Academic Innovation Meets Regulatory Reality: Lessons from Developing the HepatiCan Bioartificial Liver Device

As academic institutions increasingly transition from theoretical research to full-scale medical device development, a new study highlights both the promise and pitfalls of this evolving landscape. Researchers have detailed their experience designing and evaluating the HepatiCan™ Bioartificial Liver within academia—revealing key lessons about regulatory challenges, interdisciplinary collaboration, and real-world usability.

Historically, academia’s role in medical technology was limited to early-stage research, with industry partners taking the lead in commercialization. But advancements in rapid prototyping and open-access information have empowered academic teams to take medical innovations from concept to product. Despite this shift, the study notes that internal barriers—such as siloed departments, fragmented knowledge, and limited funding—still hinder progress.

Using the development of the HepatiCan device as a case study, the team explored how regulatory standards can be integrated into academic research. They found that current guidance is often too vague for newcomers, making it difficult for academic developers to navigate complex compliance requirements effectively. The study emphasizes the need for greater clarity and support for early-stage teams engaging with regulation.

Crucially, the researchers advocate for the use of ecological validity—designing and testing devices under realistic conditions—to ensure that medical technologies are not only innovative but also safe, efficient, and usable in clinical settings.

The findings underscore the growing potential for academia to play a central role in medtech innovation, but also call for systemic changes that foster collaboration, regulatory literacy, and patient-centered design within university environments.

Read the full article on Human Factors in Healthcare here.