Upon successful completion of this lecture/lab course, students will:
(a) be proficient in the design of medical devices with an understanding of considerations unique to the health-tech industry.
(b) understand and be able to implement basic and advanced microcontroller concepts, including Bluetooth, Wi-Fi, multi-threading, interrupts, and deep-sleep states.
(c) be familiar with various protocols used to interface with microcontrollers, including UARTs, SPIs, I2Cs, I2Ss, and low-level bit banging.
(d) be able to interface external components to microcontroller-based health-tech devices, including SD and eMMC-based memory, Pulse-Oximeter sensors, accelerometers, and RFID receivers.
(e) be able to design, build, test, and deploy a microcontroller-based health-tech device.
(f) understand concepts around medical data capture and transmission.
(g) understand concepts around medical databases, cloud-based storage, security, and encryption.
(h) understand concepts around HIPAA compliance, Protected Health Information, Personally Identifiable Information, Minimum Necessary Standard, Covered Entities, and Business Associate Agreements.
(i) understand the progression of Medical Technology Startups.
(j) understand FDA Medical Device Manufacturer Registrations and Medical Device Listings.
(k) understand internal controls necessary for FDA-Registered Device Manufacturers.
(l) understand the FDA 510(k) Process, Class I / II / III Risk Stratifications, De Novo Pathway, and 510(k) Exempt Pathway and Requirements.