closing technology gaps for the medical electronics...
TRANSCRIPT
Closing Technology
Gaps for the Medical
Electronics Industry
iNEMI Medical
Project and Initiative
Review
Chuck Richardson
September 27, 2012
Arizona State University
Agenda
Brief iNEMI Overview
Medical PEG Highlights
Medical Projects and Initiatives
Questions
Objectives for Today
Build a better understanding of how iNEMI identifies and closes technology gaps for the medical electronics industry Goal is to get great and reliable products to market
as efficiently as possible that positively affect the users quality of life
Share the directions and participation of the iNEMI medical projects and initiatives Get symposium feedback Potentially get attendees participation where it
makes sense
About iNEMI
International Electronics Manufacturing Initiative (iNEMI) is an industry-led
consortium of around 100 global manufacturers, suppliers, industry associations,
government agencies and universities. A Non Profit Fully Funded by Member Dues;
All Funding is Returned to the Members in High Value Programs and Services; In
Operation Since 1994.
Visit us at www.inemi.org
5 Key Deliverables:
• Technology Roadmaps
• Collaborative Deployment
Projects
• Research Priorities Document
• Proactive Forums
• Position Papers
4 Major Focus Areas:
• Miniaturization
• Environment
• Alternative Energy
• Medical Electronics
Mission: Forecast and Accelerate improvements in the Electronics
Manufacturing Industry for a Sustainable Future.
Highlights of iNEMI 2012 Year to Date
Added 9 new members in 2012 thus far (Plus UL Medical)
The 2013 iNEMI Technology Roadmap development is well underway
RM Inputs Sessions Conducted in all three regions; in person attendance about 110
people
Development on Track and will be available to members in December 2012
Excellent progress in Miniaturization, Environmental and Medical areas of
focus.
Industry excitement in new projects such as UL certification and Counterfeit
Electronics
Two new MEMS initiatives kicked off and a second MEMS workshop happened
in Q2 – A healthy and growing market ready for collaboration
5
International Members
Across The Total Supply Chain The International Membership Incorporated Location; Number of Members
INEMI Member Business Type North
America Asia
Region Europe Totals
OEM 15 2 2 19
ODM/EMS (inc. pkg. & test services) 4 7 11
Material Suppliers 8 12 11 33
Equipment Suppliers 8 1 2 11
Universities & Research Institutes 8 2 3 13
Organizations/consulting 11 1 2 13
Totals 54 25 20 99
OEM/ODM/EMS Members
7
Supplier Members
8
Supplier Members – PWB Supply Chain
9
Research Institutes and University
Members
10
Unique Attributes of the iNEMI
Consortium Strong Global Membership accompanied by a mission that
focuses on identifying global manufacturing challenges
Delivery of a total industry set of priorities every two years: A Technical Plan that defines key collaborative opportunities and gaps
in the 1-5 year horizon
A set of Research priorities for the 5-10 year horizon
A proven methodology for effective pre competitive
collaboration.
Ability to execute an integrated supply chain approach on
solving complex manufacturing and systems integration
issues.
A growing reputation as a proactive leading organization in
the environment and sustainability
iNEMI Medical Focus & Agenda
Background
Projects Defining Reliability Requirements for Implantable
Medical Devices
Qualification Methods for Portable Medical Products
Component Specifications for Medical Products
Active Initiatives Supply Chain Support for Medical Electronics
Medical - MRI and Implantable Compatibility
Background
Medical Electronics is one of iNEMI’s focus areas
Many members working in the fast growing area
iNEMI has been producing a Medical PEG for a
number of Roadmap Cycles, identifying the midterm
and long term development and research needs of the
industry
Industry consensus that there are opportunities for
collaboration that will help speed up the adoption of
new technologies in medical devices.
Current Members with Medical Focus
2013 Medical PEG
Highlights
16
Digital Health
Patient care enhancement
- New and Unique Medical Products
- Monitor Systems
- Sensor Technology
- Improved Diagnostics
Wireless technology for data transfer
- Instant and remote monitoring
- Power transfer by RF
- Off-load computing and data storage
to remote host system, outside the
device.
In the past 12 years, growth, innovation and
miniaturization have lead to major advances in medical
electronics manufacturing and the therapies they deliver.
17
Medical Market and Trends
Globally, the number of persons 60 and older
was 600 million in 2000. It is expected to double
to 1.2 billion by 2025 (W.H.O.)
