Measurement Methods for nist

Evaluation of the Reliability of Active pubnStion

Implantable Medical Devices 1047'^^

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Report of a Workshop Held October 3-4, 2005

Gaithersburg, Maryland

Elizabeth S. Drexler

William F. Regnault

John A. Tesk

NISTNational Institute of Standards and Technology • Technology Administration • U.S. Department of Commerce
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'At Boulder, CO 80305 'Some elements at Boulder, CO
NIST Special Publication 1047

Measurement Methods for Evaluation of the

Reliability of Active Implantable Medical Devices

Report of a Workshop Held October 3-4, 2005

Gaithersburg, Maryland

Elizabeth S. Drexler

Materials Reliability Division

Materials Science and Engineering Laboratory

National Institute of Standards and Technology

Boulder, CO 80305

William F. Regnault

Center for Devices and Radiological Health

Food and Drug Administration

Rockville, MD 20850

John A. Tesk

Polymers Division

Materials Science and Engineering Laboratory

National Institute of Standards and Technology

Gaithersburg, MD 20899

May 2006

U.S. Department of Commerce

Carlos M. Gutierrez, Secretary

Technology Administration

Robert Cresanti, Under Secretary of Commerce for Technology

National Institute of Standards and Technology

William A. Jeffrey, Director
Certain commercial entities, equipment, or materials may be identified in this document in order to describe an experimental procedure or concept adequately. Such identification is not intended to imply

recommendation or endorsement by the National Institute of Standards and Technology, nor is it intended to imply that the entities, materials, or equipment are necessarily the best available for the purpose.

National Institute of Standards and Technology Special Publication 1047

Natl. Inst. Stand. Technol. Spec. Publ. 1047, 52 pages (May 2006)

CODEN: NSPUE2

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 2006

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325
CONTENTS

Executive summary 1 Agenda 3

Objectives of the Workshop 5

Session Discussion Guidelines 6

Plenary Session I: Abstracts 7

Plenary Session II: Abstract 9

Plenary Session III: Abstract 10

Plenary Sessions I-III: Open Discussion 1

1

Working Session I: Abstracts 12

Working Session I: Open Discussion 14

Working Session II: Abstracts 16

Working Session II: Open Discussion 17

Working Session III: Abstract 19

Working Session III: Open Discussion 20

Working Session IV: Abstracts 22

Working Session IV: Open Discussion 23

Working Session V: Open Discussion 24

Summary Sessions I and II 25

Conclusions and Summary Recommendations 26

Biographies of Speakers 27

List of Attendees and Participants 35

Comments from Organizing Committee 44

Open Comments from Attendees 47

Appendix: CD of Presentations

iii
Disclaimer

The Notes from the Working Sessions included herein are as they were set down by our

recorders. They were compiled during an open discussion with consensus from the group and

the discussion was interpreted by our recorders. Only misspellings and obvious

misinterpretations of the spoken word have been corrected in this published version.

iv
Executive Summary

The US market for active implantable medical devices (AIMDs) was nearly $4.9 billion

annually in 2002 and is projected to more than double by 2007 due to aging demographics,

product advances, and changing patient-care strategies, according to the 2003 report from the

Freedonia Group, Inc. Recent recalls and publicized failures of active implanted medical devices

have highlighted the need for improved device reliability and a more visible response by the

device manufacturers to concerns of the American people and the Food and Drug Administration

(FDA).

The workshop on Measurement Methods for Evaluation of AIMDs was held on October 3

and 4, 2005 in Gaithersburg, MD. The workshop was well attended, with 94 registrants.

Fourteen device manufacturers were represented, 30 registrants were from the FDA, and eight were from the National Institute of Standards and Technology (NIST). The goal of the workshop

was to help identify the technical and measurement issues that are involved in the use of both

national and international standards for the assessment of the reliability of AIMDs, and to help

define areas for future work that will facilitate the rapid deployment of advanced implant

technologies. Specifically, the workshop sought answers to the following questions;

How have manufacturing methods for active implantable medical devices changed over

the past 20 to 25 years, and how have the sources and mechanisms for failure been

affected?

What are the conditions for assessing the overall reliability of a device? What else may

be needed in addition to ISO 9000?

How are end-point reliability measurement results for individual device components

integrated into assessment of overall reliability; how should synergistic effects be

assessed?

What new measurement and analysis methods may be employed to improve assessment

of reliability?

Are there specific test methods that need to be developed for application to devices

fabricated under different means?

What is the relative importance of fabrication quality management vs. end product test measurements?

How can government, academic, and industrial resources be applied most effectively in

the development of medical device standards (e.g., development of measurement

methods as a basis for standards, compilation of critical data as a basis for regulatory

decisions, etc.)?

Plenary Session I opened the workshop with three speakers from the FDA, who discussed

regulations, standards, and the patient's perspective. The following plenary sessions covered

"designing for device reliability" and consensus standards. Since this was the first time that the

AIMD companies all gathered under one roof, the agenda was set with experts in various aspects

of reliability to kick off the discussions during the working sessions. Working Session I focused on plausible failure mechanisms inside the can, such as electronic and hermedc reliability issues.

Corrosion and mechanical degradations of the can itself were the focus of Working Session II, to complete Day 1. On Day 2, the topic for Working Session III was choosing accelerators for

predicting reliability and lifetimes. Engineers from two device manufacturers spoke during

1
Working Session IV, one about designing for impact prior to implantation, and the other on

rehability standards and practices, specific to their own companies.

For each Working Session the speakers were followed by a period of open discussion and

questions to identify action items pertaining to the workshop goals. The open discussions

covered a wide range of topics, the contents of which are provided in bullet fonnat following the

abstracts for the working session in this report.

Reliability issues that we inferred from the discussions during the working sessions are:

The physical and chemical environment: does it change based on location in the body?

What happens at the interface between biological and engineered materials?

What are the mechanisms by which water accumulates within the can? Should improved

test methods be developed to detect smaller leaks in smaller volumes?

How do interfaces and electrical components respond to that moisture?

Is it possible to modify or improve test standards to bring potential in vivo failure

mechanisms to light? What, if any, are the appropriate accelerants for determining

lifetimes?

How should the use envelope be defined to account for the spectrum of physiques and

activities of patients in whom the device will be implanted? How do parameters such as impacts, falls, torque, G forces, etc. affect the physics of the device in vivo!

How do assembly, manufacturing, transportation, and storage stress the devices?

Which animal models are appropriate for a particular system?

At the end of the second day. Working Session V: Reliability Issues for Future Devices, and

Summarizing Working Sessions I-IV were held concuiTcntly. The items discussed in those

sessions are also provided in this volume in bullet format.

The speakers brought to the workshop a wealth of knowledge that is pertinent to AIMD.

Outside (the industry) experts from universities, microelectronic powerhouses, and the military

provided key insights into leak detection and residual gas content, corrosion, designing for and

predicting reliability, microelectronic fabrication and reliability testing, and writing consensus

standards. All agreed to participate in this workshop because they believe that designing reliable

AIMDs is imperative, and they felt that they could contribute to that goal.

The workshop ended with the identification of some definite needs. These included the need

for standard leak reference materials for leak rates three orders of magnitude lower than those

currently available, validated test methods for measuring such leak rates, and models for

calculating leaks rates from flaws of various geometrical and material combinations at the design

stage and for helping validate leak rate measurements on a reliably repeatable basis.

It was agreed that one or more follow-up workshops are desired. However, the size, topic

and format of that (those) workshop(s) should be determined by a planning committee that

includes representatives from the FDA, NIST, and the AIMD Industi"y. Further input is sought

from interested parties and should be conveyed to Elizabeth Drexler at NIST

(Drexler@boulder.nist.gov).

2
Agenda

OCTOBER 3, DAY 1 8:00 a.m. Registration & Continental Breakfast

8:55 a.m. Introductions, Moderator, John A. Tesk

9:00 a.m. Welcome to the Workshop, NIST & the FDA RichKayser NIST

9:10 a.m. NIST & Biomaterials Lori Henderson NIST

9:20 a.m. Introduction to the Workshop Issues William F. Regnauh FDA

Plenary Sessions I, II & III Moderator, William F. Regnault, FDA

9:35 a.m. Plenary Session I 9:35 a.m. Patient Perceptions Leading to Explanation James Kane FDA

10:00 a.m.. Post-Market Regulation of Medical Devices Betty Collins FDA

10:25 a.m. GMP Regulations and Standards Jan Welch FDA

10:45 a.m. BREAK

11:00 a.m. Plenary Session II—Designing for Intended Use and Reliability Ali Mosleh U MD

11:30 a.m.Plenary Session III—MIL-STDS and Consensus Standards: Their Utility and their

Inference for Device Reliability

1 1 :30 a.m. What Standards are Needed? Celeste Null Intel

12:00 a.m. Issues Surrounding the Use of Standards and Test Methods: Open Discussion

12:30 p.m.Lunch. NIST Cafeteria

Working Sessions I & II Moderator, Elizabeth S. Drexler, NIST

1:30 p.m. Working Session I—Plausible Mechanisms for Failure: Mechanisms Inside the Can

Session Chair: Jack Martinez NIST

1:30 p.m. Chip-Level Design: Developments, Failure Mechanisms and Reliability Testing

KenRodbell IBM

1:50 p.m. Package-Level Design: Developments, Failure Mechanisms and Reliability Testing

Robert Munroe (Retired) Motorola

2:10 p.m. Residual Gas Content and Ionic Content Bob Thomas (Retired) Rome AFB

2:30 p.m. Answers for Advice that the Workshop Seeks (see Session Chair's Guide)

3:30 p.m. BREAK

3:45 p.m. Working Session II—Plausible Mechanisms for Failure: Mechanisms Outside the

Can

Session Chair: Michael Schen NIST

3:45 p.m. Corrosion Issues Robert Baboian RB Corrosion Service

4:05 p.m. Impact, Trauma, and Vibration Issues Dominick Hammerer Med-El

4:25 p.m. Answers for Advice that the Workshop Seeks (see Session Chair's Guide)

5:25 p.m. End of Day 1 OCTOBER 4, DAY 2

7:45 a.m. Registration & Continental Breakfast

Working Sessions III & IV Moderators, Elizabeth Drexler, NIST & John Tesk

8:45 a.m. Working Session III—Measurements for Accelerated Reliability Testing of Packages

Session Chair: Stan Piirwin Johns Hopkins University Applied Physics Laboratory

8:45 a.m. What are the Proper Accelerators for Predicting the Reliability of Active Implantable

Medical Devices? Michael G. Pecht U MD

3
9:05 a.m. Answers for Advice that the Workshop Seeks (see Session Chair's Guide)

10:05 a.m.BREAK

10:20 a.m. Working Session IV—Medical System Concerns- Manufacturers' Perspectives

Session Chair: Keith McLain Advanced Bionics Inc. 10:20 a.m. Medical System Concerns—Manufacturers' Perspective David Erhart Medtronic

10:40 a.m. Cochlear Ltd. Internal Reliability Standards and Practices

Edmond Capcelea Cochlear Corporation

1 1 :00 a.m. Answers for Advice that the Workshop Seeks (see Session Chair's Guide)

12:00 p.m.Lunch, NIST Cafeteria

1:00 p.m. Drafting of Workshop Sessions I, II, III & IV Summaries

(Dining Room B: Session 7, J. Martinez, K. Rodbell, R.Munroe, B.Thomas;

Session II, M. Schen, R. Baboian, D. Hammerer)

(Room A149, Bldg 224, Polymers: Session III S. Pm-win, M. Pecht;

Session IV, K. McLain, D.Erhart, E. Capcelea)

1:00 p.m. Working Session V—Reliability Issues for Future Devices,

Moderator, Elizabeth Drexler NIST

Session Chair: John Suehle NIST

(Session V is open to all except the previous session chairs and presenters from those

sessions who wish to work with their session chairs on developing Summary

Recommendations)

2:15 p.m. Conclusion and Summary Recommendations Moderator, W. F. Regnault, FDA

Who is to do what?

