Webinar for Medical

Projects

November 5, 2014

2

Agenda

• 11.00am Welcome

• 11.10am 2015 Roadmap Medical PEG highlights

• 11.25am Project summaries – key learnings and potential new areas

identified

• Reliability Requirements for Implantable Medical Devices Phase 1 and 2

• Component Specifications for Medical Products

• Qualification Methods for Portable Medical Products

• 11.55am Highlights from Medical symposium

• 12.10pm Discussion

• 12.50pm Next steps and actions

3

Today’s Objective

Review data from roadmap, project teams and industry input

Start the discussion

Identify areas of interest for industry

Clarify the needs or gaps that have to be addressed

Determine if suitable for collaboration

Establish if there is leadership and critical mass available

4

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

Co-hosting for last 2 years Symposium with SMTA and Meptec focused on medical

device manufacturing.

Industry consensus that there are opportunities for collaboration that will help

speed up the adoption of new technologies in medical devices and time to market.

5

Current Members with Medical Focus

Medical Electronics Workshops held in Berlin,

Germany & Santa Clara, CA

Outcomes indentified Top Priorities for Collaboration

7

Medical Workshop - Participating Companies

HEI, Inc.

ipdia

8

Medical Workshop - Participating Companies

(Reinhardt Microtech)

9

iNEMI Medical Initiatives Identified in May 2011

2015 Medical Projects Discussion- 2015

Roadmap Medical PEG highlights

Fred Sporon-Fiedler

Director

Micro Systems Technologies

4NOV14

11

MEDICAL PRODUCTS PARTIONING

1) Implanted products (those devices implanted in a human body)

• Strict regulatory procedures

• Driven by battery life (low power loss)

• Validation and traceability

• Long term reliability paramount

• Long development cycles, primary assembly and design by OEMs

2) Portable products (those devices that are easily transported)

• Cost parity with consumer / portables

• Dynamic market, needs fast response … 9 to 24 month product cycle time

• Mixed regulatory environment

• Mostly outsourced assembly and design (SEA)

3) Diagnostic imaging devices and large scale equipment, e.g., MR, CT

• Larger scale (often similar to servers or telecom equipment)

• Often requires thermal management and heat sinking

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

• Development cycle is shorter than implantables

• Application and design well suited to EMS environment

• Often does not require clean room or sterile assembly floor

Three general categories:

Roadmap Executive SummaryDemographics:

– Worldwide demographic and lifestyle changes will continue to increase the demand for medical technologies.

– The demand will be accelerated by improved detection methods for a variety of diseases such as cancer.

Market:

– IHS Technology: Medical electronics market is expected to grow at a ~ 5-6% Y-Y.

– The market is forecast to exceed 100B$ (2025) from ~60B$ (2013)

Globalization:

– Increasing importance of Asia as a hub for development and manufacturing of medical devices/electronics

– Great opportunity for medical electronics companies and must be embraced.

Technology front:

– Stretchable electronics paradigm shift. 3’rd major substrate technology for medical over the course of the next 10 years

(Rigid and Flex being the other two).

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

• Standards:

– Establishment of standardized Component and Sub-Assembly test methods for medical applications is needed.

12

Situation Analysis

13

WW Demographics and incomes will drive increased demand for Medical

Products of all types.

# of people >65 yrs of age to

~double in next 20 yrs.

Bulk from China, India and

Developing countries

Average income levels also

increasing outside Americas/EU

Medical Electronics must execute

“turn to Asia” strategy- Design &

Build close to customers,

regulatory agencies

MEDICAL MARKET- 2014 IHS Update

Market analysis from IHS Technology

27 largest Medical OEM companies in survey

Roadmap of Key Attributes

15

207 parameters in 2013 roadmap

Divergent needs across Implantable, Large System,

Consumer Portable

16

Emulator Spreadsheet Recommendations

• New Rows / Columns for 2015:

• 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 interconnect

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

Consumer/Portable Medical Electronics

18

• Real-time diaper wetness sensor &

notification

• Impedance measurement

• RF connection

• University of Tokyo workSource: www.medgadget.com

Breadth of applications of bio-medical

sensing, connectedness will grow into

unforeseen places.