There are over 40 million persons in the U.S.
over 65 years of age (U.S. Census Bureau)
Currently, the U.S. spends 1.75 Trillion dollars
(over 16% of its gross domestic product) on
health care
It is estimated that 2012 annual spending on
medical devices / electronics is approaching 100
Billion dollars
MEDICAL MARKET
2010 2011 2012 20142013 2015 2016 2017 2018 2019 2020 2021 2022 2023
2011
$91Bn6% of
Electronics Industry
4.4% CAAGR2011-2017
3.9% CAAGR
2017-2023
$118Bn
$148Bn
$Bn
$100
$200
$150
$50
0
N212 .bes-INEMI med
0Americas Japan Europe Asia/
ROW
20%
40%
60%
80%
100%
% Production 2010
Source: Prismark 2012 iNEMI Update
Production concentrated in America & Europe – but will change
MEDICAL MARKET- High Potential
Bubble Chart Ref: IBM Institute for Business Value,” The
future of connected health devices”
3 BILLION POTENTIAL CUSTOMERS FOR
CONNECTED HEALTH DEVICES (“Worried Well”)
20 20
General Business Indicators are good - High Growth of Tele-Medicine anticipated using multi functional
portable devices.
- Continued migration from prescriptive to preventive medicine will
drive increase in portable/wearable medical monitoring devices.
- Emerging markets expected to have double digit growth.
- Focus on lower cost diagnostic equipment for developing nations and
rural areas.
- Regional assembly, design and distribution expected to continue
increase in SEA and China.
- U.S. market impacted by health care reform and conservative
regulatory stance by FDA.
- Long time to market; Hard to get suppliers engaged
- Price pressures throughout health care value chain
21
Example of differences from last Roadmap - 3D SiP and Integrated Passives
Medical PEG Roadmap New Challenges
Broader deployment of portable medical devices will
accelerate Miniaturization drive:
-Use of 3D SiP technology (w/wo TSV)
-Integration of discretes onto Si based integrated
passive devices (for high volume products or stable
topologies in low volume products)
Increased use of MEMS
Source: ASE Group
Identification of Opportunities for
Collaboration
Seven potential projects/initiatives were indentified as a result of iNEMI
roadmap, workshops and consultations in 2010 & 2011.
Webinar held in May 2011 to form teams to develop project plan.
The first 3 teams started working on developing Statement of Work (SOW)
in 3Q11
Projects approved to start by Technical Committee (TC) in Jan, 2012.
iNEMI Medical Initiatives – May 2011
Defining Requirements
for the
Development of
Implantable Reliability
Specifications
Co-Project Leaders:
John McNulty, Exponent Failure Analysis Associates, Inc.
Erik Jung, Medical Microsystems
Defining Requirements for the
Development of Implantable Reliability
Specifications Purpose of Project
The focus of the program is to identify lacking standards for product
testing to ensure reliable function of implantable electronic products
(i.e. FDA class 3)
Standardization of recurring scenarios and their application to test
routines will mitigate these factors and offer to the industry as well as
to the patient a faster level of innovation, a higher profit, and lower
personal and litigation risks
Defining Requirements for the
Development of Implantable Reliability
Specifications Project Is / Is Not Analysis
This Project IS: This Project IS NOT:
Phase 1
– Focused on implantable medical
devices, i.e. FDA class 3 – Repeat of prior work
– Identification/compilation of existing
reliability/quality/ safety standards
specific to implantable electronic
devices
– Not intended to be a static model that
can be used indefinitely without further
updates and input from the medical
electronics industry
– Information gathering: industry survey
of commonly used/modified test
standards; determination of device-
specific usage environments
– Reviewing material compatibility issues
– Applicable/relevant to a broad range of
implantable electronic technologies
– Development of reliability standards/
methodologies (this is a task for
Working Group 4)
27
Defining Requirements for the
Development of Implantable Reliability
Specifications
Scope of Work Q1 Q2 Q3 Q4 Q5
Phase 1
Task 1
Identification and compilation of
existing reliability, quality and safety
standards
X X X
Task 1(a) Compile a preliminary list of
existing standards X
Task 1 (b) Develop a project
participant questionnaire X
Task 2
Survey development X X X X X X
Task 3 – Data Collection & Analysis
Survey data collection - conclusions
& recommendations X X X
Task 5 - Project Output
- Webinar & publication
- Phase 2 SOW
- Publish white paper
X X X
Project Status Summary
Project Officially started February 2012 Conducted Industry survey to assess current standards for the reliability of implantable electronics
(Survey Closed August 17, 2012)
By collecting industry information, the group will better understand the perceived lack of reliability, quality and safety standards specific to implantable medical electronic devices
Project Chair: Project Co-Chair:
Strategy Tactics Start: Anticipated End:
Issues Graphics
Focus Area:
Oct-12 TIG:
Goal: Identify needed standards for product testing to ensure reliable function of implantable electronic products (i.e. FDA class 3)
Medical
Medical
Defining Requirements for the Development of Implantable Reliability Specifications
