Review of iNEMI Medical Initiativesthor.inemi.org/webdownload/projects/Medical/... · 7 Digital Health •Patient care enhancement -New and Unique Medical Products -Monitor Systems

Review of iNEMI Medical Initiatives

Nov 10, 2011

2

Agenda

• Objective

• Background

• Medical Initiatives:

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

– Team 2: Common Specifications for Electronic Components in Medical Devices

– Team 4: Reliability Performance Qualification Methods for Portable Devices

• Process from here

• Introduction to Teams 3 & 6; Starting Up in November

• Summary

• Contact Details

3

Objectives of this Session

• Present overview of the 3 Medical Initiatives that are

coming to competition.

• Share the process moving forward to engage you and

key industry players in collaborative R&D

• Define the steps and timeline for follow through to

create effective collaborative projects

– That deliver results and business impact.

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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 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.

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Current Members with Medical Focus

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Medical PEG: 2011 Chapter Focus

Market Environment and Economics of Medical Electronics

• 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 increase in India and China.

• High Growth of Tele-Medicine using multi functional portable devices.

• Continued migration from prescriptive to preventive medicine will drive increase in portable/wearable medical monitoring devices.

• Unknown business implications and potentially increased regulatory changes could materialize based on health care legislation.

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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 past 10 years, growth, innovation and miniaturization have lead to major

advances in medical electronics manufacturing and the therapies they deliver.

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Diagnostic Imaging

• Patient-centric, clinician-centric environment

– Comfort

– Workflow

• Demands for higher resolution maybe abating

• Demands for greater imaging volumes not

abating

• Anatomy defines package volumes

– More bits per cubic inch translates to

higher functional densities

• Portable systems for “baseline” diagnostics

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Identification of Opportunities for Collaboration

Seven potential projects/initiatives were indentified

as a result of iNEMI 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 a

Statement of Work (SOW) in 3Q11 and aim to send them to

the Technical Committee (TC) on Dec 1, 2011.

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iNEMI Medical Initiatives – May 2011

Medical Initiative No. 1

Defining Requirements and Development of

Specifications for Reliability of

Implantable Medical Electronics

John McNulty,

Exponent

&

Erik Jung,

IZM

12

Agenda

• Project Motivation

• Project Scope

• Project Goals

• Companies involved in initiative

• Contact details

13

Defining Requirements and Development of Specifications for

Implantable Reliability of Medical Electronics

Original Problem Statement:

Absence of expertise and proven/accepted best known practices in reliability for the medical products

Desired Project Goals:

– Create a library of the physics of failure by product type.

– Develop a reliability test suite library that is specific to the failure modes they are most effective with addressing Body-device interactions

– Address unique needs for bare die encapsulation & for bare modules

– Once these are in place; probability of failures occurring database can be more effectively put in place

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Specifications for Reliability of Medical Electronics

Background

• 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).

• Today´s standards for reliability testing - applied for the

development and pre-market evaluation of an implant, are derived

from typically harsh environmental operation standards, e.g.

military, automotive or avionics.

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Background (continued)

• Currently, reliability test methods and data for a specific

manufacturer and product may be available for a specific use case

• Knowhow is typically not spread to OEM´s – leading to the absence

of established standards. Consequences include:

– Multiple re-iterations of a product design due to pre-market

failures

– Missed opportunities on overall product cost reduction due to

unnecessary re-iterations

– Placing patients at risk due to non-sharing of risk factors gained

by other industry participants

– Litigation risks for failures after several years of operation

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Specifications for Implantable Reliability of Medical

Electronics Scope of Work (continued) Standardization of test routines will mitigate these factors and offer

to the industry and patient a faster level of innovation, a higher profit, and lower litigation risks.

The approach to achieving this target is separated into three

phases:

Phase 1:

Review of Reliability Standards Relevant to Implantable Medical Electronic Devices

Phase 2:

Gap Analysis and Protocol Development

Phase 3:

Methodology Recommendations (t.b.d.)

