Smarter Release: Redesigning an Endoscopic Soft Tissue Release System; Politics, Power, and the FDA: The Administrative Drift of US Medical Device Oversight 953 views

Medical device development in the United States is heavily protected by the US Food and Drug Administration (FDA). While engineers innovate for the benefit of human healthcare, the medical device industry, and American engineering prowess, the FDA’s sole responsibility is protecting public health. As the FDA drifts towards decentralized regulation, the responsibility for engineers and industry to create safe devices increases. In order to protect the public, this burden must be shared and checked by independent review while meeting economic goals on both sides. The technical portion of my project explored a product redesign of a field-leading device in endoscopic soft tissue release. Primarily, my capstone creates a more intuitive user experience and incorporates a digital endoscope to make the product self-sufficient. To do this, I first redesigned the interface between the blade and handle to simplify assembly for inexperienced users or assisting nurses by incorporating a locking mechanism with a ball detent for angular positioning and a manually articulating plunger for axial retention. Secondly, I sourced an off-the-shelf digital endoscope to pair with a USB output on a camera, eliminating the need for expensive visualization towers and making the product more accessible to surgeons and patients in outpatient settings. My experience in undergraduate engineering education has focused on developing the technical skills to innovate, and less on the regulations involved in bringing a product to market. In order to fully realize my design, it will take the marketing and regulatory teams substantial effort to get the device approved with the FDA to release it to the market. My STS research paper investigates the underlying shifts in the FDA. Using historical review and actor network theory, I developed a hypothesis that the FDA is shifting towards deregulation. Through minute changes made over the last three decades of presidential administrations, the United States has reduced the burden of work to enhance efficiency and improve the rate of American medical innovation. One specific example is the 510(k) pathway for premarket review, which allows the previous approval of existing devices to grandfather similar new ones. While these changes are often lauded by supporters as promoting innovation and efficiency, they introduce potential risks, as devices cleared through less rigorous pathways have been associated with a disproportionate number of recalls. This trend suggests a redistribution of responsibility, where safety assurance is increasingly embedded within manufacturing practices rather than centralized regulatory review. As I look toward my future as a medical device product development engineer, this experience has reshaped my understanding of the engineer’s role in the medical device lifecycle. In a regulatory environment that continues to shift towards decentralized regulation, engineers must take a more active role in upholding patient and user safety standards. Ultimately, protecting public health cannot rest solely on regulatory agencies or industry alone, but must be a collaborative effort, where thoughtful design, rigorous testing, and effective oversight work together to ensure that innovation does not come at the expense of patient safety.

BS (Bachelor of Science)

soft tissue; medical device; endoscope; carpal tunnel; FDA; surgical device; regulation

English

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

2026-05-06