webinar for medical projects - inemithor.inemi.org/webdownload/2014/webinar_medical_110514.pdf ·...
TRANSCRIPT
Webinar for Medical
Projects
November 5, 2014
2
Agenda
• 11.00am Welcome
• 11.10am 2015 Roadmap Medical PEG highlights
• 11.25am Project summaries – key learnings and potential new areas
identified
• Reliability Requirements for Implantable Medical Devices Phase 1 and 2
• Component Specifications for Medical Products
• Qualification Methods for Portable Medical Products
• 11.55am Highlights from Medical symposium
• 12.10pm Discussion
• 12.50pm Next steps and actions
3
Today’s Objective
Review data from roadmap, project teams and industry input
Start the discussion
Identify areas of interest for industry
Clarify the needs or gaps that have to be addressed
Determine if suitable for collaboration
Establish if there is leadership and critical mass available
4
Background
Medical Electronics is one of iNEMI’s focus areas
Many members working in the fast growing area
iNEMI has been producing a Medical PEG for a number of Roadmap Cycles,
identifying the midterm and long term development and research needs of the
industry
Co-hosting for last 2 years Symposium with SMTA and Meptec focused on medical
device manufacturing.
Industry consensus that there are opportunities for collaboration that will help
speed up the adoption of new technologies in medical devices and time to market.
5
Current Members with Medical Focus
Medical Electronics Workshops held in Berlin,
Germany & Santa Clara, CA
Outcomes indentified Top Priorities for Collaboration
7
Medical Workshop - Participating Companies
HEI, Inc.
ipdia
8
Medical Workshop - Participating Companies
(Reinhardt Microtech)
9
iNEMI Medical Initiatives Identified in May 2011
2015 Medical Projects Discussion- 2015
Roadmap Medical PEG highlights
Fred Sporon-Fiedler
Director
Micro Systems Technologies
4NOV14
11
MEDICAL PRODUCTS PARTIONING
1) Implanted products (those devices implanted in a human body)
• Strict regulatory procedures
• Driven by battery life (low power loss)
• Validation and traceability
• Long term reliability paramount
• Long development cycles, primary assembly and design by OEMs
2) Portable products (those devices that are easily transported)
• Cost parity with consumer / portables
• Dynamic market, needs fast response … 9 to 24 month product cycle time
• Mixed regulatory environment
• Mostly outsourced assembly and design (SEA)
3) Diagnostic imaging devices and large scale equipment, e.g., MR, CT
• Larger scale (often similar to servers or telecom equipment)
• Often requires thermal management and heat sinking
• Utilizes commercial off-the-shelf components, when available
• Development cycle is shorter than implantables
• Application and design well suited to EMS environment
• Often does not require clean room or sterile assembly floor
Three general categories:
Roadmap Executive SummaryDemographics:
– Worldwide demographic and lifestyle changes will continue to increase the demand for medical technologies.
– The demand will be accelerated by improved detection methods for a variety of diseases such as cancer.
Market:
– IHS Technology: Medical electronics market is expected to grow at a ~ 5-6% Y-Y.
– The market is forecast to exceed 100B$ (2025) from ~60B$ (2013)
Globalization:
– Increasing importance of Asia as a hub for development and manufacturing of medical devices/electronics
– Great opportunity for medical electronics companies and must be embraced.
Technology front:
– Stretchable electronics paradigm shift. 3’rd major substrate technology for medical over the course of the next 10 years
(Rigid and Flex being the other two).
– Emphasis is needed on development of a universal 3D SiP technology and improved Capacitor technology.
• Standards:
– Establishment of standardized Component and Sub-Assembly test methods for medical applications is needed.
12
Situation Analysis
13
WW Demographics and incomes will drive increased demand for Medical
Products of all types.
# of people >65 yrs of age to
~double in next 20 yrs.
