing this discipline rapidly and effectively with a global user population obviously enhances the design quality and reduces use risk across all intended markets.
An advantage of practicing iterative user engagement is that it enables teams to collaborate with regulatory agencies to review HFE-derived test data throughout the design process in order to evaluate design safety and efficacy, thus reducing the risk of failure or setbacks during the agency approval process.