Outlook on Industry-Academia-Government Collaborations Impacting Medical Device Innovation

Abstract

The nature of collaborations between industry, academic, and government entities are discussed by the authors who together have significant experience in all three of these sectors. This article examines the intricacies and coordination needed between different stakeholder environments toward successful medical device innovation. The value of different types of collaboration models is illustrated through examples and the author's perspectives on current opportunities, challenges, and future outlook.

Introduction

Collaborations between industry, academic, and government entities have the potential to produce better outcomes than work performed independently by any single group working in isolation [1–3]. As these entities typically have distinct focuses and missions [4], joint efforts can supplement and complement activities by filling voids that may exist in each system [5], thereby leveraging strengths and covering weaknesses to enhance and accelerate pursuit of common goals. Collaborations can broaden perspective through the inclusion of diverse approaches and encourage innovative solutions and may be small- or large-scale efforts, formal or informal, and involve two or all three entity types. Industry-academic-government collaborations can create meaningful opportunities to enhance harmonization of data, identification, and coordination of resources, systematization of processes, and development and management of infrastructure to support impactful scientific exploration and address critical societal needs. This editorial will examine the differences between entity types [4,6,7], identify potential goals of collaborations [6], opportunities [7], and challenges [8], and provide opinions on the future outlook.

Overview of Entities

To understand the potential benefits of collaborations, one must first understand the different entity types and the inherent differences in mission, culture, short- and long-term priorities, and working environment. For this discussion, industry will be defined as private and public companies that design, manufacture, and support the commercialization of medical devices. Academics represent colleges and universities that conduct scientific research and educate students. Government includes bodies that serve the public such as the National Science Foundation (NSF) [9], the Food and Drug Administration (FDA) [10], the National Institute of Health (NIH) [11], and National Laboratories (e.g., Oak Ridge National Laboratory [12], Sandia National Laboratories [13]). It also includes state and local governments.

Academia.

Of the three groups, academics have the most flexibility. Faculty can pursue projects of interest, apply for funding in any area that they are capable of, and subcontract during the academic year and the summer. The academic year is filled with obligations to teach, serve the university, and conduct research. Most faculty have a multitude of activities that must be performed over the course of a year which splits their time in many ways. As a result, some faculty may lack adequate time, funding, and professional resources needed to dedicate to an individual project, so progress tends to be much slower than in industry. Projects that could be completed in months in industry can take years to complete in an academic environment.

Innovations in medical devices at universities generally focus on the development of a new technology or method. Examples include developing new methods for thermal ablation [14], cryoablation [15] and electroporation [16] for the treatment of cancer; robotics [17] and exoskeletons [18] technology for rehabilitation and to support military personnel [19]. Experimental devices under development are generally funded by grants from the government or private foundations. As a result, they are active when funded, but can be stalled or abandoned if funding ceases. Because the focus is on the development of the fundamental technology, little effort is placed on product performance, reliability, manufacturability, robustness, or the cost of an eventual commercial device. Often, these devices are little more than an alpha prototype developed to verify a hypothesis. Thus, a large gap exists between the discovery of a new medical technology and a commercial device available for public use.

An area where academic institutions do well is the development of humanitarian devices. These include low-cost products for the developing world and custom medical devices for people with disabilities. Examples include eyeglasses for vision correction that use water-filled lenses that are inflated to change optical properties [20] and a prosthetic arm for a limbless child [21]. When products have no more than minimal risk, FDA regulations enable the local institutional review board to evaluate the risks and benefits of the study and provide approval to develop the device using an investigational device exemption [22]. Eliminating the normal commercial requirements for performance, quality, reliability, and profitability enables these projects to be completed by students and faculty with little or no industrial experience. Moreover, these types of projects are highly desirable for students who enjoy helping people and seeing the impact of their work.

Industry.

