Medical Product Ideation: Team Momma

Medical Product Ideation (BIOENG 2150) is a foundational course in the Medical Product Engineering program within the University of Pittsburgh Department of Bioengineering. ‘I hear and I forget. I see and I remember. I do and I understand.’ – Confucius. This ideal was kept in mind during the design of the course. To enforce the concept of ‘learning by doing’, while the various ideation tools are taught, students simultaneously get a chance to apply these learned tools to a project they are working on with a clinical mentor. A typical Medical Product Ideation classroom session consists of workshops, lectures by industry professionals, and hands-on team projects to help student teams master the skills learned in class.

Team Momma worked under the mentorship of Dr. Michael Bonidie and Dr. Pamela Moalli, from the Women’s Center for Bladder and Pelvic Health at Magee- Women’s Hospital of UPMC. A team of bright students working as a team to solve a clinical problem has been proven more effective than one individual working alone. Team Momma consisted of four students: Molly Finn, Randy Lee, Stephanie Quatchak and Josh Singer.

The first stage of the ideation process is “ethnography and needs finding”. The needs finding is done through a series of steps, starting with a process of structured observation called “ethnography”. In the case of Team Momma, the ethnography observations were done through (1) interviews with the clinical mentors, Dr. Michael Bonidie and Dr. Pamela Moalli, (2) observing procedures at the Women’s Center for Bladder and Pelvic Health and (3) observing procedures at Womancare Birth Center at Magee Women’s Hospital. Based on the ethnography observations, students used the process of “affinitization” to organize dozens to hundreds of observations into well-focused themes. These themes formed the basis of a “customer image diagram” which simplified the formulation of a clinical problem statement and a concise statement of an unmet clinical need. The problem statement described the drawbacks of how pelvic organ prolapse is currently treated. The need statement, as quoted by Team Momma, was: ‘A mechanism to improve patient acceptance of pessaries as a non-surgical treatment option for pelvic organ prolapse.’ The formulation of the needs statement was followed by a stakeholder analysis.

After weeks of brainstorming and other ideation methods, including “Design Thinking” techniques pioneered by IDEO, Inc, the Momma team mapped out a technical solution space using “morphological analysis”. Team Momma used these tools to narrow their search to two technical solutions which addressed the unmet clinical need. Before determining a preferred solution, Team Momma thoroughly studied the competitive environment and the patent landscape. This was done primarily to understand how pelvic organ prolapse is currently addressed in the medical device industry. Finally, to assess the commercial potential of their innovation, the team developed a hazard/risk analysis, regulatory strategy, reimbursement strategy, and a competitive market analysis. These processes are standard in the medical products industry today.

The engineering solution proposed by Team Momma was the “Absorbable Pessary Membrane”. The solution was explained through a presentation and a white paper submission at the end of the semester. As the team worked on their project throughout the semester, they frequently presented their work to peers, instructors, and clinical mentors. The peer and faculty evaluations gave them invaluable feedback on their work progress. Team Momma hopes to continue working on their early stage innovation to advance its clinical application in women’s health care.