Where is the work to be done?

How is the work to be accomplished?

Is there a need for a follow-up workshop or symposium?

3:00 p.m. End of Workshop

Plannins Committee

William F. Regnault, Centerfor Devices and Radiological Health, FDA & Guest

Researcher, NIST

Elizabeth S. Drexler, Materials Reliability Division, NIST

John A. Tesk, Consultant & Guest Researcher, NIST

Michael Schen, Advanced Technology Program, NIST

Workshop Scribes

Tonya Icenogle, Centerfor Devices and Radiological Health, FDA & Guest

Researcher, NIST

Tithi Dutta Roy Postdoctoral Fellow, Biomaterials Group, Polymers Division, NIST

4
Objectives of the Workshop

Purpose:

To help identify the technical and measurement issues that are involved in the use of both

national and international standards for the assessment of the reliability of active implantable

medical devices, and to help define the areas for future work that will facilitate the rapid

deployment of advanced implant technologies.

Topics:

The workshop seeks insight to answers for the following questions:

• How have manufacturing methods for active implantable medical devices changed over

the past 20 to 25 years, and how have the sources for failure mechanisms been affected?

• What are the conditions for assessing the overall reliability of a device? What else may be

needed in addition to ISO 9000?

• How are end-point reliability measurement results for individual device components

integrated into assessment of overall reliability; how should synergistic effects be assessed?

• What new measurement and analysis methods may be employed to improve assessment of

reliability?

• Are there specific test methods that need to be developed for application to devices

fabricated under different means?

• What is the relative importance of fabrication quality management vs. end product test measurements?

• How can government, academic, and industrial resources be applied most effectively in

the development of medical device standards (e.g., development of measurement methods

as a basis for standards, compilation of critical data as a basis for regulatory decisions,

etc.)?

5
Session Discussion Guidelines

This guide provides suggestions to help participants:

1 . Engage in the discussion of each session,

2. Reach conclusions and,

3. Identify action items (It is essential that your session reach this stage in order to bring the

workshop to a successful conclusion).

Please consider the following:

1. Develop a list of Critical Needs

2. Identify whether the Need is:

a. A consensus standard

b. A standardized test method

c. A standard practice (e.g., manufacturing measurement or process control, data

analysis)

d. A guidance document on the use of existing standards and practices

e. Anything else (e.g., fundamental research, measurement development)

3. Identify why each Need is considered important

Examples:

a. Improvement of an existing device component

b. Improvement of fabrication technology

c. Submission of a new device for FDA approval

d. Understanding of device-tissue and device-patient interactions

f. Uniformity of industrial practices (e.g., sampling, assembly, cleaning, tolerance control)

g. Standardization of measurement technology

h. Improvement of measurement technology (calibration, instrumentation, etc.)

i. Support for measurement science needs development

j. Reduction of barriers to trade

k. Harmonization of development of standards for national and international uses

1. Application to other regulatory purposes (GMP?)

4. Prioritize the Needs as to their importance

5. Provide Rationale for the Prioritization

6. Identify how each Need should be approached to resolve its critical issues: thorough

participation on a standards committee at a national or international level, by collaboration

with other stakeholders (e.g., round robin testing, test method development, process

measurement or development, fundamental research etc?)

The Session Chair will use the discussions to develop a summary report

The report should identify (if possible):

a. Who is to do WHAT? (The participants and organizations that must be

involved, etc.)

b. The action needed to initiate the work on each item

c. Who is best qualified to take the lead

6
Plenary Session I: Abstracts

Patient Perceptions Leading to Explantation (Cochlear Implants)

James K. Kane, Ph.D.

The three cochlear implant manufacturers who have received marketing approval from FDA

currently report similar cumulative survivability rates (CSR) per ISO 5841-2, rev. 2000

(reliability standard used by the cardiac pacemaker industry). Notably, however, two of the three

manufacturers had device problems in 2004 sufficient to voluntarily initiate device recall from

the U.S. market and, for one manufacturer, a world-wide recall. Assuming data integrity is not an issue, and recognizing that the CSR reflects only device explants over time (necessarily

ignoring ongoing functionality problems) perhaps the CSR, in and of itself, is not a sufficient

metric for illuminating device problems to the public, to potential users of the device, or to the

FDA.

Within the cochlear implant device industry, as well as within the cochlear implant clinical

community, efforts are underway to relate patients' unusual perceptual/behavioral reports to device functionality. Such reports frequently are suggestive of device malfunction prior to complete device failure and commonly are referred to as "soft" failures. These clinical

symptoms often occur even though an implant may pass the manufacturer's in situ device

integrity tests. This presentation will overview this subject area with supporting data obtained

from implant manufacturers' complaint files during the past year.

Post-Market Regulation of Medical Devices

Betty Collins

Medical devices include thousands of health products, from simple products such as latex gloves

to sophisticated robotic systems for laser surgery. The manufacturers of medical devices that

have been cleared or approved for distribution in the United States are routinely inspected to ensure that they are safe and effective for their intended uses. Thus products go from a premarket review to "post-markef surveillance. Post-market activities play a critical role in consumer protection. During post market surveillance, the Office of Compliance looks at a number of areas that provide meaningful and important indicators (signals) of a firm's

compliance with regulatory requirements. A discussion on some of these signals and their

importance in complying with post-market regulation will be covered.

The Relationship of Standards and Compliance with the Quality System Regulation

from an FDA Perspective

Jan Welch

This presentation will provide the audience with an understanding of how the FDA uses

standards and guidance documents in assessing medical device manufacturers' compliance with

the Quality System (QS) regulation. The presentation will focus primarily on post-market

activities associated with ensuring compliance with the QS regulation, but the role of standards

7
in pre-market activities will be briefly mentioned to highlight the important relationship between

these sets of activities.

This presentation will focus particularly on those major quality system subsystems where FDA

notes significant use of standards by manufacturers. This includes a discussion of the use of

standards within the design control subsystem, the production and process control subsystem,

and the corrective and preventive action subsystem. The presentation will also include a brief

discussion of FDA's inspectional approach to the use of standards.

8
Plenary Session II: Abstract

Estimating Reliability at Design

Ali Mosleh

How are end-point reliability measurement results for individual device components integrated

into assessment of overall reliability; how should synergistic effects be assessed? What new

measurement and analysis methods may be employed to improve assessment of reliability?

These questions and more will be answered as I explore techniques for assessing reliability.

9
Plenary Session III: Abstract

The Value Proposition for Medical Grade Components

Celeste Null

Monolithic and hybrid electronic silicon components have routinely been incorporated into

medical devices over the last forty years. Unfortunately, many of these components are taken

from distributor shelves or developed internally and their reliability validated by outdated and

improper military specifications because the industry has lacked appropriate standards for

medical components. Failure mechanisms may or may not accurately reflect usage envelopes.

Common stress tests shall be confronted, as well as review of the challenges that face both

semiconductor and medical industries as growing incorporation of electronic devices and

wireless connectivity occurs globally in medical devices. A call to action for development of

medical grade component standards is offered. /

10
Plenary Sessions I-III: Open Discussion

CRITICAL NEEDS

Manufacturers need to provide requirements without having all of the facts on the

biomedical devices

Medical companies outsourcing components (made by companies that aren't just

providing components for the biomedical industry)

• How do you check the companies' specifications?

• Companies repackage circuits from large companies (Intel for example) for military and

biomedical uses

• Radiation testing for implantable devices

• Use master files to protect confidentiality

• Understanding about what causes device failure - Mechanical failure, not necessarily electrical components

• Liability issues

• Specification to screen commercial components (up-screening)

Higher volume commercial parts more reliable, smaller companies have good screening

processes

• Building quality parts, preferred to screening (expensive)

• Fault grade requirements

• Place to publish adverse events

• Establishing communication with foundries and suppliers, partnership (two-way

communication)

Designer needs to understand the use of parts, constant changes in technology, integration

of components into a system (systems engineering)

• Verification and validation of systems

Assessment of reliability verses improvement (redesign)

IMPLANTABLE DEVICE COMPONENTS

• MEMS

Optical components

Where are the vulnerabilities of the components in the system?

11
Working Session I: Abstracts

Chip-Level Design Developments, Failure Mechanisms and Reliability Testing

KenRodbell

In this talk the modem silicon-based integrated circuit (IC) will be discussed from two main

perspectives—relevant failure mechanisms and reliability testing. A brief overview of chip level

design will also be considered in light of these failure mechanisms and recent novel materials

and structures that are being proposed for use. The following reliability issues will be

highlighted, with some recent examples of a small subset of these explored in greater detail (as

time allows).

• Negative bias temperature instability

Soft en-or rate (radiation induced) ,

'

Silicide defects

• Metal interconnect

Electromigration

Stress

Package-Level Design Developments: Failure Mechanisms and Reliability Testing

Robert A. Munroe

In today's technologies the most frequent causes of reliability failures in service, in my

experience, fall into three categories. One category is failures that are induced in manufacturing

of the components or assembly and are not detected in routine testing. A second category is failures due to suppliers changing processes or materials without notification to customers

despite the standard clauses prohibiting these changes. A third category of failures is the result

of using cutting edge technology without sufficient experience with that technology.

Furthermore, close monitoring of incoming components and materials and frequent sample stress testing or detailed assembly analyses is often reduced or eliminated to minimize costs of

products. Examples will be given for approaches (to new technology) that encompass that

technology and minimize risk.

Reliability testing for new products is often menu driven from history or tradition and may not

apply to the particular product being designed. The manufacturer is often reluctant to vary from

"standard" tests. The "standard" tests may be too harsh or not harsh enough for the application

intended. They may not test for the environment or reveal the failure mechanisms to which a new technology or product may be susceptible. Following the philosophy of Dorian Shainin (a

peer of Deming and Graham), few manufacturers ever verify their qualification assumptions to validate them or find unexpected failure mechanisms. Shainin suggested examining products in

the application when it has not failed; it is through the examination of such in-service products over time that unanticipated mechanisms can be revealed. (Testing for failure ensures that you

will get the expected failure mechanism.) With medical implants this may have to be done with

animals, if the appropriate model exists, but it should be done at increasing periods of time to be

able to detect unexpected results and make corrections and recalls before failures exhibit

themselves in the field.