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Phase 1 Goal: • Identification and compilation of existing reliability, quality, and

safety standards specific to implantable electronic devices • Applicable and relevant to a broad range of implantable electronic

technology

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

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Scope of Work:

Identification/compilation of existing reliability/quality/safety

standards specific to implantable electronic devices

Task 1:

Group input on existing standards specific to implantable

electronics (see preliminary slides on standards added to this file)

Task 2:

Survey the industry:

1. Existing standards

2. Most frequently referenced/modified standards from other

industries, i.e. MIL-883F, method 1015.9 (burn-in)

3. Custom reliability tests/standards (this may get to the core of the

issue in terms of what needs to be standardized)

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

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Task 1 - Protocol Development (Determination of in vivo Device

Conditions)

Background:

– For micro-implants - many governing boundary conditions are

unknown.

– Determine which parameters are relevant for long term

reliability

– Brain/computer interfaces - reliability

Phase 2 – Gap Analysis and Protocol Development

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Task 2 - Protocol Development (Determination of in vivo Device Conditions)

Scope of Work:

– Develop a protocol, which will lead to a test methodology for a

new device:

• Risk factors: issues for implantable devices that are not

immediately apparent

• Think beyond established ISO standard frameworks -

leading to FMEA - and start the definition of a standard

Phase 2 – Gap Analysis and Protocol Development

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FMEA - to define one or more of the following as a project

• Preliminarily ranked in descending order of preference

– Recommendations for standards development or further investigation

– Review on Physics of Failure (PoF) with respect to identified issues

– Identify conflicting PoF and test methods (e.g. high thermal storage for low Tg polymeric encapsulants…)

– Prioritize environmental, mechanical, radiation (common source X ray), and MRI testing

Phase 3

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Organizations that have participated in this Initiative

• ASEN Suzhou Semiconductors

• CMTC Associates

• Cochlear

• dfrSolutions

• Eitny

• Exponent

• Flextronics

• GE

• HDP User Group

• Henkel

• IBM

• IEC Electronics

• IMEC

• Medical Microsystems

• Medtronic

• Micro Systems Engineering Inc

• Molex

• NIST

• Plexus Corporation

• Premier Semiconductor Services

• PWB Corp

• Rogers Corp

• St. Jude Medical

• Texas Instruments

• Tronics

• URS Corp

• Zarlink Semiconductor

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Contact Details

Chair

• Erik Jung - Medical Microsystems

– Email: [email protected]

Chair

• John McNulty – Exponent


iNEMI

• David Godlewski - iNEMI


– Tel: 717-651-0522

mailto:[email protected]




Common Specifications

for Medical Electronic Products

Diganta Das, CALCE

& Peter Lampacher,

Vibrant Med-el

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Agenda


• Project Scope

• Project Goals

• Tasks and timeline

• Potential Benefits

• Companies involved in initiative

• Participants needed

• Summary

• Contact details

26

Project Motivation

• Need for Common Specifications for Medical

Electronics 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 for component

manufacturers since every medical device OEM can

have different requirements; often making them

unresponsive to the medical device market

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Purpose of the Project • The primary purpose of the project will be to develop a method for

developing a test and screen matrix for electronic components that

can be used to qualify the reliability performance of components

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.

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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

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Anticipated Benefits and Outcomes

Recommendations for common specifications for

medical components and manufacturing capacity of

OCMs (original component manufacturers) that meet

the test, performance, and reliability needs of

implantable and wearable medical products.

