Medical Product Sector 2015 Roadmap/TIG Plan Highlights

Fred Sporon-Fiedler, MSE, ChairChuck Richardson, iNEMI, Presenter

2015 Medical SymposiumSeptember 17, 2015Marylhurst University Portland, Oregon

Overview

• 2015 Medical PEG Chapter Highlights

– Product types

– Demographic impacts

– Market analysis

– Technology focal points

– Summary

Product Types

2015 Product Emulator Descriptions

Emulator Characteristics

Wireless / Portable

Produced in high volumes, cost is the primary

driver, hand held battery powered products are also

driven by size and weight reduction

Consumer / Office Systems Driven by the need for maximum performance over

a wide range of cost targets

Automotive ProductsProducts that must operate in an automotive

environment

High-End Systems (Cloud)

Products that serve the high performance

computing, networking, datacom and telecom

markets and cover a wide range of cost and

performance targets

Medical ProductsProducts that must operate with high reliability and,

in some cases, support life critical applications

Aerospace / DefenseProducts that must operate reliably in extreme

environments

4

5

MEDICAL PRODUCTS PARTIONING

Implanted products • Strict regulatory procedures

• Driven by battery life (low power loss)

• Validation and traceability

• Long term reliability (>10-15yrs)

• Long development cycles, primary assembly and design by OEMs

Portable products (those devices that are easily transported) • Cost parity with consumer / portables

• Dynamic market, 9 to 24 month product cycle time

• Mixed regulatory environment

• Mostly outsourced assembly and design

Diagnostic imaging devices and large scale equipment, e.g., MR, CT• Larger scale

• Thermal management and heat sinking requirements

• Utilizes commercial off-the-shelf components, when available

• Development cycle is shorter than implantables

• EMS compatible manufacturing

• Often does not require clean room or sterile assembly floor

Categories:

Demographic Impacts

Situation Analysis: Demographics

7

All Regions

experiencing increased

longevity

Aging populations will

drive increased

demand for Medical

Products of all types.

Life

Sp

an

(ye

ars

)

Situation Analysis: Demographics

8

Doubling of people >65 yrs

of age in next 20 yrs.

Bulk from China, India,

developing countries

Average income levels also

increasing outside

Americas/EU

Turn to Asia strategy: Build

close to patients,

physicians, payers,

regulatory agencies

Market Analysis

MEDICAL ELECTRONICS MARKET- 2014 IHS Update

27 largest Medical OEM companies captured

>100B$ market by 2025

Medical Electronics: MedTech growth outside Americas/EU

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Example: China

~20% per annum growth rate

Far exceeds overall 5.4% forecast

“China will continue to outpace other countries and reach near

parity with the developed nations of Europe by 2020” 1G

row

th R

ate

(Y

/Y

%)

1: Source: PwC China

Technology Focal Points

Roadmap of Key Attributes

13

>200 parameters in 2015 roadmap

Divergent needs across Implantable, Large System,

Consumer Portable

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Emulator Spreadsheet Recommendations

• New Rows / Columns for 2017:• Recommend addition of stretchable substrates (1-2 layer)

• Roll-Roll Glass processing is missing, should this be

included?

Cardiac Balloon Catheter with EKG & LED with stretchable interconnect1

1: Rogers et. al, University of Illinois at Urbana-

Champaign.

Convergence in Class III Medical Therapy Devices

Smart, Connected Medical Microelectronics Miniaturized Connected Delivering therapy

Larg

e s

yste

ms fo

r Thera

py, D

iagnostic

s,

Sto

rage a

nd C

om

munic

atio

ns

Port

able

, patient

sid

e,

dia

gnostic a

nd

monitoring

Cochlear

Vagus Nerve & Spinal

Urinary

Implant

Gastric

Retinal

Cardiac

Brain

MEDICAL DEVICE CONNECTIVITY

Bubble Chart Ref: IBM Institute for Business Value,” The future of connected health devices”

http://www-935.ibm.com/services/us/gbs/thoughtleadership/ibv-connected-health-devices.html

>THREE BILLION POTENTIAL CUSTOMERS FOR CONNECTED HEALTH DEVICES

Analytics challenge: Who is at other end of connection? What will they do with the

data?

Consumer/Portable Medical Electronics

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• Real-time diaper wetness

sensor & notification

• Impedance measurement

• RF connection

• University of Tokyo work

Source: www.medgadget.com

Breadth of applications of bio-

medical sensing & connectedness

will grow into unforeseen places.

Smartphone connected health

appliances growing for diagnostics,

monitoring

Even diapers are becoming smart…

We’ll need 1.375B units/day world-

wide (40M/day in US alone)1.

1:http://disposablediaper.net/faq/how-

many-diapers-are-required-every-day-to-

satisfy-the-world-consumption/

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Areas of Focus for 2017 Chapter

• Business Issues:• Increased globalization- Rise of Asia

• RoHS impact on Class III supply chains ->Mixed Assembly

challenges

• Refreshed market forecasts

• Technical Issues:• Miniaturization- 3D packaging, Wired/Wireless connectivity

• Alternative discrete technologies (e.g. Capacitors)

• Flexible/wearable medical applications

Summary

Roadmap Executive Summary

Demographics/Market:

Medical electronics demand increasing due to worldwide demographic and lifestyle

changes.

Additional demand acceleration fueled by improved detection methods (e.g. cancer)

New market survey/analysis by IHS Technology shows the medical electronics market is

expected to grow at a ~ 5-6% year-year rate.

The market is forecast to exceed 100B$ in the forecast timeframe.

Globalization:

Increased influence of Asia as a hub for development and manufacturing of medical

devices/electronics.

Great opportunity for medical electronics companies

Technology front – Tactical:

Introduction of stretchable electronics substrates is a paradigm shift in the business.

Emphasis is needed on development of a universal 3D SiP technology and improved

Capacitor technology.

Improved battery/power scavenging systems

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Roadmap Executive Summary

Technology front – Strategic:

The need for protocols to enable refurbishment/reuse of medical electronics was raised.

Materials for electrodes used in Neurostimulation devices is a major need, with

demonstrations of electrode arrays on flexible/expandable substrates as well as high I/O

count arrays made using Silicon process technology.

Research efforts in Nanomaterials or systems that can be configured for diagnostic or

therapy purposes is expected to potentially be game-changing.

In the implant product arena, the traditional device paradigm has been to have an

electronics module and power source hermetically sealed with electrical therapy

delivered via leads connected to an interconnect block. Opportunities for miniaturization

exist with more research into methods by which electronic modules can be made fully

biocompatible while reducing the volume overhead associated with large interconnect

blocks to a can.

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Thank You!

Each Panelist has 5

minutes to present his

views on a critical need

and then Q & A from

attendees.