Molecular breast imaging (MBI) is often recommended as a screening technique for women with probable or known breast malignancy, previous history, implants and low probability of malignancy, among other circumstances. In a screening study, MBI detected three times as many tumors as mammography while maintaining a lower false positive rate.

Digirad is a leading developer and manufacturer of solid-state gamma cameras for nuclear cardiology and general nuclear medicine applications. While the company’s mobile Ergo device could be used by multiple departments on multiple parts of the body, a women’s health department could not use Ergo for cancer detection because it wouldn’t accommodate a woman’s breast.

Digirad wished to increase Ergo’s versatility by adding the capability to detect breast cancer. Since hospital departments typically share costs to purchase new equipment, the company anticipated that making Ergo attractive to women’s health departments could potentially lead to higher sales.

Digirad wished to create an easily removable fixture that would hold the breast during an MBI procedure.

The project group had some technical solutions in mind but recognized the need to optimize the user experience for both the patient and caregiver. An MBI test frequently follows a mammography procedure that has found a possible cancerous lesion or bump. Since women referred for MBI tests are deeply distraught, meeting their needs for emotional and physical comfort was critical. Also, test accuracy depended upon the caregiver having an easy and intuitive user experience.

MindFlow began this engagement as we begin all others – by conducting research to explore the most productive directions. We started by creating a basic MBI fixture mock-up to test with the Ergo system. Then we co-moderated a task-based usability study with two patients and eight caregivers.

After observing the interactions, we identified human factors requirements. Then we fully executed the attachment’s industrial design with careful consideration to all points of human interaction. To ensure that we had interpreted these interactions properly, we conducted a second round of usability testing using a “works like, feels like” prototype that we developed.

From beginning to end, we made key technical contributions to the attachment mechanism’s design and engineering. The project included finalizing the design of the attachment and interaction points in CAD. It also included creating an intuitive electronic user interface with push buttons, LED indicators and graphics.

Digirad is extremely satisfied with the appearance and functionality of MBI attachment designed and engineered by MPE (Formerly Mindflow Design). The fixture looks like a natural extension of the Ergo product line rather than an “add on.” It is very intuitive, safe and easy to use.

The attachment has positioned Digirad to increase sales of its Ergo system because an additional department can underwrite its purchase. Early indications are that this effort will be successful.