Guidance and assistance to the medical device industry since 1999
CASE STUDY: Hospital Pilot Study
A software development company had created a point-of-care software application for the hospital market, and needed to determine clinical user group acceptance of the product as well as to obtain product validation data from the clinical environment. The client had identified hospital sites willing to support this research, and contracted BMG to design and implement the Pilot Study.
BMG had worked with the client on early stage market research for this product, so we were already intimately familiar with the product function and its end user application. With our existing product knowledge and past experience with the hospital user community, we designed a month-long, multi-site clinical study program that would generate the desired volume of product use without presenting an unacceptable burden to the study participants. Working with the client, we identified the aspects of user acceptance to be measured, as well as defined the criteria that would determine whether we had a successful validation of the product. BMG met with the hospital management to review and obtain their approval of our proposal.
During the planning process, we recognized that training would be an important part of the process but that time was also at a premium. BMG designed a brief “hands-on” user training program to quickly build user confidence in the ease-of-use of the product.
BMG coordinated and conducted the Pilot Study kickoff sessions, including delivery of the product training. Then we monitored progress at the various sites throughout the duration of the study, conducting mid-point interviews and end-point interviews with Pilot Study participants, and overseeing removal of study materials. At the conclusion, we compiled, analyzed and presented the study findings.
The Clinical Pilot Study successfully delivered the information sought by the client, with a sufficient volume of data collected to objectively assess the results.
Study participant confidence and cooperation was strong, exceeding expectations for compliance in all clinical areas, including the Emergency Room site. Hospital management was also pleased with the minimal degree of interruption which resulted from the advance preparations and logistical coordination supplied by BMG.