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\def\secNum{{"001",""}}
\def\tenSchFileName{{"",""}}
\def\classTime{{"Thursdays from 08:30 am to 11:00 am in Tolentine Hall 409.",""}}
\def\classRm{{"Tolentine Hall 309",""}}
\def\classLive{{"",""}}
\def\classInstructor{{"Edward A. Berde",""}}
\def\classInstrContact{{"https://www1.villanova.edu/university/engineering/academic-programs/departments/electrical-computer/directory.html",""}}
\def\classInstrOffHrs{{"Thursday from 11:00 am to 3:00 pm",""}}
\def\classInstrLive{{"",""}}
\def\labTime{{"Thursdays from 08:30 am to 11:00 am in Tolentine Hall 409.",""}}
\def\labRm{{"Tolentine Hall 309",""}}
\def\labLive{{"",""}}
\def\labInstructor{{"Edward A. Berde",""}}
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\newcommand\semester{Fall 2025}
\newcommand\rsemester{202620}
\newcommand\courseNum{ECE 5900}
\newcommand\courseName{TOP:Medical Device Technology Lecture/Lab}
\newcommand\courseCoordinator{Edward A. Berde}
\newcommand\credits{3}
\newcommand\contactHrs{3}
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\newcommand\meetingDesc{2.5-hour Lecture/Lab Session}
\newcommand\meetingMisc{Special notes on meeting info go here, if specified}
\newcommand\instructorMisc{Special notes on instructor(s), TA(s) go here, if specified}
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\newcommand\supplMaterials{\url{https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process}; 
\url{https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k}; 
\url{https://www.amazon.com/Play-Bigger-Dreamers-Innovators-Dominate/dp/0062407619}; 
\url{https://www.amazon.com/Hard-Thing-About-Things-Building/dp/0062273205}; 
\url{https://www.espressif.com/sites/default/files/documentation/esp32_datasheet_en.pdf}; 
\url{https://www.espressif.com/sites/default/files/documentation/esp32_technical_reference_manual_en.pdf}}
\newcommand\refPapers{}
\newcommand\textBookMisc{Special notes on textbook(s) go here, if specified}
\newcommand\catalogDesc{Addresses a special topic in electrical and/or computer engineering of interest to faculty and students.}
\newcommand\preReqs{None}
\newcommand\coReqs{None}
\newcommand\coreRequirement{N/A}
\newcommand\courseExpectation{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.}
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\newcommand\covTopics{\item Introduction to Health Technology Devices
\item Design Considerations for Medical Devices
\item Microcontroller-Based Applications in Health Technology
\item Sensor Technologies for Healthcare Monitoring
\item Wireless Communication Protocols for Health Tech Devices
\item Data Capture and Transmission in the Medical Industry
\item Medical Data Security and Encryption Requirements
\item HIPAA Compliance and Penalties
\item Introduction to Medical Databases and Cloud-Based Medical Data Storage
\item Health Tech Startups and Entrepreneurial Concepts
\item FDA Regulations for Medical Device Manufacturers
\item Medical Device Design, Development, and Testing
\item Ethics and Risks in Health Tech Device Development
\item Clinical Studies, Consenting, and Institutional Review Boards
\item Market Analysis and Product Features Design
\item Business Models and Sales Strategies
\item Non-Dilutive Grants, VC Funding, and Alternate Investment Sources for Health Tech Startups}
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\newcommand\schedule{\begin{table}[h!] \centering 
\caption*{Tentative Schedule for \textbf{All Sections}} \vspace{0.05in}
{\renewcommand{\arraystretch}{1.5} \small
\begin{tabularx}{\linewidth}{c|X|X}
\toprule
\large \textbf{Week} & \large \textbf{Lecture Series} & \large \textbf{Lab Series}\\
\midrule \midrule
1 & Introduction to Health Tech Devices & Introduction to Microcontrollers for Health Technologies\\
2 & Overview of the Health Tech Industry & Sensor Integration\\
3 & Design Considerations for Medical Devices & Wireless Communication: Transmitting Data via Bluetooth\\
4 & Microcontroller Basics and Applications in Health Tech & Data Logging: Storing Sensor Data\\
5 & Sensor Technologies in Healthcare Monitoring & Data Transmission\\
6 & Wireless Communication Protocols for Health Tech Devices & HIPAA-Compliant Database Design\\
7 & Data Capture and Transmission in the Medical Industry & Database Integration: Storing Sensor Data in the Cloud\\
8 & Security and Encryption for Medical Data & Implementing Data Encryption\\
9 & HIPAA Compliance in Health Tech & User Interface Development for Health Tech Devices\\
10 & Introduction to Medical Databases and Cloud-Based Storage & Real-Time Monitoring\\
11 & Entrepreneurial Concepts in Health Tech and the Medical Industry & Building Web Portals for Healthcare\\
