review of inemi medical initiativesthor.inemi.org/webdownload/projects/medical/... · 7 digital...
TRANSCRIPT
Review of iNEMI Medical Initiatives
Nov 10, 2011
2
Agenda
• Objective
• Background
• Medical Initiatives:
– Team 1: Review of Reliability Standards Relevant to Implantable Medical Electronic Devices
– Team 2: Common Specifications for Electronic Components in Medical Devices
– Team 4: Reliability Performance Qualification Methods for Portable Devices
• Process from here
• Introduction to Teams 3 & 6; Starting Up in November
• Summary
• Contact Details
3
Objectives of this Session
• Present overview of the 3 Medical Initiatives that are
coming to competition.
• Share the process moving forward to engage you and
key industry players in collaborative R&D
• Define the steps and timeline for follow through to
create effective collaborative projects
– That deliver results and business impact.
4
Background
Medical Electronics is one of iNEMI’s focus areas
Many members working in the fast growing area
iNEMI has been producing a Medical PEG for a number
of Roadmap Cycles, identifying the midterm and long
term research needs of the industry
Industry consensus that there are opportunities for
collaboration that will help speed up the adoption of new
technologies in medical devices.
5
Current Members with Medical Focus
6
Medical PEG: 2011 Chapter Focus
Market Environment and Economics of Medical Electronics
• Emerging markets expected to have double digit growth.
• Focus on lower cost diagnostic equipment for developing nations and rural areas.
• Regional assembly, design and distribution expected to increase in India and China.
• High Growth of Tele-Medicine using multi functional portable devices.
• Continued migration from prescriptive to preventive medicine will drive increase in portable/wearable medical monitoring devices.
• Unknown business implications and potentially increased regulatory changes could materialize based on health care legislation.
7
Digital Health
• Patient care enhancement - New and Unique Medical Products
- Monitor Systems
- Sensor Technology
- Improved Diagnostics
• Wireless technology for data
transfer - Instant and remote monitoring
- Power transfer by RF
- Off-load computing and data
storage to remote host system,
outside the device.
In past 10 years, growth, innovation and miniaturization have lead to major
advances in medical electronics manufacturing and the therapies they deliver.
8
Diagnostic Imaging
• Patient-centric, clinician-centric environment
– Comfort
– Workflow
• Demands for higher resolution maybe abating
• Demands for greater imaging volumes not
abating
• Anatomy defines package volumes
– More bits per cubic inch translates to
higher functional densities
• Portable systems for “baseline” diagnostics
9
Identification of Opportunities for Collaboration
Seven potential projects/initiatives were indentified
as a result of iNEMI workshops and consultations in 2010
& 2011.
Webinar held in May 2011 to form teams to develop
project plan.
The first 3 teams started working on developing a
Statement of Work (SOW) in 3Q11 and aim to send them to
the Technical Committee (TC) on Dec 1, 2011.
10
iNEMI Medical Initiatives – May 2011
Medical Initiative No. 1
Defining Requirements and Development of
Specifications for Reliability of
Implantable Medical Electronics
John McNulty,
Exponent
&
Erik Jung,
IZM
12
Agenda
• Project Motivation
• Project Scope
• Project Goals
• Companies involved in initiative
• Contact details
13
Defining Requirements and Development of Specifications for
Implantable Reliability of Medical Electronics
Original Problem Statement:
Absence of expertise and proven/accepted best known practices in reliability for the medical products
Desired Project Goals:
– Create a library of the physics of failure by product type.
– Develop a reliability test suite library that is specific to the failure modes they are most effective with addressing Body-device interactions
– Address unique needs for bare die encapsulation & for bare modules
– Once these are in place; probability of failures occurring database can be more effectively put in place
14
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Background
• The focus of the program is to identify lacking standards for
product testing to ensure reliable function of implantable electronic
products (i.e. FDA class 3).
• Today´s standards for reliability testing - applied for the
development and pre-market evaluation of an implant, are derived
from typically harsh environmental operation standards, e.g.
military, automotive or avionics.