12
Residual Gas Content and Ionic Content

Bob Thomas

This presentation will discuss the origin of the RGA measurement technique and the problems in

getting industry to adopt MIL-STD 883, Test Method 1018. Examples of the positive effect the

Test Method had on both industrial and military packages will be discussed, and the methods

companies tried in order to avoid using the method. Efforts at contamination control will be

presented including the photos from the human spittle experiments that are still relevant to the

medical implant field. Finally, a summary of the current implant technology will be reviewed

from a perspective of moisture and contamination control.

13
Working Session I: Open Discussion

IDEAS

Standards and test methods from companies should be shared, respecting confidentiaHty - Needed for device implants

• Need a good interface model, and need to define parameters

• Confidential task force to share ideas among the experts in the field - Is Daiiskardt from Stanford an appropriate expert?

How would you fund task force? NIST? Semiconductor International Association?

(protected data)

DISCUSSION

• No incentive to share processes with other companies

• Develop the right tools (Military Standard might be out of date)

• STACK International (London, England)

• GIDEP- publish failures in the field that people experience

Develop a networking connection guide for the Medical Implant Device community

- Website

• JEDEC - standards, problems associated with standards

Need the data to show the problems and failure rates, but without names of companies

and associations

• Can we use standards to predict failures that we are going to see?

• AIME - leads failures, ISO tag international standard for active implants

• ASTM or SEMI

• To what extent does design affect the failure

• Intermediate ranges are not understood in tenns of humidity, for example

• Synergistic effects from environment

• Measuring hermeticity - leak model without ideal gas law, (need support from industry

for NIST to pursue this issue)

• Build device that will operate at saturation

• FDA to figure out how to sanitize data

• Ultimately it needs to be the FDA that instigates standards development

NARROWING DISCUSSION

• Data

• Regulatory perspective - FDA interaction with component suppliers , -

• Current failure modes

• Future failure modes

Need a group to develop these areas: FDA, NIST, medical device people, and component

suppliers

What are the future trends in packaging?

• Development of cochlear standard in Europe (good model)

14
INSPECTIONS

Need expertise to ask the right questions

Get involved with the people who are doing the auditing

How do you gain the subject matter experts?

Who is going to participate and why? How will it be funded

15
Working Session II: Abstracts

Corrosion Issues

Robert Baboian

Corrosion is one of the most important factors in the rehability of active implantable medical

devices. The environment to which these devices are subjected is severely aggressive. In

addition, even very little contamination in electronic components can cause failure. Therefore,

proper design and relevant testing of those designs are required to insure reliability. This talk

includes discussions on types and mechanisms of corrosion in electronics devices, and,

descriptions of tests that are used to determine the corrosion resistance of these devices. The

applicability of these tests and the need for new tests for active implantable medical devices will

be included in the talk.

Impact, Trauma, and Vibration Issues: Mechanical Loading of Active Implantable Medical

Devices

Dominik Hammerer

Active implantable medical devices that are exposed to vibration, crush and/or impact/shock may

fail in a variety of manners (e.g., detachment of single electronic components from the circuit

board, collapse of the hermetic implant package), thus potentially rendering the device partially or entirely nonfunctional. Severity of these mechanical loading scenarios is dependent on the

specific root cause. Situations including device shipping, handling prior to implantation,

everyday life, and random events such as severe accidents, will be addressed. Further, it will be

presented how the type of medical implant and its specific location of implantation influence the

stress that the device undergoes.

Based on experiences with design, development, manufacturing and field performance of

cochlear implants, standards applicable to these foreseeable loading scenarios, if available, and

experiences with their implementation will be examined. Based on practical examples, (e.g.,

accident-related impacts to the device) methods of approaching un- or under-defined testing

requirements, and therefore related difficulties, will be used to define previously unaddressed

critical needs.

16
Working Session II: Open Discussion

DISCUSSION

What are the types of corrosion that are important? - Metal, glass, plastic, etc. - Internal vs. external - Simulation of liquid composition - Can these tests be used to determine reliability?

• Could use the temperature stress test to determine hermeticity

• Tests for conventional electronics, not implants

• With time the resistance will go up until failure, test in class II environment, one day of testing equals one year - Environments in class IV are in chemical factory

CORROSION

For external surface of an electronic device in the in vivo environment there is no

acceleration test for corrosion

For testing electrode - Increase duty cycle, increase temperature (perhaps precipitation)

Point: aerospace applications are not appropriate for these devices (active medical

implants)

Hermeticity breach can cause corrosion

Corrosion, residual moisture inside the package

Do we need acceptable levels of contaminates? moisture? gases? ionic contamination?

Impact of tissue capsule around implants, stationary electrochemistry of corrosion

Dynamic polarization test, run for each metal, mixed potential theory; coupled metals are very complex and difficult to understand

EXTERNAL CORROSION

What are the issues? - Strain from cardiac fatigue cycle (stents)

Impact and shock vibration? - Temperature chip, measures impact and shock

What do you need to know about the environment to redesign implanted devices? - Interface between the materials and body is problematic, there are no good ways

to simulate human interface (biological envirormient)

Understanding duty cycle and the tissue encapsulation at the interface with the medical

device (chemically)

Design for 20 years and test for 1

0

17
UNDERSTANDING THE ENVIRONMENT

Lack product specific infonnation

Specifics of location of implant in the body

Many variables on detennining the response of an implant to an impact (mass of device,

surface area of device, tissue around the device, etc.)

• Deficiency in standards, 6601

• We need to define the use envelopes - Need extreme models

• Proposed model for the head

Is there a need for a body phantom? - To simulate loading in the body for implanted devices

18
Working Session III: Abstract

What are the Proper Accelerators for Predicting the Rehabihty of Active Implantable Devices?

Michael Pecht

Active implantable devices must operate reliably, often as long as 10 years, while subjected to in

vivo and external loading conditions. While implant reliability requirements will depend upon

the target application, the reliability requirements are usually coupled with the need for minimal

or zero maintenance.

This presentation overviews some of the issues with the reliability prediction of medical

electronic devices, summarizes failure mechanisms that are of unique concern in implantable

active devices, and discusses some life cycle approaches to assess implant reliability at the levels

of device, packaging, power supply, and software. Methods reviewed cover accelerated testing

for product qualification, manufacturing process qualification to eliminate design and

manufacmring defects, and procedures for the detection of latent damage.

19
Working Session III: Open Discussion

FAILURE MECHANISMS

Unique by part type, failure mechanism - May determine a common set of tests for a specific group

Sharing of failure modes for devices over time (need more publications in this area) - Knowing the failure mechanism will help you detennine the best test method for

qualification parameters

Start with MIL-STD 883 then modify testing based on failure mechanism

Failure mechanism—moisture breaching interface and depositing water on the chips

Desire to use encapsulants, not going to take implants out of hermetic packages (can) for a long time

Test the severe, covering all the ranges, but the limits may not be observed in reality

(screening qualification process wears out the parts)

Start looking at materials that are nearly hermetic

Characterize new die lots and any other changes by the suppliers

Trailing edge circuits (usually customized chips)

Reliability of the microprocessors

Realize that surgeons are important part of the implantable device (form factor), and

familiarity with the insertion and size of the device (limited by surgical tools)

DISCUSSION 1

Improved functionality and longevity (desires of most clinicians)

Reducing the size of device: battery is limiting factor, as is the ability to manufacture it reliablyC?) - Is current density a limiting factor?

New technology development (artificial pancreas, drug delivery and sensor)

Need to consider interface with biological devices and electronics

TESTING METHODS

What is the testing methodology for the cans as they get smaller?

Perhaps the FDA could raise this as an issue, helium leak jet for example

Different failure mechanisms due to changes in the device over time, not appropriate to have a common test method

Water in a can is a universal problem - Statistically high moisture failure over 95 % of devices could be attributed to hermeticity - Need help modeling leaks for less than 10"^ atm-cc/sec - Leak detectors

20
STANDARDS

Military standard given package size and given leak rate - Medical, use only to develop test method - Equations based on ideal gas law, need to change the model, surface migration,

and need to determine the leak structure - All materials leak; it's just the rate of leak that is the issue, can't measure very

small leak rates How do you measure small leak rates and examine the physics of the leak?

MOISTURE

Sometimes moisture develops through chemical interaction in the materials

Water is bound on the surface and moves around, so volume-to-surface area ratio is important

Time period of implantation determines the moisture failures, ~6 to 7 % fail in 4 to 5

years

Are there failures in the screen? Destroy about 5 % of product by handling

883 offers both screen and qualification

Diffusion and leaks lead to moisture

DISCUSSION 2

Develop a database for copyrighted materials without violating the law

OVID - information sharing group, pay a fee and can download papers from IEEE

Test functionality on older plastic samples that didn't fail, epoxy sustained over time

Get a policy in place to get devices that are explanted to study - How do you fund implant retrieval program?

21
Working Session IV: Abstracts

Medical System Concerns - A Device Manufacturer's Perspective

David L. Erhart

Assuring the highest practical reliability is a primary objective of any active implantable medical

device manufacturer. In order to accomplish this objective the device manufacturer must

understand and characterize the intrinsic and extrinsic reliability of the medical device. The basic

material choices and design rule implementations that determine intrinsic reliability must be

studied carefully and completely. The assessment of intrinsic reliability should be performed as early as possible during the development of a new product so material and design changes may

be made with a minimal impact on the process of new product development. In this presentation, an example of an early opportunity for intrinsic reliability evaluation is examined. Through the

example of device- and hybrid-level drop testing, the challenges of mapping incompletely

defined application requirements onto a repeatable and meaningful test protocol will be

highlighted. These challenges will be generalized to reflect the full range of active implantable

medical device application requirements. The oppoitimities for improvements in application

requirements and testing methodologies will be summarized.

Self-imposed Standards and Requirements for Demonstrating Safety and Reliability:

A Device Manufacturer's Perspective

Edmond Capcelea

The implantable medical device industry has been an intensely regulated market, given obvious

considerations such as safety and effectiveness. Different regulatory bodies generally stipulate

different requirements for and approaches to the approval process, although more recently

attempts have been made to integrate, or align to, a common set of generic requirements. In addition to this, in many cases flexibility has been built in to the regulatory requirements to allow

unimpeded development of new devices while maintaining high standards of safety and

effectiveness. In some cases, according to this principle, the manufacturers are allowed to define

the low-level set of requirements that will demonstrate the safety and effectiveness of the

implantable device, providing that they strictly adhere to the high-level requirements set forward

by the regulatory body. This presentation is focused on describing the set of self-adhered

standards and/or self-defined requirements that were employed by Cochlear Ltd to demonstrate

the safety and reliability of its new implant developments, starting with wafer-level requirements

for ASIC developments, assembly requirements and finally system-level requirements.

