Duke is uniquely equipped to train the next generation of designers and leaders
The market for medical devices worldwide is growing fast. In the United States alone, the MedTech industry is growing $7 billion a year.
Few universities are as uniquely equipped as Duke to deliver best-in-class master's-level training in medical technology design. Learn why Duke is a leader in MedTech design
Duke BME offers two options for MedTech design training:
"Duke's advanced biomedical design courses not only reminded me of the impact engineering can have, but inspired me to continue to combine engineering and medicine."
ALEJANDRO PINO, MD | Pulmonologist and ELECTRICAL ENGINEER
3 Reasons Why Duke leads in MedTech design
1. Innovation is in our DNA
- First accredited BME major in the United States
- First real-time 3-D ultrasonic scanner
- First patented bioabsorbable vascular stent
2. Our faculty's decades of real-world experience
- Best practices in design, from needs-finding to prototyping to development
- Obtaining regulatory approval and licensing
- Creating curricula and courses aligned to industry needs
3. Our students work on real-world design challenges
- MedTech track students team with Duke Health clinicians
- Student teams have the real possibility of making real impacts
- At job interviews, our graduates have those all-important, real-life stories to tell
Listen to just one of those stories—
Master's Degree Track
The Medical Technology Design Track within Duke BME's Master of Engineering (MEng) degree program prepares our students for industry leadership. The track is noted on your transcript.
An intensive track of courses provides deep exposure to all phases of medical product development—from needs-finding to product launch.
You'll also take:
- Business and management courses
- A required course in advanced mathematics and another in a life science topic
- A required internship
How to Start the Track
You must first apply to Duke BME's Master of Engineering program. More about our Master of Engineering degree »
Sample Course Schedule
Fall 1 Spring 1 Summer 1 Fall 2 Skills Sequence BME 790L.X: Advanced Design and Manufacturing BME 790L.X: Medical Electrical Equipment Design Health Sequence BME 790L.X: Design in Health Care 1—Discover BME 790L.X: Design in Health Care 2—Design BME 790L.X: Design in Health Care 3—Deploy Business and Management Courses MENG 540: Business Fundamentals BME 590: Quality Management for Biomedical Engineers MENG 540: Management in High-Tech Industries Required Math and Life Science Courses Advanced Math course Life Science course Required Internship MENG 550: Internship Planning MENG: 550 Internship MENG 551: Internship Assessment
This four-course graduate certificate in medical device design provides exposure to MedTech design fundamentals. The certificate is noted on your Duke transcript.
This certificate program is open to students enrolled in Duke BME's master's degree programs:
The four (4) MedTech courses that fulfill this graduate certificate provide 12 of the 30 course credits required to complete a Duke BME master's degree:
- Advanced Design and Manufacturing, or Medical Electrical Equipment
- Design in Health Care 1, or Design in Health Care 3
- Design in Health Care 2
- Quality Management Systems
How to Start the Certificate
Apply to the certificate program during your first semester at Duke. The certificate is completed during your second and third semesters.
But first, apply to a Duke BME master's program. More about our master's degrees »
Paul J. Fearis
Associate Professor of the Practice of Biomedical Engineering
An engineer and industrial designer with decades of experience as a product development consultant to the medical device industry and lecturer at Johns Hopkins University. More »
A biomedical engineer who has managed R&D teams at Medtronic and Edwards Lifesciences who is a specialist in quality management systems and product commercialization. Certified ASQ Quality Manager and Auditor. More »
Joseph A. Knight
He is president & CEO of InnAVasc Medical Inc., a biomedical engineer, and an MBA graduate of Duke's Fuqua School of Business. More »
Eric S. Richardson
Associate Professor of the Practice of Biomedical Engineering
A biomedical engineer who has managed R&D teams at Medtronic and the founder of two innovation programs at Rice University. More »
- Advanced Design and Manufacturing
This course is designed to bring the practical application of academic engineering to medical design while developing design skills that can be immediately transferred to industry projects—making students attractive prospects to industry recruiters.
The skills course establishes a mindset and set of practical skills that form a foundation for the Design Health sequences. Students also start to build a portfolio of design projects to showcase their design thinking.