Erik Jung, Medical Microsystems John McNulty, Exponent
• Identification and compilation of existing
reliability, quality and safety standards
Compile a preliminary list of existing standards
Develop a project participant questionnaire
• Survey development
• Survey data collection - conclusions &
recommendations
• Focused on implantable medical devices, FDA class 3
• Identification/compilation of existing reliability/quality/ safety standards specific to implantable electronic devices
• Information gathering: industry survey of commonly used/modified test standards; determination of device-specific usage environments
• Applicable/relevant to a broad range of implantable electronic technologies
Standardization of recurring scenarios and their
application to test routines will mitigate these factors
and offer to the industry as well as to the patient a
faster level of innovation, a higher profit, and lower
personal and litigation risks
2/2012 5/2013
Common
Specifications of
Components for
Medical Electronic
Products Chair:
Peter Lampacher,
Vibrant Med-el
Project Motivation
Need for Common Specifications for Medical
Products
Focus on electronic components
Every electronic component that is purchased for
high reliability medical products today must be
individually qualified
No medical industry specifications exist for
qualification of components or their suppliers.
This situation increases costs and TTM & NPI
Time
Project Deliverables
Develop a test and screen matrix for electronic components that can be
used to qualify the reliability performance for electronic medical devices.
Several example screen and test matrices will be included in the
report as validation of the practicality of the method.
This project will result in a standard reliability method that can be
implemented by medical device manufacturers within their component
management process. In those cases when critical defects and failure
mechanisms or test methodologies are already known, the
implementation process will be easier.
For those situations in which the failure mechanisms or test
methodologies are not known, this project will be part of a more complex
solution.
Project Scope
What the Project IS / IS NOT:
This Project IS: This Project IS NOT:
To define a set of reliability qualification methods
on a component level accepted by OEMs and
supported by suppliers (that is, original
component manufacturers)
To define reliability qualification methods for
medical devices
To define: What is acceptable ageing of
components and what is failure?
A qualification effort for a specific product
line at a specific supplier
To quantify reliability within a suitable framework
in defined operating conditions
Further work on already known
ageing/failure mechanisms
To re-use qualification methods successfully
employed and rationalized in other industries To recreate the wheel of component
qualification test methods and processes To create guidelines for OCMs to utilize physics
of failure based reliability assessment
To create guideline for medical OEMs on how to
assess OCMs
To create guideline on minimum levels of tests
for various component types
Project Tasks & Timeline
Q1 Q2 Q3 Q4 Q5 Q6 Q7 Task 1-Determine the
coverage of the components
for the first phase
Task 2 - Identify the most
common defects, degradation
and failure mechanisms of
the selected items under
medical device applications
Task 3 - Determine the
screens for identification of
the defects and tests for
precipitation of the
mechanisms
Task 4 - Create a minimum
set of tests and screens
related for each part referring
to industry standard methods
whenever possible
Task 5 - Final report including
a methodology description on
the process of developing the
tests and screens for other
parts
Method of Project Implementation
Task 1 will be achieved through web based survey followed
by data analysis by the core team: Survey will be released
to industry in 3Q12 (Next Slide).
Tasks 2 through 4 will be implemented by small work groups
for each component type selected in task 1. The work
groups will include representatives of OEMs, OCMs and
other subject specialists from industry and academia
Task 5 will be performed using contributions from the work
groups by the core team that will ensure that the completed
document is a practical one that can be used by OEMs and
OCMs in an economic manner
Identification of Critical Components for Medical Devices
About the Survey
Survey was developed by the iNEMI Component Specifications for Medical Products
Project.
The project team plans to identify and define a set of component-level reliability
qualification methods for electronic components used in implantable and wearable
medical devices.
Their goal is to develop much-needed specifications that can be accepted by device
OEMs as well as supported by component suppliers.
The survey will be used to determine the selection of the most relevant components
to be considered by the project team. We would appreciate your taking 10 minutes to
give us your input at:
http://www.surveymonkey.com/s/Identification_of_Critical_Components_for_Medical
_Components
Survey Results
All survey responses go directly to iNEMI and all information in the survey will be
treated as confidential. All results will be anonymous.