Industry is the most focused group of the three. Industrial entities must identify opportunities that meet a public need for a specific product or service, generate sufficient profit to sustain the business, and maintain their fiduciary responsibility to shareholders and ethical responsibilities to customers and regulatory agencies. Investment opportunities are assessed based on the balance of these considerations. Opportunities in which technical feasibility and/or public demand are less certain come with inherent increased financial risk and are therefore adopted more cautiously compared to academic applications which carry less expectation of short-term financial return. Conversely, the financial structure of most industrial entities can offer more robust access to resources, therefore enhancing the scalability and experience of research and development efforts compared with academic institutions. In the medical device industry, decisions to invest in specific development opportunities require assessment of technical, financial, regulatory, and legal feasibility as well as value to the customer. Consumers in the medical device industry include patients and healthcare providers, including individual staff such as physicians, nurses, and/or organizations such as hospitals. Value statements for potential products may include but are not limited to reduced cost, reduced sourcing complexity (e.g., combining three products into one, enhanced usability, improvements in device safety and efficacy, improvements in patient outcomes, or a combination thereof). Assessment of proposed value statements requires rigorous voice of customer interviews to elucidate the potential adoption in the market. Once opportunities are properly vetted, a development process is initiated which requires a coordinated and cross-functional effort to ensure value, efficacy, and compliance in R&D, operations, quality assurance, regulatory, clinical, legal, finance, marketing, and sales domains. Failure in any one domain may compromise success for the entire project; thus, continuous communication across the functions is key to ensure that valuable products can achieve introduction and penetration into the market while maintaining patient health and safety as a paramount focus.

Government.

The federal government is a large comprehensive entity with divided responsibilities and minimal overlap. Each institute, administration, center, or laboratory has a different and well-defined mission. This makes strategic investment possible, and effort is made to align individual actions with long-term goals. Thus, government employees have a work environment more like industry than academics because objectives and deadlines are more tightly controlled. The government employs scientists and engineers who conduct research to advance the mission of the entity. They provide critical infrastructure, convene people, distribute funds, and support high-risk foundations for innovation. The federal government in the United States plays several different roles in the development and use of medical technologies. Through its various agencies, such as NIH and FDA, the U.S. government seeks to promote public health and scientific innovation by sponsoring promising basic and translational research and development of baseline technologies; it regulates the use of animals in scientific research and the investigational use of medical technologies with human subjects; and allows only those products that have been evaluated as safe and effective to be introduced to the commercial market. It also makes coverage and reimbursement decisions for Medicare and monitors for unintended adverse outcomes after products enter the market; and promotes education and workforce development programs across technical and nontechnical areas. State and local governments perform similar functions but with more focus on community projects and business development than the advancement of research.

Collaboration Examples

Industry-Academia Collaborations.

With academia and industry on opposite sides of the work environment spectrum, there is great potential for complementary support to enhance technology development. The flexibility of academics enables faculty to invest time developing cutting-edge technology, often through support from the federal government. Faculty may be able to bring a new technology or product idea to the proof-of-concept stage, but they generally lack resources and knowledge to advance the product to commercialization. In contrast, while industry has the infrastructure to develop commercial products, companies face a challenging balance between investment in growth opportunities and mitigation of financial risk. Many large companies balance the risk through a combination of internal funding opportunities (intrapreneurship) and acquisition of smaller entities. Internal funding opportunities are typically smaller financial investments compared to external acquisitions. Internal research therefore requires sharp focus on technology domains that align with the mission and scope of the company. Smaller entities such as startup companies often begin in a “high risk, high reward” atmosphere with a specific goal of disruptive innovation and must also maintain sharp focus to ensure sustainable development and commercialization of a single product or family of products.

Collaborations can benefit industry by enabling them to hire a subject matter expert (SME) knowledgeable on a given topic [23]. Internal funding opportunities at companies may include the financial support to initiate such arrangements with academic SMEs. The decision to invest in an academic collaboration versus another company in the industry (e.g., a contract research organization) depends on the nature of the scope of work. Typically, an academic collaboration is required for highly specialized work aimed at demonstrating “proof-of-concept” for a device prototype or technology platform. These efforts often do not include commercialization considerations outside of technical and/or financial feasibility, whereas industrial partnerships maintain a greater focus on additional factors such as regulatory compliance and manufacturability. Though companies may have similar SMEs on staff, their additional focuses beyond the technical feasibility of a project may lead to higher costs compared to academia. Moreover, corporate SMEs may be occupied with other high-priority projects and be unavailable. Consequently, academic collaborations may be ideal for the proof-of-concept stage as SMEs are able to provide equivalent technological guidance at lower cost.