Through a series of modules, the skills course introduces Design for Manufacture and important concepts around production cost and the interplay between design choices, manufacturing processes and cost. Medical image reconstruction and the design of an implanted device take students inside the body, designing for specific anatomy and bio-compatibility.
The Duke skills course is supported by industry leader Protolabs, and the program is hugely grateful for their input and assistance in readying students for careers in design and development.
- Medical Electrical Equipment
- This course will make students aware of the design process and considerations associated with electronics and software functionality in medical devices. Electronic hardware topics will include microcontrollers, data communication protocols (e.g., SPI, I2C, Bluetooth, WiFi, Zigbee), power supplies, analog and digital signal management, UI/UX for input/output, electronic signal transduction, heat management, PCB layout and fabrication, and cabling and connectors.
Software topics will include firmware, server/client communications, Restful APIs, HIPAA, data privacy, cybersecurity, encryption, software development process, continuous integration/deployment, version control systems, and AI-assisted algorithms. The Verification & Validation process for hardware and software will be reviewed, along with relevant industry standards (eg, IEC60601, IEC62304).
- Design in Health Care 1—Discover
This course concentrates upon the identification of medical device innovation opportunities through the detailed identification and analysis of unmet, underserved and unarticulated stakeholder needs. Students work closely with clinical staff from Duke Health and other clinical experts to identify needs through primary qualitative research including first-hand observation, stakeholder interviews and other secondary processes.
Utilizing industry best-practice techniques captured in the Insight Informed Innovation process students take a broad area of focus and work with clinicians, engineering and business faculty to focus, identify and specify impactful opportunities that will become the basis of design projects take forward in the Design in Healthcare 2–Design course.
Students define their projects, considering clinical impact, regulatory and reimbursement strategy, technical feasibility and interest with an eye to the generation of intellectual property, licensing and/or startup opportunities.
- Design in Health Care 2—Design
In this course, teams take a validated problem from Design in Healthcare 1—Discovery, and then generate broad ranges of solutions, iterate, and mature toward proof of principle and proof of (market) concept prototypes.
Students work in multidisciplinary teams, representative of industry team make-up, including clinical, engineering and business functions to develop engineering solutions, business plans and supporting regulatory documentation as would be required in industry.
Design in Healthcare 2 draws heavily upon the Skills and Quality courses, training students to consider product development as a holistic process where decisions are complex and interrelated.
The course is taught by industry veterans who maintain active industry roles and projects in order to stay current and relevant.
- Design in Health Care 3—Deploy
This course progresses a group of active projects from Design in Health Care 2—Design, and other sources, to a level of maturity appropriate for the consideration of licensing and/or startup opportunities.
Largely self-guided, student teams apply risk management and other practices to eliminate unknowns, and generate supporting performance and usability data and investor pitches.
Interaction with Duke Engineering Entrepreneurship (EngEn) and Duke's licensing and venture functions brings a sharp focus to projects—exposing students to the realities of the medical device business today.
- Quality Management for Biomedical Engineers
Quality Management Systems (QMS) form the backbone of medical device companies, from specification through development to regulatory submission and commercial launch, medical device designers must be comfortable working with and producing a broad spectrum of supporting documentation.
Using projects from the Design in Health Care courses as the active vehicle, this course introduces students to the workings of industry quality management systems and standards adherence.
Students generate QMS documentation to support development, risk management, design controls and regulatory submissions.
The course is taught by an American Society of Quality-certified Quality Manager and Quality Auditor and equips students with up-to-date practices designed to make the transition into a regulated industry seamless.
- MedTech Business Fundamentals
After an introduction to the broader landscape of healthcare innovation (including BioTech, MedTech, and Pharma), the course provides a high-level introduction to the key non-technical areas to consider when bringing forward a medical device—including regulatory, reimbursement, business model, funding, sales, and marketing.
The focus is not only on a basic understanding of each area but also on the interplay between and among each. The course concludes with an exploration of finance-related topics where students learn the importance and application of financial statements to medical device innovation, as well as various methods of how a MedTech company is ultimately valued at acquisition.
- Management of High-Tech Industries
This course addresses critical qualities of leadership, management skills, and decision-making in complex environments.
Essential topics include:
- Leadership and communication principles
- Strategic decision-making where outcomes depend on high technology
- Management of project-based and team-based organizational structures
- Role of the manager in expertise-driven organizations