Development of a Dynamic Tensioning Ankle Brace for Chronic Ankle Instability; The Medical Network: An Analysis of the Factors Influencing Medical Prescriptions

In recent years, we have seen an unparalleled development in technology leading to new
manufacturing methods, complex computer aided design processes and extremely accurate data
collection. Despite this, innovation in the medical device industry has been hindered by intense
regulations and established distribution networks that are resistant to change. The US Food and
Drug Administration’s (FDA) regulations on devices make the development of these devices
costly and time consuming. On top of this, medical devices are dependent on approval from
physicians and insurance companies to achieve mass-scale distribution to patients. Extremely
innovative and effective devices have failed to prosper simply due to their inability to earn
physician loyalty. The combination of these factors has created a lack of device innovation in the
external bracing subsection of the medical device industry. The distribution of bracing devices in
the US is dominated by a small number of large corporations that have established physician
exclusivity to their products. The following technical thesis aims to address these issues by
introducing innovative processes for the design and manufacturing of bracing devices, while the
corresponding STS thesis examines the factors that are influencing physicians’ prescription
decisions in our healthcare system.

The technical thesis proposes an innovative ankle brace designed to treat chronic ankle
instability. The production of the device uses patient data obtained from a 3D scan of the ankle to
rapidly model a custom brace using computer aided design methods. The model is manufactured
using 3D printing technology that provides high cost efficiency and the potential for mass
scalability. Currently, the external bracing industry relies on manufacturing methods such as
injection molding for the production of rigid components, making custom braces time consuming
and expensive to manufacture. Due to this, bracing companies seeking mass distribution have
placed a focus on standard ‘off the shelf’ braces that provide less functionality and comfort to
patients. By establishing a methodology to produce custom braces just as efficiently as
non-custom ones, this technical project introduces the potential for extreme innovation in this
industry.

The STS thesis analyzes what factors contribute to the inconsistencies seen in the
treatment decisions of medical professionals. Medical device companies and insurance providers
are established as the major entities that have gained influence over the distribution of medical
devices in our healthcare system. These private entities hold control over the device production
and the financial coverage of devices, covering both sides of the distribution process. This thesis
examines the ways in which this network has affected the level of care provided to patients and
why the medical industry may be more profit driven than we believe.
Ultimately, both of these projects aim to improve the healthcare industry in our country
by introducing innovations in the external bracing sector, while also uncovering the factors
negatively impacting the level of care provided to patients. Both of these could become crucial to
establishing a healthcare industry that is truly focused on the treatment provided to those
suffering.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Timothy Allen
STS Advisor: Sean Ferguson
Technical Team Members: Andrew Quigley, Benjamin Scire, Evan Wendell, Daniel Carrier