Collaborations can take the form of a contract between a company and an academic institution or between a company and an individual faculty member [24]. When partnering with an institution, the goal is typically to leverage the domain expertise of the faculty member as well as the resources that they have (e.g., staff researchers, students, equipment). These arrangements typically involve a formal scope of work with explicit deliverables. This provides obvious benefits for the company through a finalized work product and adds benefit for the faculty member as external funding acquisition is a key performance metric for many academic institutions. Furthermore, students benefit from networking opportunities and financial support to continue the work required for their education. Conversely, faculty members may be hired as part-time consultants to leverage their domain expertise for internal technical and scientific guidance and/or projects with smaller scope. In this case, the collaboration provides additional income for the faculty member and a “real world” project to support. Despite these benefits, there are inherent challenges that arise due to differences in culture between the two entities. Project timelines or scale expected by industry may not be possible to achieve in an academic setting due to competing commitments. Moreover, faculty who lack industrial experience may not understand the business aspects of new product development and the need for return on investment and agility.

Industry-Government Collaborations.

Starting with the founding of the U.S. Patent Office [25] in the U.S. Constitution, the federal government has consistently recognized discrete roles for itself in the domain of technology innovation and implemented policy to affect market mechanisms and change markets to achieve desired public benefits. Governments are integral to convening relevant stakeholders and driving innovation by serving a key “entrepreneurial” role envisioning and financing the creation of entirely new fields, from information technology to biotech, nanotech, medtech, and others. Industry-Government collaborations focused on advancing innovation and technology transfer priorities significantly benefit from partnerships in resource and knowledge sharing that enable scalability and sustainability through the adoption of consensus standards, harmonized policies, and best practices. While these collaborations can proceed quickly once all relevant approvals and official requirements are met, working through the paperwork can be intimidating to the novice innovator and requires expert legal advice to ensure compliance and accuracy. Established Industry-Government collaboration frameworks may include memorandums of understanding (MOUs), research collaboration agreements (RCAs) [26], Cooperative Research and Development Agreements (CRADAs) [26,27], and other types of agreements. Importantly, the government can act as a strategic early-stage investor through a decentralized network of public institutions, such as the Defense Advanced Research Projects Agency (DARPA) [28], the National Aeronautics and Space Administration (NASA) [29], the NIH [11], the NSF [9] and other government entities. CRADAs provide exciting opportunities for NIH investigators to collaborate with industry and academic colleagues toward the joint pursuit of common research goals. Government scientists can leverage intramural research resources, and draw from their extramural experiences, expertise, and networks, to promote the development of creative program initiatives that advance the development and commercialization of novel biomedical innovations.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) [30], collectively the small business programs, also known as America's Seed Fund, have the same goal—to help entrepreneurial researchers launch small businesses, engage in research and development, and commercialize new products that will benefit the public. Since federal Agencies like NIH cannot commercialize their own discoveries, they rely upon corporate partners. Each year, hundreds of new inventions are made at NIH, the Center for Disease Control, and other national laboratories and transferred through licenses to the private sector for further research and development and eventual commercialization. Often, companies require patent protection to justify the expenditure of resources needed to fully develop an invention. Similarly, to ensure the rapid and effective development of an invention, government agencies may strategically seek intellectual property protection (both domestic and foreign). Typically, a royalty-bearing exclusive license agreement with the right to sublicense is given to a company from NIH to use patents, materials, or other assets to bring a therapeutic or vaccine product concept to market. Companies may also leverage their own R&D efforts while collaborating in state-of-the-art NIH research.

Government-Academia Collaborations.

Some collaborations between government and academia are a natural fit. These include funding of innovative research to advance science and engineering by the NSF or projects to promote human health by the NIH. The government entities support their mission by funding projects that are evaluated through competitive review. Because research topics, timelines, and budgets are all proposed by the academic investigators, there is no need to adapt expectations. Other projects between academics and government can be more challenging. When faculty collaborate with scientists and engineers from government laboratories, they must consider the documents and necessary approvals needed to support the collaboration. Like industry-government collaborations, this can take time depending on the sensitivity of data transferred and associated security clearances and U.S. citizenship requirements. In addition, differences in culture between full-time government and academic researchers juggling multiple commitments can lead to differences in priorities and time expectations.

Informal Arrangements.

Collaborations between industry, academic, and/or government entities can also be informal. One such example is the development of standards by the American Society of Mechanical Engineers (ASME). Volunteers from the medical device industry, university faculty, and FDA scientists and engineers worked together to develop the ASME V&V40 standard. This standard describes the processes used to assess the credibility of computational modeling through verification and validation with applications to medical devices. Because all members were ASME volunteers, minimal documentation was required for the collaboration. However, the outcome of this work has a significant impact on the medical device industry and the FDA by providing a framework for the use of computational modeling and simulation in the regulatory approval process.

Public Private Partnerships.