Bulk from China, India and
Developing countries
Average income levels also
increasing outside Americas/EU
Medical Electronics must execute
“turn to Asia” strategy- Design &
Build close to customers,
regulatory agencies
MEDICAL MARKET- 2014 IHS Update
Market analysis from IHS Technology
27 largest Medical OEM companies in survey
Roadmap of Key Attributes
15
207 parameters in 2013 roadmap
Divergent needs across Implantable, Large System,
Consumer Portable
16
Emulator Spreadsheet Recommendations
• New Rows / Columns for 2015:
• Recommend addition of stretchable substrates (1-2 layer)
• Roll-Roll Glass processing is missing, should this be included?
Cardiac Balloon Catheter with EKG & LED with stretchable interconnect
Convergence in Class III Medical Therapy Devices
Smart, Connected Medical Microelectronics Miniaturized Connected Delivering therapy
Larg
e s
yste
ms fo
r Thera
py, D
iagnostic
s,
Sto
rage a
nd C
om
munic
atio
ns
Port
able
, patient
sid
e,
dia
gnostic a
nd
monitoring
Cochlear
Vagus Nerve & Spinal
Urinary
Implant
Gastric
Retinal
Cardiac
Brain
Consumer/Portable Medical Electronics
18
• Real-time diaper wetness sensor &
notification
• Impedance measurement
• RF connection
• University of Tokyo workSource: www.medgadget.com
Breadth of applications of bio-medical
sensing, connectedness will grow into
unforeseen places.
Even diapers are becoming smart…
We’ll need 1.375 Bunits/day world-wide
(40M/day in US alone)1.
1:http://disposablediaper.net/faq/how-many-diapers-are-required-every-day-to-satisfy-the-
world-consumption/
2015 Future Technical Projects
Possible Projects• 3D Heterogenous Packaging:
– A working group needs to be formed with participation from all industry segments that seek miniaturization of their electronics. This group
can help drive development of multiple test vehicles to compare multiple technology options (First an Interconnect vehicle which can then
lead to a Functional demonstration of a Sense/Control/low power RF 3D package for medical applications). Participation from the Medical
PEG will help establish needed quality and reliability performance targets.
• Discrete Component initiative:
– Continuation of the High Density/High Rel ultra-dense capacitor work already in progress w. iNEMI support on the “Component specifications
for medical products” project. In particular, this effort will need to investigate alternatives to Ta/MLCC capacitors due to leakage concerns
impacting portable and implantable electronics.
• Cleanliness:
– New: Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?
• Development of low profile, compact miniaturized passives
• Development of higher density, miniaturized connectors -> 4K I/O in 1 inch. Too nichy?
• A scoping exercise to address component validation standards- already done.
• Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative,
high resolution serialization, other?)
• A scoping exercise should be conducted by iNEMI to determine the suitability of iNEMI participation in development of system
architecture
19
Thank You
Questions?
20
Project summaries –key learning and
potential new areas identified
Reliability Requirements for Implantable Medical
DevicesPhase 1 and 2
Project Leader: John McNulty, Exponent Failure Analysis
Associates, Inc.
Project Leader: Erik Jung, Medical Microsystems
Project Co-Chair:
Strategy Tactics Start: Anticipated End:
Issues Graphics
Focus Area:
Nov-14TIG:
Goal:Identify lacking standards for product testing to ensure reliable function of implantable electronic products (i.e. FDA class 3)
Medical
Medical
Defining Requirements for the Development of Implantable Reliability Specifications
John McNulty (Exponent) and Erik Jung (Fraunhofer IZM)
• Survey data collection - conclusions & recommendations
• Detailed analysis of standards identified in the survey in addition to those identified by the working group with respect to:
– Product hierarchy (component vs. assembly)
– Test hierarchy (stress/screen vs. life test)
– Test specifications (maturity; utility)
– Body stresses (high or low; how well understood)
• Focused on implantable medical devices, FDA class 3
• Identification/compilation of existing reliability/quality/ safety standards specific to implantable electronic devices
• Information gathering: industry survey of commonly used/modified test standards; determination of device-specific usage environments
• Applicable/relevant to a broad range of implantable electronic technologies
• Standardization of qualification test methods most applicable to implantable medical devices and identification of areas most in need of standards development will offer to the industry as well as to the patient a faster level of innovation, a higher profit, and lower personal and litigation risks
6/2013 7/2014
23
Focus Area:
Nov-14TIG:
Project Members
24
Medical Electronics
Medical
Defining Requirements for the Development of Implantable Reliability Specifications
Problem Statement
• The proposed focus of the program is to identify lacking standards for product testing to ensure reliable function of implantable electronic products (i.e. FDA class 3)
• The situation is becoming more acute with recent developments in novel implantable electronic products, which cannot utilize traditional hermetic packaging (e.g. sealed Ti housings) in order to operate properly at the desired site (e.g. subcutaneous glucose monitors, retinal implants, brain-computer interfaces, etc.).