22
Working Session IV: Open Discussion

DISCUSSION

• Intrinsic and extrinsic factors

• Need for process design or validation

• Delamination not correlated to functional failures

Studies on reproducibility of testing for characterization

• MIL-STD testing ~ $ 1 00,000

• Save money by defining use envelopes

Important to look at ASIC standard testing, but there's no good standard for testing in

medical device industry

• Standards (for example MIL-STD 1031) are good for a minimal set of requirements - How do we get meaning from these tests?

• Meta analysis of the medical device literature

• Patient issues for spinal cord device lead breakage (mechanical failure), battery depletion

• Need to continue researching the basic science with a foundation in physics (model for all failures that will reflect back to the design of the devices)

How do we get the FDA and NIST to help the medical device industry? - Providing a list of priorities from the industry

• Devices that need the greatest help with reliability - Infusion pumps, defibrillators, ventilators

• Workshops in the future - Smaller or bigger - More input

23
Working Session V: Open Discussion

DISCUSSION

Standards for mechanical testing of flexible substrates

Avoid using off-the-shelf consumer electronics - Choice of vendors - Passive vs. active components

Developing screening for parts

Standard tests for in vitro testing - Understanding key parameters

Looking towards other industries for material selection - Dental industry

Encapsulation of devices with fibrous tissue - mechanical issues - Contraction of fibrous tissue around implant - EN 45502 - Fatigue test for pacing leads

New polymers and testing - Life expectancy, etc.

- Buddy Ratner - University of Washington - Polymer Technology Group - Berkeley, CA

- Biomaterials Group, Polymers Division, NIST

- Materials Reliability Division, NIST Boulder

24
Summary Sessions I and II

Database (Intel/National Labs) - Database development (using Bob Thomas' presentation to start up) - User groups can access available data - Avoid rediscovering the wheel

Commonality (Standards Bodies, Device Manufactuers) - When it works and when it doesn't

• E.g., Within can vs. exposed - Devices and test methods

Standard Tests (NIST and Standard Bodies) - Proper use

E.g., High/low temp for parts; leak rates - Definition

E.g., Use 5 V when today lower voltages are used - Pass/Fail criteria

Let each group define pass/fail for medical applications - Failure results are captured by manufacturers

Basic models (Academia, CALCE)

- Theory and experimental data - Interfaces

• Permeability

Diffusion/bio-environment - Long term hermiticity (NIST)

• Requirements

• Cans/No cans - Corrosion (NIST)

External and internal

• Known acceleration factors

• Proper corrosion modeling

Environment - Need to know (NIST, FDA, Device Mfrs.) - Chemical - Special attention to mechanics

• Body phantoms?

• Feedback sensors

25
Conclusions and Summary Recommendations

" NOT NEEDED

• Medical grade components

• Medical device specific qualification standard

Database medical device failure

WHAT IS NEEDED?

• Responsibility of each company to define use environment

• The development of non-prescriptive guidelines for device/application specific usage

(Device Manufacturers) - System or device level (group similar devices)

Stresses applied to device

, - Transportation, storage

• Sweat related to diet (for example)

Thickness of skin flaps differ for varying ages

• Anatomical guideline

Knowing animal model limitations

Human simulator systems

Identify stresses applied to device during assembly/manufacturing

• Standardize leak test (NIST) - Modify methodology for measurement techniques - Standards - Limits

• To cover range in volumes

To detect range in leak rates

• Gage study DSC, EDS, XPS, EDX, SIMS, CSAM, TMA

• Develop set of guidelines

• Common consensus on reporting the data - Factor in the clinicians interfacing with their patients

ACTION ITEMS

• Schedule another meeting with a specific scope

• Liz Drexler contact for feedback

26
Biographies of Speakers

Robert Baboian is a corrosion consultant with RB Corrosion Service. He retired from

Texas Instruments Inc. in December, 1996, as Principal Fellow and Head of the Electrochemical

and Corrosion Laboratory. His career has been dedicated toward the design and development of

corrosion-resistant materials, devices, and test methods. He is the editor of 13 books, author of

over 175 technical publications, and holds 15 U.S. patents. He received his B.S. degree in

Chemistry from Suffolk University in 1959 and his Ph.D. in Physical Chemistry from Rensselaer

Polytechnic Institute in 1964. In 1976, he was elected a TI Fellow, in 1980 a TI Senior Fellow,

and in 1988 a TI Principal Fellow. The Fellow position at TI is the highest honor the company

gives for scientific and technological achievement. He is also an ASTM Honorary Member, an ASTM Fellow, an SAE Fellow, a NACE Fellow, and was a Ford Foundation Postdoctoral

Fellow in 1964. He received the NACE Speller Award in 1988, the ASTM LaQue Award in

1990, the Suga Foundation Award of Japan in 1991, the ASTM Cavanaugh Award in 1992, the

ECS Vittorio de Nora Award in 1996, the LaQue Award of the Sea Horse Institute in 1996, the

National Materials Advancement Award of the Federation of Materials Societies in 1998, the

Dudley award from ASTM in 1999, and the T. J. Hull award from NACE in 2002.

Edmond Capcelea obtained his M.S. in Physics in 1987, specializing in semiconductor

physics, from the University of Bucharest, Faculty of Physics. He worked for a few years as a physicist in the Safety and Probabilistic Risk Assessment department of the Cemavoda Nuclear

Power Plant (Romania) and later for a brief period as the Head of Physics Department in the

Biomaterials Division at a Petrochemical Institute (also in Romania). In 1992 he emigrated to Australia. After arriving in Sydney, he worked as a physicist in the Applied Physics Dept. of

Sydney University, and in 1993 he was employed by Cochlear Ltd. as Reliability and Safety

Engineer. In 1999 he was promoted to the Head of Reliability, Failure Analysis and Sustaining

Engineering Dept at Cochlear. In mid 2003 he was promoted to the position of Head of Speech

Processors Design and Development Department (Cochlear Ltd.) and this year he moved to the

position of Head of Implants Design and Development Department (Cochlear Ltd.). His interests

include safety and reliability of implantable devices, analogue audio design, data communication

protocols, reliability of new IC packaging technologies, and nanotechnology.

Betty Collins is the Director, Division of Enforcement A, Office of Compliance, Center for

Devices and Radiological Health (CDRH). She has held this position for the past three years.

Prior to that, she was the Chief of the In-Vitro Diagnostics Branch for 10 years. Before coming

to CDRH she worked in the Office of Regulatory Affairs for a number of years, and before that

was a field investigator in the Atlanta District Office, experienced in conducting medical device,

pharmaceuticals, and in-vitro diagnostic inspections. She has intensive experience in the area of

regulatory case processing and enforcement activities. Her division is responsible for seven medical specialty product areas. They include Dental, Ear, Nose and Throat, Gastroenterology

and Urology, General and Plastic Surgery, General Hospital, Obstetrics and Gynecology, and

Ophthalmic devices. Ms. Collins holds a B.S. degree in Chemistry from South Carolina State

University and worked on her M.S. in Governmental Administration at the University of

Georgia. She is currently pursuing a Master of Divinity degree from Howard University in

Washington, D.C.

27
David Erhart received a B.S. degree in chemical engineering from the IlHnois Institute of

Technology, Chicago, and a Ph.D. degree in chemical engineering from the University of

California, Berkeley. He is an ASQ Certified Reliability Engineer and received a professional

certificate in Quality and Reliability from the University of Arizona, Tucson. David is the

Director of Reliability and Product Analysis at the Medtronic Microelectronics Center, Tempe,

AZ, where he is responsible for developing and implementing strategic reliability activities

during the development of implantable pulse generators (IPG) and implantable cardioverter

defibrillators (ICD). Prior to joining Medtronic, he held various reliability engineering positions

at ON Semiconductor and Motorola Semiconductor Products Sector.

Dominik Hammerer is an implant development engineer employed by the Austrian-based

cochlear implant manufacturer MED-EL Elektromedizinische Geraete GmbH. The MED-EL

implant development group is responsible for the design and development of implant electronics

and their hermetic encapsulation. Additionally, the implant development group provides

technical support to the implant manufacturing department with aspects related to manufacturing

and testing procedures. Dr. Hammerer's activities are focused on development of hermetic

implant package components, hermetic sealing technologies, such as laser welding and vacuum

brazing, and definition of testing procedures and methods, applied during development and

manufacturing to assure (long-term) hermeticity and mechanical stability of the devices. In

addition, he is involved in root cause investigation with field-failed implants and cooperates

closely with regulatory affairs in preparation of technical submissions.

Dr. Hammerer joined MED-EL Elektromedizinische Geraete GmbH, in September, 2000,

after he had been working as a research fellow in the field of thermodynamic simulation at Graz

University of Technology, Austria. At this same institution he received his Master's degree and

Ph.D. in mechanical engineering.

Lori Henderson, of the National Institute of Standards and Technology (NIST), received her

B.S. from Marygrove College in Chemistry, M.S. from University of Detroit in Macromolecular

Chemistry, and later a M.S. in Organic Chemistry and Ph.D. in Polymer Science from University

of Massachusetts, Lowell. Her technical expertise ranges from synthetic polymer chemistry and

applied materials to molecular biology, which includes protein chemistry, microbial physiology,

and enzymology.

Dr. Henderson currently works in the Polymers Division at NIST, where she is the Group

Leader of the Biomaterials Group. The Biomaterials Group provides basic materials science,

engineering, test methods, and standards to sectors of the health care industry for the

development of new or improved materials and delivery systems, with a strong emphasis on

tissue engineering and related technologies. Current project areas involve structure-property

relationships in dental polymers and composites, combinatorial methods for rapid screening of

biomaterials, and metrologies for tissue scaffolds.

Prior to joining NIST in January 2005, Dr. Henderson worked for BASF, Akzo Nobel

Coatings, and Novozymes North America, where she was a senior scientist, global project

leader, and research supervisor. Her latter appointment as a professor at North Carolina State

University resulted in the start-up of a new Biomaterials-Biotechnology Center.

James K. Kane is a senior-level, scientific reviewer and team leader in the Ear, Nose, and

Throat Devices Branch (ENTB) in the Office of Device Evaluation (ODE) in the Center for

Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). The

28
Ear, Nose and Throat Devices Branch reviews /evaluates apphcations submitted by

manufacturers seeking approval to market audiological, nasal and throat devices, such as hearing

aids, middle-ear implants, cochlear implants, auditory brainstem implants, audiological

diagnostic devices, and other ENT device products. Dr. Kane also provides scientific and

regulatory support to other Offices in the Center on matters involving activities such as recalls,

health hazard evaluations, and petitions for reclassification for medical devices. He represents

ODE as the Audiology expert for the current FDA and Centers for Disease Control (CDC)

investigation of the association between meningitis and cochlear implants. In addition, he is involved with standards development (ANSI, ASTM).

Prior to joining FDA in January, 2000, Dr. Kane had extensive experience in many areas of

Audiology, academically and clinically, in a variety of public, private and government health- care settings. Dr. Kane received his M.S. and Ph.D. in Audiology from the University of

Pittsburgh. His post-doctoral work was conducted in the Bioacoustics Laboratory of Eye and

Ear Hospital, University of Pittsburgh Medical School. His publications and presentations relate to understanding the relationships clinical diagnostic tests and auditory rehabilitation have to basic science research, and the way clinical knowledge evolves to stimulate new ideas about

patient care.

