Sharing best practices for educational programs on venture creation and commercialization

Abstract

Longitudinal evaluation of the Biomedical Entrepreneurship Educational Program suggests the program successfully educates and inspires the next generation of life science and biotechnology innovators.

Technology and innovation in the life sciences can be stymied by the high cost of product development, a protracted timeline and nuanced challenges with commercialization. Educational programs focused on biomedical entrepreneurship can help scientists address these challenges. Medical school and scientific curricula often lack relevant innovation-based coursework, leaving graduates with a limited understanding of product development, venture creation and the process of commercialization¹. Insufficient knowledge in this area can become a barrier to the advancement of drug discovery, device development and health technology creation, which in turn leaves potentially impactful therapeutics and technologies on the laboratory floor.

To improve training opportunities, some US universities (and academic consortiums) have developed programs that facilitate collaboration between experts in business, engineering and scientific research. Prominent examples with published metrics include the New York University Grossman School of Medicine (NYUGSOM) Biomedical Entrepreneurship Educational Program (BEEP); the Center for Integration of Medicine and Innovative Technology (CIMIT, a consortium of the Boston-area institutions Massachusetts Institute of Technology and Harvard, Northeastern, Boston and Yale Universities); Stanford Biodesign; the BioEngineering, Innovation, and Entrepreneurship (BioENGINE) program at the University of California, Irvine; the Alfred Mann Institutes at the University of Southern California; and the Entrepreneurship for Biomedicine (E4B) training program at the Washington University School of Medicine^2–11 (Table 1).

Table 1 |.

A comparison of US-based biomedical entrepreneurship programs with published metrics

Program	Affiliations	Years evaluated	Number of participants	Number of respondents or data points	Patents	Participant publications	Companies started or products developed	Additional article highlights
Biomedical Entrepreneurship Educational Program (BEEP)2,3	New York University Grossman School of Medicine	2019–2020	153 participants	Short term: 80 Longitudinal: 23	NA	NA	NA	Short-term surveys2: • 95% reported the course met its objectives • 95% reported a higher likelihood of pursuing commercialization of discoveries after the course • Participants rating themselves as very interested in therapeutics, venture creation and devices after the course increased 14%, 27% and 18% respectively. Longitudinal surveys3: • 70% of participants had plans for forming a startup, creating a drug or device, or working for a company to bring a product to market • 94% of participants stated BEEP was suitable for those with all prior levels of entrepreneurial experience
Center for Integration of Medicine and Innovative Technology (CIMIT)5,6	MIT, Harvard, Yale, Boston University and Northeastern University	1998–2012	585 projects	428 (228 solutions (with some projects built on other previous projects) out of an estimated 1,000 evaluated)	458 US patents issued	2,293 peer-reviewed publications	70% of projects still active, 27% reached commercialization, 17% approved for clinical use	• $69 million invested in 585 projects ($55 million for 428 projects analyzed)6 • 49% of projects received follow-up funding6. • 37% of projects “touched patients”6 • 30% of projects had a significant impact on at least one team member’s career6 • $516 million follow-on funding, $597 million commercial investment6 • CIMIT Accelerator-specific statistics: 17 solutions funded (130 candidates evaluated), 29% of projects ongoing, 7 projects commercialized (41% commercialization success rate)6
Stanford Biodesign7	Stanford University	2001–2012	106 graduated fellows	69	141 provisional patents and 38 utility or methods patents filed during the program	NA	26 companies that have raised over $200 million and created of over 500 new jobs	• 4 projects have received regulatory approval and are in clinical use; they have been used to treat more than 150,000 patients7 • 33% of fellows are in leadership positions in companies created at the program7 • 17% of fellows are in startups not directly founded by the program7
BioEngineering, Innovation, and Entrepreneurship (BioENGINE) program8	Department of Biomedical Engineering at the University of California, Irvine	2015–2017	326 students	110	43/110 (39%) filed a record of invention or provisional patent	NA	5 startups	• 91/110 (83%) felt more confident in pursuing their careers after completing the program8 • Over 80% of students met course learning outcomes each year, higher than the 70% expected to8
Alfred Mann Institute9,10	University of Southern California	2008–present	5 companies	5	26 issued patents since 2010	9 research publications since 2008	Companies launched: • Pulse Biosciences • Varocto • Dermaport • Proa Medical Current project: • Mesencyte
Entrepreneurship for Biomedicine (E4B) training program11	Washington University School of Medicine	2020	77 trainees for E4B 13 trainees for E4B2	77 for E4B 13 for E4B2	NA	NA	3 graduates have started a company	• 4 graduates have received external funding for an innovation11 • 3 graduates submitted a grant to develop or evaluate an innovation11 • 8 graduates have participated in further entrepreneurial training11