Even diapers are becoming smart…

We’ll need 1.375 Bunits/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/

2015 Future Technical Projects

Possible Projects• 3D Heterogenous Packaging:

– A working group needs to be formed with participation from all industry segments that seek miniaturization of their electronics. This group

can help drive development of multiple test vehicles to compare multiple technology options (First an Interconnect vehicle which can then

lead to a Functional demonstration of a Sense/Control/low power RF 3D package for medical applications). Participation from the Medical

PEG will help establish needed quality and reliability performance targets.

• Discrete Component initiative:

– Continuation of the High Density/High Rel ultra-dense capacitor work already in progress w. iNEMI support on the “Component specifications

for medical products” project. In particular, this effort will need to investigate alternatives to Ta/MLCC capacitors due to leakage concerns

impacting portable and implantable electronics.

• Cleanliness:

– New: Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?

• Development of low profile, compact miniaturized passives

• Development of higher density, miniaturized connectors -> 4K I/O in 1 inch. Too nichy?

• A scoping exercise to address component validation standards- already done.

• Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative,

high resolution serialization, other?)

• A scoping exercise should be conducted by iNEMI to determine the suitability of iNEMI participation in development of system

architecture

19

Thank You

Questions?

20

Project summaries –key learning and

potential new areas identified

Reliability Requirements for Implantable Medical

DevicesPhase 1 and 2

Project Leader: John McNulty, Exponent Failure Analysis

Associates, Inc.

Project Leader: Erik Jung, Medical Microsystems

Project Co-Chair:

Strategy Tactics Start: Anticipated End:

Issues Graphics

Focus Area:

Nov-14TIG:

Goal:Identify lacking 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

John McNulty (Exponent) and Erik Jung (Fraunhofer IZM)

• Survey data collection - conclusions & recommendations

• Detailed analysis of standards identified in the survey in addition to those identified by the working group with respect to:

– Product hierarchy (component vs. assembly)

– Test hierarchy (stress/screen vs. life test)

– Test specifications (maturity; utility)

– Body stresses (high or low; how well understood)

• 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 qualification test methods most applicable to implantable medical devices and identification of areas most in need of standards development will offer to the industry as well as to the patient a faster level of innovation, a higher profit, and lower personal and litigation risks

6/2013 7/2014

23

Focus Area:

Nov-14TIG:

Project Members

24

Medical Electronics

Medical

Defining Requirements for the Development of Implantable Reliability Specifications

Problem Statement

• The proposed 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)

• The situation is becoming more acute with recent developments in novel implantable electronic products, which cannot utilize traditional hermetic packaging (e.g. sealed Ti housings) in order to operate properly at the desired site (e.g. subcutaneous glucose monitors, retinal implants, brain-computer interfaces, etc.).

• Existing standards for products used in harsh environments do not cover the specific environmental conditions that an implant may see during long years of operation, e.g. X-ray screening, aggressive cell agglomeration, local changes in the ambient chemistry, thereby under- or over-estimating risk to the patient.

Scope of the Project

• Goal: Standardization of qualification test methods most applicable to implantable medical

devices and identification of areas most in need of standards development will offer to the

industry as well as to the patient a faster level of innovation, a higher profit, and lower

personal and litigation risks

• Our approach to achieving this goal is separated into three phases:

– Phase 1: Review of Reliability Standards Relevant to Implantable Medical Electronic Devices

– Phase 2: Gap Analysis

– Phase 3: Methodology Recommendations (dependent on feedback for Phase 2) – may

become separate working groups (WG)

Key Learnings:

• There are a few critical areas where there are insufficient medically-specific standards to guide manufacturers

& their supply chains:– RF performance: protocol security, broadband signal response, wireless charging, unintentional coupling, wireless

coexistence, and body area networks are all subtopics that require industry/government collaboration to develop

standards

– Biocompatibility/biostability: current standards lack accelerated tests to evaluate long term issues

– MRI: guidance on design to ensure device compatibility with rapidly evolving MRI tool capabilities

– Damp heat: acceleration models are needed for non-hermetic devices

• OEM involvement and sharing of information is key to the success of this and future projects

Reliability Requirements for Implantable

Medical Devices Project, Phase 2

27

Component Specifications for Medical Products

)