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Project Tasks & Timeline

– Task 1 Determine the coverage of the components for the first

phase (Months 0 – 3)

– Task 2 Identify the most common defects, degradation and failure

mechanisms of the selected items under medical device

applications (Months 3 – 6)

– Task 3 Determine the screens for identification of the defects and

tests for precipitation of the mechanisms (Months 6 – 15)

– Task 4 Create a minimum set of tests and screens related for each

part referring to industry standard methods whenever possible

(Months 10 – 17)

– Task 5 Final report including a methodology description on the

process of developing the tests and screens for other parts (Month

12-18)

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Possible Follow-On Activities

• Create new tests and screens when none are applicable

in the industry standards

• Expand to other types of components (including

possibly non-electronic components)

These can be future iNEMI projects or can be company

specific activities

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Method of Project Implementation

• Task 1 will be achieved through web based survey

followed by data analysis by the core team

• 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

33

Organizations that have participated in this

Initiative

• CALCE

• Med-el

• ATS

• AVX

• Benchmark electronics

• Boston scientific

• Celestica

• CALCE

• DfR Solutions

• EITNY

• Exponent

• Fairchild Semiconductor

• GE Research

• Indium

• Kemet

• MSE

• Molex

• NIST

• Northrop Grumman

• Valtronic

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Organizations that Would Benefit from

Participation

• Medical Device OEMs

• EMS companies that source part for OEMs

• Original Component Manufacturers (OCMs)

• Testing companies

• Industry standard bodies

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Summary

• With this industry led project, medical device industry

will emulate the processes successfully followed by

other low volume complex electronic system

manufacturers such as avionics and automotive to

create practical solution to component availability

problems

• Development will help create a trusted relationship

between OEMs and OCMs and reduce problems of

availability shocks

• It will also help create alternate part sources more

easily

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Contact Details

• Diganta Das - CALCE, University of Maryland, USA


– Tel: +1 301 405 7770

– Fax: +1 775 218 5209

• Peter Lampacher - VIBRANT MED-EL, Innsbruck, Austria

– E-Mail: [email protected]

– Phone: +43 (0)512 – 28 88 89 – 256

– Fax: +43 (0)512 – 28 88 89 – 299

• Grace O’Malley - iNEMI


– Tel: +353 87 904 0363

• Jim Arnold – iNEMI


– Office (East): +1 978 649 4717

– Office (West): +1 480 854 0906

– Mobile: +1 480 703 0133






Reliability Performance

Qualification Methods for Portable Devices

Jack Zhu,

Boston Scientific

&

Grady White,

NIST

38

Agenda


• Project Scope

• Project Goals

• What the project IS/ IS NOT

• Project tasks and timeline

• Anticipated Benefits & Outcomes

• Organizations that have participated in this Initiative

• Contact details

39

Project 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 slow to introduce new technologies and products.

• 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 (NPI) 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.

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Project Scope – 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 device 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.

• There is an urgent need for medical device manufacturers and supplier industries both to understand and to optimize qualification requirements and, concomitantly, device reliability.

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Project Goals

• The primary purpose of the project is to provide a methodology that can be used to qualify reliability performance of portable electronic medical devices.

• The greater emphasis on reliability for medical electronic devices than for comparable non-medical devices underscores the need for industry accepted reliability assessment procedures for medical device applications

• It is anticipated that this project will result in a standard reliability method that can be implemented in those cases for which the failure mechanisms or test methodologies are known

• For those situations in which the failure mechanisms or test methodologies are not known, it is anticipated that this project will provide part of a more complex solution.

42

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

43

Project Tasks & Timeline • Months 1 – 2: (Task 1) Identify companies and champions to lead

investigations

– Select and identify task leaders

– Select and identify task members

• Months 3 – 5: (Task 2) Identify tools and methodologies that already exist

– Identify extant reliability tools and standards

– Identify gaps in tools and needed standards

• Months 6– 12: (Task 3) Decide how to address the identified gaps

– Identify extant tools that cover all or most of the gaps

– Identify potential solutions for identified gaps

– Identify needed additional knowledge (e.g., external expertise, required research, additional statistical tools)

• Months 13 – 15: (Task 4) Conclusion of the project

– Define appropriate reliability standards protocols

– Identify remaining needs

– Agree upon transition of results to appropriate standards organization

• Month 16: (Task 5) Final report

– Final report to iNEMI

44

Anticipated Benefits & Outcomes

• Business impact:

– A standardized qualification process reduces the overall qualification cost because time will be reduced and OEMs will no longer need to spend money and resources to define a process every time they introduce a new portable device. They will be able to utilize existing standards that are defined for various devices.