Education, skills and training in biomedical entrepreneurship

With support from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), BEEP was developed in 2019 in partnership with the New York University (NYU) Technology Opportunities and Ventures Office and the NYU Clinical and Translational Science Institute to educate graduate and doctoral students, medical students, postdoctoral students and faculty in the commercial application of scientific research¹². Using a framework developed by the Martin Trust Center for MIT Entrepreneurship and adapted to the life sciences, the core curriculum is administered in three overlapping stages: nucleation, product definition and venture development³. The introductory nucleation stage focuses on participants’ skills in venture creation, including opportunity discovery and approaches to innovation. The product definition stage refers to exploration of the commercial potential of new technologies and to the development of viable business models, intellectual property and valuation. Venture development focuses on opportunity and resource integration to facilitate launch. The curriculum includes Foundations of Biomedical Startups (FBS, an introductory course), various workshops (Design Thinking and Valuation) and modular courses including Translational Pathways for Cardiovascular Devices (TPCVD). While we have incorporated feedback and shown that participants appreciate the curricula and feel more confident in their entrepreneurial skills, the ultimate goal of BEEP is to encourage more early-stage scientists and innovators to contribute to the advancement and impact of biomedical research through commercial application. Therefore, the dissemination of BEEP is central to achieving that goal; here we report on longer term follow-up across institutions^2–4.

Data to support dissemination

We conducted post-program surveys and interviews with BEEP graduates (FBS and TPCVD courses, 2019–2022; Supplementary Data 1–4) and interviews with program directors (2023) to inform program dissemination strategies and best educational practices.

Student surveys.

Since program implementation, students have completed surveys pre- and post-course to assess short-term knowledge acquisition and self-assessed competency in various entrepreneurial domains. Demographic information, professional goals and general reflections have also been solicited and published. Longitudinal follow-up surveys were sent to FBS course graduates (2019–2020)^2–4.

This year, we used Qualtrics to conduct additional follow-up surveys of FBS and TPCVD course participants (2021–2022), 1–2 years after participation. A post-participation survey was distributed to individuals who took part in TPCVD during the 2021–2022 academic year at the following four US institutions: NYUGSOM, Purdue University Weldon School of Biomedical Engineering, University of Massachusetts Lowell Francis College of Engineering and Chan School of Medicine, and University of Arizona James E. Rogers College of Law. Additional post-TPCVD course surveys were shared by the program director from the Purdue University Weldon School of Biomedical Engineering. The goal of the 1- to 2-year post-participation surveys was to assess longitudinal program performance, to whom the activity is best suited, how to reach a broader audience, motivating factors for course registration, and how to improve content, engagement, delivery and impact on career development. The survey also queried students’ interest in biomedical entrepreneurship and whether that interest changed since program participation. Finally, we evaluated post-participation engagement in the planning or development of commercial ventures. Chi-squared tests were used for non-parametric analysis post-FBS and post-TPCVD with Yates’ continuity correction to calculate significance.

Interviews with FBS graduates.

Phone interviews were conducted with three program graduates who agreed to be contacted for additional feedback and reflections. Interviewees were asked about their reasons for course enrollment, career stage and future plans, engagement in entrepreneurial activities, and course impact and relevance.

Interviews with program directors.

Three program directors were interviewed (BEEP program director, FBS director and TPCVD director) to better understand programmatic objectives and future directions.

BEEP longitudinal performance

There were 47 post-FBS and/or TPCVD course survey respondents (16% of 290 participants between 2019 and 2022). The majority of respondents were from NYUGSOM or Purdue University Weldon School of Biomedical Engineering; 1 was from the University of Massachusetts Chan School of Medicine and 2 did not disclose an affiliation.

Post-FBS course 2019–2020 and 2021–2022.

Nineteen post-FBS course surveys were collected in 2021 (16% of 118 2019–2020 NYUGSOM participants) and 14 were collected in 2023 (12% of 116 2021–2022 NYUGSOM participants).

Student impact.

