Twin Cities campus

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Twin Cities Campus

Medical Device Innovation M.S.

Technological Leadership Institute
College of Science and Engineering
Link to a list of faculty for this program.
Contact Information
Technological Leadership Institute, College of Science and Engineering, University of Minnesota, Suite 290 McNamara Alumni Center, 200 Oak Street SE, Minneapolis MN 55455 Phone: 612-624-5747 Fax: 612- 624-7510
Email: tli@umn.edu
Website: https://cse.umn.edu/tli
  • Program Type: Master's
  • Requirements for this program are current for Fall 2024
  • Length of program in credits: 31
  • This program does not require summer semesters for timely completion.
  • Degree: Master of Science
Along with the program-specific requirements listed below, please read the General Information section of this website for requirements that apply to all major fields.
The Medical Device Innovations master of science degree is an interdisciplinary program comprising courses in the core areas of technology innovation management and medical industry dynamics. Students’ experiences are enhanced through therapeutic-area-based group activities and hands-on experiences in innovative biodesign through practicums at the Medical Devices Center. The 21-month program draws upon the fields of technology innovation, product development, project and business management, intellectual property, regulatory affairs, clinical needs, entrepreneurship, emerging trends, globalization, reimbursement, and public policy. This program provides students with a full understanding of medical device innovation from start to finish. In doing so, it goes well beyond the traditional technology focus of most master's programs.
Program Delivery
  • via classroom (the majority of instruction is face-to-face)
Prerequisites for Admission
The preferred undergraduate GPA for admittance to the program is 3.00.
A bachelor's degree in a related field, such as biological or physical sciences, engineering, computer science, mathematics, statistics, or business.
Other requirements to be completed before admission:
A strong background in science, engineering, and math is preferred.
Special Application Requirements:
Applications are accepted on a rolling basis for the program's start in fall of each year. The following are accepted as proof of English language proficiency: - PTE Academic: minimum score for admission is 65 - Duolingo: overall score 120 and above, literacy score 120 and above
International applicants must submit score(s) from one of the following tests:
  • TOEFL
    • Internet Based - Total Score: 90
    • Internet Based - Writing Score: 21
    • Internet Based - Reading Score: 19
  • IELTS
    • Total Score: 7.0
The preferred English language test is Test of English as Foreign Language.
Key to test abbreviations (TOEFL, IELTS).
For an online application or for more information about graduate education admissions, see the General Information section of this website.
Program Requirements
Plan B: Plan B requires 31 major credits and 0 credits outside the major. The final exam is written and oral. A capstone project is required.
Capstone Project:The capstone project is independent, original, and applied research on a relevant subject, problem, or issue in areas of medical device technologies, policy, business, or innovation. The capstone project is rooted in real-world topics in the industry, and is usually framed in cooperation with the student’s organization or employer.
Plan C: Plan C requires 31 major credits and 0 credits outside the major. There is no final exam.
This program may be completed with a minor.
Use of 4xxx courses towards program requirements is not permitted.
A minimum GPA of 3.00 is required for students to remain in good standing.
Courses offered on both the A-F and S/N grading basis must be taken A-F.
Core Courses (29 credits)
Take the following courses:
MDI 5004 - Clinical Foundations of Medical Device Innovation (3.0 cr)
MDI 5008 - Quality, Regulatory and Operations Management (3.0 cr)
MDI 5010 - Product Innovation & Development Management (2.0 cr)
MDI 5013 - Biodesign Practicum I (2.0 cr)
MDI 5014 - Biodesign Practicum II (2.0 cr)
MDI 5015 - Biodesign Practicum III (2.0 cr)
MDI 5101 - Introduction to Medical Device Cybersecurity (3.0 cr)
MOT 5010 - Enhancing Technology Leadership Skills (2.0 cr)
MOT 5011 - Creating a High Performing Technology Organization (2.0 cr)
MOT 5012 - Understanding Technology of the Future (2.0 cr)
MOT 5013 - Leading the Business of Technology (2.0 cr)
MOT 8133 - Managerial Communication for Technological Leaders: Persuasive Writing and Speaking (2.0 cr)
MOT 8214 - Technology Foresight and Forecasting (2.0 cr)
Plan Options
Plan B
Capstone Project (2 credits)
Take 2 credits of the following in consultation with the advisor:
MDI 5020 - Medical Device Innovation Capstone (1.0-2.0 cr)
-OR-
Plan C
Project Coursework (2 credits)
Complete a 2 credit class-based project guided by the instructor.
MDI 5060 - MDI Independent Study (1.0-3.0 cr)
 
