Designing an Injectable Hydrogel Scaffold and Delivery System for Post-Lumpectomy Breast Tissue Regeneration; Poly Implant Prothese Scandal: An Analysis on the Ethics that Drive Implant Design 5 views

My technical capstone and STS research are connected through the development of implantable medical technologies and the responsibilities ingrained in that process. While both projects focus on devices intended for use within the body, they differ in how this responsibility is examined. My technical work addresses how an implantable material must function reliably within a biological environment, while my STS research analyzes how failures in ethical judgment during device development can lead to harmful outcomes. Together, these projects examine how the conduct of those who develop implantable technologies is integrated into their design. The approach my technical work takes, to explore the responsibility of device development, is focused on minimizing risk and ensuring patient safety through quality assurance. The project centers on the design of an injectable acrylated hyaluronic acid-based hydrogel scaffold reinforced with methacrylated hyaluronic acid-based nanofibers for post-lumpectomy breast tissue regeneration. One of the central motivations for this design is to avoid UV-mediated cross-linking, which can introduce cytotoxic effects and limit clinical applicability. The acrylate components enable cross-linking through chemical bonding, forming a scaffold without external radiation and offering safer integration. The material is designed to exhibit shear-thinning behavior for injection and to recover its mechanical integrity after deformation, while sustaining high cell viability over time. These characteristics are necessary not only for function but also for reducing risk during both delivery and long-term use. My STS research also examines responsibilities of medical device development, but focuses on the ethical conduct of product developers. My paper analyzes the Poly Implant Prothèse (PIP) breast implant scandal using a duty ethics framework grounded in Kant’s categorical imperative and the NSPE Code of Ethics. I argue that the failure of the implants was driven by deliberate violations of professional responsibility, specifically the failure to prioritize patient safety and the use of deceptive practices. The analysis demonstrates that company leadership ignored known defects, failed to implement proper validation procedures, and concealed critical information from regulatory bodies. These actions indicate that the failure of the device cannot be attributed solely to regulatory shortcomings, but must be understood as the result of unethical decisions made during the design and production process. Working on these projects together strengthened both and clarified the importance of each. My technical work deepened my understanding of the responsibility to design biomaterials that are not only functional but safe and suited for patient use. In turn, my STS research established why a strong and consistent ethical commitment is necessary to uphold those standards. It emphasized that without this commitment, technical decisions can shift toward convenience or efficiency at the expense of safety. Together, these projects provided complementary perspectives on medical device development, showing that effective design and ethical accountability are inseparable.

BS (Bachelor of Science)

injectable hydrogel; biomaterials; regenerative medicine

School of Engineering and Applied Science Bachelor of Science in Biomedical Engineering Technical Advisor: Chris Highley STS Advisor: Benjamin Laugelli Technical Team Members: Siena Rodeschin, Anthony Scotto, Rachel Pritz

English

All rights reserved by the author (no additional license for public reuse)

2026-05-08