Ninety-five percent of respondents stated that they were motivated to enroll in FBS to gain introductory knowledge in or to pursue a career in biomedical entrepreneurship. Eighty-nine percent of respondents either had interest in or had already enrolled in related courses after FBS. The majority (76%) also reported currently having or maybe having plans to implement a startup, create a drug/device, or work for a company to bring a product to market (Fig. 1a). Thirty-five percent were more inclined to pursue biomedical entrepreneurial activities, 15% were less inclined, and 50% did not report a change (Fig. 1b).

Fig. 1 |. Post-FBS course respondents, student impact.

One to two years post-FBS course, respondents indicated the following: a, Whether they had plans to pursue implementing a startup, creating a drug/device, and/or working for a company to bring a product to market. b, How their interests in entrepreneurship changed since course completion as either less inclined to pursue a career in entrepreneurship, no change, or more inclined to pursue a career in entrepreneurship. By percentage; 95% confidence intervals are listed in parentheses when applicable.

Post-course change in entrepreneurial interest (that is, more, less, or unchanged interest in entrepreneurship) was associated with participant likelihood of engaging in post-course entrepreneurial activities (P = 0.04). While participant role (for example, faculty, resident, fellow) was not associated with post-course changes in entrepreneurial interest (P = 0.74), role was associated with engagement in entrepreneurial activities (P = 0.014). Further engagement in post-course entrepreneurial activity was associated with having plans to implement a startup (P < 0.001), create a drug/device (P = 0.004) and/or work for a company to bring a product to market (P = 0.005).

Impressions of course content.

In regards to FBS course utility, 86% of respondents considered sessions at least somewhat useful (Fig. 2). Forty-two percent reported attending only sessions they were interested in, and 41% disagreed that full course attendance was essential (scheduling conflicts presented a barrier to full participation). Seventy-five percent of respondents stated they made meaningful connections in the course, which many students stated as another motivating factor for enrollment. Moreover, 86% stated they would like to see networking and team building events to connect scientists and industry representatives.

Fig. 2 |. Post-FBS course respondents, impressions of course content: usefulness of FBS course sessions, post-participation.

One to two years post-FBS course, respondents rated each session as did not attend, has not been useful thus far, has been somewhat useful thus far, or has been very useful thus far. By percentage; 95% confidence intervals are listed in parentheses when applicable.

Indications for rollout (level, modality, lecturers).

Ninety-five percent of respondents felt that graduate students, postdoctoral fellows or junior faculty should be targeted for course enrollment on the basis of topics covered and 90% considered the material at least somewhat well suited for all levels of entrepreneurial experience (Fig. 3a,b). Fifty-nine percent found some merit in a recorded, asynchronous learning model, and 53% favored an in-person, synchronous learning model (Fig. 4). All respondents mentioned the importance of inviting engaging, expert instructors.

Fig. 3 |. Post-FBS course respondents, indications for rollout (level, modality, lecturers): suitability and target audience.

a, Assessment of FBS suitability as not well suited at all, somewhat well suited, or very well suited based on participant level of entrepreneurial knowledge and expertise by percentage. b, Assessment of target student audience as do not recommend targeting, consider targeting, or definitely target participants on the basis of educational level obtained. By percentage; 95% confidence intervals are listed in parentheses when applicable.

Fig. 4 |. Post-FBS course respondents, indications for rollout (level, modality, lecturers): ideas regarding design and delivery.

One to two years post-FBS course, respondents stated whether they strongly disagree, somewhat disagree, somewhat agree or strongly agree with various statements concerning how BEEP courses and workshops can best be designed and delivered. By percentage; 95% confidence intervals are listed in parentheses when applicable.

Post-TPCVD course, 2021–2022.

Fourteen post-TPCVD course survey responses (25% of 56 participants) were obtained from participants from 2021 to 2022. All respondents considered this online, modular, asynchronous course to be at least a little relevant to their career goals, and 75% considered the course to be either moderately or greatly relevant in this domain. Fifty-nine percent of respondents rated TPCVD modules as either excellent or good and 41% were neutral. Eighty-three percent of respondents stated they were at least somewhat likely to develop a medical device in the future, although participant role was not found to be associated with likelihood of creating a device (P = 0.17) or a drug (P = 0.17) or implementing a startup (P = 0.22). All respondents stated they would possibly be interested in attending a medical device bootcamp to help them develop and commercialize a biomedical device in the future. Not all questions were answered by all respondents.

Post-TPCVD course, Purdue University 2022.