Individuals who complete the survey and provide contact information will receive a
summary of the results from the iNEMI project team after their analysis of the data is
complete in Q1 2013.
Anticipated Outcomes and Benefits
Recommendations for common specifications for electronic
components for use in medical devices that meet the test,
performance, and reliability needs of implantable and
wearable medical products.
This will reduce the resources expended presently on
testing to unique requirements.
It will also enable the faster introduction of new
components and suppliers into the supply chain.
Enhance the relationships along the supply chain
39
Qualification Methods for Portable
Devices
Reliability Performance
Qualification Methods
for Portable Devices
Co-Chairs:
Jack Zhu, Boston
Scientific
Grady White, NIST
Project Background and Motivation
The medical electronics industry is developing very quickly. Historically the industry has been vertically integrated with a narrow supply base. The market has been conservative and new technologies and products introductions have been slow.
Both the rapid growth of the use of electronics in medical devices and the recent market-driven needs to shorten time to market for new products has revealed the lack of a consistent approach to determine the reliability performance of devices, such as is done in the military applications, e.g., use of MIL STD.
This results in time consuming and redundant testing at many stages of the product development and qualification cycle.
Development of a standard methodology and qualification procedure would enable the industry to enact changes quicker and to bring products to the market in a shorter time.
Portable Medical Electronics Devices
Portable medical electronic devices include: Patient monitoring systems that are used to measure and monitor patients’
vital signs and other bodily functions Including home diagnostics products such as blood pressure cuffs (including wireless),
blood glucose meters, pulse oximeters, and biochemical analysis meters. Peripheral products of the implantable medical systems
Such as external charger, remote controls.
Why portable medical electronic devices?
While failure of most types of portable devices will typically not impose immediate risk to patient life, it will largely affect the consumers’ confidence with the product.
Compared with large infrastructure devices like x-ray systems or small implantable devices, such as pacemakers, portable medical devices have a larger production volume and, thus, a larger user base.
For implanted devices, the external supporting electronic devices are critical to routinely maintain or monitor the active implanted components and, thereby, can greatly impact the patient’s safety or life quality.
What the Project IS / IS NOT
This Project IS: This Project IS NOT:
Focused on portable medical devices,
including stand alone devices and
peripheral devices associated with
implantable systems.
To determine failure processes or time
dependence
Identification of extant industry tools
and standards
To define accelerated test parameters
for components or devices
Identification of gaps in extant industry
tools and medical devices
To identify failure processes or conduct
extensive reliability test
To lead to well-defined, industry-
accepted lifetime/reliability assessment
procedures for portable medical
devices
To develop a test methodology
Project Tasks & Timeline
Q1 Q2 Q3 Q4 Q5 Q6
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Phase 1
Task 1 x x
Identify companies
and champions to lead
investigations
Task 2 x x x x
Identify what tools and
methodologies already
exist
Task 3 x x x x x x x x
Identify how to
address the identified
gaps
Task 4 x x x
Conclusion of the
project
Task 5 x
Final report
Organizations that have participated in
this Initiative – Current Members in Red
Boston Scientific NIST CALCE MST Imec DfR Solutions EITNY Benchmark electronics Atotech Cochlear UL Medical Exponent
• GE Medical
• IST
• Kemet
• Medtronic
• Med-el
• MSE
• Philips
• Texas instruments
• Toshiba
• Tyndall Institute
Active Medical
Initiatives In Definition
Medical Initiative
Supply Chain Support
Project Lead: Eddie
Suckow; Fairchild
Semiconductor
Medical Initiative Supply Chain Support
Problem: Lack of effective supply chain support in Medical
Electronics. Key Contributors from the supplier side: • Medical market aversion – Liability and Volume
• Ambiguity in the NPI process and Timeline
• Forecast Variability
• Life cycle challenges – drawn out NPI and lengthy end of life
Key Contributors from the OEM side: • Poor communication of upstream process/material characterizations and of
problem dissemination.
• Challenges from social issues; child labor, third world labor practices
• Unique specs for components not met by existing parts/suppliers
• Scarcity of Materials – REM’s, Plastics, Plasticizers
• Supply base consolidation and requalification as a result.
• Counterfeit part challenges.