15
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Background (continued)
• Currently, reliability test methods and data for a specific
manufacturer and product may be available for a specific use case
• Knowhow is typically not spread to OEM´s – leading to the absence
of established standards. Consequences include:
– Multiple re-iterations of a product design due to pre-market
failures
– Missed opportunities on overall product cost reduction due to
unnecessary re-iterations
– Placing patients at risk due to non-sharing of risk factors gained
by other industry participants
– Litigation risks for failures after several years of operation
16
Defining Requirements and Development of
Specifications for Implantable Reliability of Medical
Electronics Scope of Work (continued) Standardization of test routines will mitigate these factors and offer
to the industry and patient a faster level of innovation, a higher profit, and lower litigation risks.
The approach to achieving this target is separated into three
phases:
Phase 1:
Review of Reliability Standards Relevant to Implantable Medical Electronic Devices
Phase 2:
Gap Analysis and Protocol Development
Phase 3:
Methodology Recommendations (t.b.d.)
17
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Phase 1 Goal: • Identification and compilation of existing reliability, quality, and
safety standards specific to implantable electronic devices • Applicable and relevant to a broad range of implantable electronic
technology
Phase 1 – Review of Reliability Standards Relevant to Implantable Medical Electronic Devices
18
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Scope of Work:
Identification/compilation of existing reliability/quality/safety
standards specific to implantable electronic devices
Task 1:
Group input on existing standards specific to implantable
electronics (see preliminary slides on standards added to this file)
Task 2:
Survey the industry:
1. Existing standards
2. Most frequently referenced/modified standards from other
industries, i.e. MIL-883F, method 1015.9 (burn-in)
3. Custom reliability tests/standards (this may get to the core of the
issue in terms of what needs to be standardized)
Phase 1 – Review of Reliability Standards Relevant to Implantable Medical Electronic Devices
19
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Task 1 - Protocol Development (Determination of in vivo Device
Conditions)
Background:
– For micro-implants - many governing boundary conditions are
unknown.
– Determine which parameters are relevant for long term
reliability
– Brain/computer interfaces - reliability
Phase 2 – Gap Analysis and Protocol Development
20
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
Task 2 - Protocol Development (Determination of in vivo Device Conditions)
Scope of Work:
– Develop a protocol, which will lead to a test methodology for a
new device:
• Risk factors: issues for implantable devices that are not
immediately apparent
• Think beyond established ISO standard frameworks -
leading to FMEA - and start the definition of a standard
Phase 2 – Gap Analysis and Protocol Development
21
Defining Requirements and Development of
Specifications for Reliability of Medical Electronics
FMEA - to define one or more of the following as a project
• Preliminarily ranked in descending order of preference
– Recommendations for standards development or further investigation
– Review on Physics of Failure (PoF) with respect to identified issues
– Identify conflicting PoF and test methods (e.g. high thermal storage for low Tg polymeric encapsulants…)
– Prioritize environmental, mechanical, radiation (common source X ray), and MRI testing
Phase 3
22
Organizations that have participated in this Initiative
• ASEN Suzhou Semiconductors
• CMTC Associates
• Cochlear
• dfrSolutions
• Eitny
• Exponent
• Flextronics
• GE
• HDP User Group
• Henkel
• IBM
• IEC Electronics
• IMEC
• Medical Microsystems
• Medtronic
• Micro Systems Engineering Inc
• Molex
• NIST
• Plexus Corporation
• Premier Semiconductor Services
• PWB Corp
• Rogers Corp
• St. Jude Medical
• Texas Instruments
• Tronics
• URS Corp
• Zarlink Semiconductor
23
Contact Details
Chair
• Erik Jung - Medical Microsystems
– Email: [email protected]
Chair
• John McNulty – Exponent
– Email: [email protected]
iNEMI
• David Godlewski - iNEMI
– Email: [email protected]
– Tel: 717-651-0522
Medical Initiative No. 2
Common Specifications
for Medical Electronic Products
Diganta Das, CALCE
& Peter Lampacher,
Vibrant Med-el
25
Agenda
• Project Motivation
• Project Scope
• Project Goals
• Tasks and timeline
• Potential Benefits
• Companies involved in initiative
• Participants needed
• Summary
• Contact details
26
Project Motivation
• Need for Common Specifications for Medical
Electronics Products
– Focus on electronic components
– Every electronic component that is purchased for
high reliability medical products today must be
individually qualified – no medical industry
specifications exist for qualification of components
or their suppliers.