A separate post-TPCVD course survey (2022) from participants enrolled at the Purdue University Weldon School of Biomedical Engineering was shared with the BEEP evaluation team (N = 17). When questioned about key knowledge gained from TPCVD, 65% of respondents highlighted clinical and commercialization potential, 53% acknowledged insights into conflicts of interest, 35% noted the importance of regulatory strategy, 24% recognized the significance of statistics, 24% valued the insights from expert perspectives and 18% appreciated the role of the patient’s viewpoint in shaping the process (Fig. 5).

Fig. 5 |. Key knowledge gained from TPCVD: Purdue University 2022.

Students were asked to describe a key take-away message or insight from TPCVD that can be applied to their career. Responses were analyzed for key words and phrases and quantified.

BEEP graduate interviews.

Three BEEP graduates (two years post-program) were interviewed by phone or video chat. Interviewee 1 (visiting researcher, FBS 2021, TPCVD 2022) had no entrepreneurial experience before BEEP. This graduate is currently employed as an associate professor of clinical pharmacy. The motivation for enrollment was to learn more about biomedical entrepreneurship and novel technologies, specifically how to develop a medical device of interest. Interviewee 1 learned that scientists could successfully commercialize their research and ideas and has since submitted proposals to support further product development.

Interviewee 2 (PhD student, FBS 2020) had some exposure to the pharmaceutical industry before BEEP. This graduate had experience with utility patents and is currently employed as a research scientist. Interviewee 2 plans to obtain an advanced degree in business. The motivation for enrollment was to keep current in the field while engaged in scientific research. Interviewee 2 believed BEEP was useful to those with minimal exposure to entrepreneurship.

Interviewee 3 (postdoctoral fellow, FBS 2019) had minimal exposure to biomedical entrepreneurship before BEEP. This graduate is currently employed as a biotechnology consultant. The motivation for enrollment was to learn about the business side of life science innovation. Interviewee 3 stated that insights gained from BEEP are especially helpful during meetings with technology and pharmaceutical clients. Interviewee 3 believed BEEP was advanced, but prompted deeper thinking and investigation into a topic, and was therefore useful to those at any level. This interviewee believed that additional advanced courses would benefit those with more formulated ideas.

Director interview results.

Three course or program directors have acknowledged the successful accomplishment of BEEP’s short-term objectives, underlining the consistent positive feedback received after the course(s). They identified crucial goals such as introducing new activities, enhancing marketing efforts, and promoting the integration of BEEP within and across universities. All directors expressed their support for establishing an intensive medical device training program in response to participant feedback. However, potential obstacles to cross-institutional expansion were mentioned, including the absence of a robust network or infrastructure and competition from other programs.

One director advocated offering virtual courses to broaden accessibility; another supported in-person courses and workshops with a smaller, more engaged audience; and the third endorsed a hybrid approach.

The directors also pointed out that, like many voluntary entrepreneurship courses and workshops, BEEP experienced a significant attrition rate. Proposed solutions included making BEEP courses eligible for academic credit (pending internal and state approvals), adjusting the timing of courses and workshops (potentially during lunch or dinner), and communicating with participants to emphasize the significance of each session.

All directors agreed that metrics of success should include attainment of enrollment targets, research involvement, products developed, patents obtained, grants received, publications and ventures commercialized (launched, licensed, scaled and sold), as well as continued interest in professional development and biomedical entrepreneurship and innovation.

Discussion

Longitudinal data delineate BEEP’s ability to educate and inspire course graduates in biomedical entrepreneurship years after participation. All respondents stated that obtaining an introductory level of knowledge in the field was an early motivator for program enrollment, and their initial interest in the field either remained unchanged or increased by the time of survey completion. The courses were still useful to graduates years later, as was the effect on professional development. Most survey respondents reported plans to engage in entrepreneurial activities, and several are already involved in such activities. We expect this metric to increase as participants complete their respective educational or postdoctoral programs. Entrepreneurial activities that respondents planned to pursue included drug and medical device development (most common), launching a startup, and working for a company to bring a novel product to market (least common).

The relatively low survey response rate (16%) stems from several factors, including potentially outdated participant contact information. Participant-level characteristics, such as degree of interest in biomedical entrepreneurship, may also have contributed to that person’s likelihood of responding, reflecting a degree of bias in the data. In the future, additional means of communication such as phone numbers and social media profiles (in particular, LinkedIn) should be collected at the time of course registration. To reduce response bias, program staff should emphasize the importance of maintaining relationships with participants and instructors to ingrain an early expectation of sustained contact with the program in order to network and collect longer-term data.