Richard F. Kayser received a Sc.B. from Brown University (1973) and a Ph.D. (1976) from

Rice University in physical chemistry. He joined the National Bureau of Standards (now NIST)

in May 1976. Over the next 10 years. Dr. Kayser performed research in the Thermophysics

Division on a wide variety of theoretical and experimental topics, ranging from phase transitions

to wetting phenomena.

Dr. Kayser became Chief of the Thermophysics Division in May 1989 and Chief of the

Physical and Chemical Properties Division in May 1996. In August 1999, Dr. Kayser became

Director of Technology Services, which supports NIST in the provision of calibration services.

Standard Reference Materials, and Standard Reference Data. In March 2004, Dr. Kayser served

as Acting Deputy Director and Chief Operations Officer, NIST. In July 2005, Dr. Kayser was

named Acting Director of the Materials Science and Engineering Laboratory (MSEL). MSEL

provides technical leadership for the nation's materials measurement and standards infrastructure,

using its expertise to anticipate and respond to measurement-related industry needs in many

technology sectors, including microelectronics, automotive, and health care. Dr. Kayser has participated in numerous outside activities over the years. He currently serves on the Board of Directors of ASTM International.

Joaquin V. Martinez de Pinillos is a senior scientist at the National Institute of Standards

and Technology (NIST). He joined this institution in 1999 after 24 years at Air Products and

Chemicals, Inc., in Allentown, PA. He started at Air Products in 1975 as a Research Chemist

and continued with positions of higher responsibility and retired in 1999 as the Senior Research

Associate and Manager, Analytical Technology of the Electronics Division. Prior to that, he had

worked at American Cyanamid Co., and Cyclo Chemicals Corp. He received a Ph.D. in

Chemical Physics from the University of Florida in 1974, and M.A. in Physical Chemistry from

Bowling Green State University in 1968, and a B.S. in Chemistry from the University of Miami

in 1966. He has published several papers and is the author of several patents.

Keith McLain heads the Quality Assurance group at Advanced Bionics; a Boston

Scientific Company. His group provides reliability and quality engineering services that

29
support the development and manufacture of neuro stimulation devices that include cochlear

implants and pain management systems. Mr. McLain has over 20 years applying reliability

methods to complex systems. Previously, he managed reliability engineering groups at Ortho

Clinical Diagnostics and Bayer Diagnostics. He has developed comprehensive reliability

programs for several in vitro diagnostic products. His areas of expertise include Reliability

Growth Modeling, Reliability Growth Testing, Integrated Fault Tree/FMECA, Reliability

Program Planning, and Remote Diagnostics. Prior to working in the medical device industry,

Mr. McLain was a member of the technical staff at The Analytical Science Corporation

(TASC) where he provided reliability consulting services to the automotive, aerospace, and

semiconductor manufacturing industries. He holds B.S. and M.S. degrees from Case

Western Reserve University.

His publications include:

1 . Robert Gates, Greg Gibson, Keith McLain: "Reliability Growth Prediction," 1986,

Reliability Analysis Center (RAC)

2. Jan S. Krouwer and Keith McLain: Predicting and Improving Product Quality,

Critical Care Business Leadership Forum, Coalition for Critical Care, September,

- 1998 Andover, MA

3. Warren and McLain: "Automated analysis of life data of missiles in storage and

flight," 1990, RAMS Proceedings

4. "FRACAS: The Most Effective Reliability Improvement Tool?," 1993, Forty-Ninth

Annual Quality Control Conference, Rochester ASQC

5. "Improving the Reliability of Diagnostic Systems," Medical Device and Diagnostic

Industry, January 1 994

6. "Experiences using a Hybrid Fault Tree and FMECA Tool in the Medical Diagnostics

Industry," 2001 IEEE Boston Spring Reliability Symposium

Ali Mosleh is professor and director of the Reliability Engineering Program and director of

the Center for Risk and Reliability at the University of Maryland. He conducts research on methods for reliability of complex systems and probabilistic risk analysis (PRA), and has made

many contributions in diverse fields of theory and application. These include Bayesian methods

for inference with uncertain evidence; analysis of data and expert judgment; treatment of model

uncertainty; risk and reliability of hybrid systems of hardware, human and software; methods and

tools for dynamic PRA; cognitive models for human reliability analysis; and models of the

influence of organizational factors on system reliability and safety. He is the developer of the

Accident Precursor Analysis methodology and many of the methods currently used for the

treatment of common causes of failures in highly reliable systems. On these topics he holds

several patents, and has edited, authored or co-authored more than 250 publications including

books, guidebooks and papers in technical journals and for conferences.

Dr. Mosleh has led numerous projects on reliability, risk, safety, and security assessments for

the aerospace, nuclear, chemical, and information systems and telecommunication industries. He

also led the design and development of more than 10 major risk and software packages for

reliability analysis currently in use by various government agencies and the private sector. Dr. Mosleh was appointed by President George W. Bush in 2004 to the U.S. Nuclear Waste

Technical Review Board for a four- year term. He is a Fellow of the Society for Risk Analysis

(SRA), Chair of the Engineering Division of SRA, and Engineering Editor of the SRA Journal.

He is the recipient of several scientific achievement awards, and a consultant and technical

advisor to national and international organizations on reliability analysis and risk assessment. He

30
has chaired or organized numerous international technical conferences on risk and reliability. Dr.

Mosleh received his Ph.D. in Engineering from the University of California, Los Angeles in

1981.

Bob Munroe has 43 years of experience in electronics packaging design and manufacturing

from frrst level to box level including structural and cooling design, second level packaging, and

device interconnections of all kinds. The first 16 years involved military and aerospace

packaging (man-rate). Bob was employed by IBM from 1961 to 1991 and by Motorola from

1991 to 2000. He has done considerable work involving appropriate qualification and

engineering evaluation tests during this period. He has several patents, technical papers, and

corporate awards for performance.

Celeste Null currently leads Biomedical Engineering in the Digital Health Group of Intel

Corporation. Celeste has held engineering management positions in all facets of semiconductor

manufacturing, including product, process, and technology development, as well as design,

qualification, and customer engagements. Her pathfmding work has included development of

quality systems, chaos modeling in risk management, automated product qualification systems,

operation/planning development, and software quality engineering. She was a key developer of

Intel's initial biotechnology strategies.

She has chaired the national liaison Solid State Technology Division of JEDEC, where she

led international specification developments in Residual Gas Analysis, Statistical Process

Control, Process Characterization, and Tape Automated Bonded military packaging. She is a member of JEDEC JC-13 (reliability) and JC-14 (Quality Systems), the Electronics Industry

Alliance Quality/Reliability Engineering Working Group, and serves on the U.S. N.S.F.-

supported Management of Accelerated Technology Innovation. At Intel, Celeste is a member of

the Nanotechnology Safety Board and received the 2002 Leadership Breakthrough Award for

quality management systems. She is a Senior Member of the American Society of Quality, a

Certified Quality Auditor, an ISO 9001 :2000 RAB national certified auditor, and a certified

Baldrige Award examiner for California and Arizona. At Arizona State University, she has

served on the Advisory Board for the Biodesign Institute, the Bioengineering Advisory

Committee, and was founding member of Alpha Eta Mu Beta, a bioengineering honor society.

She currently is on the editorial board for the Journal of Biomedical Microdevices as well as the

Scientific Advisory Board for the World Nanotechnology Conference.

Prior to coming to Intel in 1995, Celeste was with Medtronic Corporation, Fairchild

Semiconductor Corporation, and Texas Instruments.

Celeste has a B.S. in Microbiology and Chemistry from Texas Tech University, a Master's

degree in Bioengineering from Arizona State University, and is currently completing her

doctoral work in Bioengineering at ASU in bioelectricity. She and her husband, Randy, have

two boys, and are community leaders with the Ahwatukee YMCA.

Michael Pecht has a B.S. in Acoustics, an M.S. in Electrical Engineering and an M.S. and

Ph.D. in Engineering Mechanics from the University of Wisconsin at Madison. He is a Professional Engineer, an IEEE Fellow and an ASME Fellow. He has received the 3M Research

Award, the IEEE Undergraduate Teaching Award, and the IMAPS William D. Ashman

Memorial Achievement Award for his contributions. He has written 18 books on electronic

products development, use, and supply chain management. He has also edited a series of books on the Asian electronics industry including a recent book titled "The Chinese Electronics

31
Industry - 2004 edition." He served as chief editor of the IEEE Transactions on ReHabihty for

eight years and on the advisory board of IEEE Spectrum. He is the founder and the Director of

the CALCE Electronic Products and Systems Center at the University of Maryland and a Chair

Professor. He is chief editor for Microelectronics Reliability and an associate editor for the IEEE

Transactions on Components and Packaging Technology. He has consulted for over 50 major

international electronics companies, providing expertise in strategic planning, design, test, IP,

and risk assessment of electronic products and systems.

Stan Purwin is Manager of Supplier Quality Assurance at the Johns Hopkins

University/Applied Physics Lab (APL) Space Department where he is a member of their

Principal Professional Staff. For the last decade he was the Group Supervisor of Safety, Quality,

and Reliability for the Space Department. He supervised all quality, reliability, safety, material

acquisition (principally electronics), and contamination control on all spacecraft. Prior to joining

APL he was the Director of Manufacturing at a former division of a Fortune 1 0 Company. He

has held allied positions at other Fortime 10 companies. He holds a B.Eng in Electronics, a M.S.ME, and an MBA. He was fonnerly a registered Professional Engineer and an American

Society for Quality (ASQ) Quality Engineer. He is currently an ASQ certified Quality Manager

and ASQ certified Software Quality Engineer.

William Regnault is the Senior Materials Scientist for the Division of Chemistry and

Materials Science (DCMS) within the Office of Science and Engineering Laboratories (OSEL)

of the Center for Devices and Radiological Health (CDRH). After graduating from The

Pennsylvania State University, Dr. Regnault worked for a photovoltaic firm developing low-cost

silicon-based alternative solar cells. Dr. Regnault joined the Government and CDRH as a materials scientist in 1985, where he has worked on numerous projects dealing with the effects of

fabrication processes and in-use service conditions on the long-term stability and reliability of

biomaterials and medical devices.

Ken Rodbell is a Research Staff Member and Manager of the Thin Film Metallurgy and

SER Research Department at the IBM Thomas J. Watson Research Center in Yorktown Heights,

NY. He joined IBM Research in 1989 after spending three years at the IBM Semiconductor

Development Laboratory in East Fishkill, NY. Dr. Rodbell received his B.S. (1982), M.S.