– This situation increases costs for component
manufacturers since every medical device OEM can
have different requirements; often making them
unresponsive to the medical device market
27
Purpose of the Project • The primary purpose of the project will be to develop a method for
developing a test and screen matrix for electronic components that
can be used to qualify the reliability performance of components
for electronic medical devices. Several example screen and test
matrices will be included in the report as validation of the
practicality of the method.
• This project will result in a standard reliability method that can be
implemented by medical device manufacturers within their
component management process. In those cases when critical
defects and failure mechanisms or test methodologies are already
known, the implementation process will be easier.
• For those situations in which the failure mechanisms or test
methodologies are not known, this project will be part of a more
complex solution.
28
Project Scope
What the Project IS / IS NOT:
This Project IS: This Project IS NOT:
To define a set of reliability qualification methods
on a component level accepted by OEMs and
supported by suppliers (that is, original
component manufacturers)
To define reliability qualification methods for medical
devices
To define: What is acceptable ageing of
components and what is failure?
A qualification effort for a specific product line at a
specific supplier
To quantify reliability within a suitable framework
in defined operating conditions
Further work on already known ageing/failure
mechanisms
To re-use qualification methods successfully
employed and rationalized in other industries To recreate the wheel of component qualification test
methods and processes To create guidelines for OCMs to utilize physics
of failure based reliability assessment
To create guideline for medical OEMs on how to
assess OCMs
To create guideline on minimum levels of tests
for various component types
29
Anticipated Benefits and Outcomes
Recommendations for common specifications for
medical components and manufacturing capacity of
OCMs (original component manufacturers) that meet
the test, performance, and reliability needs of
implantable and wearable medical products.
30
Project Tasks & Timeline
– Task 1 Determine the coverage of the components for the first
phase (Months 0 – 3)
– Task 2 Identify the most common defects, degradation and failure
mechanisms of the selected items under medical device
applications (Months 3 – 6)
– Task 3 Determine the screens for identification of the defects and
tests for precipitation of the mechanisms (Months 6 – 15)
– Task 4 Create a minimum set of tests and screens related for each
part referring to industry standard methods whenever possible
(Months 10 – 17)
– Task 5 Final report including a methodology description on the
process of developing the tests and screens for other parts (Month
12-18)
31
Possible Follow-On Activities
• Create new tests and screens when none are applicable
in the industry standards
• Expand to other types of components (including
possibly non-electronic components)
These can be future iNEMI projects or can be company
specific activities
32
Method of Project Implementation
• Task 1 will be achieved through web based survey
followed by data analysis by the core team
• Tasks 2 through 4 will be implemented by small work
groups for each component type selected in task 1. The
work groups will include representatives of OEMs,
OCMs and other subject specialists from industry and
academia
• Task 5 will be performed using contributions from the
work groups by the core team that will ensure that the
completed document is a practical one that can be used
by OEMs and OCMs in an economic manner
33
Organizations that have participated in this
Initiative
• CALCE
• Med-el
• ATS
• AVX
• Benchmark electronics
• Boston scientific
• Celestica
• CALCE
• DfR Solutions
• EITNY
• Exponent
• Fairchild Semiconductor
• GE Research
• Indium
• Kemet
• MSE
• Molex
• NIST
• Northrop Grumman
• Valtronic
34
Organizations that Would Benefit from
Participation
• Medical Device OEMs
• EMS companies that source part for OEMs
• Original Component Manufacturers (OCMs)
• Testing companies
• Industry standard bodies
35
Summary
• With this industry led project, medical device industry
will emulate the processes successfully followed by
other low volume complex electronic system
manufacturers such as avionics and automotive to
create practical solution to component availability
problems
• Development will help create a trusted relationship
between OEMs and OCMs and reduce problems of
availability shocks
• It will also help create alternate part sources more
easily
36
Contact Details
• Diganta Das - CALCE, University of Maryland, USA
– Email: [email protected]
– Tel: +1 301 405 7770
– Fax: +1 775 218 5209
• Peter Lampacher - VIBRANT MED-EL, Innsbruck, Austria
– E-Mail: [email protected]
– Phone: +43 (0)512 – 28 88 89 – 256
– Fax: +43 (0)512 – 28 88 89 – 299
• Grace O’Malley - iNEMI
– Email: [email protected]
– Tel: +353 87 904 0363
• Jim Arnold – iNEMI
– Email: [email protected]
– Office (East): +1 978 649 4717
– Office (West): +1 480 854 0906
– Mobile: +1 480 703 0133
Medical Initiative No. 4
Reliability Performance
Qualification Methods for Portable Devices
Jack Zhu,
Boston Scientific
&
Grady White,
NIST
38
Agenda
• Project Motivation
• Project Scope
• Project Goals
• What the project IS/ IS NOT
• Project tasks and timeline
• Anticipated Benefits & Outcomes
• Organizations that have participated in this Initiative
• Contact details
39
Project Motivation • The medical electronics industry is developing very quickly.
