Engaging with Academic Medical Centers for Digital Innovation

Academic medical centers are generally differentiated from community hospitals by their three-part mission of clinical care, medical research and health education. As part of this mission, they encourage innovation and entrepreneurship, engage in research and development, identify and validate emerging healthcare technologies, contribute to quality improvement, and provide education and training for the next generation of healthcare providers.

Digital innovation has become a key priority in academic medicine and we’re seeing them collaborate with digital health companies to develop, validate, translate, scale and disseminate the best of what digital innovation has to offer for healthcare improvement. However, innovation can be challenging even in the most favorable of circumstances and partnering with academic organizations brings unique challenges specific to the industry.

Academic Innovation Process Basics

The pathways for developing therapeutics, medical devices and diagnostics are well established in academic medicine. Research labs serve as the core vehicle for research in these areas and technology transfer offices facilitate their translation in the industry through licensing agreements or facilitating startups.

However, such well-travelled paths for fostering research and commercialization do not translate as well to the digital health domain due to issues including, but not limited to, access to patient data, intellectual property considerations, speed of innovation and clinical adoption concerns. Naturally, this has led to academic medicine and digital health companies struggling to find ways to collaborate and innovate as they learn how to deal with these new considerations.

For companies in the digital health domain, partnering or collaborating with academic medical centers is generally separated into two pathways: research and development (R&D) and quality improvement (QI).

A company sponsoring research, including clinical studies, or collaborating on product development generally falls in the R&D pathway. From the academic perspective, the R&D pathway should result in publishing information for wide use across populations and settings.

The QI pathway generally involves the use of existing knowledge or technology developed outside of the medical center to improve healthcare outcomes within a local institution or setting. Piloting or validating a research prototype or product in a clinical setting would generally fall into the QI pathway.

Another consideration for both pathways is whether the project involves using patient data that already exists versus a project where new data will be gathered. Each medical center will likely have different policies, processes and considerations for access to these types of data.

Breaking Down Academic Stakeholders

While academic medicine aims to drive digital innovation, the complexities of their organizational structure, research silos, functional teams, compliance issues, regulatory approval, decision-making and clinical adoption processes can pose significant challenges to a digital health company. Navigating through a myriad of participants and stakeholders within an academic medical center can easily seem like a maze not only for industry but also for their own innovators.

For a company or startup looking to collaborate to pilot and adopt their digital health technologies, having insights into major stakeholders and their roles as decision makers, advocates, facilitators, gatekeepers and influencers can help provide some clarity.

Decision Makers

The first step for a digital health company to engage on the R&D pathway would be to identify an innovator/researcher/clinician with the appropriate interests and clinical/research expertise as a potential investigator/collaborator. This could be an individual, a lab, a group, an office, a center or an institute. For an R&D project, the innovator/researcher serves as the advocate and decision maker.

For the QI pathway, the first step would be identifying a clinician or a group of clinicians who are interested in using, validating and/or improving a research prototype/minimum viable product developed by the digital health company by piloting it within their clinical pathways. Under the QI pathway, beyond the clinicians, key decision makers would include an administrator such as clinical head of a division, department or center who would have to not only approve the pilot project but also allocate resources for the project and plan for potential adoption.

In some academic medical centers, the key decision maker could be an administrative committee or group. In such a case, both the clinicians and their administrator will serve as advocates. If a digital health company needs assistance in identifying the appropriate advocates/decision makers, they can approach the facilitators who can help make connections.

Facilitators

Facilitators can help digital health companies navigate the process with both R&D and QI pathways through the medical center’s technology transfer and research administration offices.

A technology transfer office often acts as a channel between the academic medical center and the digital health company and is responsible for managing intellectual property, technology licensing and venture development of R&D, QI and innovation activities. They also work closely with the research administration, particularly as it relates to intellectual property matters.

Research administration offices manage the development, management and implementation of research initiatives in academic medicine. This office touches all aspects of innovation projects including R&D, funding opportunity identification, proposal preparation and submission, award acceptance and negotiation, and project and financial management.

Since both technology transfer and research administration offices must comply with certain federal, state and institutional regulations and policies, they often have gatekeeper aspects in addition to their roles as facilitators.

These stakeholders are responsible for drafting, negotiating and executing legal agreements including research, licensing and collaboration agreements under guidance of legal counsel. Some also have an industrial collaboration unit that can help facilitate the process.

Influencers

The key influencer in both pathways, especially the QI pathway, is the information and technology (IT) office. IT supplies the information systems infrastructure, governance and polices for all clinical and non-clinical applications. IT is also responsible for managing the EHR system, engaging with market suppliers and controlling access to its EHR data. IT can also act as advocates and decision makers since clinicians commonly have key roles within IT, such as chief information officer and chief medical information officer. Other important units within IT include information security and vendor management that also may act as gatekeepers.

Key influencers within the R&D pathway are research leadership, which includes but is not limited to, administration across or within functional areas like basic sciences, clinical research, translational research, data sciences and research informatics. Similarly, clinical leadership may be a key influencer in the QI pathway, including but not limited to, the chief medical officer, clinical labs, clinical informatics, patient care and nursing. These key influencers also regularly act as advocates and decision makers.

Gatekeepers

Other stakeholders may have key gatekeeper roles in the R&D and QI pathways.

• Compliance: Ensures that the units and their employees comply with relevant federal, state and local laws, regulations and internal policies
• Scientific integrity: Ensures compliance with ethical and legal responsibilities in research involving biosafety, chemical safety, radiation safety, human subjects and financial conflicts of interest
• Institutional review board: Reviews all research involving human participants
• Regulatory affairs and quality assurance: Provides regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond
• Information security: Protects healthcare information and information systems from unauthorized access, use, disclosure, disruption, modification or destruction
• Procurement and supply chain: Engages with vendors through agreements like license and service agreements, can also act as influencers

It is quite evident that the different stakeholders have intersecting roles as decision makers, advocates, facilitators, influencer and gatekeepers. Due to these intersecting roles, academic medical centers benefit from prioritizing digital innovation by having a single point of contact for facilitating and coordinating partnerships in digital innovation.

In the absence of a single point of contact, academic medical centers can develop an internal roadmap or flowchart including the participants and stakeholders for developing and adopting digital health solutions. Such a roadmap can help demystify the internal process for creating innovative digital health solutions and will help not only digital health companies navigate the process maze but also provide an opportunity to systematically coordinate and prioritize digital innovation.

These roadmaps can help promote collaboration and the rapid adoption of new digital health tools that have the potential to unlock the full potential of the digital health enterprise and thereby revolutionize healthcare in the long term.

The views and opinions expressed in this blog or by commenters are those of the author and do not necessarily reflect the official policy or position of HIMSS or its affiliates.