The ability to identify unmet needs and new product opportunities is an important skill for biomedical engineering students planning a career in the medical device industry. Most biomedical engineering graduates will work in industry where many projects will not be defined for them. They will need to work with physicians, surgeons, nurses, clinical engineers, and other users of medical technology to identify problems and unmet needs and will work closely with marketing, sales, and other personnel to identify new product development opportunities. Students will be better prepared for careers involving the development of new medical devices if they are able to gain experience in the problem identification/needs-finding phase of the design process as part of their undergraduate education.
Many schools provide students with needs-finding opportunities through clinical immersion activities. These typically involve students observing surgical procedures in the operating room and shadowing physicians in the hospital for several hours each day, often for several weeks. Students learn how technology is used in the clinical environment and how to identify unmet needs that could lead to opportunities for new product development.
Clinical immersion activities are helpful in identifying the unmet needs of those working in the operating room and other areas within a hospital, typically surgeons, physicians, and nurses. However, many medical devices are not used by these medical professionals, and there are many unmet needs that exist outside of the clinical environment. A significant percentage of medical devices is used by patients, caregivers, physical therapists, dentists, and other end users in clinics, medical and dental offices, and the home environment. To identify the unmet needs of people in these groups, needs-finding activities should include exposure to these stakeholders in their various respective environments. This could include shadowing medical and dental professionals outside of the hospital environment, observing patients and caregivers using products in their homes and workplaces, and speaking directly to potential end users of new medical devices. For example, assistive technologies are used by people with disabilities in their home, school, and work environments. Identifying the needs of people in this group involves observing them in these environments as well as speaking to them along with their caregivers.
To provide biomedical engineering students at Marquette University (MU) with broad experiences in needs finding, eight years ago, I developed a course titled “Clinical Issues in Biomedical Engineering Design,” in which students observe procedures in various areas within Froedtert Lutheran Memorial Hospital, a local teaching hospital associated with the Medical College of Wisconsin [1], [2]. These areas include the operating room, cardiac catheterization laboratory, interventional radiology laboratory, urology clinic, and several specialized intensive care units. Students also visit nonhospital environments such as the Milwaukee Center for Independence, the MU School of Dentistry, and the Wheaton Franciscan Center for Nursing Simulation on the campus of MU. Students learn to listen, observe, ask questions, and identify unmet needs, both articulated and latent. They develop their clinical literacy and learn how technology is used to solve problems in the clinical environment. The end deliverable is a proposal for a product development project based on a need that was identified during the course. Ideally, this proposal would be converted into the student’s senior design project the following fall semester. The first example of this conversion occurred during the fall of 2014. In May 2015, a project team delivered a prototype of an automated blood glucose monitoring device based on a problem they identified during a visit to the intensive care unit as part of the needs-finding course.
Three years ago, one of our senior design teams developed a feeding device for a child with arthrogryposis multiplex congenita (AMC), a condition that prevented her from feeding herself with her hands and arms. The client was able to feed herself with her feet but as she got older, her parents were concerned that when she began junior high, this would draw attention to her during lunch periods and could prevent her from being accepted by the other students. The device allowed her to eat at home, school, and in public in a manner that was more socially acceptable than using her feet. While the team, which included two industrial design students from the Milwaukee Institute of Art and Design (MIAD), developed the device, a writer from Milwaukee Journal Sentinel followed the progress of the team during the year and published an article about the collaboration between the MU and MIAD students, their relationship with the client, and how the device helped her feed herself independently [3], [4]. Shortly after its publication, I received several e-mails from parents around the country whose children had a similar disability. They read the article and felt that their child could benefit from the device and wanted to know how they could obtain one. These calls confirmed my belief that there were many people who had difficulty feeding themselves and who could benefit from the feeding device. The market for this product was much larger than just the one client with whom the students had been working.
