1. Introduction to Medical Electronics
Day 1: Executive Overview – Introduction to Medical Electronics
May 6, 2013 Charles J. Lord, PE President, Consultant, Trainer Blue Ridge Advanced Design and Automation

2. This Week’s Agenda
5/6 Medical Device Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

3. This Week’s Agenda
5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

4. Medical Electronics – Definition (at least for this week’s class)
“The research and development of electrical equipment and supplies for such medical applications as diagnosis, therapy, research, anesthesia control, cardiac control, and surgery.” (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) 

5. The Market
Baby Boomers now at or approaching retirement, medicare age – more medical problems, more need for telemedicine and self-monitoring
Health consciousness growing – needs for support for monitoring condition in healthy individuals while training

6. Trends Driving Medical Electronics Growth
Aging population* that is expensive to service via traditional channels
Need for reduced hospital visits, more remote/home-based monitoring
5747 US hospitals, 947k beds, $607B hospital expenses**
Increasing incidents of cardiovascular, diabetes, & cancer illnesses
More home monitoring, self-diagnosis and therapy administration
Rising healthcare costs
Demand for ways to reduce need for physician use for basic health care needs (“doctor-in-a-box”)
Growing acceptance of technology in the medical field
Reliability and liability concerns persist for deeply invasive products such as pacemakers, respirators, etc.
OEMs shoulder burden of regulatory compliance
Urgency in increasing quality of healthcare and medical technology
Medical expenditures are 2nd-largest portion of US Federal Budget (after defense)
Medical technology industry second only to the pharmaceutical industry in R&D expenditures, investing, on average, 11% of sales in R&D***

7. Healthcare Spending is on the Rise
4% of money spent on healthcare goes towards equipment.
In the US, this amounts to $281 per capita per year (2009) growing to $524 in 2017.
Using the same assumption, in Japan the per capita spend for equipment is $108 (2009).
Source: Time Magazine,

8. Access to Healthcare Facilities Must Change in the US
Doctors are scarce in rural areas of the US (i.e. a majority of the land)
Above statistics help prove why on-demand diagnostic tools are becoming a necessity
Portable ultrasound equipment is a good example
Source: Time Magazine,

9. Telehealth Demo Concept
Graphics
Audio / Video
Wired / wireless connectivity
Touch U/I
Medical Database
(eg. Microsoft HealthVault, etc)
Terminal / PC to access medical data via the web

10. Home Portable Medical

11. Diagnostics / Therapy

12. Classification
All medical devices are classified according to the criticality of the device and the risk imposed by a device malfunction
Determines the level of documentation, testing, and certification
Level I-III in US FDA
More on this tomorrow!

13. Typical Medical Device Features
Illustration courtesy Freescale

14. Specific Features Touch sensors Displays Cost Cleaning issues
Reliability vs mechanical
Displays
Lighting
Reliability – fail-safe
Readability (older population)

15. Specific Features Analog Flash / EEPROM
High accuracy / repeatability A/D
High stability glitch-free D/A
High accuracy internal amplifiers on-chip (example – Freescale MM Flexis and K53 ARM)
Flash / EEPROM
High Reliability
Known power-down and reset characteristics

16. Specific Features Communications
Growing trend toward USB, wireless (ZigBee particularly, some WIFI)
Full handshaking and checksum – reliability!
Security – US HIPAA
Standards for interdevice comms
More on Wednesday and Thursday!

17. Environmental Challenges
Most devices will not see outside the typical temperature ranges for commercial silicon, but will need for measurements to be accurate over that range
Humidity and direct moisture are issues to be addressed (sweat, etc)
Physical shock
EM fields

18. Conclusions
Medical electronics is a major growth area for the future – we are all getting older!
Depending on the application, design challenges can be minimal to major
Semi manufacturers are gearing up with uCs and software (RTOS, comm stacks) to support this market
Challenging and rewarding!

19. This Week’s Agenda
5/6 Overview 5/7 Safety, Reliability, Regulatory Issues 5/8 Communications Part 1 5/9 Communications part 2 5/10 Medical Data Storage

20. Please stick around as I answer your questions!
Please give me a moment to scroll back through the chat window to find your questions
I will stay on chat as long as it takes to answer!
I am available to answer simple questions or to consult (or offer in-house training for your company)