MTU BE 4775 / BE 5775 Medical Devices
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1 MTU BE 4775 / BE 5775 Medical Devices Fall 2014 MWF, 12:05 12:55 PM, EERC 501 Michael R. Neuman (mneuman@mtu.edu) Orhan Soykan (osoykan@mtu.edu) Bruce H. Barkalow (bruce@bhbi.com)
2 Course Information This is a one semester introductory course on medical devices. Course consists of two main components: (A) Lecture Component: Part 1: Lectures 03 12: Introduction to various medical devices, Part 2: Lectures 13 23: General issues common to many medical devices, and Part 3: Lectures 24 32: Contemporary technologies and trends. (B) Case Studies: Students will form groups and each group will study a given case SEP 2014 WED MTU - BE 4775 /
3 Part 1: Introduction to various devices [ LECTURE 02 ON 08 SEP 2014 MON Introduction of the five case studies ] LECTURE 03 ON 10 SEP 2014 WED Diagnostic Imaging Systems (MRI, CT) LECTURE 04 ON 12 SEP 2014 FRI In vitro diagnostics (ELISA, mass spect) LECTURE 05 ON 15 SEP 2014 MON Extracorporeal therapueutic devices (hemodialysis, drug pumps) LECTURE 06 ON 17 SEP 2014 WED Implantable therapeutics (stimulators) LECTURE 07 ON 19 SEP 2014 FRI Recorders and monitors (Cath lab tools) LECTURE 08 ON 22 SEP 2014 MON Surgical tools (Endoscopes, respirators) LECTURE 09 ON 24 SEP 2014 WED Surgical robots (davinci) LECTURE 10 ON 26 SEP 2014 FRI Radiation Systems (Gamma knive) LECTURE 11 ON 29 SEP 2014 MON Dental (Ultrasound) & Ophthalmic devices LECTURE 12 ON 01 OCT 2014 WED Review before exam # 1 EXAM 1 ON 03 OCT 2014 FRI 03 SEP 2014 WED MTU - BE 4775 /
4 Part 2: Issues common to medical devices LECTURE 13 ON 06 OCT 2014 MON Safety LECTURE 14 ON 08 OCT 2014 WED Device reliability LECTURE 15 ON 10 OCT 2014 FRI Tracebility LECTURE 16 ON 13 OCT 2014 MON Data transmission and protection LECTURE 17 ON 15 OCT 2014 WED Preclinical testing - Renee Gerhart LECTURE 18 ON 17 OCT 2014 FRI Clinical trials - Luc Mongeon LECTURE 19 ON 20 OCT 2014 MON Quality Assurance - Matt Bergan LECTURE 20 ON 22 OCT 2014 WED Compliance - Jeff Silberberg LECTURE 21 ON 24 OCT 2014 FRI Regulatory pathways - Janice Kruse LECTURE 22 ON 27 OCT 2014 MON Post market surveillance - Martyn Smith LECTURE 23 ON 29 OCT 2014 WED Review before exam # 2 EXAM 2 ON 31 OCT 2014 FRI 03 SEP 2014 WED MTU - BE 4775 /
5 Part 3: Contemporary technologies & trends LECTURE 24 ON 03 NOV 2014 MON Technologies for patient isolation (electrical and optical) LECTURE 25 ON 05 NOV 2014 WED Technologies for sterilization (EtO and e-beam) LECTURE 26 ON 07 NOV 2014 FRI Artificial organs (Bionic pancreas) LECTURE 27 ON 10 NOV 2014 MON Software design (firmware) LECTURE 28 ON 12 NOV 2014 WED Electronic medical records LECTURE 29 ON 14 NOV 2014 FRI Remote monitoring / telehealth LECTURE 30 ON 17 NOV 2014 MON Current trends: Cost pressures LECTURE 31 ON 19 NOV 2014 WED Current trends: Intellectual property LECTURE 32 ON 20 NOV 2014 FRI Current trends: Affordable care act 03 SEP 2014 WED MTU - BE 4775 /
6 Grading Information BE 4775 Grading: BE 5775 Grading: Exam 1: 20 % 03 OCT 2014 FRI Exam 1: 15 % Exam 2: 20 % 31 OCT 2014 FRI Exam 2: 15 % Case Study: 15 % Case Study: 15 % Homework: 15 % Homework: 15 % Final Exam: 30 % Final Exam: 25 % Term paper: 20 % BE 5775 students will be asked to prepare a term paper on the analysis of a medical device. The contents of the paper as well as the particular device to be analyzed will be chosen by the student but must be approved by one of the course instructors before the end of the third week (19 September 2014). 03 SEP 2014 WED MTU - BE 4775 /
7 FDA Defines Medical Devices As: A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." 03 SEP 2014 WED MTU - BE 4775 /
8 Medical Devices The United States (U.S.) medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patients in healthcare systems worldwide. Medical devices differ from drugs in that they do not achieve their intended use through chemical reaction and are not metabolized in the body. Medical devices range in nature and complexity from simple tongue depressors and bandages to complex programmable pacemakers and sophisticated imaging systems. 03 SEP 2014 WED MTU - BE 4775 /
9 Medical Device Industry in U.S. U.S. Gross > $100 Billion, Global > $300 Billion US Exports $30 Billion - US Imports $30 Billion Employment > 300,000 jobs in the U.S. GM = $155 Billion MEDICAL DEVICE INDUSTRY IS PROFITABLE BUT SMALL! 03 SEP 2014 WED MTU - BE 4775 /
10 US + EU + JP = 3/4 World medical technology market by region based on manufacturer prices. Data as of CY SEP 2014 WED MTU - BE 4775 /
11 Size of Medical Device Sectors 5.8% 11.6% 4.7% 35.3% 12.7% 4.7% 27.6% 33.6% 03 SEP 2014 WED MTU - BE 4775 /
12 Employment in Medical Device Industry 03 SEP 2014 WED MTU - BE 4775 /
13 Top 25 Employers in Minnesota 1. State of Minnesota 14. U.S. Bancorp 2. U.S. Federal Government 15. Essentia Health 3. Mayo Clinic 16. Delta Air Lines 4. Target Corporation 17. Park Nicollet Health 5. University of Minnesota 18. Supervalu 6. Allina Health 19. Hormel Foods 7. Wal-Mart Stores 20. Thompson-Reuters 8. Wells Fargo 21. Medtronic 9. Fairview Hospitals 22. Best Buy 10.United Health 23. Hennepin County 11.Minnesota State Colleges 24. Health East 12. 3M Company 25. CentraCare 13. Health Parners 03 SEP 2014 WED MTU - BE 4775 /
