Medical Device Innovation Curriculum
Master the Medical Device Industry
The Technological Leadership Institute's M.S. in Medical Device Innovation (MDI) curriculum offers career-driven, technology-oriented individuals the tools and connections to master end-to-end medical device commercialization.
The Medical Device Innovation (MDI) curriculum follows a 30-credit degree program in technology innovation management, medical device innovation practicum, medical technology macro environments, and a capstone. Students meet on average two to three nights per week with a practicum course on occasional Saturdays, completing the program in just 21 months.
2-3 evenings per week
In-person
30 Credits
Rigorous Core Curriculum
Personalized Career and Academic Advising
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Term 1 - Fall
MDI 5004 Clinical Foundations of Medical Device Innovation (3 credits)
Become effective in clinical environments by gaining knowledge regarding surgical protocols; physician, surgeon, nursing and technical support functions; medical terminology, anatomy and physiology; ethnology research; healthcare law; Medicare/Medicaid; and HIPAA requirements.
MDI 5010 Product Development and Innovation Management (2 credits)
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.
MOT 5009 Communication for Technology Leaders (2 credits)
In the rapidly evolving domain of technology, effective communication stands paramount for technological leaders. This course focuses on developing foundational and advanced communication strategies, underscoring the importance of clear, impactful, and influential communication. Recognizing the myriad challenges and nuances of communicating in a technological environment—from risk assessment to executive decision-making—the curriculum provides a holistic exploration of theories, practices, and real-world applications. Through a combination of case studies, hands-on exercises, theoretical insights, and practical application, students will be equipped to navigate various communication scenarios as they prepare to lead, influence, and drive success in diverse technological settings.
MOT 5012 Understanding Technology of the Future (2 credits)
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.
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Term 2 - Spring
MDI 5013 Medical Device Center Practicum I (2 credits)
Gain added focus on teaching innovation steps and processes using known clinical needs as examples in collaboration with the Medical Device Center.
MOT 5010 Enhancing Technology Leadership Skills (2 credits)
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 5013 Leading the Business of Technology (2 credits)
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 8214 Technology Foresight and Forecasting (2 credits)
Examination of tools and techniques for strategic foresight and forecasting of technology deliverables. Applies tools and concepts to critical decision-making for corporate and organizational strategy. Topics include technology analysis, dynamics, evolution, management and resource allocation.
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Term 3 - Fall
MDI 5008 Quality, Regulatory, and Operations Management (3 credits)
MDI 5008 is built on understanding and applying the Total Product Life Cycle (TPLC) and Product Development Stage Gate methodologies as they relate to the global quality and regulatory environment in which the medical device industry operates. This is a practicum-based course using authentic FDA and ISO requirements to prepare the real-world documents and reports that are associated with the development of medical devices through to commercialization (pre-market to post-market) and includes key Operations Management principles that translate to delivering the product to market. The framework of the course and materials studied focus on effectively navigating the regulatory labyrinth to bring new and novel medical devices to market.
MDI 5014 Medical Device Center Practicum II (2 credits)
Apply the skills learned in the first practicum through a clinical immersion at the University of Minnesota's Academic Health Center, which is in collaboration with the Medical Device Center.
MOT 5020 Capstone Workshop (0.5 credits)
The Capstone Workshop culminates a graduate student’s experience at TLI. Using concepts and methods learned throughout their course of study, students will identify a problem and opportunity to complete one of the following: an applied or hypothetical project, a technology analysis, or a start-up/business plan. Students will conduct primary research and secondary research and analyze resulting data to produce evidence-based, actionable recommendations. Based on project results, students will complete a written report and presentation.
MOT 5011 Creating a High-Performing Technology Organization (2 Credits)
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.
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Term 4 - Spring
MDI 5015 Medical Device Center Practicum III (2 credits)
Build on the skills and clinical experiences from the first practicums to develop a business model and turn innovation into a viable business proposition with exit strategies.
MDI 5101 Medical Device Cybersecurity (2 Credits)
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 5020 Capstone Workshop (1.5 credits)
The Capstone Workshop culminates a graduate student’s experience at TLI. Using concepts and methods learned throughout their course of study, students will identify a problem and opportunity to complete one of the following: an applied or hypothetical project, a technology analysis, or a start-up/business plan. Students will conduct primary research and secondary research and analyze resulting data to produce evidence-based, actionable recommendations. Based on project results, students will complete a written report and presentation.
Medical Device Innovation Capstone
Some examples of capstone projects are:
- “An Evaluation of Digital Therapeutics: Should MedTech Companies be Interested?”
- “The Application of Quality Assurance to Marketing Compliance for an International Medtech Startup”
- "Innovations in Ostomy Care: Minimizing Leakage and Enhancing Quality of Life"