Consistent with that of other voluntary courses and workshops, the FBS attrition rate was high¹³. The most common reasons for absence were scheduling conflicts between work and home. However, this may be a reflection of participant unwillingness to attend sessions less relevant or interesting to them (unlikely related to the availability of appealing courses). It may be beneficial to students if lecturers describe how they balance competing priorities. In addition, virtual or recorded sessions may increase attendance by minimizing travel burden and helping participants avoid scheduling conflicts. Furthermore, the availability of recorded sessions could grant students the freedom to review content on their own that held little initial appeal. Program staff should also clarify the importance of content covered each week in order to further motivate participation. However, as noted by the directors, a virtual or prerecorded format may actually discourage engagement. Offering the course for credit is another feasible way to reduce attrition regardless of format, although doing so may be financially prohibitive or unappealing and thereby lead to an unintended enrollment decrease. In a postpandemic world, course format has become an increasingly salient concern for many academic stakeholders, particularly given its theoretical impact on enrollment, attendance, engagement and comprehension. Classroom engagement arose as a topic of particular concern for our program directors, who expressed support for a range of different formats in their interviews. Surveyed FBS graduates were equally divided in preference for virtual versus in-person sessions. While learner comprehension remains another critical issue, studies indicate that this tends not to vary by course format in many cases; however, certain learning styles are better suited to certain learning modalities^2,14,15. An integrated model may therefore provide a catchall that honors the cognitive diversity and individual preference of all students. New formats have in fact already been introduced for this reason; the TPCVD course now includes some live panel sessions⁴. Future surveys will investigate reasons for specific format preferences and ideas on how to develop an integrated model that optimizes the learning experience.

Post-FBS course entrepreneurial interest was associated with a likelihood of engagement in subsequent entrepreneurial training activities, and post-course engagement in entrepreneurial activity was associated with plans to implement a startup, create a drug/device, or work for a company to bring a product to market. In keeping with these and previous post-course findings, participants expressed a desire for supplementary activities linked to the advancement of medical technology and devices. In response to similar feedback, the modular TPCVD course was added to the BEEP curriculum in 2021. This course has been successfully implemented at four US universities, with positive findings⁴. BEEP program directors and participants agree that an intensive activity focused on medical device development is needed to further maximize participant engagement and commercialization potential. All TPCVD respondents stated that they would possibly be interested in attending an intensive bootcamp to help them develop and commercialize biomedical devices in the future. This training model for medical device development does not yet exist in the United States.

Despite the paucity of biomedical entrepreneurship education in traditional scientific and medical curricula, BEEP allows students to pursue educational opportunities that can translate into meaningful entrepreneurial outcomes. Improving outcomes relies on recruiting appropriate candidates. Although entrepreneurial interest is not associated with participant role, pursuit of entrepreneurial activities is, with graduate and medical students exhibiting a higher tendency to engage in additional training. These groups were also disproportionately recommended as ideal targets for future course recruitment, suggesting a strategy to target graduate and medical students for enrollment and to remove barriers to subsequent course enrollment and utilization of commercialization resources. To track outcomes among course graduates in more detail, we plan to create an index of relevant industry-standard metrics (research involvement and grants, products developed, patents obtained, and commercialization in the life sciences) and will follow BEEP graduates longitudinally to measure impact over time^2–11. Regardless of participant role, the BEEP model presents an opportunity to enable intra and inter-institutional crosstalk that is vital for life science innovation. Leveraging the Clinical and Translational Science Institute’s educational networks may also enhance interdisciplinary collaboration and facilitate broader dissemination of curricula.

Conclusions

BEEP successfully educates scientific innovators in the complexities of biomedical entrepreneurship and commercialization that traditional biomedical curricula do not cover. Targeted recruitment of students and instructors as well as improvements to course content and delivery based on participant interests and learning styles will maximize engagement and impact. Long-term objectives encompass conventional entrepreneurial performance indicators, professional growth and a sustained enthusiasm for biomedical innovation and entrepreneurship, shown to be linked to subsequent entrepreneurial activities. BEEP’s longitudinal data strongly suggest that curricula can be tailored to industry neophytes to impart knowledge and facilitate networking and collaboration, thereby enabling participants to apply lessons to their own research and ventures.

Supplementary Material

Supplementary information The online version contains supplementary material available at https://doi.org/10.1038/s41587-024-02199-y.