Curriculum & Capstone

Curriculum

Product Development

• MDD401: Introduction to Product Development | 3 Units | Fall
  Provides an overview of the product development process and design controls embedded within. Emphasizes clinical/customer needs finding and screening using principles of the Biodesign process together with clinical exposure. Introduces elements of establishing a business case through market analysis, intellectual property, and reimbursement considerations. Case studies of medical devices and drug/device combination products illustrate the product life-cycle.

  Learning Outcomes

  • Describe medical device industry and product development lifecycle and deliverables
  • Compare modern product development methods
  • Describe design process and controls
  • Define human centered design
  • Describe basic IP and reimbursement strategies
  • Describe quality management systems and risk management
  • Evaluate impact of AI and digital health on product development
     

• MDD402: Advanced Product Development | 3 Units | Winter
  Builds on the Introduction to Product Development course and focuses 1) concept selection, 2) design, 3) prototype manufacturing, 4) initial testing, 5) iteration, and 6) product and process verification and validation activities. Introduces intellectual property considerations such as patents, trademarks, and trade secrets.  Covers US and OUS regulatory options and the design of clinical trials including treatment groups, control groups, and sample sizes.

  Learning Outcomes

  • Apply tools for concept selection and iteration
  • Specify design targets and performance metrics
  • Define human factors on design functionality and safety
  • Articulate industry risk-based testing approaches (FMECA)
  • Design validation methods to assess product performance
  • Apply US and OUS regulatory approval processes and clinical trial design considerations
     

• MDD403: Manufacturing Market Readiness | 3 Units | Spring
  Continues the Product Development Lifecycle and provides an overview of manufacturing readiness strategies employed in the medical device and life science industries including contract manufacturing.  Provides an overview of the tools utilized to reduce manufacturing waste and variation including Lean Six Sigma.  Describes the regulatory requirements for quality assurance through quality management systems.  Describes post market activities including complaint investigation and reporting, FMEA impacts, clinical trial support and closure, and product obsolescence.  

  Learning Outcomes

  • Define manufacturability and environmentally-conscious design
  • Apply common methodologies for quality assurance and waste reduction
  • Analyze, evaluate, and minimize risk
  • Describe industry practices for post-market surveillance and product support

Business Leadership

• MDD411: Introduction to Business Development and Planning | 3 Units | Fall
  Introductory overview of business planning philosophies. Introduces business ethics from consumer to corporate responsibility/integrity, market analysis through target consumers and demand, fundraising needs for financial backing, business finance principles and legal consideration (licensing, liability, patents). The focus is on taking an initial product introduction through an industry approach and the phases to start a product launch.

  Learning Outcomes

  • Explain fundamental marketing concepts (e.g., STP, 4Ps, product design, and consumer behavior)
  • Develop basic marketing plans and campaigns using research, data, and strategic decision-making
  • Develop basic marketing plans and campaigns using research, data, and strategic decision-making
  • Analyze workplace behavior and describe how this impacts productivity and culture
     

• MDD412: Business Management | 3 Units | Winter
  Broad overview of industry operations, engagement strategies, product marketing, project management and leadership. Introduces concepts on manufacturability, marketing to targeted clients/partners, developing project management tools and resources, and beginning team leadership principles. This focus is on the beginning design for manufacturing and usability for consistent manufacturability, managing risk and the people/resources needed.

  Learning Outcomes

  • Describe the innovation process from idea generation to implementation
  • Apply creative problem-solving techniques to create and evaluate innovative solutions
  • Describe key strategic models including SWOT analysis, Porter’s Five Forces, and Value Chain
  • Apply strategic thinking to real-world case studies that involve complex business challenges
     

• MDD413: Business Leadership | 3 Units | Spring
  Builds further depth in business management through advanced leadership and management principles: understanding and managing stakeholders, defining a leadership style, managing conflict, building trust and setting expectations. The focus is on managing a real project from beginning to end, influencing stakeholders, building and managing a team and building brand trust and loyalty.

  Learning Outcomes

  • Develop proficiency in financial accounting
  • Develop proficiency in financial accounting
  • Define basic negotiation theories and strategies
  • Apply basic skills in negotiation to facilitate solutions to complex business problems

Engineering Skills

• MDD421: Engineering Skills 1:  Computer Aided Design and Simulation | 3 Units | Fall
  Develops essential engineering skills driven by modern computing including computer aided design (CAD) and numerical simulation. Emphasis is to develop advanced CAD skills focused on design intent and manufacturability, and to implement and test engineering design concepts using finite element methods. Students will apply simulation and optimization techniques integrated in CAD software to analyze physical phenomena such as fluid and solid mechanics in medical devices.

