Planning a CI Study for Medical Device Development

Mary Beth Privitera,    University of Cincinnati and Know Why Design, LLC, Cincinnati, Ohio, USA

Contextual inquiry (CI) studies in medical device development (MDD) focus on the “what” and the “why” while in the field, and then through analysis and interpretation the “so what?” that drives medical device design can be determined. The process is based on a set of principles that allow it to be adapted to each situation studied. This is achieved through visiting with medical device users as they use the devicesand developing a rapport for the sharing of methods and opinions. The data are collected and interpreted for multiple purposes, including opportunity identification. Conducting a CI study in this environment requires formal planning. However, the actual conduction of the study and interaction with the participants is largely informal. Like best practices in MDD, the best results happen when a multidisciplinary research and design team are involved at every step. Each discipline brings expertise and lens through which they view the clinical problem and will add value to the research.

Keywords

Contextual inquiry; medical device development; key opinion leaders; protocol development; data management

Contents

2.1 Overview of CI Study

Contextual inquiry (CI) studies in medical device development (MDD) focus on the “what” and the “why” while in the field, and then through analysis and interpretation the “so what?” that drives medical device design can be determined. The process is based on a set of principles that allow it to be adapted to each situation studied (Beyer and Holtzblatt, 1998). This is achieved through visiting with medical device users as they use the devicesand developing a rapport for the sharing of methods and opinions. The data are collected and interpreted for multiple purposes, including opportunity identification. Conducting a CI study in this environment requires formal planning. However, the actual conduction of the study and interaction with the participants is largely informal. Like best practices in MDD, the best results happen when a multidisciplinary research and design team are involved at every step. Each discipline brings expertise and lens through which they view the clinical problem and will add value to the research.

CI is a flexible and adaptable method; however, there are common steps for conducting a study in support of MDD. These include (Figure 2.1)

This chapter describes an overview of each step in a CI study for MDD. It discusses the importance of secondary research, determining appropriate sites and participants. Study preparation by the research team includes the necessary training and certifications as well as Institutional Board Review requirements. Study protocol development is discussed in detail with multiple examples. Finally, a summary on conducting CI studies outside the United States is discussed.

2.2 Preparation and Setting the Background

In conducting a CI study, there will always be a degree of uncertainty that is welcomed but can be stressful to a research team. The uncertainty is precisely what a CI studies: it is watching users as they perform their tasks without unduly influencing the outcome. In watching a clinical procedure in order to observe a medical device being used, it is easy to get lost, confused, and have no idea what is really going on unless the researcher has spent time dedicated to gaining the knowledge necessary to begin asking the questions. The equivalent of this is poor medical-based television programs wherein the use of devices, terminology, and clinical procedures is not accurate to real practice, yet the audience has no idea. The research team is the audience and they have a responsibility for the success of the study to gain knowledge in anatomy, typical patient presentations or diagnostic conditions as well as any procedure protocols that are readily available in published literature. The uncertainty in a healthcare CI study should be the interactions and behaviors of the user and not the procedure itself.

2.2.1 Beginning where Others Left Off

Device companies, especially large companies, typically have a wealth of information regarding their customers, their devices, and their uses within the organization. Spending time conducting research that has already been done is a waste of time and valuable resources. Before launching into a new research program, it is imperative to understand what work has already been conductedand the results and potential impact it may have for a CI study. For example, many marketing departments will have data regarding their customers. They have an understanding of the market; however, they lack the understanding of what exactly to design (Beyer and Holtzblatt, 1998). Marketing information and design information are different pieces of information. Each is valuable and often interrelated. Almost always there is marketing data available from within an organization that can assist in jump-starting the secondary research. However, there is no harm in gathering further information prior to the onset of a CI study.

As mentioned, designing a medical device requires clinical knowledge. The ability to tap the mind of the internal scientist or technologists who have tenure at the company can advance the scientific knowledge of the research team. Many times these internal resources are aware of published studies or projects the research team would struggle to find. Starting from what is known, confirming the knowledge and building upon the foundation should be the goal of a CI program. Typically this wealth of knowledge can be used to determine key opinion leaders (KOLs) who may be target study participants, other sites of interest, provide the research team with anatomy and procedural knowledge, and identify gaps in the knowledge. In addition, many studies involve the KOLs as hired consultants to the medical device industry. These individuals are viewed as leaders within their respective clinical community and have likely been involved in publishing clinical studies on techniques, device comparisons, and best practices. A KOL or advanced users seamlessly perform a difficult technique while others, who are less skilled or experienced, have challenges. Thus, a common goal of a CI study is to determine the behaviors and methods that enable KOLs perform with ease. Lastly, should the research team have knowledge of authorship and techniques as published by a study participant, it is a surefire means to gaining a relationship of trust and deepening the conversation.

2.2.2 Conduct Secondary Research

The foundation of advancing clinical practice is through published clinical trials and research. Thoroughly researching the existing landscape by conducting secondary research consists of gathering information collected and synthesized from existing data can add additional insights into user behaviors, opinions, and bias.

This information can be obtained by reviewing journal articles, research papers, other publications, books, state-of-the-art product manuals, procedure protocols, and available demographic and usage data. Conducting a literature review and synthesizing the results into key insights that can be used in the CI study can be time consuming. It requires adequate resources and attention in order to be effective.

Secondary research can be summarized in well-documented reviews...