Historically the industry has been vertically integrated with a narrow supply base. The market has been conservative and slow to introduce new technologies and products.
• Both the rapid growth of the use of electronics in medical devices and the recent market-driven needs to shorten time to market for new products (NPI) has revealed the lack of a consistent approach to determine the reliability performance of devices, such as is done in the military applications, e.g., use of MIL STD.
• This results in time consuming and redundant testing at many stages of the product development and qualification cycle.
• Development of a standard methodology and qualification procedure would enable the industry to enact changes quicker and to bring products to the market in a shorter time.
40
Project Scope – Portable Medical Electronics
Devices
• Portable medical electronic devices include:
– Patient monitoring systems that are used to measure and monitor patients’ vital signs and other bodily functions
• Including home diagnostics products such as blood pressure cuffs (including wireless), blood glucose meters, pulse oximeters, and biochemical analysis meters.
– Peripheral products of the implantable medical systems
• Such as external charger, remote controls.
• Why portable medical electronic devices?
– While failure of most types of portable device will typically not impose immediate risk to patient life, it will largely affect the consumers’ confidence with the product.
– Compared with large infrastructure devices like x-ray systems or small implantable devices, such as pacemakers, portable medical devices have a larger production volume and, thus, a larger user base.
– For implanted devices, the external supporting electronic devices are critical to routinely maintain or monitor the active implanted components and, thereby, can greatly impact the patient’s safety or life quality.
• There is an urgent need for medical device manufacturers and supplier industries both to understand and to optimize qualification requirements and, concomitantly, device reliability.
41
Project Goals
• The primary purpose of the project is to provide a methodology that can be used to qualify reliability performance of portable electronic medical devices.
• The greater emphasis on reliability for medical electronic devices than for comparable non-medical devices underscores the need for industry accepted reliability assessment procedures for medical device applications
• It is anticipated that this project will result in a standard reliability method that can be implemented in those cases for which the failure mechanisms or test methodologies are known
• For those situations in which the failure mechanisms or test methodologies are not known, it is anticipated that this project will provide part of a more complex solution.
42
What the Project IS / IS NOT
This Project IS: This Project IS NOT:
Focused on portable medical devices,
including stand alone devices and
peripheral devices associated with
implantable systems.
To determine failure processes or time
dependence
Identification of extant industry tools and
standards
To define accelerated test parameters for
components or devices
Identification of gaps in extant industry
tools and medical devices
To identify failure processes or conduct
extensive reliability test
To lead to well-defined, industry-accepted
lifetime/reliability assessment procedures
for portable medical devices
To develop a test methodology
43
Project Tasks & Timeline • Months 1 – 2: (Task 1) Identify companies and champions to lead
investigations
– Select and identify task leaders
– Select and identify task members
• Months 3 – 5: (Task 2) Identify tools and methodologies that already exist
– Identify extant reliability tools and standards
– Identify gaps in tools and needed standards
• Months 6– 12: (Task 3) Decide how to address the identified gaps
– Identify extant tools that cover all or most of the gaps
– Identify potential solutions for identified gaps
– Identify needed additional knowledge (e.g., external expertise, required research, additional statistical tools)
• Months 13 – 15: (Task 4) Conclusion of the project
– Define appropriate reliability standards protocols
– Identify remaining needs
– Agree upon transition of results to appropriate standards organization
• Month 16: (Task 5) Final report
– Final report to iNEMI
44
Anticipated Benefits & Outcomes
• Business impact:
– A standardized qualification process reduces the overall qualification cost because time will be reduced and OEMs will no longer need to spend money and resources to define a process every time they introduce a new portable device. They will be able to utilize existing standards that are defined for various devices.
• Outcome of Project:
– Will include a final report that contains a review of the industry status for qualification of portable electronic medical devices, a description of the assessment procedure, and a listing of current industry approaches with detailed discussion of identified gaps and gap mitigation procedures.
