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Do No Harm!

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BME 182 ������

Week 1 ������

Overview & Brief Introduction to BME Product Design and

Development I ������

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Course Description A ‘mini-BME capstone’

introduction to medical device product design and

development delivered via a hands-on design laboratory experience focused on US FDA-regulated & related

global medical device technologies that are

purposefully developed using best practices to meet

demands of existing healthcare markets and emerging

opportunities.

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BME Senior Capstone Design is a year long, independent major design experience

where an unmet healthcare need is identified that can be adequately addressed

with an appropriate medical technology that does not yet exist but which can be

satisfactorily developed to meet that need in the presence of realistic constraints using

best industry practices such that it performs safely and effectively over the product

lifecycle for its intended use. Pizziconi

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Global Factors in Engineering Design

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BME 182 Course Objectives

Students will understand the process of FDA-regulated medical device product development in US , as well as,

Global Healthcare For-Profit and Non-Profit entrepreneurial markets.

Develop student competency and proficiency in

applying engineering design theory to the practice of design and development using medical device product

development best industry practices.

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Diverse Medical Device Product Development Tools & Skills •  Intro Health Care & the Medical Device & Diagnostic Industry •  FDA Regulatory Best Industry Practices •  Medical Product and Project Management Planning •  Medical Product Component and Device Design Processes •  Identification, Selection and Translation of Customer Needs •  Product Specification •  Medical Device Technology Design and Development •  Virtual and Physical Prototyping •  Medical Device Verification & Validation •  Product Design and Development Process Documentation •  Entrepreneurial Business Development Strategies in a

Regulated Medical Product Environment

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I

A value chain is a chain of activities that a firm operating in a specific industry performs in order to deliver a valuable

product or service for the market.

The Value Chain

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Which of these are medical devices?

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Top Ten Medical Uses of the iPhone http://internetmedicine.com/2012/12/14/top-ten-

medical-uses-of-the-iphone/

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Smartphone Ultrasound Imaging FDA Will Regulate Some Apps As Medical Devices

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FDA Will Regulate Some Apps As Medical Devices

In an important move, the U.S. Federal Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on devices like the iPhone and Android mobile devices. Some applications, it said, will be treated

with the same scrutiny as traditional medical devices.

https://securityledger.com/2013/09/fda-says-some-medical-apps-a-kind-of-medical-device/

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Medical Devices, Technology, Emerging Sectors, Patent Trends and Roadblocks

http://www.youtube.com/watch?v=l-UZ6_WnZ4I

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Course Prefix: BME 182 SLN 25576/25577; 1 Credit-3 Hour Lab Days: Mondays / Time 9:00am -11:50 am Location: Lib L50 (plus Design Center SCOB 286/290)   Dates: January 13, 2014 –May 2, 2014 Drop/Add Deadline: January 19, 2014(without college approval) Course Withdrawal Deadline: April 6, 2014

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Dr. Antonio Garcia

Dr. P

BME Product Design & Development I BME 182 Instructor

Dr Jerry Coursen

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Guest Lecturers

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BME 182 Instructor Assistant

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Keivan Mojtahedi BME PhD Candidate

UGTA & Graders Colin Barry BS BME Candidate

BME Design Center Staff Robert Espinoza

MS BME 2013 Chitra Meduri

Masters Candidate

Julio Morera Masters Candidate

Kimia Seyedmadani MS BME 2013

ChongJi Liu Masters Candidate

Colin Barry BS BME Candidate

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BME Product Design & Development I

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Dates Topic Assignment_ Week 1 January 13/14** Introduction: Medical Device Prod Design & Develop I See Blackboard Week 2 January 20/21 MLK Day - US & Global Healthcare – Blackboard Lab Blackboard: Worksheet Week 3 January 27/28 Med Device Prod Dev: Best Industry Tools/Practices/Needs Assessment& Product Specs Design Lab Worksheet Week 4 February 3/4 Medical Device Product Develop: Prototyping/3D Fabrication Technology Design Lab Worksheet Week 5 February 10/11 Medical Device Market Segment I Design Lab Worksheet Week 6 February 17/18 Medical Device Market Segment I Design Lab Worksheet Week 7 February 24/25 Medical Device Market Segment II Design Lab Worksheet Week 8 March 3/4 Medical Device Market Segment II Design Lab Worksheet Week 9 March 10/11 Spring Break No Worksheet Week 10 March 17/18 Medical Device Market III Design Lab Worksheet Week 11 March 24/25 Medical Device Market Segment IV Design Lab Worksheet Week 12 March 31/April 1 Product Design Launch/Medical Device Development Design Lab Worksheet Week 13 April 7/8 Medical Device PD Team: Clin Need, Concept & Prototype Development Design Lab Worksheet Week 14 April 14/15 Medical Device PD Team: Clin Need, Concept & Prototype Development Design Lab Worksheet Week 15 April 21/22 Medical Device PD Team: Clin Need, Concept & Prototype Development Design Lab Worksheet Week 16 April 28/29 Elevator Pitch Presentations IPD Team PPT/Report Week 17 May 5/6 * Monday section/**Tuesday section

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Class Rules: •  Laptop computers are allowed in the classroom. •  No mobile phones or tablet devices are allowed. •  You have to sign the sign-sheet each session. It is your responsibility to sign it.

•  If you attended class but you did not sign the sign-sheet, you would be assumed as absent for that session.

•  The sign-sheet is available in the front desk of the entrance door of class between 9:00am-9:15am. If you were coming late, you would mark as late.

•  Each group member is responsible to grade the performance of his/her other teammates.

•  All lecture slides, readings, homework assignments, etc will be posted on the blackboard.

•  It is your responsibility to check the announcements in the blackboard and your ASU email. It is your responsibility to attend class and keep track of what is due and when.

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Worksheets: I.  Your worksheet score will be decreased 5% if you do not

follow the worksheet submission guidelines: •  Please write your “group number” and the names of your group member on the worksheet.

•  We have one worksheet and one answer-sheet for each device. You can keep the worksheet, but you have to return your answer sheet in the end of class of each session. The answer sheets will be collected at the front desk. The worksheets are also available in the blackboard.

•  If you were asked to submit your assignment electronically on blackboard, then only the following formats are acceptable: - any file that you are asked to upload to blackboard, then

the file should be named as follows:   Group number-Name of worksheet   PDF format for text-document.   STL file for your 3D design. You also have to attach a

picture of your design for us in the format of JPEG file.

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Class Participation: Class participation is mandatory. Attendance is recorded.

Students who accrue excessive absences will be subject to a grade reduction

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Assessment: Determined by Performance & Deliverables: Class Participation: Attendance & ‘Due Diligence’ ~ 15% Design Lab Competencies:Worksheets & Team Participation~60% Product Concept & Business Development: Elevator Pitch ~25% Extra Credit: TBA   Grade Levels: A-/A/A+: 90% – 100% B-/B/B+: 80% – 89.9% C-/C/C+: 70% – 79.9% D-/D/D+: 60% – 69.9% E: < 60%

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Worksheet #1 US & Global Healthcare System

Changing Landscape, Barriers to innovation & New Product Development Opportunities

Due January 26th by 6pm

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Questions ?

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