Chair: Peter Lampacher (Vibrant MED-EL)

Project

Leader(s):

Project Start:

Estimated End:

Purpose and Scope of Project Project Tasks

Status Update

Problem

Statement:

2929

Peter Lampacher, Vibrant Med-e

Need for Common Specifications for Medical Electronics Products, 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 for component manufacturers

Component Specifications for Medical Electronic Products

• Identify critical components for medical devices• Define a set of reliability qualification methods on a component

level for given critical component• To define: What is acceptable ageing of components and what is

failure mode?• To create guidelines for OCMs to utilize physics of failure based

reliability assessment• To create guideline for medical OEMs on how to assess OCMs

3/12

11/13

• To develop a method for developing a test and screen matrix for identified electronic components that can be used to qualify the reliability performance of components for electronic medical devices

• Provide standard reliability method that can be implemented by medical device manufacturers within their component management process

The project group worked with industry experts and OCMs to understand failure mechanisms for tantalum capacitors and prepared

recommendations for a test and screens matrix for tantalum capacitors. End of Project webinar on March 25th 2014

Focus Area:

Nov-14TIG:

Project Members

30

Medical

Medical

Component Specifications for Medical Electronic Products

Anticipated Outcomes and Benefits

• It is not possible to develop generic recommendations for

common specifications for electronic components for all

applications

However, we can:

– Reduce the resources expended presently on testing to unique

requirements

– Enable the faster introduction of new components and suppliers into the

supply chain

– Enhance the relationships along the supply chain

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Conclusions

There is a need for component level standards for medical applications

– A number of relevant screens and test methods exist, but they do not all consider the

unique requirements of medical devices applications.

– A methodical approach and commitment of resources are required,

– Ideally manufacturers in key areas of medical devices e.g. implantable should leverage

their resources and influence with the supply base to work together to define a standard

testing specification that would eliminate the need and cost of unique testing by the

OCMs

• Understanding the risk management process for medical device manufacturing is an

important point that must be considered by device manufactures and by suppliers

32

Component Specifications for Medical Electronic Products

33

Key learnings:

There is a need for component level standards for medical applications.

Understanding the risk management process for medical device manufacturing is an

important point that must be considered by device manufactures and by suppliers.

Qualification Methods for Portable Medical

Products

Project Leader: Grady White, NIST

Project Co-leader: Jack Zhu, Boston Scientific

Project

Leader(s):

Project Start:

Estimated End:

Purpose and Scope of Project Project Tasks

Status Update

Problem

Statement:

3535

Grady White, NIST

The lack of a standard methodology and qualification procedure is costing the industry. The medical electronics

industry is growing very quickly. The market is demanding quicker time to market particularly for portable medical

devices

Standard Reliability Performance Qualification Methods for Portable Devices

• This project is intended – To review existing standards and reliability performance

qualification procedures– to identify those procedures that can be applied to assessing

portable medical devices, – to identify any gaps/concerns in those procedures,– to obtain a set of procedures/recommendations acceptable to the

medical electronics industry for assessing reliability of portable medical electronic devices

3/12

11/13

• Focus on the portable medical devices, including the stand alone devices , wearable and the peripheral devices in the implantable systems.

• Leverage OEM, EMS and other expertise to identify current best practices in assessing reliability of portable electronic devices and apply them to medical applications

• An industry wide approach to qualifying the reliability performance of medical devices will enable the industry to grow faster

The project group reviewed test methods, reliability testing and standards being used in the industry.

The team is preparing a final report that will contain a review of the industry status for qualification of portable electronic medical devices, a listing

of current industry approaches and relevant standards. There will be discussion on identified gaps and recommendations on gap mitigation

procedures and next steps. End of project webinar on March 27th

Focus Area:

Nov-14TIG:

Project Members

36

Medical

Medical

Qualification Methods for Portable Devices

• What the Project Is: Develop a set of procedures/recommendations acceptable to the medical electronics industry for assessing reliability of portable medical electronic devices. An industry wide approach to qualifying the reliability performance of medical devices will enable the industry to grow faster– It will shorten the time to market and also the time to adopt and integrate new technologies into

portable electronic medical devices.– It will provide regulatory bodies with standardized criteria for acceptance of new devices or device

designs – An industry wide qualification method that is supported across the supply chain will reduce

redundant costly testing and increase confidence in the qualification procedure. • What is next for the Project:

– The team is preparing a final report that will contain a review of the industry status for qualification of portable electronic medical devices, a listing of current industry approaches and relevant standards. There will be discussion on identified gaps and recommendations on gap mitigation procedures and next steps

Standard Reliability Performance Qualification Methods for Portable Devices

37

• Anticipated project goals:– A comprehensive survey of existing reliability testing practices relevant to

portable medical devices– Identification of relevant standards and gaps or opportunities for new standards

Dissemination of results through iNEMI forums, conferences, and white papers

• Business Impact:– Clear insight for participating device manufacturers and electronic component

suppliers regarding current test methods and their limitations for particular device technologies and/or device environments

– Stimulation of standards development efforts– Harmonization of test needs and methods across the medical electronics

industry

Identify a set of procedures/recommendations acceptable to the medical electronics industry

for assessing reliability of portable medical electronic devices

Anticipated Outcomes and Benefits

38

Key learnings: • ESSENTIAL PERFORMANCE criteria must be considered throughout the fabrication process as

part of the manufacturer’s Risk Management assessment.

• A process flow that can guide the development of the qualification methods by end use

manufacturers has been identified

• Important gaps in the available standards for portable medical devices have been identified, e.g., – RF communication, interference, security

– Biocompatibility between device and body at attachment points

– Synergistic effects (multi-axis and impact mechanical loading, electrical/mechanical/environmental interactions)

Standard Reliability Performance Qualification Methods for Portable Devices

39

Review of Recent Medical symposium

Bill Bader

Medical Symposium

Co hosted with SMTA and MEPTEC

Approx 240 attendees - 49 Exhibitors - 39 speakers

Track 1: Components and Designs for Higher Density Functionalities --

Track 2: Solutions for Best-in-Class Assembly and Volume Manufacturing --

Track 3: Next-Generation Microelectronics for Changing Healthcare Markets

Keynotes:

Digital Health and the Connected Consumer

Matthew Hudes, U.S. Managing Principal, Biotechnology, Deloitte Health Sciences

What can Medical Devices Leverage from Consumer Electronics?

Chandra Subramaniam, Vice President CRDM Research & Development, Medtronic

Ensuring Quality Medical Devices Meet Regulatory Scrutiny in the Face of Industry Cost Pressures

Mike Tendick, Healthcare/Life Sciences Market Sector Vice President, Plexus

Follow up webinar for iNEMI members interested in medical electronics scheduled for Nov 5th

2014

at 11am EDT. http://www.inemi.org/events/inemi-webinar-medical-projects

Medical Symposium

Medtronic Key Note needs:

· Low Power advanced packaging

· High Reliability 3D integration

· High density batteries at low cost

· Lower power wireless with privacy and security

Other :

· Need for RF interoperability definition and appropriate standards dev.

· Incremental work on characterizing flexure for bendable applications, reliability testing etc.

· Measurements and test method for peel test of flexible/wearables

· Health data analysis tools and techniques (big interest of MSEI)

· Medical industry access to key players throughout the supply chain on advanced

miniaturization

· Medtronic panel discussion item ( Mark Ricotta Medtronic) – Definition of aligned

miniaturization elements looked at from a system integration standpoint – Implications are scaling

in size is well aligned of all critical system pieces and parts. Not useful to just shrink one part or

package.

43

Discussion topics - inputs

• 3D integration

– For implantables

– For portables

• Industry Test Vehicle development

– Interconnect testing

– RF module in the mixed band with 3D technologies e.g. Embedded components

Areas of common interest - inputs

•Biocompatibility

•Environmental regulations

•Supply chain readinessMaterials

•Integrity of supply

•Counterfeit

•Long life time of products

•Liability

Supply chain

•Interoperability

•Data SecurityCommunication

Reliability

• Impact of changes in Europe. e.g. common parameters for assessment of suppliers.

• UDI – how should we do this?