• Outcome of Project:

– Will include a final report that contains a review of the industry status for qualification of portable electronic medical devices, a description of the assessment procedure, and a listing of current industry approaches with detailed discussion of identified gaps and gap mitigation procedures.

45

Summary

• This activity is intended to:

– Combine OEM and EMS expertise to identify current

best practices in assessing reliability of portable

electronic devices,

– Identify those procedures that can be applied to

assessing portable medical devices,

– Identify any gaps in those procedures, and

– Obtain a set of procedures acceptable to the medical

electronics industry for assessing reliability of

portable medical electronic devices.

46

Organizations that have participated in this

Initiative

• Boston Scientific

• NIST

• CALCE

• MSI

• Imec

• DfR Solutions

• EITNY

• Benchmark electronics

• Atotech

• Cochlear

• Delphi

• Exponent

• GE Medical

• Imec

• Kemet

• Medtronic

• Med-el

• MSE

• Philips

• Texas instruments

• Toshiba

• Tyndall Institute

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Contact Details Chair

• Grady White - NIST


– Tel: 303 497 4638 & Mobile: 240 731 2501

Co –Chair

• Jack Zhu – Boston Scientific


– Tel: 661 949 4473 & Mobile: 626 698 2011

iNEMI

• Grace O’Malley - iNEMI


– Tel: +353 87 904 0363

• Jim Arnold – iNEMI


– Office (East): +1-978-649-4717

– Office (West): +1-480-854-0906

– Mobile: +1-480-703-0133

Next Steps We Estimate These Three Initiatives Will Move to

Projects in Early December

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SELECTION

DEFINITION

PLANNING

EXECUTION / REVIEW

CLOSURE

1

2

3

4

5

The Project Process - 5 Steps

Limited to Committed Members

Open for Industry input

------------------- iNEMI Technical Committee (TC) Approval Required for Execution

Goal is to submit Statement of Work (SOW)

To Technical Committee (TC) on Dec 1, 2011

50

Actions from here

• Review SOWs

• Attend remaining team calls

• Submit feedback to the chairs of the initiatives

• Technical Committee review in Dec 2011

• Six week sign up Period

• Project Start by 1/15/2012

51

And…Two New Initiatives Will Start Up in November

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Initiative # 3: Supply Chain

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.

53

Initiative #3: Supply Chain Desirable Outcomes (not in priority order):

• Create widely available information on component and supplier

capabilities

• Need to stimulate supply base for medical (components, materials, etc.)

• Consider looking at combined needs of military & medical

• Development of data declaration standards for medical – electronically

transferrable

• Liability indemnification

• Clarity of supplier/OEM business models that support:

– NPI for innovative new products

– Change Control and Product Requalification

– Support requirements for long life products

• For REM’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

• Clarity of OEM/Supplier operating agreements (e.g. BKM templates)

54

Initiative # 6: MRI/X-ray & Implantable compatibility

• Problem: Existing MRI and X-ray technologies are not compatible

with electronic implantable devices – limits treatment options for

patients with implants

• Desirable Solution: Imaging products & protocols that are more

friendly to patients with implants

– Device compatibility for implantable devices & imaging equipment

– Patient safety

– Acceptability from FDA; involve them up front

– Check on knowledge base from interventional MRI

– Study work underway by other groups working this issue

• Big Players for needed from the following market segments:

– Imaging Equipment

– Cardiac Implantable

– Cochlear Implants

– Implantable battery and lead OEM’s

www.inemi.org Email contacts:

David Godlewski [email protected]

Jim Arnold [email protected]

Grace O’Malley [email protected]

Documents

Review of iNEMI Medical Initiativesthor.inemi.org/webdownload/projects/Medical/... · 7 Digital Health •Patient care enhancement -New and Unique Medical Products -Monitor Systems