Medical Device Design and Development

ABSTRACT

Medical device design is one of the fundamental pillars of the worldwide healthcare system. Engineers around the globe constantly work to create and innovate treatment options for increasingly complex diseases. In the US, heart disease and stroke make up two of the top five leading causes of death, and as such, are the focus of significant innovation. A multitude of treatment options currently exist, such as stents and thrombectomy devices, but new innovations are constantly required to ensure that the best patient outcomes can be achieved. This seminar will review the core concepts behind medical device design, the phases of design control associated with bringing a medical device from the drawing board to the operating room, and a few examples of different medical devices that are either in development or currently in use, with a particular focus on intravascular medical devices, such as stents and thrombectomy devices. Additionally, the seminar will include a summary of some common materials used in medical devices, with an emphasis on nitinol, a shape memory alloy that has increased the possibilities for complex geometries and shapes in medical device design.

BIOGRAPHY

Cory Zegel attended Stevens Institute of Technology, where he earned his bachelor's and master’s degrees in biomedical engineering in 2015. At Stevens, he performed research in both gene therapy and prosthetics labs, while also working at Wytech as a quality control analyst. Upon graduating, Cory began working at Becton Dickinson, where he performed test method development for self-administered injection systems. After, he joined Svelte Medical Systems to work on coronary stents and stent delivery systems. At Svelte, Cory quickly became a technical lead, managing the entirety of the design verification and validation testing for two coronary stent devices. Ultimately, Cory helped the company achieve FDA approval for both the SLENDER and DIRECT coronary stents. Cory now leads a team of eight engineers and five technicians at MDI, working on design, development, prototyping, and manufacturing for over 50 different medical devices. He specializes in bringing medical devices from concept to reality. He has written several patents, including designs for recapturable neurovascular stents, neurothrombectomy devices, and delivery systems for intravascular implants. At MDI, Cory is an expert in nitinol and puts his expertise to use in designing all manner of medical devices. With an ultimate goal of improving overall patient health, he has a passion for designing mechanical methods to treat some of the most problematic disease states.