Electro-spun Poly-4-Hydroxybutyrate for Hernia Repair; Examining the FDA Medical Device Approval Process.

Medical devices and biotechnology have come a long way since the 1970’s when the US Food and Drug Administration (FDA) received authorization from Congress for the regulation of these devices. Unfortunately, the very FDA regulations responsible for keeping devices safe for consumer use have not changed much and their obsolescence causes an estimated 300,000 medical device related deaths and injuries each year. The socio-technical project examines how FDA medical device regulation, particularly the 510(k) clearance, can be overhauled to protect consumers and keep pace with the modern medical device industry. The technical project combines the two proven technologies of biomaterial Poly-4-hydroxybutyrate (P4HB) and the electrospinning scaffold generation method to create a hernia mesh that fills in the existing gaps in innovation. The technical and socio-technical projects are tightly coupled as hernia repair meshes are exclusively cleared through the flawed 510(k) premarket notification process. Additionally, several hernia repair meshes have been subject to FDA recall over the years due to their adverse effects on human health.
More than 20 million inguinal hernia repair surgeries are performed annually: a surgeon pushes the internal organ or body part back in and reinforces the muscle or tissue wall with hernia mesh. Despite being one of the most common surgeries and the advancements in hernia repair technology, 10-12% of patients still suffer from chronic pain after surgery and 11% have a recurrence within 10 years. To evaluate the feasibility of electrospun P4HB for use in humans, the technical project tested the infiltration of mouse myocytes within the material. This involved several rounds of cell culture of the mouse myocytes and material at varying degrees of alignment and then observing the viability and morphology of cells present on the material.
The technical project yielded a cell culture protocol for seeding myocytes on the electrospun material to ensure reliable and reproducible results. Additionally, a statistically significant difference in fiber alignment between the material hand stretched at varying degrees of unilateral strain was established. Cell morphology was unable to be calculated because the cells on the material were consistently dead after any period of incubation and thus had a viability of zero. While the current material does not support mouse myocyte life, the protocol was developed to drive future research forward as the project is handed off to Becton Dickinson (BD), the industry sponsor of the technical project. The technical project did not yield all the results BD was hoping for, but it has provided them with a sense of direction on where to take the research next and established a relationship between the company and the UVA Biomedical Engineering Department.
Two pathways exist for manufacturers seeking FDA authorization needed to bring their medical devices to market, the 510(k) premarket notification process and the premarket approval (PMA) process. Originally intended to allow updated versions of medical devices quick entry to the market, forgoing clinical trials and manufacturer inspections, the 510(k) provision has mutated into a loophole that device manufacturers exploit to have their dangerous and untested products brought to market. While the 510(k) premarket notification path certainly has its flaws, the major upside is the speed at which medical devices are approved. The idea is that patients are getting the latest and greatest treatment options as soon as possible. The socio-technical project examined the FDA’s 510(k) premarket notification process through an Actor Network lens and developed solutions to increase the safety and efficacy of medical devices for their end users.
The socio-technical research paper identified four avenues by which to improve the existing medical device regulation using Actor Network Theory, developed by Callon and Law in 1988, which serves to identify the key medical device actors and their relationships with one another that need to be altered to implement the solutions and ultimately bring a new level of safety and control to the medical device industry.
The overarching goal in both the technical and socio-technical projects is to improve the quality of patient care. Execution of the technical project has provided initial guidance to Becton Dickinson and the entire medical device industry on whether electrospun P4HB has the potential to be the next big thing in hernia repair mesh. Possible improvements to the FDA’s medical device regulation process identified through the socio-technical project, if implemented, will give patients greater peace of mind about the medical device, like a hernia mesh, being put in their body.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: George Christ
STS Advisor: Catherine Baritaud
Technical Team Members: Alexa Pass