  Learning Outcomes

  • Apply CAD modeling/simulation for engineering solutions
  • Demonstrate design intent and an understanding of design for manufacturability
  • Apply basic coding skills to the analysis of engineering problems
     

• MDD422: Engineering Skills 2:  Electronics, microcontrollers, and coding | 3 Units | Winter
  Develops essential skills associated with electronic circuit design, analysis, and prototyping. Emphasis on programming of commonly used microcontrollers or single board computers (SBCs) for use in medical device applications. Leverages CAD tools and PCB prototyping to realize simple designs. Survey of the role of artificial intelligence and the internet of things in the medical device and healthcare industries.

  Learning Outcomes

  • Apply CAD tools and rapid prototyping techniques to design engineering solutions
  • Adhere to design and manufacturing constraints in producing a functional prototype 
  • Create accurate medical models from DICOM image files 
     

• MDD423: Engineering Skills 3:  Prototyping | 3 Units | Spring
  Develops essential skills required for prototyping medical devices.  Emphasis on rapid prototyping techniques including 3D printing, soft lithography, laser cutting and etching, 3D scanning, medical modeling from imaging data.  Students will leverage CAD and simulation skills from the Engineering Skills I course to design for fabrication by rapid prototyping. Projects include enclosure design and assembly for the electronic assembly from Engineering Skills II.

  Learning Outcomes

  • Apply Python and machine learning techniques to the analysis of engineering problems
  • Apply circuit analysis and CAD modeling techniques to prototype a simple functional PCB 
  • Program an embedded microcontroller for application to a simple control problem 

Capstone Design and Commercialization

• MDD431: Capstone Design: Clinical Operations | 3 Units | Fall
  Students will be introduced to hospital and clinical operations and gain hospital privileges.  The course will begin developing a needs assessment in accordance with medical device development based on real-world unmet need for final capstone commercialization plan.  Students will be divided into their respective 4-5 person teams for the capstone project, and the teams will utilize access to the hospital settings and their Faculty Advisor to secure topic for their capstone project.

  Learning Outcomes

  • Identify unmet needs in hospital and clinical operations
  • Assess unmet needs through treatment options, stakeholder and market screenings
  • Describe basic clinical workflow for inpatient or outpatient settings
  • Generate initial design solutions based on needs screening and operational constraints
     

• MDD432: Capstone Design: Commercialization 1 | 3 Units | Winter
  This team-based design course will provide graduate students with a major practicum design experience in which student teams will apply product development, business leadership and engineering content to propose, implement, and validate a unique solution.  The first capstone course will focus on application of engineering principles and design theory to deliver a functional prototype that meets client needs and necessary constraints. 

  Learning Outcomes

  • Compare design solutions based on IP analysis, regulatory strategy and reimbursement options
  • Select design solution based on prototyping options, biocompatibility and product specifications
  • Apply business and engineering principles and design theory to deliver initial prototypes
  • Conduct benchtop assessments on manufactured prototype
     

• MDD433: Capstone Design: Commercialization 2 | 3 Units | Spring
  The second course in the capstone sequence will focus on the development of a commercialization plan, in which regulatory strategy, reimbursement and intellectual property feasibility will be addressed.  Packaging, labeling and sterilization considerations will also be integrated. Written and oral communication, along with relevant professional and ethical responsibilities will be emphasized throughout the capstone course.

  Learning Outcomes

  • Develop a commercialization plan for their selected product concept
  • Demonstrate understanding of business planning and fundraising materials
  • Translate relevant professional and ethical responsibilities towards commercialization

Capstone Design Project

A key component of our graduate program in medical device development is the capstone engineering design project that provides students with hands-on, practical experience delivering a functional prototype.

Learning outcomes for the project overall include:

• Hands-on Experience: Students will gain insights through clinical projects, focusing on the product development pipeline.
• Biodesign Process: Students follow the “identify”, “invent” and “implement” sequence across fall, winter and spring quarters.
• Clinical Integration: Students will access hospital operations, develop needs assessments and work in teams with faculty advisors.
• Practicum Design Experience: Students will apply product development, business leadership and engineering principles to propose, implement and validate solutions.
• Functional Prototype: Students will deliver a prototype that meets client needs and constraints.
• Regulatory Strategy: Students will explore and address regulatory, reimbursement and intellectual property feasibility.
• Communication Skills: Students will demonstrate written and oral communication, professional and ethical responsibilities.