• Do we need regulators involved and when

• Need to be aware of the AMMI & UL std work -

•Types of testing & standards

•Consumer reliability vs. Medical requirements

•Software

45

Potential Long term Future Technical Projects - Inputs

• 3D Heterogenous Packaging:

– Need for test vehicles and components to investigate miniaturization for electronic devices with RF and sensoring. and processes. A working group

needs to be formed with participation from all industry segments that seek miniaturization of their electronics. This group can help drive development

of multiple test vehicles to compare multiple technology options (First an Interconnect vehicle which can then lead to a Functional demonstration of a

Sense/Control/low power RF 3D package for medical applications.

• Discrete Component initiative:

– Continuation of the High Density/High Rel ultra-dense capacitor work already in progress w. iNEMI support on the “Component specifications for

medical products” project. In particular, this effort will need to investigate alternatives to Ta/MLCC capacitors due to leakage concerns impacting

portable and implantable electronics.

• Cleanliness:

– New: Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?

• Development of low profile, compact miniaturized passives

• Development of higher density, miniaturized connectors -> 4K I/O in 1 inch. Too nichy?

• Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative, high

resolution serialization, other?). How to implement to UDI (Unique Device Indicators)

• Supply Chain

– How to be prepared for more stringent assessment of supply chain for medical applications as being driven in Europe.

45

Key Potential Projects AreasPre standards work

Critical areas where there are insufficient medically-specific standards to guide manufacturers & their supply chains:

– RF performance: protocol security, broadband signal response, wireless charging, unintentional coupling, wireless coexistence, and body area networks are all subtopics that require industry/government collaboration to develop standards

– Biocompatibility/biostability: current standards lack accelerated tests to evaluate long term issues

– MRI: guidance on design to ensure device compatibility with rapidly evolving MRI tool capabilities

– Damp heat: acceleration models are needed for non-hermetic devices

– Synergistic effects (multi-axis and impact mechanical loading, electrical/mechanical/environmental interactions)

Enable low power Miniaturization / 3D Heterogeneous Packaging:

– Need for test vehicles and components to investigate miniaturization for electronic devices including RF and sensing

– Need for low power

Supply chain

– How to handle the Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative, high resolution serialization, other?).

– How to implement the UDI, particularly in miniaturized devices (Unique Device Indicator)

– How to enable the Integrity of supply chain for medical applications so that it meet the assessment criteria of regulators and notified bodies

Manufacturing related

– Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?

– Development of low profile, compact miniaturized passives

– Incremental work on characterizing flexure for bendable applications, reliability testing etc

– Measurements and test method for peel test of flexible/wearables

46

Review of 2015 Initiative Process

Project Selection/Initiation

• Projects must be beneficial to all project participants.

– Pre Competitive in Nature. Not core IP development

– Level Playing Field at End Game desirable

– Benefits of shared R&D Desirable and Needed

– Works when supply chain players are not vertically oriented

– Development of knowledge and data not otherwise doable by individual companies or

firms.• Requires design, assembly, test, modeling, characterization, stress testing (or subset of above)

• Requires subset of industry leaders to agree on best known practices with end goal of

stakeholder alignment.

• Can result in industry organized standards or white papers.

– Preparing inputs for members survey at the end of the year to identify projects of interest

and critical mass to lead them.

iNEMI Project Process Flow

Initiative raised

• Member company/Workshop/Survey output

• Committee members/Project teams

• Roadmap gaps/Technical plan/Research priorities

Planning

• Facilitated by iNEMI staff/Identify leaders

• Develop statement of work & project statement agreement

• Approve by iNEMI Technical Committee

Project execution outputs

• Knowledge/ results for the project team members

• White paper/Industry survey report

• Common specification/Recom-mendation on standard

• Presentation/paper at conference/Project report/webinar

Potential Project Area

• Need leaders

• Need participants

Actions and Next steps

• Review the inputs

• Identify potential project areas

• Input need by Dec 10

• Discuss with iNEMI and determine if the critical mass is there to

1. Develop a project plan (iNEMI Initiative phase – 1-3 months)

2. Commence a collaborative project to deliver on indentified need (typically 8-10 iNEMI

member team, project length typically 12-18 months)

52

www.inemi.orgEmail contacts:

Grace O’Malley

gomalley@inemi.org

Bill Bader

Bill.Bader@inemi.org

David Godlewski

dgodlewski@inemi.org