45
Summary
• This activity is intended to:
– Combine OEM and EMS expertise to identify current
best practices in assessing reliability of portable
electronic devices,
– Identify those procedures that can be applied to
assessing portable medical devices,
– Identify any gaps in those procedures, and
– Obtain a set of procedures acceptable to the medical
electronics industry for assessing reliability of
portable medical electronic devices.
46
Organizations that have participated in this
Initiative
• Boston Scientific
• NIST
• CALCE
• MSI
• Imec
• DfR Solutions
• EITNY
• Benchmark electronics
• Atotech
• Cochlear
• Delphi
• Exponent
• GE Medical
• Imec
• Kemet
• Medtronic
• Med-el
• MSE
• Philips
• Texas instruments
• Toshiba
• Tyndall Institute
47
Contact Details Chair
• Grady White - NIST
– Email: [email protected]
– Tel: 303 497 4638 & Mobile: 240 731 2501
Co –Chair
• Jack Zhu – Boston Scientific
– Email: [email protected]
– Tel: 661 949 4473 & Mobile: 626 698 2011
iNEMI
• Grace O’Malley - iNEMI
– Email: [email protected]
– Tel: +353 87 904 0363
• Jim Arnold – iNEMI
– Email: [email protected]
– Office (East): +1-978-649-4717
– Office (West): +1-480-854-0906
– Mobile: +1-480-703-0133
Next Steps We Estimate These Three Initiatives Will Move to
Projects in Early December
49
SELECTION
DEFINITION
PLANNING
EXECUTION / REVIEW
CLOSURE
1
2
3
4
5
The Project Process - 5 Steps
Limited to Committed Members
Open for Industry input
------------------- iNEMI Technical Committee (TC) Approval Required for Execution
Goal is to submit Statement of Work (SOW)
To Technical Committee (TC) on Dec 1, 2011
50
Actions from here
• Review SOWs
• Attend remaining team calls
• Submit feedback to the chairs of the initiatives
• Technical Committee review in Dec 2011
• Six week sign up Period
• Project Start by 1/15/2012
51
And…Two New Initiatives Will Start Up in November
52
Initiative # 3: Supply Chain
Problem: Lack of effective supply chain support in
Medical Electronics.
Key Contributors from the supplier side:
• Medical market aversion – Liability and Volume
• Ambiguity in the NPI process and Timeline
• Forecast Variability
• Life cycle challenges – drawn out NPI and lengthy end of life
Key Contributors from the OEM side:
• Poor communication of upstream process/material characterizations
and of problem dissemination.
• Challenges from social issues; child labor, third world labor practices
• Unique specs for components not met by existing parts/suppliers
• Scarcity of Materials – REM’s, Plastics, Plasticizers
• Supply base consolidation and requalification as a result.
• Counterfeit part challenges.
53
Initiative #3: Supply Chain Desirable Outcomes (not in priority order):
• Create widely available information on component and supplier
capabilities
• Need to stimulate supply base for medical (components, materials, etc.)
• Consider looking at combined needs of military & medical
• Development of data declaration standards for medical – electronically
transferrable
• Liability indemnification
• Clarity of supplier/OEM business models that support:
– NPI for innovative new products
– Change Control and Product Requalification
– Support requirements for long life products
• For REM’s and Scarce/Threatened plastics – Clarify the medical market
priorities and create an action plan:
– Needs to be an on-going effort as the priorities will continually
evolve/change
• Clarity of OEM/Supplier operating agreements (e.g. BKM templates)
54
Initiative # 6: MRI/X-ray & Implantable compatibility
• Problem: Existing MRI and X-ray technologies are not compatible
with electronic implantable devices – limits treatment options for
patients with implants
• Desirable Solution: Imaging products & protocols that are more
friendly to patients with implants
– Device compatibility for implantable devices & imaging equipment
– Patient safety
– Acceptability from FDA; involve them up front
– Check on knowledge base from interventional MRI
– Study work underway by other groups working this issue
• Big Players for needed from the following market segments:
– Imaging Equipment
– Cardiac Implantable
– Cochlear Implants
– Implantable battery and lead OEM’s
www.inemi.org Email contacts:
David Godlewski [email protected]
Jim Arnold [email protected]
Grace O’Malley [email protected]