Biomedical innovation in academic health centers has led to new drugs, devices, diagnostics, and other high-impact technologies that have helped patients worldwide; however, the growing costs of technology development, exacerbated by the fragmented nature of the innovation process amongst disparate stakeholders, has made the road to biomedical innovation fraught with risk. Compounding this challenge is the growing demand on medical academicians to be more productive in their clinical, teaching, and research duties within a resource-constrained environment. In congruence, the Institute of Medicine’s 2013 review of the National Institutes of Health (NIH)/Clinical Translational Science Award (CTSA) emphasized the need to advance innovation in education and training in order to better prepare a future clinical and translational workforce through team science and entrepreneurship.1
In 2011, the National Science Foundation (NSF) launched the Innovation Corps (I-Corps) program to foster entrepreneurship and facilitate commercialization of NSF-funded technologies.2 Using the Lean Startup concept developed by Eric Ries,3 and made popular by Steve Blank and Bob Dorf,4 I-Corps instructors teach NSF-funded principal investigators (PIs) to identify product opportunities from their research. Since July 2011, over 300 teams and 100 institutions have completed the seven-week curriculum.5
In July 2014, NSF I-Corps partnered with the NIH to develop a commercialization-focused program for PIs in the biomedical field with funding from a Small Business Innovation Research or Small Business Technology Transfer award. A nine-week program was piloted, and it is still under evaluation.5
The NSF and NIH I-Corps programs have been successful for their target audiences; however, they do not address the unique characteristics of biomedical commercialization, such as the different investment timelines and requirements for therapeutics, devices, diagnostics, and health information technology (IT) advances; the unique regulatory approval process; and the particular intricacies of health care reimbursement. Moreover, these two programs do not accommodate the schedule of busy medical academicians, nor do they address the reality that the need to procure funding, develop a team, and travel6 severely limits the number of eligible applicants.
In September 2014, Fast Forward Medical Innovation (FFMI), a unit of the University of Michigan (UM) Medical School’s Office of Research, in partnership with the UM College of Engineering’s Center for Entrepreneurship, designed and implemented an accelerated version of the NSF I-Corps program for medical academicians exploring the commercial potential of their early-stage biomedical innovations. FFMI’s Early Tech Development (ETD) Course covers the Lean Startup concept3 in only four weeks, supports the formation of teams around projects, and leverages live and Web-based formats to accommodate busy schedules. This report details the design, implementation, success factors, and outcomes of the ETD Course across its first three cohorts.
The ETD Course provides a real-world learning experience for the medical academician exploring the commercial potential of a novel biomedical technology while de-risking projects (in terms of the success of a business venture) and exploring potential follow-on resources, such as funding and partnership. Using the Business Model Canvas, a simplified business plan template, and the Value Proposition Canvas, a tool to design compelling value propositions, participants frame hypotheses to be tested during a process called Customer Discovery.4,7,8 Customer Discovery, also known as Customer Development, is the process of gathering critical insight about the project by conducting in-person interviews. Teams build a business case for diverse commercialization pathways, including license agreements, partnerships with industry, and startups.
Enrollment and team formation
Enrollment criteria are minimal to eliminate barriers to participation. Interested and committed academicians enroll after completing a brief online application and meeting with course planners to discuss the details of their innovation or idea for new technology, including any possible conflicts of interest. During this meeting, they register with the UM Office of Technology Transfer, and course planners match team members. Unlike the NSF and NIH I-Corps programs, the ETD Course does not require project teams to already have a PI, entrepreneurial lead, or mentor, thereby increasing participation from academicians who have not made these contacts. Participants are certainly not excluded if they have already recruited other scholars for these roles, although most enroll without these team members. Connecting academicians with medical and graduate students to serve as team members during the course enhances the overall experience, increases the likelihood of success, and capitalizes on the growing demand from students seeking faculty mentors participating in translational research and commercialization activities.
The course objectives and curriculum
The objectives of the four-week course, provided in List 1, are similar to that of the NSF I-Corps program.
The content is delivered on five consecutive Fridays (see Figure 1). Course directors assign project teams of three to four members to one of three vertical product-based tracks (devices, therapeutics/diagnostics, or health IT), so course directors can provide tailored education to address the unique characteristics of biomedical commercialization (e.g., differences in intellectual property strategies, Food and Drug Administration [FDA] regulatory processes, and health care reimbursement strategies).