To make more people aware of the device and to confirm additional interest in it, I contacted the AMC Support Group, a national support group for people with AMC and their caregivers, to see if their members would be interested in hearing about this device. To help me identify future potential capstone design projects, I also asked if I could speak with members to find out what assistive technologies were needed to help their children with the activities of daily living. I was invited, along with the project team, to come to their 2012 national meeting in Indianapolis, Indiana, to present the device and conduct an hour-long needs-finding session. Two members of the project team accompanied me to the meeting, along with Dr. Maya Evans, a pediatric physiatrist from the Medical College of Wisconsin. The team members presented their device to a group of attendees and assisted Dr. Evans and me during the needs-finding session that followed. We were able to speak to more than 20 families and identified many unmet needs that could serve as a basis for future senior design projects.
One identified need was for assistance with dressing to enable clients in their early teens to dress themselves more independently and not rely as much on their parents to get dressed in the morning. One year later, this problem was included in a list presented to the capstone design class and was chosen by a team of five biomedical engineering students. Working with three of Dr. Evans’ clients with AMC and two industrial design students from MIAD, the team developed a device to allow the clients to don and doff a shirt (without buttons). One prototype was made for and transferred to each of the clients at the end of the course. We were again invited to present to the AMC Support Group membership and conduct another needs-finding session, this time at the 2014 meeting in Minneapolis, Minnesota. During the needs-finding session, several attendees stated that their children were unable to traverse the playground terrain at their schools, preventing them from participating in recess activities and the important socialization processes that occur during recess. From these comments, a project involving the development of an all-terrain walker was created and presented to capstone design students during the following fall semester, one month later. The project was chosen by a team of four biomedical and two mechanical engineering students. The team added two industrial design students during the spring semester 2015, and prototypes were transferred to two of Dr. Evans’ clients in May 2015.
There was significant interest among the AMC Support Group meeting organizers and families in the student presentations as well as the needs-finding sessions at the 2012 and 2014 meetings. Several attendees expressed interest in obtaining the devices developed by the students. Attendees appreciated the opportunity to discuss their needs, and the students (recent graduates) gained a new perspective on their designs and the potential impact of their work outside of the classroom. The list of assistive technology needs developed during the 2012 and 2014 needs-finding sessions helped identify several common needs. These needs resulted in the creation of several “real-world” project ideas that were presented to senior capstone design students at the beginning of the next capstone design course. Dr. Evans found clients from her practice who shared the same needs and were willing to work with MU and MIAD students for each project. This allowed the students to work with a local group of interested clients to develop a solution that could benefit clients with similar needs around the United States.
In summary, the ability to identify unmet needs and new product opportunities is an important skill for biomedical engineering students who plan a career in the medical device industry. Not all medical products are used by surgeons in the operating room. For these products, alternative needs-finding activities are required that do not involve observing surgical procedures in the operating room.
Attending meetings of national or regional support groups for people with disabilities such as AMC, spina bifida, and cerebral palsy can provide opportunities for students and capstone design faculty to interview many potential users, clients, and caretakers to identify unmet needs and potential new product opportunities, which can serve as the basis for real-world assistive technology capstone design projects. Similar approaches can be taken to identify unmet needs in other market segments such as home health care, physical therapy and rehabilitation, nursing home care, and dentistry. National support groups for people with diabetes, incontinence, and other specific disease conditions can also provide students and faculty with ideas for capstone design projects. Allowing students to attend these meetings to gain experience in the problem identification/needs-finding phase of the design process will help prepare them for careers involving the development of new medical devices.
References
- J. Goldberg, “Learning to identify problems, unmet needs, and new product opportunities,” IEEE Eng. Med. Biol. Mag., vol. 27, no. 4, pp. 104–105, July/Aug. 2008.
- J. R. Goldberg, “Learning to identify unmet needs and new product opportunities,” Int. J. Eng. Educ., vol. 28, no. 2, pp. 349–354, 2012.
- M. Johnson, “Student project with a purpose,” Milwaukee J. Sentinel, June 2012.
- M. Johnson. (2012, June 9). Student engineering project helps young girl feed herself. [Online]. (accessed June 18, 2015)