Prototyping A Novel Foot And Ankle External Fixator To Improve Rehabilitation Outcomes In Patients Following Closed Reduction; Innovation in the Waiting Room: Institutions and Operations That Impede Effective Implementation of New Medical Treatments

According to a 2020 survey, 85% of companies had plans to raise their investment in patient-centric capabilities over the next 18 months (Meskó MD, PhD & deBronkart SB, 2022, pg. 2). Yet, it can be challenged whether innovation through a patient-centric approach is actually being achieved. Standards of care still fail in many ways to address practical needs that would allow for effective and equitable recovery across diverse populations. Much of the design process remains with engineers, company executives, and members of healthcare organizations (Meskó MD, PhD & deBronkart SB, 2022, pg. 2-3). Current medical design processes prevent care options from addressing the needs of all patients in the most impactful way, either because practical concerns like the ability to return to work (RTW) are not being addressed or designs meet other institutional barriers in the development and implementation stages. Therefore, through my final technical and sociotechnical projects, I designed a device to address an overlooked patient need while examining how innovative technology transfer can be obstructed by certain barriers in the healthcare system.
Current treatment options for ankle fractures have various limitations. Surgical complications include infection and scarring while non-invasive methods like casting can cause discomfort and limit range of motion. Patients express the frustration of regaining normal mobility, loss of independence, pain, sleep disturbance, and low mood during the healing phase (McKeown et al., 2020, pg. 3-8). My technical project aimed to design an external fixator for ankle fractures that incorporates micromovements following closed reduction, as previous research on wrist fractures demonstrates movement at the fracture site during healing contributes to faster recovery through preservation of fracture biology (Bajwa et al., 2015, pg. 4). My team identified elderly females as a primary patient population and utilized average female foot measurements to develop a sex-specific design for our first iteration of the fixator. We created and assembled the fixator in CAD, with structural analysis reporting that our design can withstand 20% body weight. A 3D-printed visual prototype was generated. Based on the present testing, further development of the fixator shows promise in improving range of motion, advancing recovery, and providing greater comfort to patients through breathability and the use of waterproof materials.
However, my experience in the medical device industry and clinical settings has revealed to me that even excellent designs may fail to ever make it to market. Therefore, as I went through the motions of designing my own medical device, my sociotechnical research aimed to identify some of the barriers to device implementation. In applying Pacey’s Triangle to define technology as a technical, organizational, and cultural entity, I evaluated the interconnection of medical devices with various institutional and individual stakeholders in the American healthcare system. Citing case studies, government databases, and qualitative observation and interviews, I make the argument that interactions between insurance companies, medical device companies, and physicians often bar innovative medicine from the larger patient population. Given the current approach to design and development, it is not patients but rather insurance policies, engineers, government regulators, and physicians that directly dictate whether the technology is to ever exist or be distributed.
Through both my technical design and sociotechnical thesis, I embraced the concept of patient-centric care. My technical project successfully contributes to addressing the complications experienced and complaints expressed by patients during ankle fracture recovery. My sociotechnical work identified insurance companies and physician priority in medical device development to be significant barriers to innovation that could otherwise provide betterment to patient outcomes. The question to remain and which engineers, physicians, patients, and other relevant stakeholders must collaborate in addressing is how patient-centric design and equitable innovation can complement or successfully overcome the broader institutional structures of the American healthcare system. I believe that further vocalizing the importance of patient centricity while simultaneously designing with institutional blockades to overcome in mind will eventually allow novel ideas to reach the people who truly need them.
I’d like to thank my fellow Capstone team members Brynn Earl and Remy Brettell for their collaboration on our technical project, along with advisors Dr Ali Bajwa and Isi Azeke for providing the opportunity to design through Cambridge Orthopaedic Labs. I am grateful for the Capstone graduate teaching assistants who provided feedback throughout my team’s technical work. Thank you to my sociotechnical professors William Davis and Dr Caitlin Wylie for guiding me through the writing process so that an issue I had for years witnessed can now be put into words.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Dr Ali Bajwa and Isi Azeke
STS Advisor: Caitlin Wylie
Technical Team Members: Brynn Earl, Remy Brettell