(1983) and Ph.D. (1986) in Materials Science and Engineering from Rensselaer Polytechnic

Institute. He also worked at Fairchild Camera and Instrument Company, South Portland, ME

(1982) and Carpenter Technology, Bridgeport, CT (1981). Dr. Rodbell's research interests have

focused on Si-based electronic materials; specifically thin film metallurgy and crystallographic

texture, electromigration, chemical mechanical polishing, 1/f noise in metallic films, positron

annihilation spectroscopy, radiation induced soft errors, and low-k dielectric materials. He has

co-authored more than 100 publications and more than 40 issued U.S. patents (named Master

Inventor at IBM Research in 2003) and has given numerous invited talks. He is a reviewer for

JAP, APL and the J. Vac. Sci. and Tech. He has served on program committees for the IEEE,

ICOTOM, NSREC, MRS and the International Workshop on Stress-Induced Phenomena in

Metallization and is a member of the Editorial Advisory Board for Materials Science in

Semiconductor Processing. He is also a member of the external advisory committee for the

Materials Science and Engineering department at Johns Hopkins University.

32
Michael Schen is Group Leader of the NIST Advanced Technology Program's Electronics

and Photonics Group of the Information Technology and Electronics Office. Rejoined ATP in

1997. ATP, a cost-sharing program, helps American industry invest in longer-term, high risk

research with payoffs far beyond private profit. ATP investments accelerate the development of

early-stage, innovative technologies that help industry raise its competitive potential and provide

Americans with a higher standard of living.

Since 1991, approximately 30 % of the 768 projects funded by ATP involve direct

developments in biotechnology and/or healthcare related technologies. This translates to approximately $620 million that ATP has awarded to 224 biotechnology and/or healthcare

projects, with an industry's cost share of more than $516 million, thus stimulating more than

$1.13 billion of biotechnology and/or healthcare R&D.

Prior to joining ATP, Michael was a Program Analyst for the NIST Director's Office;

Program Manager within the NIST Laboratories; a NIST staff scientist; and a research chemist

at the Eastman Kodak Co.

Michael completed a Fulbright and French Government co-sponsored post-doctoral

appointment at the Universite de Montpellier, CNRS Laboratories, in Montpellier, France;

received his Ph.D. in Polymer Science and Engineering from the University of Massachusetts in

Amherst; gained his Bachelor's degree in chemistry from the Rochester Institute of Technology,

Rochester, NY; and received his Associates in Applied Sciences from the State University of

New York at Alfred.

John S. Suehle received his B.S., M.S., and Ph.D. degrees in electrical engineering from the

University of Maryland, College Park, in 1980, 1982, and 1988 respectively. In 1981 he received

a Graduate Research Fellowship with the National Institute of Standards and Technology

(NIST), Gaithersburg, MD. Since 1982 he has been working in the Semiconductor Electronics

Division at NIST, where he is leader of the Advanced MOS Device Reliability and

Characterization Project. His research activities include failure and wear-out mechanisms of

semiconductor devices, radiation effects on microelectronic devices, micro-electro-mechanicalsystems (MEMS), and molecular electronic devices. Dr. Suehle is currently serving on the

management committees of the IEEE International Reliability Physics Symposium and the IEEE

Integrated Reliability Workshop. Both conferences deal exclusively with reliability physics of

microelectronic devices. He also serves as the chairman of the Oxide Integrity Working Group of

the EIA/JEDEC JC 14.2 Standards Committee responsible for developing national standard test procedures for wafer-level reliability. He is a Senior member of IEEE.

Robert Thomas has a Ph.D. in solid state science from Syracuse University. He was an

engineer and manager at Rome Air Development Center for 32 years, retiring from the Air Force

in 1992. A major portion of his career focused on developing techniques for moisture

measurement of integrated circuit packages. A portion on his accomplishments includes:

managing an AF contract with John Pemicka to commercialize the first rapid cycle mass

spectrometer residual gas analysis system, coauthoring with Connie Zierdt of Bell Labs, MILSTD 883 Test Method 1018 for control of moisture in integrated circuit packages, perforaiing

gas analysis on packages from the Apollo and Viking Mars Lander, hosting NBS/NIST

workshops on Pacemakers and integrated circuit moisture measurement, conducting round robin

inter-laboratory correlation tests, participating in the development of the three volume calibration

valve for RGA analysis, as well as authoring many papers on moisture and contamination

control. Dr. Thomas is currently a principal partner in Arthur Jonath Associates, an expert

33
network assisting medical and aerospace companies in quality and reliability analysis. Dr.

Thomas is an RADC Fellow and a Life Fellow of the IEEE.

Jan Welch is a Consumer Safety Officer in the U.S. Food and Drug Administration's Center

for Devices and Radiological Health, Office of Compliance, Division of Enforcement A, in

Rockville, Maryland. She has been in this position for 1 1 years. Mrs. Welch is a medical

device Quality System Expert with additional expertise in the areas of process validation, design

control, and in vitro diagnostic devices. Mrs. Welch serves as one of CDRH's Quality System

experts in medical device legal actions involving complex and precedent-setting regulatory

actions involving medical devices and specifically in vitro diagnostic devices. Mrs. Welch is a member of several FDA Course Advisory Groups where she develops, plans, and presents

training courses for FDA staff in areas pertaining to devices.

Mrs. Welch is a representative to ISO TC 210 [Quality Management and Corresponding

General Aspects for Medical Devices], Working Group 1 [Application of Quality Systems to Medical Devices]. Mrs. Welch is also a member of the Global Harmonization Task Force, Study

Group 4, Regulatory Auditing.

Prior to her position with CDRH, Mrs. Welch worked for over four years in FDA's Center

for Biologies Evaluation and Review, Office of Compliance, Division of Case Management.

Prior to her employment with the FDA, Mrs. Welch worked for the American Red Cross in

Washington, DC, the National Institutes of Health in Bethesda, MD, and Vanderbilt University

Medical Center in Nashville, TN.

Mrs. Welch graduated with a B.A. in Biology from Wake Forest University, completed a one-year certificate program in Medical Technology at Vanderbilt University, and earned a Masters degree in Health Sciences in Immunohematology from the Medical University of South

Carolina. She is an ASCP registered Medical Technologist and Specialist in Blood Banking.

34
List of Attendees and Participants

Kay Adair Patti Amdt

Advanced Bionics Corp. Cochlear Americas

12740 San Fernando Rd. 400 Inverness Pkwy.

Sylmar, CA 9 1 342 USA Ste. 400

Phone: (661)362-1669 ext. 1669 Englewood, CO 801 12 USA

Fax:(661)362-1511 Phone:(303)524-7162

Email: Kay.Adair(c^advancedbionics.com Fax: (303)524-6764

Email: pamdt@cochlear.com

Lawrence Ame " Robert Baboian

Proteus Biomedical RB Corrosion Service

750 Chesapeake Dr. 84 Ruff Stone Rd.

Redwood City, CA 94063 USA Greenville, RI 02828 USA

Phone: (650)568-0580 ext. 122 Phone: (401)949-5398

Email: lame(a^proteusbiomed.com Fax: (401)949-1661

Email: rbaboian(a)aol.com

Merry Bain

Falcon Advisors

P.O. Box 2672

West Lafayette, IN 47996 USA

Phone: (765)564-1056

Fax: (765)564-2187

Email: mleebain@insightbb.com

Karen Baker

FDA/CDRH/ODE/DOED

9200 Corporate Blvd.

HFZ-460

Rockville, MD 20850 USA

Email: khb@cdrh.fda.gov

Michael Bazaral

FDA

2094 Gaither Rd.

HFZ 340

Rockville, MD 20850 USA

Email: mgb@cdrh.fda.gov

Peter Borgesen

Universal Instruments Corp.

P.O. Box 825

Binghamton, NY 13902 USA

Phone: (607)779-7343

Email: borgesen@uic.com

Susan Bowley

FDA/CDRH/ODE/DCD

9200 Corporate Blvd.

HFZ-450

Rockville, MD 20850 USA

Email: sub@cdrh.fda.gov

Nancy Brehm

Cochlear Americas

400 Inverness Pkwy.

Ste. 400

Englewood, CO 801 12 USA

Phone: (303)524-7122

Fax: (303)524-6764

Email: nbrehm@cochlear.com

35
Charles Byers

Alfred Mann Foundation

25 1 34 Rye Canyon Loop

P.O. Box 905

Santa Clarita, CA 91380-9005 USA

Phone: (661)702-6734

Fax:(661)702-6711

Email: chuckb(^aemf.org

Dulciana Chan

FDA/CDRH

12725 Twinbrook Pkwy.

Rockville, MD 20852 USA

Email: dulciana.chan(aJfda.hhs.gov

Ethan Cohen

OSEL/CDRH/FDA

HFZ130

12725 Twinbrook Blvd.

Rockville, MD 20853 USA

Phone: (301)827-4953

Fax: (301)827-4947

Email: edc(aicdrh. fda.gov

Edmond Capcelea

Cochlear, Ltd.

14 Mars Rd.

Lane Cove, 2066 NSW AUSTRALIA

Phone: 61 294286573

Fax: 61 294286264

Email: ecapcelea(^cochlear.com.au

Keith Checca

Texcel LLC

55 Deer Park Dr. East Longmeadow, MA 01028 USA

Phone: (413)525-5700 ext. 1026

Email: kchecca@texcelaser.com

Dean Cole

U.S. Dept. of Energy

1000 Independence Ave., SW

Washington, DC 20585-1290 USA

Phone: (301)903-3268 ext. 0

Email: dean.cole@science.doe.gov

Betty Collins

FDA

2094 Gaither Rd.

Rockville, MD 20850 USA

Phone: (240)276-0115

Fax: (240)276-0114

Email: byc@cdrh.fda.gov

Teri Cygnarowicz

FDA/CDRH/ODE/DOED

9200 Corporate Blvd.

HFZ-460

Rockville, MD 20850 USA

Email: tyc@cdrh.fda.gov

John Daley

Cordis Corp.

7 Powderhom Dr. Warren, NJ 07059 USA

Phone: (909)412-3258

Fax: (908)412-3737

Email: maimovil@crdus.jnj.com

Bob De Luca

9200 Corporate Blvd.

HFZ-410

Rockville, MD 20850 USA

Email: rjd@cdrh.fda.gov

36
Elizabeth Drexler

NIST

325 Broadway

Div 853

Boulder, CO 80305 USA

Phone: (303)497-5350

Fax: (303)497-5030

Email: drexler@boulder.nist.gov

Tithi Dutta Roy

NIST

100 Bureau Dr. Mail Stop 8543

Gaithersburg, MD 20899-8543 USA

Phone: (301)975-6747

Email: tithi. duttaroy(S)nist. gov

Diane Dwyer

FDA

1350 PiccardDr.

HFZ 520

Rockville, MD 20850 USA

Phone: (301)594-2385

Fax: (301)594-1967

Email: ded@cdrh.fda.gov

Lynn Elliott Guidant Corp.