14 Comes in all sizes > 5,000 medical device companies in the U.S. Most are small and medium-sized enterprises. 3/4 of companies < 20 employees. Only 15% have > 100 employees. Increasingly outsourcing to: Specialty firms, Domestic and international suppliers, Partners in Asia. 03 SEP 2014 WED MTU - BE 4775 /
15 How is the money spent NetSales 16,590 Production 4,126 R&D 1,557 Administrative 5,698 Other 958 IncomeTax 784 NetEarning 3,467 IN MILLIONS OF DOLLARS. SAMPLE ANNUAL BUDGET. 03 SEP 2014 WED MTU - BE 4775 /
16 How to succeed in this class Attend the lectures No recordings will be made Take notes There is no text book Keep up Material is new to most students Ask questions Best way to learn Start working on the case study now Work with the instructors on the term paper Your best friend is: SEP 2014 WED MTU - BE 4775 /
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This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document at https://eoc.anthem.com/eocdps/fi or by calling 1-888-650-4047.
Why This Matters: You don t have to meet deductibles for specific services.
Summary of Benefits and Coverage: What This Plan Covers & What You Pay for Covered Services Coverage Period: on or after 01/01/2018 Blue Care Elect Saver with Coinsurance Teradyne, Inc. - HDHP with HSA
Summary of Benefits and Coverage: What This Plan Covers & What You Pay for Covered Services 01/01/ /31/2019.
Summary of Benefits and : What This Plan Covers & What You Pay for Covered Services 01/01/2019-12/31/2019 Period: Important Questions What is overall deductible? Are re services covered before you meet
Important Questions Answers Why this Matters:
This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document at www.mhc.coop or by calling (406) 447-9510. Important Questions
$800 individual/$1,600 family network. $1,600 individual/$3,200 family out-ofnetwork.
Summary of Benefits and Coverage: What this Plan Covers & What You Pay For Covered Services Coverage Period: 01/01/2019-12/31/2019 Laborers District Council of Western PA Welfare Fund: Community Blue PPO
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5251 Midland Rd FOR SALE DBA PROPERTY HIGHLIGHTS 2.91 Acres of Commercial Development Land Outstanding frontage location off Interstate 90 and Midland Road Within walking distance of 7 major hotel/motels
You don t have to meet deductibles for specific services.
Summary of Benefits and Coverage: What this Plan Covers & What You Pay For Covered Services Coverage Period: 01/01/2018 12/31/2018 UMR: MARINETTE COUNTY: 76-440038 011, 012, PLAN B Coverage for: Individual
Premium, balance-billed charges, and health care this plan doesn't cover.
Assurant Health Silver Plan 002: Time Ins. Co. Coverage Period: 01/01/2015-12/31/2015 Summary of Benefits and Coverage: What this Plan Covers & What it Costs Coverage for: Family Plan Type: PPO This is
HealthPartners. Are there other deductibles for specific services? Is there an out-ofpocket. There are no other specific deductibles.
PEIP Advantage HSA Single Plan Cost Level 1 Coverage Period: Beginning on or after 1-01-2014 Summary of Benefits and Coverage: What this Plan covers & What it Costs Coverage for: Single coverage only Plan
Coverage for: Individual/Family Plan Type: PPO
The Summary of Benefits and Coverage (SBC) document will help you choose a health plan. The SBC shows you how you and the plan would share the cost for covered health care services. NOTE: Information about
You don t have to meet deductibles for specific services.
Summary of Benefits and Coverage: What this Plan Covers & What You Pay For Covered Services Coverage Period: 01/01/2019 12/31/2019 Highmark Delaware: Shared Cost Blue EPO Gold 1000-2 Free PCP Visits Coverage
Coverage for: Individual/Family Plan Type: PPO
The Summary of Benefits and Coverage (SBC) document will help you choose a health plan. The SBC shows you how you and the plan would share the cost for covered health care services. NOTE: Information about
This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan
This is only a summary. If you want more detail about your coverage and costs, you can get the complete terms in the policy or plan document at www.bcbsnc.com/members/itg or by calling 1-800-451-5278.
What is the overall deductible? Generally you must pay all of the costs from providers up to the deductible amount before this plan begins to pay.
Summary of Benefits and Coverage: What this Plan Covers & What You Pay For Covered Services Coverage Period: 01/01/2018-12/31/2018 HDHP code 22: AETNA OPEN CHOICE Coverage for: Self Only, Self Plus One
Participating: Self $1,000 / Self Plus One or Self & Family $2,000 Yes. In-network preventive care is covered before you meet your deductible.
Summary of Benefits and Coverage: What this Plan Covers & What You Pay For Covered Services Coverage Period: 01/01/2018-12/31/2018 CDHP EP, F5, G5, H4, JS: AETNA OPEN CHOICE Coverage for: Self Only, Self