Revenue from the sale of new products fuels the growth of many companies. It often plays a key role in a company’s strategic plan and justifies significant spending on research and development. To meet their goals for growth resulting from new product sales, medical device companies need to identify new market opportunities, evaluate and predict the associated potential returns on investment, and select the opportunities with the best potential for success. Although some opportunities result from finding applications for new technologies (technology push), many opportunities are based on products that meet unmet clinical needs (market pull). For these reasons, innovative companies are constantly trying to identify unmet clinical needs that can lead to new commercializable medical products.
Most of our BME students will be employed by medical device companies. Many of them will be involved in medical device design and will work with marketing, sales, and other company personnel to identify unmet needs and opportunities for new product development. Products that meet previously ignored (or unknown or poorly understood) market needs provide value to patients, medical personnel, and other stakeholders, and may have significant potential for commercial success. New products can include line extensions (new color, new size), product enhancements (new features), cost reductions, newly positioned products (existing product introduced to a new market), or new-to-the-world (did not previously exist) products or technologies [1]. Understanding problems that need to be solved and identifying unmet needs that must be met to solve these problems are critical first steps in the design and new product development process.
There are many books and articles that discuss methods for identifying unmet clinical needs such as ethnography, contextual inquiry, fly-on-the-wall, and others [2]. Many of these methods involve observing firsthand how medical devices are used (or misused) in their use environments by actual users of the devices.
To prepare BME students for careers involving new product development, it is important to provide them with opportunities to develop their clinical needs finding skills. For this reason, many BME programs offer opportunities for students to learn firsthand how medical devices are used in the clinical environment. This is often accomplished through clinical immersion experiences in which students observe surgical (and other) procedures in the operating room and other clinical locations within a hospital. Since 2011, many of these clinical immersion experiences have been funded through NIH/NIBIB R25 “Team-Based Design in Biomedical Engineering Education” and were offered during the summer semester just before the start of students’ senior capstone design courses [3]. The end deliverables often include a list of unmet clinical needs (identified by participants of the immersion experience) that are shared with senior capstone design students and used to create senior design projects that address some of these unmet needs.
Because students often observe procedures in hospitals in areas such as operating rooms and other clinical sites where physicians and surgeons work, it is common for BME design courses and clinical immersion programs to focus on the needs of surgeons and physicians. However, there are several other sources of unmet needs to be considered and clinical sites to be visited when gathering this information. Focusing only on the needs of surgeons ignores the needs of other health care providers and users of medical devices as well as the associated opportunities for new product development. Not all devices are used by surgeons, so it is important to speak with and observe other medical and nonmedical personnel who use medical devices. Sources of unmet clinical needs include various medical personnel such as surgeons, nurses, surgical technicians, physicians, physical therapists, and dentists, and nonmedical personnel such as patients, caregivers, and people with disabilities.
When designing assistive devices and technologies for people with disabilities, unmet needs can be found by speaking with people with disabilities, their caregivers, and support groups that focus on the issues and needs of people with a specific syndrome, disease, or disability. There are many support groups, such as the arthrogryposis multiplex congenita (AMC) support organization that sponsor local, regional, and national meetings of their members. At these meetings, patients and their families discuss and share common issues, problems, and solutions and they learn of new developments in the treatment and/or management of a specific, common condition, including assistive technologies available to help their family members perform activities of daily living.
Support groups can help designers identify unmet needs. For example, in June 2012, two BME students from Marquette University, a pediatric physiatrist from Children’s Hospital of Milwaukee, and I attended the AMC support national meeting in Indianapolis, IN, USA. During the meeting, we conducted a 1-hour needs finding session with conference attendees, including adults and older children with AMC, and the parents of children with AMC. From this experience, we learned that several unmet needs existed among this segment of the disability community. One of these needs involved a solution to help children with AMC dress themselves independently. This led to Project DressUp, a collaboration between six Marquette University (MU) BME and two Milwaukee Institute of Art and Design (MIAD) industrial design students during the 2013–2014 academic year. This senior design project led to the development of a device that allowed young teenage girls to independently put on and remove a shirt in significantly less time than it took without use of the device. The team worked with three AMC clients under the guidance of the pediatric physiatrist, and with the help of an NIH grant, one prototype was delivered to each of the three clients, at no cost to their families. This device was discussed during a presentation to meeting attendees by two student team members at the July 2014 AMC support meeting in Minneapolis, MN, USA, followed by another 1-hour needs finding session with AMC families, the students, the pediatric physiatrist, and myself. The meeting helped identify several additional common needs among AMC children and resulted in another team of six MU engineering students and two MIAD students creating an all-terrain walker during the following academic year. This walker was designed to traverse various playground surfaces (woodchips, stones, etc.) to allow students with disabilities to access playgrounds and participate in the important socialization and recreation activities that occur during recess.
These examples demonstrated the value of meeting with clients, families, and caregivers at a national support group meeting. It was an effective, efficient, and unique method for learning of the assistive technology needs of people with disabilities that helped create a list of unmet needs upon which senior capstone design projects could be based. When searching for unmet needs involving people with disabilities, consulting with support groups focused on specific syndromes or diseases that result in disabilities can be very useful.
When trying to understand problems and identify unmet needs, it is important to not only speak with users of medical devices, but also to observe them using these devices in the environment in which they are used (use environment). Observations in use environments in which health care is delivered and medical devices are used, such as operating rooms, specialty surgical suites, physician’s and dentist’s offices, physical therapy offices, ambulances, nursing homes, and other sites, should be considered. For people with disabilities and their caregivers, observations might be appropriate in the school, home, and workplace environments.
In summary, surgeons and medical professionals are not the only users of medical devices with unmet clinical needs. There are many unmet clinical needs involving other medical and nonmedical personnel and users. When trying to understand problems and identify unmet needs that could serve as the basis for a senior capstone design project, in addition to speaking with surgeons and physicians, it is helpful to speak with a variety of other users of different kinds of devices and observe the use of these devices in the appropriate use environment, often outside of the traditional operating room and hospital environments. Doing so can expand the number of unmet needs that can be addressed by our BME students as part of their senior capstone design projects. It will also expand their awareness of the different types of medical devices used by different users in different use environments and will better prepare them for careers involving the design and development of medical devices.
References
- J. Tranquillo, J. Goldberg, and R. Allen, Biomedical Engineering Design. Amsterdam, The Netherlands: Elsevier, Jun. 2022.
- B. Ku and E. Lupton, Health Design Thinking: Creating Products and Services for Better Health. New York, NY, USA: Cooper Hewitt, Smithsonian Design Museum, 2020.
- M. Kotchie et al., “Perspectives on bioengineering clinical immersion: History, innovation, and impact,” Ann. Biomed. Eng., vol. 48, no. 9, pp. 2301–2309, Sep. 2020.