During the in-person opening session (five total hours), teams map their innovation ecosystem, a technique used to identify critical stakeholders for the project, and develop testable hypotheses for potential customer segments, stakeholders, and value propositions (three hours). Teams then present their work as an initial business case for immediate feedback (one hour). Next, course directors introduce the concept of Customer Discovery and train teams on how to best schedule, conduct, and analyze the interviews (one hour) prior to the team members embarking on their first week of gathering insight, which is focused on validating their hypotheses.
Weekly 90-minute Webinars occur on the next three Fridays in the three separate tracks. They include team report-outs and guest expert lecturers who introduce biomedical commercialization concepts and focus areas for the teams to consider during the following week of Customer Discovery. During the report-out period (one hour), each team is given 10 minutes to present insights gathered during the prior week of Customer Discovery. Guest lecturer topics comprise Intellectual Property and Freedom to Operate (Webinar #1), FDA Regulations (Webinar #2), and Reimbursement and Revenue Strategies (Webinar #3).
During the in-person closing session (three hours total), teams from all tracks come together and present their final business case, a culmination of their Customer Discovery work. The course concludes with a panel discussion on follow-on resources and next steps for graduates. Immediately after the course, all participants receive a link to a course evaluation.
A teaching team of instructors
One of the greatest benefits of the course is the opportunity for participants to network with the teaching team of instructors and lecturers who come from a variety of backgrounds, including industry, technology transfer, and academia (see Figure 2). Each member of the teaching team is assigned a particular role and an educational track based on his/her experience.
Core instructors, all experts in biomedical commercialization, teach content, mentor teams in their track, hold weekly office hours, and provide feedback and guidance. The guest lecturers who deliver a 30-minute lecture covering a specific area of biomedical commercialization during the Webinars are available to provide feedback and mentoring, including networking. Teaching assistants, commonly staff members responsible for educational planning, are trained on the Lean Startup concept, support the day-to-day operations of the course by actively monitoring the progress of each team’s Customer Discovery interviews and facilitating the weekly Webinars.
List 1Objectives for the Early Tech Development Course at the University of Michigan
* Master the entrepreneurial concept of testing hypotheses through Customer Discovery.
* Develop a compelling business case for the technology, focused on value propositions, customer segments, and additional stakeholders.
* Determine the commercial viability of the technology and explore potential paths to a business startup or license agreement.
* Expand the team’s network of key innovation partners, including instructors, mentors, investors, and customers, as part of the university innovation ecosystem.
* Develop greater self-confidence and business presentation skills in preparation for investors and partners.
Course materials, tools, and budget
The course directors and participants use several tools throughout the course. The Business Model Canvas,7 the foundational tool for the course, and Customer Discovery4 are taught and captured using LaunchPad Central (LPC; San Francisco, California), an online platform for information sharing and course communication. A Web conferencing tool called BlueJeans (BlueJeans Network, Inc.; Mountain View, California) and slide deck templates guide all communications. A postcourse evaluation is delivered using Qualtrics (Qualtrics, LLC.; Provo, Utah), an online survey platform, and the same tool is used to track teams for follow-on funding and other commercialization activities.
The total cost for one ETD Course cohort is approximately $24,000, consisting of four components: (1) program management ($10,000), (2) instructor honoraria ($9,000), (3) software license ($2,500), and (4) other ($2,500). Program management is provided by an education coordinator (approximately $80,000 salary and benefits) at 50% effort over three months, who coordinates the teaching team, recruits and forms teams, conducts precourse consultations, collects postcourse evaluations, and tracks metrics. Honoraria include $1,500 per core instructor (× 3 tracks = $4,500) and $500 per guest lecture (3 tracks × 3 lectures = $4,500). A software license fee of $50 per participant is purchased through LPC to teach the Business Model Canvas and to facilitate communication between the teaching team and the project teams (× 50 = $2,500). Videoconferencing, room rentals, and catering are estimated at $2,500.
Challenges and key success factors
As the course was created to help de-risk early-stage projects for technology development, it was imperative to also de-risk the potential impact on a medical academician’s career as they embarked on entrepreneurial activities. Concurrently, FFMI spearheaded the modernization of the UM Medical School’s promotion and tenure guidelines to value and reward innovation and entrepreneurship. The convergence of developing academic programming (e.g., the ETD Course), which values the currency of time for the busy medical academician, and of creating a necessary culture shift (viewed through the lens of promotion and tenure), significantly reduced perceived barriers to participation.