Supply Chain Support for Medical
Electronics
1. Identify/develop OEM/supplier business models (e.g. identify/develop BKM
templates)
– OEM/supplier operating models (“cookbook” reference)
NPI for innovative new products
Change Control and Product Requalification
Support requirements for long life products
2. Collect and publish widely available information on component and supplier
capabilities
3. Develop data declaration protocols for medical components – electronically
transferrable
4. Identify commonalities for military & medical devices/components
5. Rare Earth Metal’s and Scarce/Threatened plastics
Clarify the medical market priorities and create an action plan
Needs to be an on-going effort as the priorities will continually evolve/change
Topics of Interest
IS / IS NOT Analysis
Supply Chain Support for Medical Devices
This Project IS: This Project IS NOT:
Supply Chain Support for Medical Devices
Identify/develop OEM / supplier business models (e.g., identify / develop BKM templates)
Not Intended to be a static development that can be used indefinitely without further updates and input from the Medical device industry
OEM/supplier operating models (“cookbook” reference)
NPI for innovative new products Not a repeat of prior or existing work
Change Control and Product Requalification
Not biased toward specific suppliers or OEMs
Support requirements for long life products
Not a standards development
Potential Formation Team Members
Altera
AT&S
Endicott Interconnect
GE Global Research
GE Healthcare
Heraeus
Indium Corporation
IBM
KEMET
Micro Systems Technologies
NIST
Northrop Grumman
Philips Healthcare
Plexus
Sanmina-SCI
TE Connectivity
Underwriters Laboratory
Valtronic Technologies
MRI/-X-ray and
Implantable
Compatibility
Chair:
Bill Burdick,
GE Global Research
MRI & Implantable Compatibility
Imaging protocols to affect new applications and improve
image quality, patient comfort, and temporal processing: System and device needs and compatibility:
Requirements, limitations, compatibilities
Check on knowledge base from interventional MRI
Get contact for other collaborative group working this issue
Patient safety: up to 7T magnetic fields not compatible with implants
(pacemaker, dental, etc.)
Acceptability from FDA (get right contacts)
Project Is / Is Not Analysis This Project IS: This Project IS NOT:
MRI Inter-compatibility with Implantable Medical Devices
Build on the knowledge from the medical industry,
published literature, and publicly available data /
information
Not a standards development
Reduce impact of materials used in implantable
products on image quality Not focused X-ray at this point
Development of protocols (processes) to access
inter-compatibility of implantable medical devices
with large MRI “scanner” type products
Not intended to be static that can be used indefinitely
without further developments and input from the
medical industry
Identify and publish a material list to investigate Not a repeat of prior or existing work
Identify gaps in existing material technology for inter-
compatibility pulling together the information from
both sides of the industry
Not to Identify or assess the risks associated with
incompatibility – defining a project around this may
be an output
Identify device compatibility requirements Not biased towards specific suppliers or geographies
Holistic approach on material interactions Not focused on Increasing patient safety
Investigate acceptability by the FDA
Focused on those attributes which are of most value
to supply chain and the participating project members
Categorize classes of materials that are
incompatible, conditionally compatible and fully
compatible
Current Formation Team Distribution List GE Global Research Bill Burdick [email protected] Boston Scientific Jordi Parramon [email protected]
Boston Scientific Neuromodulation Jack Zhu [email protected]
CALCE-University of Maryland Diganta Das [email protected]
Cicor Reinhardt Microtech Alexander Kaiser [email protected]
DfR Solutions Gregg Kittlesen [email protected]
GE Healthcare James Vetro [email protected]
GE Healthcare Joe Schaefer [email protected]
GE Healthcare Nick Momcilovic [email protected]
IBIDEN Shiguo LIU [email protected]
Indium Carol Gowans [email protected]
Indium Corporation Andy Mackie [email protected]
Intel Celeste Fralick [email protected]
IPDIA Stephane Bellenger [email protected]
KEMET Allen Mayar [email protected]
MED-EL Medical Electronics Peter Lampacher [email protected]
Micro Systems Engineering Anthony Primavera [email protected]
Micro Systems Technologies Fred Sporon-Fiedler [email protected]
Micro Systems Technologies Java Von Arx [email protected]
Molex Oliver Bischoff [email protected]
NIST Herbert Bennett [email protected]
Philips Ed Leono [email protected]
Philips Healthcare Wendy Phippen [email protected]
Philips Medical Po Tse [email protected]
Philips Medical Marc de Samber [email protected]
Sorin Group Olivier Carbonaro [email protected]
Texas Instruments Chris Griffith [email protected]
* Current Project Formation Team Chair
Summary and Discussion
Three active projects well underway all working the
refinement of reliability test and qualification On implantable devices
On components and sub assemblies
On portable products
Two additional initiatives working scope definition and project
plans.
Thoughts…………Feedback
Discussion