An effective product design resonates with both your customer and your product team. We employ various research methods, including observational research, technical analysis, and usability research, to help develop the voice of your customer and facilitate its integration into your product design.

Observational Research

Latent Needs and Ethnographic Research are unique approaches that we employ to understand end-user needs. You may be motivated to conduct Observational Research by an interest in new and competitive product features, or as a foundation for understanding your user profile and environment. Our collaborative methodology includes interviews with key stakeholders and provides an analysis of how current procedures affect the ways in which the end-user interacts with your medical device in the intended use environment. This involves viewing the product use in its natural environment. This analysis identifies both blatant (spoken) and latent (unspoken) needs, allowing your product team to determine any design challenges, discover innovative features, optimize product features, and improve the end-user experience. These insights can aid in new product development, product launch, product acceptance, and total product life-cycle management.

Technical Analysis

Our goal is to provide a useful, detailed, product-orientated analysis to support you through the development process and enable your product team to establish key product features for a timely product launch that meets current regulatory standards. At the start of a product life-cycle, we facilitate brainstorming sessions with key stakeholders to generate and capture innovative ideas during ideation. We employ a variety of tools to foster creative thinking, sort ideas, and identify the most valuable technical solutions. From there, we can partner with you to develop appropriate product specifications and provide support and guidance for your product teams as they prioritize mandatory from desirable features. We can also assist you in exploring technologies, assessing product risks, and developing a risk management strategy.

Usability Research

Usability Research is the discipline of understanding the end user, the use environment, and identifying the risks associated with operating a medical device in a safe and effective manner. Although it is a relatively new regulatory requirement, when properly implemented in the development cycle of a product, Usability Research can provide many benefits. These include potential for reduced development costs and time-to-market, a well-managed use risk program, and increased product acceptance.
Our systematic and thorough Usability Research process also provides direction for product specifications, product enhancements, and training material development. We offer customized services for conducting usability testing and developing usability plans, use risk management, and formative and summative protocols.
As you prepare to bring your next medical device or combination product to market, let us help you improve the usability of your product while reducing the risk of harm from use errors. We are a member of the AAMI human factors committee that developed the United States’ medical device usability design standard and have incorporated the new best practices into our consulting services. We can help you develop a user-centered design and integrate the activities that support your regulatory submission