The ETD Course has successfully graduated 39 project teams in its first three cohorts from UM (34 teams) and other institutions (5 teams), equally distributed across the three educational tracks (13 teams in devices, in therapeutics/diagnostics, and in health IT). The first cohort (September 2014) received 25 applications, matriculated 16 teams, and graduated 13 teams with a total of 38 participants, including one team from Wayne State University (Detroit, Michigan). The second cohort (June 2015) received 25 applications, matriculated 19 teams, and graduated 15 teams with a total of 45 participants, including teams from Michigan Technological University (Houghton, Michigan), Grand Valley State University (Allendale, Michigan), and Spectrum Health (Grand Rapids, Michigan). The third cohort (October 2015) received 19 applications, matriculated 15 teams, and graduated 11 teams with a total of 29 people, including one from Montana State University (Bozeman, Montana).
Project teams have represented a breadth of biomedical technologies including therapeutics (e.g., a cell-specific polymer delivery system for inflammatory disease), devices (e.g., a brain-cooling helmet to induce hypothermia in stroke patients), diagnostics (e.g., an antibody-mediated test for tuberculosis), and health IT (e.g., mobile applications for social anxiety management and to guide car seat selection for parents and pediatric health care workers).
As mentioned, participants receive a postcourse evaluation, exempt from UM Medical School institutional review board approval, immediately following each course. Of 112 participants from the 39 graduating project teams, 58 (52%) completed the evaluation. Of these 58, approximately half (n = 26) identified themselves as faculty (45%), followed by postdocs or graduate students (n = 13; 22%), and other (n = 19; 33%). When asked if the course achieved the stated objectives, using a five-point scale, 48 respondents (83%) indicated that they “strongly agreed” or “agreed”; only 1 participant (< 2%) disagreed. When asked if they would recommend the course to others, 48 respondents (83%) strongly agreed or agreed that they would; just 2 participants (about 3.5%) indicated that they would not. When respondents were asked if they would take a follow-up course, 45 participants (77%) strongly agreed or agreed; 5 (9%) indicated they would not.
Follow-on funding and commercialization activities
Many graduates have continued to pursue their projects. In the first cohort, 10 of the 13 teams (77% of the cohort) have continued their project. Six of these 13 (46%) have received follow-on funding, 2 (15%) are in discussions with industry partners, and 2 (15%) have been accepted to participate in NSF I-Corps (each of these 2 teams has received a grant of $50,000). In the second cohort, 8 of the 15 teams (53% of the cohort) have continued their project. Five (33%) have received follow-on funding, 2 (13%) are in discussions with industry partners, and 1 (7%) has been selected to receive the $50,000 grant and participate in the NSF I-Corps program. Preliminary results of the third cohort are promising, and we expect that a similar number of graduates will continue to pursue their projects. Despite the short amount of time since graduation, 2 teams (22% of the cohort of 9 teams) have already received follow-on funding, and 2 teams (22%) have applied to the NSF I-Corps program.
In total thus far, 13 of the 39 teams (33%) have applied and received follow-on funding. Four teams (10%) have received interest from industry partners, and 3 (8%) have received an additional $50,000 grant to participate in the NSF I-Corps program.
We believe that the ETD Course is a valuable addition to the family of I-Corps programs offered by the NSF and NIH. Its unique format and biomedical commercialization focus capture a target audience of medical academicians unable to commit to a full I-Corps program, while also engaging other unique stakeholders in academic medicine, such as medical and engineering students, graduate students, and those pursuing postdoctoral degrees. Furthermore, as evidenced by the first three cohorts, the ETD Course can serve as a pipeline for the NSF or NIH I-Corps program for teams desiring additional discovery and mentorship. To better understand the effects of the ETD Course, we will conduct a study comparing the outcomes, productivity, and careers of ETD Course graduates with peers who have not received similar education, including others who enroll in the NSF or NIH I-Corps program.
FFMI is partnering with the Michigan Institute for Clinical & Health Research, UM’s CTSA program, to reach a broader audience by disseminating the ETD Course to the CTSA network and other institutions across the country. Course materials, including a resource guide and train-the-trainer model, will allow the UM team to deliver the ETD Course on-site at partner institutions, providing the opportunity for broader dissemination and impact.
Acknowledgments: The authors wish to thank the William Davidson Foundation, the University of Michigan Medical School Office of the Dean, the National Science Foundation, and the Michigan Institute for Clinical & Health Research.