Integrating Medicine, Engineering, and Business to Educate Early-Stage Researchers in Cardiovascular Device Development

Abstract

Device development is a burgeoning, innovative industry, yet early stage scientists have little knowledge of venture creation and the steps required to develop a device, likely contributing to the high failure rate of device technology. At present, there is no national program that provides specialty education for biomedical product development. In response to this critical problem, the Translational Pathways for Cardiovascular Devices course was developed with the goal of integrating medicine, engineering, and business education to targeted multidisciplinary early stage researchers. Pilot data show there was a greater than 300% increase in cardiac device translational practices competency; 67% of respondents indicated they planned to develop a cardiac device. The data highlight the need to develop a device development educational core to further enhance national, international and multidisciplinary innovation and collaboration in the biomedical device domain.

Introduction

Academic researchers and physicians play a critical role in biomedical innovation, particularly in the field of medical devices.¹ Collaborations between physicians/researchers and industry have led to such devices as steerable cardiac catheters and artificial heart valves.¹ Now more than ever, there lies the potential to treat and cure diseases with devices and technology.

The Problem

In 2017, only 23% of US PhDs in the health and life sciences held a tenure track position in academia.²Internationally, about half of biomedical PhD graduates obtain employment outside academia: in industry and tech (27.4%), government (14.7%), nonprofit/other (9%). Surprisingly and despite these numbers, the vast majority of PhD graduates are unfamiliar with device development and commercialization; early-stage researchers receive little or no training in biotechnology, venture creation, commercialization, and entrepreneurship.^3-5 While required skill sets and knowledge in the device development involve and integrate concepts in biomedical engineering, business planning and practices, regulatory processes, as well as community and patient adoption practices, there is at present no institution that provides specialty training in device development, nor is such essential training and skills development part of standard US medical curricula. Moreover, there is little integration across campuses and institutions when generalized entrepreneurship programs do exist.^5,6

About 10% of all venture capital go to the medical device industry, but 75% of all medical device startups fail in the United States.⁷ This is not due to a lack of need for devices, but rather likely a mismanagement of the project by those scientists who are unfamiliar with the entrepreneurial landscape and how to navigate within it.⁸ Furthermore, it takes more than 15 years and costs more than $1 billion to translate a new concept to a useful medical product with potential lucrative market share.^7-10 As the demand increases for safer, more efficacious, and cost-effective healthcare, it is critical that the pathways to acquire the necessary education and skills are more accessible to early stage researchers and innovators to potentially lower cost, time to market, and improve success rates.

Entrepreneurship Educational Programs

Entrepreneurship educational programs have been shown to enhance self-assessed competency of participants.¹¹ Formal training increases the level of intention in pursuing a career in entrepreneurship for people with no prior experience, such as students or early scientists.⁸ Despite the evidence, resources for early stage researchers hoping to bring their ideas to market are scarce and knowledge is lacking.

To fill this vital training and skills development gap, the International Society for Cardiovascular Translational Research (ISCTR) team, comprised of international cardiovascular device innovators and field experts, created an extensive and comprehensive online, module-based cardiovascular device course called, Translational Pathways for Cardiovascular Devices.¹² The course was launched in 2021 and has since been integrated within curricula at national institutions within different, yet connected, innovative disciplines (Medicine, Engineering, and Law). The course aims to train those who work or plan to work in product development, whether as an innovator, physician, scientist, engineer, regulator, or at a governmental or third party agency to build the necessary skills to creatively innovate and facilitate venture creation and adoption. The course consists of 80 recorded lectures by national experts and is designed to take students through the translational pathway for cardiovascular devices to address knowledge gaps in: proof of concept, prototype development, preclinical and clinical evaluation, regulatory, reimbursement, statistical methods, and practice guideline and community strategies (Figure 1). A major goal is to improve students' familiarity and interest in medical innovation, thus empowering them to pursue their entrepreneurial visions.

Figure 1: Translational Pathway for Cardiovascular Devices.

Significant knowledge and expertise gaps exist at every transition point in the extensive translational process.

Course Descriptives

As of July 2022, 87 participants (51% female) have enrolled in Translational Pathways for Cardiovascular Devices. Students were recruited from leading technology transfer and commercialization indexed institutions¹³ such as the New York University Grossman School of Medicine (9), Purdue University Weldon School of Biomedical Engineering (56), The University of Arizona James E. Rogers College of Law (15), The University of Massachusetts Lowell Frances College of Engineering (2), and Industry/Other Enterprises (5) (Figure 2). Although there were few survey respondents and the respondents were from a single institution, 80% self-assessed their level of expertise in medical device development as a novice (pre-course) and 20% as advanced beginner. In contrast to the post-course survey, 67% of respondents considered themselves to be competent in the field and 33% as novice. In response to the question, “How likely is it that you will end up developing a medical device in the not too distant future,” 67% of post-course survey respondents answered that they were either somewhat or very likely to do so.

Figure 2: 2021-2022 Translational Pathways for Cardiovascular Devices Course Registration Data.

Since 2021, there are 87 enrollees from 4 universities and industry/other enterprises.

The qualitative data highlight a level of product development interest; free responses included:

“The course helped broaden my mindset and ignited my thinking as an entrepreneur by exposing me to perspectives from people of different training backgrounds. I plan to seek opportunities in biomedical business development.”

“This course has already encouraged me to begin thoughtfully planning my idea for a cardiovascular diagnosis device. My short-term goal is to find a collaborative engineer to partner with.”

Conclusion

The Translational Pathways for Cardiovascular Devices course details the process of medical product development from the outset, identifying unmet patient needs, to the desired endpoint, providing a quality and quantity of life altering therapeutics to patients. At present, this specialty device development educational program is the only one of its kind. More data is needed to provide meaningful metrics such as course impact on entrepreneurial outcomes and cross disciplinary collaborations. In summary, as innovators gain better understanding of the strategies and processes required for medical innovation, they can apply knowledge to existing technology and development platforms. The acquired skills and knowledge will ultimately challenge scientists to contribute to the development of well-designed health technologies and commercial ventures that can positively impact people with disease. Looking beyond independent institutions and discipline-specific educational programs, integration of like-minded programs across campuses and between universities is also needed to promote networking and sharing of resources to increase the likelihood of success. Collaborative efforts to educate and empower promising innovators in the device, biotechnology, and entrepreneurship sectors will cultivate impactful innovation, venture creation, and translation to therapeutics and healthcare technologies.