To paraphrase well-known philosopher Jiddu Krishnamurti, education systems teach us what to think but often not how to think. When it comes to medical innovation, we try to think of solutions to clinical problems or ways to improve on current design. Learning how to think through that process, however, requires us to honestly assess our needs. We need to eliminate biases, minimize the risks in our strategy, consider all present and future stakeholders, and analyze timeline and costs. This way of thinking is the mantra behind the innovation taught and practiced at Johns Hopkins University Center for Bioengineering Innovation and Design (CBID).
Outreach to IR
CBID represents a close collaboration between the Johns Hopkins medical innovation program and its IR department. In 2009, CBID began formally offering a one-year Master of Science degree in bioengineering innovation and design. CBID Executive Director Youseph Yazdi, PhD, and Graduate Program Director Soumyadipta Acharya, MD, MSE, PhD, selected SIR member Clifford Weiss, MD, FSIR, to serve as the medical director because they recognize IRs as critical thinkers in the clinical setting.
A basic promise of engineering is to serve as a bridge between human knowledge and human need. It is evident to those in biodesign that IRs are ideally suited to facilitate this relationship. A rapidly evolving field with cutting-edge tools, IR is considered ideal biodesign education. An IR’s discipline is innovative and adaptive by nature, with the aim of modifying or trying new strategies to improve patient care.
“This collaboration, which opened up the IR space to students of innovation, has benefited both the IR department and the spirit of humanity in the hospital,” says Dr. Weiss. “The department’s willingness to participate in its institution’s medical innovation education helps promote the specialty in the sphere of influence over medical technology. It also allows trainees to acquire superb critical thinking skills and the know-how to effectively build on their ideas.”
The spiral iterative model
The program has developed its own unique model of innovative teaching, called “spiral iterative.” CBID students and clinical partners are trained to think critically in a staged, iterative approach to innovation in which four themes—clinical, commercial, technical and organizational—are continuously addressed, starting with the needs assessment and continuing through to prototyping and testing. The idea is to avoid pitfalls and blind spots that can lead to significant losses in time and cost. The strong possibility of failure, however, remains an important lesson for participants, as are the often unpredictable reactions of regulatory agencies and other stakeholders.
The program emphasizes clinical experience and mentorship, starting with a three-month boot camp that consists of clinical rotations and basic didactics on the spiral-iterative process. A clinical immersion in medical and surgical spaces follows, with the goal of identifying hundreds to thousands of unmet clinical needs.
The clinical immersion process is an opportunity for learning on both ends. Dr. Weiss provides an in-depth introduction to the field of IR, highlighting the tools and the clinical environment, then walks students through procedures in the IR suite, step by step. This foray into IR answers their questions, after which they are sent to collaborate with other specialties. All IR faculty members have the opportunity to interact with these students and learn about formalizing ideas and design.
Reciprocal returns
According to Dr. Weiss, it does not matter if the students ultimately innovate an IR tool or mechanism. Returns will invariably cycle back to the field, whether in an increased opportunity to teach bright, young minds; the creation of new corporate relationships; or improved communication and collaboration with other specialties. “If you love the process, other opportunities will present themselves,” he says.
Dr. Weiss recommends that IRs-in-training take an extra year to earn this formal master’s degree. “Residents who expose themselves to innovation not only develop superb critical thinking skills but will also better understand what to do when they have an idea,” he says. “More importantly, they will become familiar and comfortable with the idea of failure and constructive criticism.”
Although the Hopkins model benefits from the resources available to an institution of this size, Dr. Weiss says it is 100 percent scalable. “Engineering schools across the U.S. are already incorporating a biomedical innovation curriculum,” he says. “It is the natural leadership role for academic IRs to step up and provide insight for these programs. Getting involved is as easy as approaching the chairs of these respective departments and describing the benefits of IR leadership.”
Dr. Weiss says such involvement benefits both the IR and the institution. “One cannot overstate the benefits of studying needs assessments, technical derisking, regulatory knowledge, and business modeling and planning,” he says. “I encourage all institutions to make an honest effort to strengthen the natural bond that exists between bioengineering and academic radiology and to start familiarizing your residents with the process of innovation.”
Dr. Weiss praises the CBID program for creating a unique web of communication in the hospital between the biodesign students and a wide variety of other surgical and medical specialties. As the CBID students’ mentor, he is largely responsible for facilitating this collaboration. To him, the real benefit is improving lives and overall patient care.
Student success
Aine O’Sullivan
Aine O’Sullivan is an undergraduate at Hopkins who became interested in biodesign as a complex process of identifying problems and anticipating challenges.
She started working with Dr. Weiss in May 2016 on a product to improve brush biopsies. In April 2017, O’Sullivan’s team completed its first major brush biopsy prototype test—a “capstone moment” for O’Sullivan. It was the culmination of a year of formal innovation education in which she read about cholangiocarcinoma and currently available diagnostic strategies, interviewed an array of clinicians, conducted modeling and design testing, minimized the risks, and prototyped her product. She met with Dr. Weiss regularly at 7 a.m. via Google Hangouts. Finally, the team sat down with a pathologist to view pig cells on a slide acquired from the product. According to Aine, “When we showed our slides to the pathologist she was very excited about the results and commented particularly on the high quality of the samples (as far as clear cellularity and even some larger pieces of tissue).” It is possible that patients will soon benefit from her team’s design.
The full CBID team of undergraduates working to improve brush biopsies
“Being a part of CBID and working on this project has truly been one of the most defining aspects of my undergraduate career at Hopkins,” said Aine. “It has made me appreciate the vital role biomedical engineers play in ensuring that revolutionary research and innovation find their way into clinical practice so that patients may ultimately receive better care. For this reason, I hope to become a physician scientist so that I may continue to help bridge this gap between research and medicine.”
