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

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

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

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) 

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

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***

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, 12-1-09

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, 12-1-09

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

Home Portable Medical

Diagnostics / Therapy

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!

Typical Medical Device Features Illustration courtesy Freescale

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

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

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!

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

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!

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

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) c.j.lord@ieee.org http://www.blueridgetechnc.com