Medical Technology Design (MedTech): Master's Degree and Certificate

Discover. Design. Deploy.

The global markets for medical devices is growing fast — by $7 billion a year in the United States alone, by one estimate.

Few universities are as equipped as Duke to deliver best-in-class graduate education in medical technology design. Learn why Duke is the leader

Duke BME offers two options in this exciting and high-impact field:

Contact admissions »

Alejandro Pino

"Duke's advanced medical technology design courses reminded me of the impact engineering can make."


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
Design imag of a 4-D ultrasonic scanner

2. Our faculty has 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 master's 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

Hear just one of those stories—

Master of Engineering Degree

Become a designer through intensive, hands-on experiences


The core of Duke's MedTech Design Master of Engineering is a carefully curated program of lockstep courses.

As they progress through a diverse series of projects, our master's students build strong, practical design skills.

In addition to design courses, you'll complete:

  • Core courses on management fundamentals for high-tech and MedTech design industries
  • A required course in advanced mathematics and another in a life science topic
  • A required internship

How to Get Started

Apply to this Duke Master of Engineering program. How to apply »

Sample Course Schedule

 Fall 1Spring 1Summer 1Fall 2
Skills SequenceBME 790L.X: Advanced Design and Manufacturing  BME 790L.X: Medical Electrical Equipment
Design Health SequenceBME 790L.X: Design in Health Care 1—DiscoverBME 790L.X: Design in Health Care 2—Design BME 790L.X: Design in Health Care 3—Deploy
Business and Management CoursesMENG 590: Business Fundamentals in MedTechBME 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 PlanningMENG: 550 InternshipMENG 551: Internship Assessment

 Browse course descriptions »

Graduate Certificate

The Duke graduate certificate in medical device design exposes students in other Duke BME master's programs to a four-course design skills sequence. Completion of the certificate is noted on your Duke transcript.

This certificate program is open to students in Duke BME master's degree programs in biomedical engineering:


The four (4) MedTech Design courses that fulfill this graduate certificate provide 12 of the 30 course credits required to complete a master's degree in BME at Duke:

  • 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

Browse course descriptions »

How to Start the Certificate

Apply to the certificate program during your first semester at Duke BME. The certificate is completed during your second and third semesters.

But first, apply to a Duke master's program in biomedical engineering. More about our master's degrees »


Paul J. Fearis

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 »

Kristy Fearis

Kristy Fearis


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

Joseph A. Knight

Adjunct Professor

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

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 »

Course Descriptions

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.

Business Fundamentals in MedTech

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