Cryoballoon surgery at Duke University

Master's Certificate in Medical Device Design

Hands-on design experiences prepare you for a career in a growing industry

The need for effective, creative medical device designers is great. With roles spanning upstream marketing to R&D, medical device designers create the future.

Through the Certificate in Medical Device Design, Duke BME prepares master's students to be leaders in an industry which is expected to grow to $200 billion-plus in the US alone.

In close partnership with the Duke Design Health Program, our four-course certificate experience culminates in two advanced biomedical design courses. These courses feature intensive, need-driven, hands-on opportunities to work alongside clinicians from the Duke Health and beyond.

Our students gain strategic and programmatic thinking while working on real-world team projects

Courses are taught by seasoned industry veterans who possess deep understanding of how the industry operates and how projects progress to market.

We prepare students to a high level of career readiness, with a portfolio of applied design skills. Our students gain strategic and programmatic thinking while working on real-world team projects—which equips our graduates with those all-important stories to tell.

Important Notes

  • To work toward the certificate, students must apply, either prior to or during their first semester at Duke
  • The certificate accounts for 12 credits of the required 30 master's credits 
  • The program is open to Master of Engineering (MEng) and Master of Science (MS) students intending to pursue careers in the medical device industry

How to Apply


Student Team Startup Pitch Video

Students identify clinical problems, design solutions and develop concepts to a level at which licensing and other startup opportunities would be considered.



Faculty

Paul J Fearis

Paul J. Fearis

Senior Lecturing Fellow

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

Instructor

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 »

Alejandro Pino"Duke's advanced biomedical design courses not only reminded me of my love for engineering and the impact it can have on people, but inspired me to continue to combine engineering and medicine."

Alejandro Pino, MD
Electrical Engineer and Duke Pulmonology Fellow
Read an interview with Dr. Pino »

Courses

Students complete three required courses and at least one optional course.

Advanced Design and Prototyping Skills

Required

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 design projects that 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 takes 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.

Design in Health Care 1—Discover

Optional

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

Required

In this course, teams take a validated problems 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

Optional

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, 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

Required

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 make the transition to into a regulated industry seamless.


How to Apply

  1. Apply to a Duke BME master's degree program
  2. Indicate Certificate in Medical Device Design on your master's application