Improving medical devices Collaboration by design

Image caption: Clare Donohue at Medical Device Sandbox redesign session. Credit: Lauren Stuart.

by Kim Roth

The design of health-related and medical devices directly impacts patient safety, and engineers and clinicians designing, and using, medical devices depend upon each other’s expertise.

A new experiential learning opportunity at U-M, the Medical Device Sandbox (MDS), helps both BME students and health care learners, including medical students, residents, nurses, and other health providers, collaborate across disciplines to improve device design and, ultimately, patient safety.

“Interprofessional collaboration and shared learning between BME students and health care learners is absolutely critical to designing and using medical devices in the clinic that are effective and safe for patients,” says John Gosbee, MD, a lecturer in the Departments of Biomedical Engineering and Internal Medicine and a human factors engineering and patient safety consultant.

“Interprofessional collaboration and shared learning between BME students and health care learners is absolutely critical to designing and using medical devices in the clinic that are effective and safe for patients,” -John Gosbee

Gosbee conceived of the MDS and, working closely with colleagues, BME Professor Jan Stegemann and BME Lecturer Rachael Schmedlen, has held more than two dozen MDS sessions to date.

The guided, structured, and interdisciplinary sessions begin in a simulated patient examination or hospital room at either the U-M Center for Experiential Learning and Assessment or the Clinical Simulation Center. Gosbee presents the group – typically four to six BME students and four to six medical learners – with a realistic scenario that involves the use of a medical device.

Guided by the instructor, the students identify potential design flaws, use errors, and safety issues.

During a recent session, Gosbee asked a participant to climb on and off the examination table, just as doctors routinely ask patients to do. The other students observed. Gosbee continued to prompt students with probable scenarios – the patient has a twisted ankle, the patient is short, the patient’s hands slip on the paper as they try to climb on.

BME students and health care learners constructing prototypes of their redesign ideas. Credit: John Gosbee and Jennifer Lee.

Next, the group brainstorms possible solutions. In the case of the exam table, students suggested moving the step to the side of the table, adding an extra step, and adding handrails.

Interactivity is key. Instead of simply talking about or sketching the changes they would make, students use prototyping materials – items such as foam core, scrap fabric, glue, and tape – to build a three-dimensional representation of their ideas. Participants then share their ideas with the group, and Gosbee helps them synthesize takeaway lessons.

Sessions have included a range of devices and scenarios, including layperson use of an automated external defibrillator, a pulse oximeter found in a first responder’s medical bag, and a medication organizer a patient would use at home.

Students also have brought course projects to the sessions, for example, a liver biopsy simulator from BME 450 and an existing and redesigned EKG device, brought by internal medicine residents.

The MDS name, fittingly, refers to sandbox mode in gaming, where players are freed from the usual rules and constraints.

“Bringing learners from these two disciplines together has transformative potential,” says Gosbee. “Having a creative physical and intellectual space where this kind of interaction can take place brings everyone closer to their shared goal of safer, more effective devices.”

To date, about 100 medical learners and 136 BME students – from BME 450, 452, 499, 599, and M-HEAL – have participated. BME undergraduate Jennifer Lee (’17) played an important role in organizing and running sessions and ensuring as many BME students as possible participated.

BME students who have taken part in the MDS have said it’s helped them think more about patient safety and usability testing as a crucial part of the design process – and that working with health care learners was a key way to better incorporate their expertise.

Other students said they no longer felt resigned to work with products as they currently exist and felt empowered by the redesign process.

In the words of one participant, “Redesign is an outlet for change.”

The MDS has been supported by the Third Century Initiative at U-M and by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number R25-EB019898.