12 & FDA Regulations for Medical Device Manufacturers & Integration to EMR/EHR Systems\\
13 & Ethics and Risk Management in Health Tech Devices & Implementing Alerts for Abnormal Data Readings\\
14 & Prototyping and Testing Health Tech Devices & Generating Reports from Patient Data\\
15 & Market Analysis and Product Positioning & Final Project: Medical Device Design\\
16 & Business Model Analysis and Health Tech Entrepreneurship & Final Project: Medical Device Build\\
17 & Funding and Investment Strategies for Health Tech Startups & Final Project: Medical Device Presentation\\
\bottomrule \end{tabularx} } \end{table}}
\newcommand\gradingPolicy{Letter grade scale: A(93--100), A--(90--92), B+(87--89), B(83--86), B--(80--82), C+(77--79), C(73--76), C--(70--72), D+(67--69), D(63--66), D--(60--62), F(<60)}
\newcommand\HWandLabPolicy{Homework is assigned weekly and is due in one week. Late homework is accepted with the permission of instructor only. There is 25\% penalty for late homework. Grades are reviewable up to a week after graded work is returned.}
\newcommand\AIPolicy{\textcolor{red}{
Since you opted for an AI Policy, you should edit this part, choosing one of the following statements, modifying as desired:\\
\\
The use of AI-generated content is not permitted in this course.
Its use will result in an academic integrity violation and a zero on the assignment.\\
\\
OR\\
\\
The use of AI-generated content is allowed in this course.\\
\\
OR\\
\\
The use of AI-generated content is permitted as follows: (a) for generating a first draft or (b) for generating an outline or (c) for generating XXX.\\
\\
AND, if AI is allowed:\\
\\
Even if you have significantly edited AI-generated material, you must identify the AI tool used to assist in generating your work. You are required to provide the name of the tool, date used, and prompts used to generate the output.  As you may be required to submit the original AI output, you must keep a copy of the original output and provide it when requested.  If questions arise about the authorship of submitted work, you are responsible for authenticating your authorship.  You should save evidence of your authorial process, such as drafts, notes, version histories, and complete transcripts of AI assistance.
}}
\newcommand\AttendancePolicy{The full version of the official Villanova class attendance policy is posted at \url{https://live-villanova-catalog.cleancatalog.io/class-attendance}, but the main points are as follows.
Attendance is required.
Whenever possible, students should inform the instructor if they plan to be late or absent from
class. In all cases, documentation is required to petition for excused absences to the Associate Dean
for Student and Strategic Programs, Dr. Stephen Jones. The excused absence form is posted at:
\url{https://forms.office.com/r/H2kbHKLUmw}.
Excused absences do not count towards a failure in the course for first year students. Absence
from class does not release the student from assigned work. Students who miss an in-class obligation
such as an exam, a presentation, etc., due to an excused absence will not be penalized - the instructor
may offer a make-up test, arrange an alternative time for a presentation, exempt a student from
the assignment, or provide another arrangement. In the case of illness or injury, the form must
be submitted within 24 hours of missing a class. The University’s list of excused absences for all
students includes the following:
1. Participation in NCAA athletic competitions
2. Participation in special academic events such as: conferences, field trips, project competitions,
etc., and in official university business such as student representatives attending meetings
related to university governance
3. Attendance at significant events of the immediate family such as: funerals, weddings, etc.
4. Religious holidays - see the University’s policy on Religious Holidays
5. College-approved participation in placement activities such as: job interviews, graduate school
interviews, job fairs
6. Legally required absence such as: jury duty, court appearance, short-term military service
7. Documented serious illness or disability}
\newcommand\ElectronicsPolicy{\textcolor{red}{Since you opted for a customize electronics policy, you should edit this part. Your policy should address your general stance on recording of class sessions and the circumstances under which recording will be allowed or prohibited. If you generally prohibit recording, yet allow recording of certain classes for some reason, then ypu should notify all students that those classes will be recorded. If recording is permitted as an ADA accommodation for a student, you obviously should not identify that student(s).)}}