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MDI 5004 - Clinical Foundations of Medical Device Innovation
Credits: 3.0 [max 3.0]
Grading Basis: A-F only
Typically offered: Every Fall, Spring & Summer
Master essential topics to deepen knowledge of Clinical Environment in which products will be conceived, tested, used. Topics include surgical protocols, physician, surgeon, nursing, technical support functions. Medical terminology, anatomy/physiology, ethnology research, Healthcare Law, Medicare/Medicaid, HIPAA requirements. prereq: MDI grad student. Non-MDI graduate students and non-degree graduate students may register for this course with permission of the MDI program.
MDI 5008 - Quality, Regulatory and Operations Management
Credits: 3.0 [max 3.0]
Grading Basis: A-F only
Typically offered: Every Fall, Spring & Summer
Course provides students with understanding of the global regulatory environment in which the medical device industry operates. Students gain a fundamental understanding of critical quality systems regulations including ISO13485/ISO14971 and their relationship to the FDA's cGMP regulations. Students gain practical experience using tools that are essential to both product development and continuation/sustaining engineering including; design control procedures, FMEA, verification and validation, internal and external (supplier) management and audit methods. prereq: MDI graduate student only
MDI 5010 - Product Innovation & Development Management
Credits: 2.0 [max 3.0]
Grading Basis: A-F only
Typically offered: Every Spring
Framework for conceptualization, design, development, commercialization process for medical products. Survey of key steps in innovation, from engineering/business perspective. Cross-functional development of concepts/processes. prereq: Grad MDI student. Non-MDI graduate students and non-degree graduate students may register for this course with permission of the MDI program.
MDI 5013 - Biodesign Practicum I
Credits: 2.0 [max 2.0]
Grading Basis: A-F only
Typically offered: Every Fall, Spring & Summer
First of three part series of practicum courses for MDI program. Focus on teaching innovation steps/process using known/pre-assigned clinical needs as examples in collaboration with Medical Device Center. Essential steps in BioDesign process. Apply knowledge to specific real-world examples. prereq: Grad MDI student
MDI 5014 - Biodesign Practicum II
Credits: 2.0 [max 2.0]
Grading Basis: A-F only
Typically offered: Every Fall, Spring & Summer
Second of three part series of practicum courses for MDI program. Clinical environment, including research tools/methods, filtering/translating needs, ideation/prototype development, communication with functional managers, corporate executives/investors. prereq: Grad MDI student
MDI 5015 - Biodesign Practicum III
Credits: 2.0 [max 2.0]
Grading Basis: A-F only
Typically offered: Every Spring
Medical Device Innovation Practicum III is the third of a three part series. Students will gain a high-level understanding of essential steps in the BioDesign process related to ideation. The steps of the ideation process will include brainstorming and prototyping of potential solutions, risk assessment, and business strategy development. Students will prepare and present a technical evaluation that articulates the value of their new technology or device to functional managers, corporate executives, and/or investors. prereq: Grad MDI student
MDI 5101 - Introduction to Medical Device Cybersecurity
Credits: 3.0 [max 3.0]
Grading Basis: A-F or Aud
Typically offered: Every Fall & Spring
The course will introduce the student to all the security-specific activities needed to meet regulatory and customer expectations across the medical device lifecycle. Emphasis on security testing and post-market vulnerability management are essential goals of the course. The intended audience is graduate students, upper-class undergraduate students, and working professionals.
MOT 5010 - Enhancing Technology Leadership Skills
Credits: 2.0 [max 2.0]
Typically offered: Every Fall
This course focuses on preparing students to be leaders in the technology industry ? with a focus on understanding their personal values, emotional intelligence strengths and challenges, business and technical communication, persuasion, personal management, and impact. Critically important to success is demonstrating executive presence and gravitas when dealing with all levels of the organization ? staff, leaders, and customers. Organizations, team responsibilities, and roles are constantly evolving, and it is up to savvy technology leaders to be future-focused ? anticipating and understanding what the organization needs today ? and what it will need to grow, and change driven by the business strategies. A technology leader must be a strategic thought leader, a catalyst for change, and think through innovative and values-driven strategies for their work and their organizations.
MOT 5011 - Creating a High Performing Technology Organization
Credits: 2.0 [max 2.0]
Typically offered: Every Fall
This course will provide the student with a blueprint for creating and maintaining a technical workforce that is high-performing and diverse, helping students become technical leaders that can effectively lead a transformation to support business strategies. This course will provide the tools and context to ensure the technology leader is creating and sustaining a culture of innovation, accountability, and creativity.
MOT 5012 - Understanding Technology of the Future
Credits: 2.0 [max 2.0]
Typically offered: Every Spring
This course is designed to give students knowledge and skills necessary to be successful technology leaders in a variety of business settings and industries. Technology leadership begins with the understanding of what new and innovative technologies are being developed around them. But it is also important for leaders to be able to understand if those technologies are relevant and important for their business. Technology leaders need to work collaboratively with other business leaders to ensure new technologies are grounded in business strategies and understand what the company can leverage
MOT 5013 - Leading the Business of Technology
Credits: 2.0 [max 2.0]
Typically offered: Every Spring
This course is designed for people with a basic understanding of business principles in a technical setting and are looking to progress toward being a technology leader. This course will bring together knowledge and skills necessary to be a leader in budget, legal, pricing, marketing, and finance facets, strategies, and formulation, and consider portfolio management and business governance on a foundational level. There will be lecture and hands-on components.
MOT 8133 - Managerial Communication for Technological Leaders: Persuasive Writing and Speaking
Credits: 2.0 [max 2.0]
Grading Basis: A-F or Aud
Typically offered: Every Fall & Spring
Oral and written communication. Introductory and specialized workshops on topics such as presentation skills, memo and report writing, listening skills, and visual aid design and integration. prereq: Grad MOT major
MOT 8214 - Technology Foresight and Forecasting
Credits: 2.0 [max 2.0]
Grading Basis: A-F only
Typically offered: Every Fall
Fundamental definitions, understanding, and dynamics of technology from several perspectives, including science, engineering, and society. Introduces and applies tools and concepts for critical decision-making in engineering, research, and technology strategy. Topics include the analysis and forecasting of technology, the development of product and technology roadmaps, and how to identify new technologies that are relevant to the company or organization. prereq: Grad MOT major
MDI 5020 - Medical Device Innovation Capstone
Credits: 1.0 -2.0 [max 2.0]
Grading Basis: A-F only
Typically offered: Every Spring & Summer
The MDI capstone is an independent, original, and applied investigation on a relevant subject, problem, or issue in areas of medical device technologies, policy, business, and innovation. All students in the MDI program are required to complete a capstone project as part of the program. Registration is open to MDI students only.
MDI 5060 - MDI Independent Study
Credits: 1.0 -3.0 [max 3.0]
Grading Basis: A-F only
Typically offered: Periodic Fall, Spring & Summer
Independent study in MDI-related topic. prereq: MDI grad student