The Pediatric Surgery Innovation Fellowship at U-M is designed for post-graduate professionals with advanced degrees in medicine or engineering. The fellowship program assembles a team of talented post-graduates in medicine (MD, DO), engineering (Masters and above) to develop medical technologies which will significantly impact healthcare options for pediatric patients. The action learning approach begins with a deep understanding of the unmet medical need and progresses through design, prototyping, regulatory and business planning on the way to full commercialization.
This fellowship offers:
- Learning in teams: The fellowship matches 2-4 trainees from pediatric surgery and engineering to form a year-long team as they study problem spaces in pediatric health care and then devise opportunities for new devices or other improvements.
- Support for commercialization: Drawing on the resources and expertise within the Michigan Pediatric Device Consortium and U-M’s vast innovation resources, we’re well-positioned to guide innovations from conception to commercialization. Fellowship teams are encouraged to take part in conferences, compete for innovation support in and outside of the university pursue funding opportunities for prototype development. Teams receive training in the business of medical innovation as well as the science.
- Time for research: Ideas generated as a result of the design process naturally dovetail with research and publication opportunities for trainees, with many fellows in the program publishing their work by the end of the program.
The fellowship partners with the Michigan Pediatric Device Consortium (MPED), led by program director Dr. James D. Geiger, to provide training and research opportunities for fellows.
“The best part of the fellowship is the immersion into the surgical and clinical work, with a first-hand experience of the surgeries and patient-based interactions. That is really the main driver that helps new ideas take shape, when you are faced with a patient that you know can benefit from your team’s work."
Sophia P. Pilipchuk, PhD, BME (2017-2018)
Innovation fellows are assembled into interdisciplinary innovation teams comprised of medical and dental residents, engineers of different disciplines, scientists in biomedical disciplines and business professionals. These groups collaborate in a process of nascent biomedical innovation and development, with a focus on solving pediatric-specific medical device needs.
The teams go through a systematic process involving didactic education, full clinical immersion for problem identification and verification, innovation, intellectual property evaluation, market research, prototyping, early-stage testing, and technology distribution planning. Fellows are under the auspices of U-M clinicians, engineers and business school faculty, but also tap the specific expertise available from technology transfer professionals and industry R&D leaders, as well as regulatory, reimbursement and financial experts.
Fellows' efforts are expected to lead to new, innovative solutions to address major clinical and surgical needs, with outcomes to include invention disclosures, patents, licensing of technologies, company startups, and, ultimately, commercialization that positively impacts the lives of our pediatric patients.
The cornerstone of the fellowship is the curriculum, designed to complement a thematic focus of pediatric medical needs. The curriculum is comprised of three phases — Innovator's Foundation, Opportunity Exploration, and Opportunity Execution — each geared toward the advancement of skill and thought to transform knowledge into innovations that improve health.
“I have found that my 'eyes' for potential opportunities have become keener. Every inefficiency, complication, difficulty, or bad outcome encountered in the clinical world becomes a chance for improvement.”
Farokh Demerhi, MD (2014-2015)
Biomedical Innovation Fundamentals
- Front-end innovation training
- Medical domain specific curriculum with academic and industry thought leaders
- Formal training in human-centric observation techniques
- Identifying opportunities through clinical immersion
- Needs identification, concept generation and concept selection
- Design and prototype lab hands-on training
- Intellectual property strategy
- Research and development strategy
- Regulatory and reimbursement strategy
- Business strategy and business plan development
- Personal interactions / tours with industry
Phases & Teaching Modules
The first phase, known as the Innovator's Foundation, incorporates a "mini-graduate school", enabling the Fellows to become fully aware of the issues related to health technology and processes. The team will engage in formal instruction of fundamental core topics including biological, medical, engineering and business concepts.
Additionally, foundational learning will occur through academic and industry networking, research seminars, field trips, and overall team organization. The backbone of this phase will be the basic instruction of the innovation process. It will be introduced, as well as the tools required, with the ultimate goal of identifying a path to market.
- Health System I
- Understand the health industry and processes and outcomes that define success
- Organizational Development and Leadership
- Address the principles of organizational structure, group dynamics, influence
- Skill Development I
- Develop interviewing skills which will be vital to the clinical immersion
- Develop brainstorming skills for individual and group effort
- Community Interaction
- Network locally, regionally and nationally
- Engage in "think-tank" activities
- Take field trips
- Engineering Fundamentals
- Understand the topics and disciplines that underlie the field of biomedical engineering
The second phase, Opportunity Exploration, commences as the Fellows begin to apply the tools of innovation to undertake problem identification within the defined opportunity space. The Fellows execute each tool at the proper stage under the guidance of an innovation expert/mentor. The focal point of this phase is full clinical immersion, providing the Fellows with first-hand exposure to the realities and complexities of healthcare delivery. Through observation and inquiry, the Fellows engage in intense study of health, disease, and current treatments which gives them insight into the impact of healthcare delivery on providers and patients. This phase culminates with numerous ideas that are considered viable candidates for further assessment as potential products or businesses.
- Health System II
- Obtain background and knowledge necessary for FDA approval, potential reimbursement, human issues
- Obtain core methodologies in outcomes and health services research along with their applications in healthcare
- Skill Development II
- Learn methods of stakeholder analysis and customer discovery
- Learn how to effectively observe and interview
- Advanced Engineering
- Become exposed to the entire design process such as problem definition, design review and prototyping
- Business and Law Fundamentals
- Develop a flexible way of thinking about and defining the market domain
- Examine key concepts of patent law
Once the opportunity space has been explored and ideas validated, Fellows will engage in Opportunity Execution, the third phase of the curriculum. They will realize opportunities through proof-of-concept prototyping, market analysis, intellectual property evaluation and, ultimately, forge a path to commercialization and eventual integration into society. Fellows will be under the auspices of U-M clinicians, engineers, and business school faculty, but will also tap the specific expertise available from technology transfer professionals, industry R&D leaders, and regulatory, reimbursement, and financial experts associated with MPED.
- Health System III
- Experience a deeper dive into the regulatory process
- Advanced Business and Law
- Examine the concepts associated with commercialization and technology transfer
- Advanced Engineering II
- Explore the principles of design and prototyping and identify process technologies amenable to medical device production