4100 Hamline Ave., N

St. Paul, MN 551 12 USA

Email: lynn.elliott@,guidant.com

David Erhart

Medtronic Microelectronics Ctr. 2343 W. Medtronic Way

Tempe, AZ 85284 USA

Email: david.erhart@medtronic.com

Boozarjomehr Faraji

Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar, CA 91342 USA

Email: bfaraji@2-sight.com

Shaw Feng

NIST

100 Bureau Dr. Mail Stop 8263

Gaithersburg, MD 20899-8263 USA

Phone: (301)975-5777

Fax: (301)975-4482

Email: shaw.feng@nist.gov

Robert Fischer

FDA/CDRH/OSB/DPS/PEB/II

1350 PiccardDr.

HFZ520

Rockville, MD 20850 USA

Phone: (301)594-3585

Fax: (301)594-2965

Email: raf@cdrh.fda.gov

Valerie Floumoy

FDA

2094 Gaither Rd.

Rockville, MD 20850 USA

Phone: (240)276-0115

Fax: (240)276-0114

Email: vaf@cdrh.fda.gov

Beverly Gallauresi

FDA

1350 PiccardDr.

HFZ520

Rockville, MD 20850 USA

Phone: (301)594-2101

Fax: (301)594-1967

Email: bxg@cdrh.fda.gov

37
Xiao-Yan Gong

Nitinol Devices & Components

47533 Westinghouse Dr. Fremont, CA 94539 USA

Phone: (510)498-1819

Fax: (510)623-6808

Email: xgong@ndcus.jnj.com

Jove Graham

FDA

12725 Twinbrook Pkwy.

HFZ170

Rockville, MD 20852 USA

Phone: (301)827-4882

Fax:(301)827-4853

Email: jhg@cdrh.fda.gov

Brian Greig

St. Jude Medical

8300 E. Pacesetter Way

Scottsdale, AZ 85255 USA

Email: bgreig@sjm.com

Lori Henderson

NIST

100 Bureau Dr. Mail Stop 8543

Gaithersburg, MD 20899-8543 USA

Phone: (301)975-4348

Email: lori.henderson@nist.gov

Vivianne Holt

FDA/CDRH/ODE/DCD

9200 Corporate Blvd.

HFZ460

Rockville, MD 20850 USA

Phone:(301)443-8243 ext. 170

Email: vzh@cdrh.fda.gov

Marcus Ignacio

Cochlear, Ltd.

14 Mars Rd.

Lane Cove, 2066 NSW AUSTRALIA

Phone: 61 294255216

Fax: 61 29428 6264

Email: mignacio@cochlear.com.au

Hernando Gonzalez

Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar, CA 91342 USA

Email: tfisher@2-sight.com

Robert Greenberg

Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar, CA 91342 USA

Email: tfisher@2-sight.com

Dominik Hammerer

MED EL

Furstenweg 77, A 6020

Innsbruck, 43 AUSTRIA

Phone: 43 512288889462

Email: dominik.hammerer@medel.com

Greg Hertzig

Sandell Asset Management

40 W. 57th St. 26th Floor

New York, NY 10019 USA

Phone: (212)603-5700

Email: ghertzig@sandellmgmt.com

Tonya Icenogle

FDA

9200 Corporate Blvd.

HFZ150

Rockville, MD 20850 USA

Phone: (301)827-4876

Marc Jensen

Proteus Biomedical

750 Chesapeake Dr. Redwood City, CA 94063 USA

Phone: (650)568-0580 ext. 107

Email: mjensen@proteus.bz

38
Guangqiang Jiang

Alfred Mann Foundation

25134 Rye Canyon Loop

Santa Clarita, CA 91355 USA

Phone: (661)702-6700 ext. 6766

Fax: (661)702-6711

Email: jiang@aemf.org

Lee Johnson

SFA, Inc. for Naval Res. Lab.

Naval Res. Lab.

4555 Overlook Ave.

Washington, DC 20375 USA

Phone: (202)404-3752

Email: ljohnson@nrl.navy.mil

Soma Kalb

U.S. FDA

1350Piccard Dr. HFZ520

Rockville, MD 20850 USA

Phone: (301)594-2581

Fax: (301)594-1967

Email: sxk@cdrh.fda.gov

James Kane

U.S. FDA

9200 Corporate Blvd.

Rockville, MD 20850 USA

Phone: (301)597-2080

Fax: (301)480-4201

Email: james.kane@fda.hhs.gov

David Kaplan

U.S. FDA

12725 Twinbrook Pkwy.

HFZ170

Rockville, MD 20852 USA

Phone: (301)827-4754

Fax: (301)827-4853

Email: david.kaplan@fda.hhs.gov

Peter Lampacher

VIBRANT MED-EL AMBH

Fuerstenweg 77a

Innsbruck, 6020 AUSTRIA

Phone: 43 512288889256

Fax: 43 512288889299

Email: peter.lampacher@medel.com

James Little Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar, CA 91342 USA

Email: jiml@2-sight.com

Chih-hsin Liu

U.S. FDA

1350 Piccard Dr. HFZ520

Rockville, MD 20850 USA

Phone: (301)594-3948

Fax: (301)594-1967

Email: chl@cdrh.fda.gov

Beverly Lorell

Guidant Corp.

1 1 1 Monument Cir.

Ste. 2900

Indianapolis, IN 46204 USA

Phone: (317)971-2204

Fax: (317)971-2208

Email: beverly.lorell@guidant.com

Qijin Lu

U.S. FDA

12725 Twinbrook Pkwy.

HFZ170

Rockville, MD 20852 USA

Phone: (301)827-5626

Fax: (301)827-5604

Email: qxl4@cdrh.fda.gov

39
Marian Maghribi

NDC

47533 Westinghouse Dr. Fremont, CA 94539 USA

Phone: (510)498-1809

Email: mmaghribi@ndcus.jnj.com

Suzanne Malli

U.S. FDA

1350 Piccard Dr. HFZ520

Rockville, MD 20850 USA

Phone: (301)594-3660

Fax:(301)594-1967

Email: swm(^cdrh.fda.gov

Eric Mann

FDA/CDRH/ODE/DOED

9200 Corporate Blvd.

HFZ460

Rockville, MD 20850 USA

Email: exm(^cdrh.fda.gov

Steve Maschino

Cyberonics, Inc. 100 Cyberonics Blvd.

Ste. 600

Houston, TX 77058 USA

Phone: (281)228-7232

Fax: (281)291-9332

Email: sem@cyberonics.com

Stephen Meeks

St. Jude Medical-CRMD

8300 E. Pacesetter Way

Scottsdale, AZ 85255 USA

Phone: (480)502-6360 ext. 6428

Fax: (480)502-6417

Email: smeeks@sjm.com

Subhas Malghan

U.S. FDA

12725 Twinbrook Pkwy.

HFZlOO

Rockville, MD 20852 USA

Phone: (301)827-4777

Fax: (301)827-4787

Email: subhas . malghan@fda.hhs. gov

Vasant Malshet

FDA/CDRH/ODE/DOED

9200 Corporate Blvd.

HFZ460

Rockville, MD 20850 USA

Email: wgm@cdrh.fda.gov

Jack Martinez

NIST

100 Bureau Dr. Mail Stop 8101

Gaithersburg, MD 20899-8101 USA

Phone: (301)975-8125

Fax: (301)975-6513

Email: jack.martinez@nist.gov

Keith McLain

Advanced Bionics

25129 Rye Canyon Loop

Valencia, CA 91355 USA

Phone: (661)352-1833

Email: kmclain@advancedbionics.com

Audrey Morrison

CDRH

13705 Modrad Way

Silver Spring, MD 20904 USA

Phone: (301)827-7534

Email: axm@cdrh.fda.gov

40
Ali Mosleh

Univ. of Maryland

2100 A Marie Mount

College Park, MD 20742 USA

Phone: (301)405-5215

Fax: (301)314-9601

Robert Munroe

Electronic Packaging Consultant

1 6 Avalon Dr. Trophy Club, TX 76262 USA

Phone: (682)831-0993

Email: munroe.bob(S)sbcglobal.net

Srinivas Nandkumar

9200 Corporate Blvd.

HFZ460

Rockville, MD 20850 USA

Email: szn@cdrh.fda.gov

Celeste Null

Intel Corp.

5000 W. Chandler Blvd.

CH7318

Chandler, AZ 85226 USA

Phone: (480)554-0248

Fax: (480)554-7490

Email: celeste.null@intel.com

Michael Pecht

CALCE EPSC - Univ. of MD

1103 Eng. LabBldg.

College Park, MD 20742 USA

Email: pecht@calce.umd.edu

John Pemicka

Pemicka Corp.

1 1 2 Racquette

Fort Collins, CO 80524 USA

Email: rga@pemicka.com

Dave Peterson

Advanced Bionics

25129 Rye Canyon Loop

Valencia, CA 91355 USA

Phone: (661)362-1768

Fax: (661)362-1508

Email: dpeterson@advancedbionics.com

Eric Peterson

Guidant Corp.

4100 Hamline Ave., N

MS C260

St. Paul, MN 55112 USA

Phone: (651)582-2965

Fax: (651)582-2945

Email: eric.peterson@guidant.com

Stan Purwin

Johns Hopkins Univ.

Applied Physics Lab.

11100 Johns Hopkins Rd.

Laurel, MD 20723 USA

Phone: (240)228-6279

Email: stan.purwin@jhuapl.edu

Richard Raisner

Texcel LLC

55 Deer Park Dr.

E. Longmeadow, MA 01028 USA

Phone:(413)525-5700 ext. 1011

Fax: (413)525-6644

Email: rraisner@texcelaser.com

Bill Regnault

U.S. FDA

9200 Corporate Blvd.

HFZ150

Rockville, MD 20850 USA

Phone: (301)827-4748

Fax: (301)827-4853

Email: wfr@cdrh.fda.gov

Charles Reid

Guidant

4100 Hamline Ave., N

Mail Stop El 05

St. Paul, MN 551 12 USA

Phone: (651)582-4110

Fax: (651)582-7599

Email: chuck.reid@guidant.com

41
Ron Reimarm

Guidant CRM

4100 Hamline Ave., N

St. Paul, MN 551 12 USA

Phone:(651)582-4629

Fax: (651)582-2830

Email: ron.reimann@guidant.com

Anne-Marie Ripley

Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar,CA 91342 USA

Email: tfisher@2-sight.com

Amp Roy

Second Sight Medical Products, Inc. 12744 San Fernando Rd.

Bldg. 3 Sylmar, CA 91342 USA

Email: ampr@2-sight.com

Joseph Schulman

Alfred Mann Foundation

P.O. Box 905

Santa Clarita, CA 91380 USA

Phone:(661)702-6700 ext. 6811

Fax: (661)702-6705

Email: joes@aemf.org

Louis Skarda

Guidant

4100 Hamline Ave., N

St. Paul, MN 55 112 USA

Phone: (651)582-2187

Email: louis.skarda@guidant.com

Gail Stricter U.S. FDA, CDRH/OSEL

12720 Twinbrook Pkwy.

HFZ84

Rockville, MD 20850 USA

Phone: (301)827-0027

Fax:(301)827-9097

Email: gail . strieter@fda.hhs. gov

Karen Riley

Clinica: World Medical Tech. News

4004 Jefferson St. Hyattsville, MD 20781 USA

Phone: (301)927-1485

Fax: (301)927-1486

Email: kjriley@ccconline.net

Keimeth Rodbell

IBM Watson Res. 1101 Kitchawan Rd., Rt. 134

Yorktown Heights, NY 10598 USA

Phone: (914)945-1012

Fax: (919)945-2141

Email: rodbell@us.ibm.com

Michael Schen

NIST

100 Bureau Dr. Mail Stop 4720

Gaithersburg, MD 20899 USA

Phone: (301)975-6741

Email: michael.schen@nist.gov

Andreas Schweinzer

BIOTRONIK GmbH & Co. KG

Woermannkehre 1 Berlin, 12359 GERMANY

Phone: 49 3068905 ext. 4316

Email: andreas.schweinzer@biotronik.de

Matthew Stonehouse

Guidant CRM

4100 Hamline Ave., N

Arden Hills, MN 551 12 USA

Phone: (651)582-6572

Fax: (651)582-2830

Email: matthew. stonehouse@guidant. com

Ravi Subrahmanyan

Micro Sys. Eng., Inc. 6024 S.W. Jean Rd.

