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lecture_1 - Design of Biomedical Devices ME 128 S Laguette...

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Unformatted text preview: Design of Biomedical Devices ME 128 S. Laguette September 28, 2007 9/28/07 ME 128 1 Agenda Course Description Course Objectives Topics Covered Course Assignments Guest Speakers 9/28/07 ME 128 2 Course Description Introductory course that is intended to address the challenges of: Biomedical device design Prototyping and testing Material considerations Regulatory requirements Design Control Human Factors Ethics 9/28/07 ME 128 3 Course Objectives Text, Reference King, P.H. and R.C. Fries, Design of Biomedical Devices and Systems, Marcel Dekker, 2003 King, P.H. lectures series 9/28/07 ME 128 4 Biomedical Engineering Biomedical Engineering blends traditional engineering techniques with biological sciences and medicine to improve the quality of human health and life. The discipline focuses both on understanding complex living systems - via experimental and analytical techniques - and on development of devices, methods and algorithms that advance medical and biological knowledge while improving the effectiveness and delivery of clinical medicine. Univ of Conn, BME program 9/28/07 ME 128 5 For What Uses Might Products be Designed? 9/28/07 ME 128 6 Course Objectives Course Objectives (1) to introduce students to the biomedical device industry, (2) introduction to biomedical design from concept to market, (3) design problem solving, creative thinking, design control, project planning and teamwork and (4) insight into human factors and ethical challenges. 9/28/07 ME 128 7 Topics Covered Engineering Design and Medical Devices Need Identification Human Factors, Anatomy and Physiology Design Specifications Regulatory Requirements and Quality System Regulations 9/28/07 ME 128 8 Topics Covered Biomaterials and Materials Selection Design Control Patents and Intellectual Property Manufacturing and Quality Control Animal Testing, Clinical Studies, and Ethical Consideration 9/28/07 ME 128 9 Design of Biomedical Devices Device Design 9/28/07 ME 128 10 Design of Biomedical Devices Clinical Needs Device Design 9/28/07 ME 128 11 Design of Biomedical Devices Clinical Needs Device Design Customer Needs 9/28/07 ME 128 12 Design of Biomedical Devices Clinical Needs Device Design Customer Needs Company Needs 9/28/07 ME 128 13 Design of Biomedical Devices Clinical Needs Device Design Regulatory Requirements Customer Needs Company Needs 9/28/07 ME 128 14 Course Assignments Weekly reading assignments, Homework assignments (20%) Lecture Quizzes (20%) Team Case Study Benchmark Design Engineering Report (30%) 5 to 10 page technical report Working in teams, the students must identify and select a commercially available medical device as a benchmark for review. The students should review and discuss the device within the framework of the course topics including: Need Identification and Problem Definition Patents and Intellectual Property Regulatory Requirements Biomaterials and Materials Considerations ME 128 9/28/07 15 Course Assignments Team Case Study Design Review (30%) Working in teams, the students should propose the design and fabrication of a medical device with "improved" performance characteristics as compared with the benchmark design. The students should review and discuss the following: Technical Considerations Design Considerations including Patents and IP Proposed Efforts and Activities including Regulatory Requirements Proposed schedule/critical path including Clinical Studies and Quality System Requirements 9/28/07 ME 128 16 Program Outcomes The student should acquire the experience of working as part of a team to solve a practical design problem. The student should be aware that an engineer often faces ethical issues and should know that the engineer has a responsibility to work within ethical principles. 9/28/07 ME 128 17 Program Objectives Gain experience in applying principles of mathematics, science and engineering to solve problems. Demonstrate the ability to understand and design a useful product in the context of solving a design problem. Work effectively as part of a team. Effectively communicate a design 9/28/07 ME 128 18 The Product Design Process What is Engineering Design? Product Design Process Design Requirements Phases of the Design Process 9/28/07 ME 128 19 What is Engineering Design? Engineering Design is the result of a process An identified need or problem Involves engineering related activities such as analyses, modeling and testing Provides a solution for the identified need or problem 9/28/07 ME 128 20 Design What is a Good Design? 9/28/07 ME 128 21 Engineering Design Design is the product of planning and work A good design requires both analysis and synthesis Analysis involves the use of engineering and scientific disciplines to characterize product performance Synthesis involves the combination of solutions into a total workable system 9/28/07 ME 128 22 Engineering Design A Good Design provides a solution to the identified need or problem in an innovative manner and defines a standard for others to follow 9/28/07 ME 128 23 Product Design Process The emphasis of the text and this course is on Product Design 9/28/07 ME 128 24 Design Process The iterative nature of design provides an opportunity to improve the design on the basis of a preceding outcome. The design method starts with knowledge of the state of the art. 9/28/07 ME 128 25 Guest Speakers Guest Speakers Stephen Hanlon Jeff Goldberg Larry Wissman Leanne Lintula Boston Scientific Helix Medical Mentor Medtronic 9/28/07 ME 128 26 Plastic Surgery 9/28/07 ME 128 27 ENT 9/28/07 ME 128 28 Intensive Care 9/28/07 ME 128 29 Neurosurgery 9/28/07 ME 128 30 Pain Management 9/28/07 ME 128 31 Ophthalmology 9/28/07 ME 128 32 Orthopedics 9/28/07 ME 128 33 Cardiovascular 9/28/07 ME 128 34 Monitoring and Delivery 9/28/07 ME 128 35 Course Schedule Day/Date Week 1 F 9/28 Week 2 M 10/1 W 10/3 F 10/5 Week 3 M 10/8 W 10/10 F 10/12 Topic/Activity Introduction/Course Objectives Medical Device Industry Medical Devices Need Identification Anatomy and Physiology Product Documentation (guest) Task to be completed Chap1, 2 Form Teams Chap 3, 4 HW#1 Due/ Select Design 36 9/28/07 ME 128 Course Schedule Day/Date Week 4 M 10/15 W 10/17 F 10/19 Topic/Activity Task to be completed Biomaterials and Material Selection Overview of FDA Regulations (guest) Chap 5, 10 __________________________________________________________ Week 5 M 10/22 Regulatory Requirements Quiz #1 W 10/24 Quality System Regulations FDA website F 10/26 Mentor (guest) Chap 13, 14 HW#2 Due 9/28/07 ME 128 37 Course Schedule Day/Date Week 6 M 10/29 W 10/31 F 11/2 Topic/Activity Prototyping and Testing Design Control Medtronic Neuro (Guest) Task to be completed Chap 12 Benchmark Design Due ______________________________________________________________ Week 7 M 11/5 Human Factors in Design W 11/7 Manufacturing and Quality Control Chap 8, 15 HW#3 Due F 11/9 Implantable devices 9/28/07 ME 128 38 Course Schedule Day/Date Topic/Activity Task to be completed Week 8 M 11/12 Holiday W 11/14 Animal Models and Testing F 11/16 Helix Medical (guest) Chap 19 __________________________________________________________ Week 9 M 11/19 Human Clinical Studies W 11/21 Packaging and Sterilization Chap 21 HW#4 Due F 11/23 Holiday 9/28/07 ME 128 39 Course Schedule Day/Date Topic/Activity Task to be completed Week 10 M 11/26 Ethical Considerations W 11/28 (TBD) F 11/30 (guest) ___________________________________________ Week 11 M 12/3 W 12/5 F 12/7 Team Design Review Presentations Team Design Review Presentations Team Design Review Presentations 9/28/07 ME 128 40 ...
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