Partnerships between government agencies and private industry have extended and accelerated research, research training, and the dissemination of information in diverse and creative ways. In the area of medical devices, public private partnerships (PPPs) aim to accelerate biomedical innovation, product development, and commercialization through robust data-sharing, governance, evaluation of progress toward sustainable outcomes, harmonization of regulations and best market practices, and rapid dissemination of key findings. These efforts can help theoretical ideas and basic research translate to applications enabling the development of medical technologies that change patient lives.

Recognizing the value of PPPs, NSF has authorized the formation of a new directorate—Technology, Innovations, and Partnerships (TIP) [31]. TIP spans across other NSF directorates to integrate research and fosters partnerships with government, industry, nonprofits, civil society, and communities of practice. Support from NSF TIP could provide additional opportunities to establish new collaborations. Similarly, NIH [11] partners with representatives from industry, academia, and patient advocates, among others, to support and conduct medical research to improve human health. Each partner brings its unique resources and strengths, and the resulting synergy improves and accelerates progress toward common goals. For example, as one of its strategic priorities, the National Institute of Dental and Craniofacial Research (NIDCR) [32] at NIH is expanding existing partnerships and creating new ones to advance the research enterprise and increase its reach and impact through the Accelerating Medicines Partnership^® Program [33].

Opportunities and Challenges

Leveraging Complementary Expertise.

Collaborators benefit from having overlapped subject matter expertise. This overlap enables them to jointly develop ideas, easily share knowledge, and divide work. Yet, it is also beneficial to not be fully overlapped, because these differences can be beneficial as well. The strong foundation in theory provided by subject matter experts in academia and government finds its value in long-term applications where innovation is meant to forge new pathways for technological development and application. Such expertise is especially valuable when the problem is of significant scale and the solution is ambiguous, requiring creative thinking and freedom of exploration. Subject matter experts in the industry may be more valuable when the problem is well-defined, and the value proposition is clearly stated. Thus, collaborations can enhance projects by providing both a strong understanding of the fundamental principles and the details necessary for successful application.

Changes in Critical Infrastructure.

The COVID-19 pandemic was a disruptive force shifting the way people communicate and collaborate. The world is becoming smaller, with collaborations no longer limited to only the immediate area. Subject matter experts can be sought from around the world, thus providing new opportunities for all parties. However, collaborating with people outside one's organization can present specific logistical challenges depending on the location of potential collaborators. Additional technology and security may also be required for outside entities. Initiating collaboration with financial stakes may require extended negotiations regarding roles, responsibilities, and ownership. In cases where collaborators have no financial stakes (e.g., technical advisory boards, community initiatives), initiation of the collaboration may be less complex than those requiring legal execution. Participants may also have competing priorities that draw effort from the collaboration, a scenario of particular concern when collaborations are established on a volunteer basis. Participants may also have internal procedural requirements which create administrative hurdles for tasks associated with the collaboration. While even established collaborations can have logistical delays, many of the longest delays can be associated with initiating the collaboration.

Technology Transfer and Innovation Management.

Intellectual property (IP) and trade secrets [25] can be a key element of a technology company's portfolio [34]. Ownership of IP protects the financial investment associated with the development of an idea. Thus, IP ownership is a significant consideration for all parties involved when engaging in collaborations [3]. With a few exceptions, academic faculty have little knowledge or practical experience with patents. However, they and their universities are often interested in capitalizing on new inventions and many universities have some form of profit sharing to support this. Thus, collaborations involving technology development ventures between industry and academia are often difficult to implement where IP ownership is unclear. Government entities tend to not pursue gains from intellectual property as such profits are often seen as a conflict of interest and should be avoided. Consequently, collaborations involving industry and government entities are at less risk for delays related to negotiation over IP ownership (Fig. 1).

Fig. 1.

Word cloud illustrating important components in industry government and academic collaborations [35]

Future Outlook

There are many reasons to improve connections between industry, academia, and government. Collaborations between entity types have the potential to yield benefits beyond those possible within industry, academia, or government alone. Moreover, in our highly connected digital world, collaborations are no longer limited by distance. While no single approach applies to all cases, opening one's mind to the possibilities and potential opportunities that such a collaboration could achieve is the first step to making it a reality. Overall, the outlook for industry-academic-government collaborations seems to be on an upward trend having the potential to synergize and complement the unique roles of universities, government institutes and centers, and private companies toward achieving the broader mission of promoting scientific innovation and addressing public health needs.