Lake Oswego, OR 97035 USA

Phone: (503)697-5281

Email: ravi.subrahmanyan@biotronik.com

42
John Suehle

NIST

100 Bureau Dr. Mail Stop 8123

Gaithersburg, MD 20899-8123 USA

Phone: (301)975-2247

Fax: (301)975-5668

Email: john.suehle@nist.gov

Alford Taylor

U.S. FDA, CDRH

Bldg. 1 HFZ-160

12720 Twinbrook Pkwy.

Rockville, MD 20851-1720 USA

Phone:(301)443-2536 ext. 147

Fax: (301)443-9101

Email: Alford.Taylor@fda.hhs.gov

Robert Thomas

Tech. Experts Network

104 Cedar St. Rome, NY 13440 USA

Phone: (315)336-0286

Fax: (315)336-0286

Email: bobtrome@aol.com

Jan Welch

U.S. FDA

2094 Gaither Rd.

Rockville, MD 20850 USA

Phone: (240)276-0354

Fax: (240)276-0114

Email: jan.welch@fda.hhs.gov

Ronald Swarm

U.S. FDA

2094 Gaither Rd.

Rockville, MD 20850 USA

Phone: (240)276-0115

Fax: (240)276-0114

Email: rzs@cdrh.fda.gov

John Tesk

NIST

100 Bureau Dr. Mail Stop 8545

Gaithersburg, MD 20899-8545 USA

Phone: (301)975-6799

Email: john.tesk@nist.gov

Jeffrey Toy

U.S. FDA/CDRH/ODE/DOED

9200 Corporate Blvd.

HFZ460

Rockville, MD 20850 USA

Email: jyt@cdrh.fda.gov

Stuart Wenzel

NDC

47533 Westinghouse Dr. Fremont, CA 94539 USA

Phone: (510)413-1133

Email: swenzel@ndcus.jnj.com

Joyce Whang

U.S. FDA

12725 Twinbrook Pkwy.

Rm. 235

Rockville, MD 20852 USA

Fax: (301)827-0421

Email: jmw@cdrh.fda.gov

Eileen Woo

U.S. FDA

1350 Piccard Dr. HFZ520

Rockville, MD 20850 USA

Phone: (301)594-2446

Fax: (301)594-1967

Email: ekw@cdrh.fda.gov

43
Comments from the Organizing Committee

Personal impressions of John A. Tesk about the workshop on active implantable medical devices

(AMDs):

1 . The workshop was attended by the AIMD industry mainly because it was an FDA workshop

and it seems that whenever the FDA puts on a workshop, industry feels compelled to attend

in order to keep up with what might be new developments that affect them.

2. The Industiy failed to grasp what was clearly stated in the purpose of the workshop, namely;

"The objective is to help identify the technical and measurement issues that are involved in

the use of both national and international standards for the assessment of the reliability of

active implantable medical devices. It is the intention of this workshop to help define the areas for future work that will facilitate the rapid deployment of advanced implant

technologies." In general, industry came expecting measurements to be given to them rather

than their partaking in the identification of generic needs for standards and measurements

that should be developed soon for the future good of the industry, customers, and patients.

3. There was a reluctance on the part of the industry to say much in the presence of the FDA,

which had a great presence (in numbers) at the workshop, in short, the FDA was feared more

than being seen as a potential partner in aniving at good standards that could be of benefit to

all. 4. The workshop had a beneficial effect in bringing together the major developers of the

different kinds of AIMDs and elucidating problems that need to be overcome for greater

cooperation in the development of consensus standards, such as those that already exist

between the FDA and The ASTM F04 Standards Committees and through the Orthopaedic

FDA Forum, a regular meeting of the FDA and orthopaedic surgical device manufacturers.

Something like the latter should be attempted between the FDA and the AIMD industry.

Perhaps the AIMD Industry could be invited to one of the Orthopaedic Device Forum

meetings to observe how it functions and to hear from the Orthopedic Industry about its effectiveness. I recommend this or, at least, asking the Orthopaedic Fomm participants to consider setting aside a couple of hours to meet with the AIMD industry just prior to or after an Orthopaedic Device Forum meeting.

5. Major issues in the measurement methods for leak detection and validation of those methods

were acknowledged by all. NIST was chided for not having produced the needed

measurement methods and "reference materials" for calibration of low level helium leak

tests.

6. Leak test models for various kinds of leaks through tortuous paths through different kinds of

materials and combinations of materials, including seals between materials comprising a "can" are needed.

7. This observer sees the possibility of extending the kind of modeling used for fluid transport

through scaffolds used for tissue engineering and models for permeation of resins for fiber

composites to serve as starting points for modeling of leaks. Many such geometrical models

already exist in the MSEL that would obviate the need to start from the beginning all over

again; two-three years of effort could be avoided. Nearly immediate extension to much

' smaller scales could begin with material/fluid property, then interactions based on size could

begin to be added and effects validated.

44
The time is now ripe for holding follow-up workshops that will focus on individual or related

issues; it may be necessary for NIST to lead some without the FDA directly co-hosting and

others may require the FDA via interactions with Standards Development Organizations.

45
Liz Drexler 's thoughts on how to build on the accomplishments ofthe workshop on Measurement

Methodsfor Evaluation ofthe Reliability ofActive Implantable Medical Devices (AIMDs).

I believe that there are two parallel AIMD needs to be fulfilled. The October 2005 workshop

was very successful in getting the FDA scientists and engineers talking with one

another, members of the FDA Device Evaluation Group (those who qualify new devices and set the necessary test standards and requirements) and the Compliance Group (those who assure that

the qualifying tests and standards are properly applied). Individuals within these groups

specialize in particular devices. But in the past there has been little interaction and discussion

within a group and between groups about holding all AIMDs to the same standards. The FDA

people learned a lot from our speakers, but further education in the forni of workshops could be

valuable.

The second group, of course, is the AIMD manufacturers. As I see it, they need to design,

qualify, and manufacture highly reliable devices, so that they get product to market in a timely

fashion, with negligible numbers of failures in service. It would seem that it would be to their

benefit to cooperate on finding solutions to problems that are universal. I think that they are

starting to see this as well, based on the foraiation of the iNEMI technology integration groups

(TIGs) on Pb-free solders and medical grade component standards. We also know that

hermeticity is an issue for the AIMD manufacturers.

So how can NIST best serve these two groups?

1 . I believe in general we need more education on hermeticity. A half-day workshop in

conjunction with the fall ASTM F04 meeting has been proposed, dealing with hermeticity

and leak testing, methods, standard references, etc. I believe that we will need to work

through the ASTM because the FDA has a relationship with them and established standards

are the only mechanism that the FDA can use to communicate their requirements. But I am

concerned about who is our audience for this workshop? Manufacturers, is this a venue with

which you can work? Would you prefer a different setting? This probably is not the best

situation for educating people from the FDA. Do we need two educational workshops on

hermeticity, leak testing, and residual gas analysis? Where should they take place? Are

there other pressing educational needs? How should we cover costs?

2. Bob Thomas presented an idea on forming a Task Force that would meet in a pleasant

neutral setting with no reports or agendas other than participation. That offer is still on the

table if the device manufacturers would like to take him up on it. Do you feel as though your

needs are being met with the iNEMI TIGs, and another venue is unnecessaiy? Do you feel

the need for more diverse participation in the iNEMI TIGs?

In conclusion, I would encourage individuals to respond to me and let me know how I can

help. I am committed to researching the problems and needs of the AIMD community, and how

NIST might best serve that community. I look to you for guidance.

Liz Drexler, drexler(§) boulder.nist.gov

Materials Research Engineer, NIST

46
Open Comment from Attendees

We feel that the workshop was successful in getting device manufacturers and the FDA to at least talk to each other about their issues and problems related to measurement methods in

evaluating/establishing the reliability of AIMDs. Obviously, follow up work needs to be done

and we are definitely interested in actively participating in any fomm or workshop that aims to address the industry issues and problems identified in the first workshop.

Please continue to keep us informed of any updates and we look forward to meeting you again

soon.

Marcus Ignacio

Edmund Capcelea

Cochlear Limited

14 Mars Road, PO Box 629

Lane Cove NSW 2066

Australia

Here are some quick thoughts:

1 . The Medical Device attendees would benefit greatly by having a "Task Force"-like meeting

as I described in my presentation. The Minnowbrook Lodge at Blue Mountain Lake is an ideal

location and provides a relaxed atmosphere for exchanging ideas. This would be a makers

meeting only without any record. All you need is a facilitator and it funds itself. No outside

money needed. The purpose of the meeting would be to solve common problems at the physics

level. One possibility is to hold it jointly with the October 2006 Moisture and Packaging

meeting already in place. There is enough room to host an additional meeting at the same time.

Medical attendees would benefit from the discussions on hermeticity, RGA and packaging, but

could hold a parallel session for makers only to air their dirty linen. I think that it would work

well. The only problem is that it is a year away. An alternative, suggested by John Pemicka is a small island off Florida in January or February to get things started. Makers only with

participation by some independents like Ken Rodbell and Celeste.

2. The second need is a seminar for the FDA and NIST people at Gaithersburg to bring the

group up-to-date with the hermeticity and RGA lessons learned over 30 years in measurement

and manufacturing issues that are directly related to the monitoring of the implant makers. Need

three days. Have the speakers in mind. Use training funds to support the attendees.

3. The third need is to work with the FDA assessment organization via a series of seminars and

a shadow assessment using QML type auditing techniques. This is really important if you want

to get the cooperation of the implant industry. This also should be held at NIST with training

funds as the source of support.

4. I am currently proposing a Semiconductor Smart Site© for the IEEE Reliability Society.

47
Using this as the lead demo, the group needs to move ahead in providing a service Uke this to the

implant groups as was discussed at the October Workshop. Will have a business plan that

includes revenue from Google to support the expert analysis that will be used in maintaining the

Smart Site. More on this later, but getting knowledge on demand to the manufacturers is the way

to reduce recalls and cost.

Bob Thomas

Technology Experts Network

104 Cedar St. Rome, NY 13440 USA

48 GlO-'' U.S. GOVERNMENT PRINTING OFFICE: 2006-560-019/42005
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