• Existing standards for products used in harsh environments do not cover the specific environmental conditions that an implant may see during long years of operation, e.g. X-ray screening, aggressive cell agglomeration, local changes in the ambient chemistry, thereby under- or over-estimating risk to the patient.
Scope of the Project
• Goal: Standardization of qualification test methods most applicable to implantable medical
devices and identification of areas most in need of standards development will offer to the
industry as well as to the patient a faster level of innovation, a higher profit, and lower
personal and litigation risks
• Our approach to achieving this goal is separated into three phases:
– Phase 1: Review of Reliability Standards Relevant to Implantable Medical Electronic Devices
– Phase 2: Gap Analysis
– Phase 3: Methodology Recommendations (dependent on feedback for Phase 2) – may
become separate working groups (WG)
Key Learnings:
• There are a few critical areas where there are insufficient medically-specific standards to guide manufacturers
& their supply chains:– RF performance: protocol security, broadband signal response, wireless charging, unintentional coupling, wireless
coexistence, and body area networks are all subtopics that require industry/government collaboration to develop
standards
– Biocompatibility/biostability: current standards lack accelerated tests to evaluate long term issues
– MRI: guidance on design to ensure device compatibility with rapidly evolving MRI tool capabilities
– Damp heat: acceleration models are needed for non-hermetic devices
• OEM involvement and sharing of information is key to the success of this and future projects
Reliability Requirements for Implantable
Medical Devices Project, Phase 2
27
Component Specifications for Medical Products
)
Chair: Peter Lampacher (Vibrant MED-EL)
Project
Leader(s):
Project Start:
Estimated End:
Purpose and Scope of Project Project Tasks
Status Update
Problem
Statement:
2929
Peter Lampacher, Vibrant Med-e
Need for Common Specifications for Medical Electronics Products, every electronic component that is purchased for high reliability medical products today must be individually qualified – no medical industry specifications exist for qualification of components or their suppliers, this situation increases costs for component manufacturers
Component Specifications for Medical Electronic Products
• Identify critical components for medical devices• Define a set of reliability qualification methods on a component
level for given critical component• To define: What is acceptable ageing of components and what is
failure mode?• To create guidelines for OCMs to utilize physics of failure based
reliability assessment• To create guideline for medical OEMs on how to assess OCMs
3/12
11/13
• To develop a method for developing a test and screen matrix for identified electronic components that can be used to qualify the reliability performance of components for electronic medical devices
• Provide standard reliability method that can be implemented by medical device manufacturers within their component management process
The project group worked with industry experts and OCMs to understand failure mechanisms for tantalum capacitors and prepared
recommendations for a test and screens matrix for tantalum capacitors. End of Project webinar on March 25th 2014
Focus Area:
Nov-14TIG:
Project Members
30
Medical
Medical
Component Specifications for Medical Electronic Products
Anticipated Outcomes and Benefits
• It is not possible to develop generic recommendations for
common specifications for electronic components for all
applications
However, we can:
– Reduce the resources expended presently on testing to unique
requirements
– Enable the faster introduction of new components and suppliers into the
supply chain
– Enhance the relationships along the supply chain
31
Conclusions
There is a need for component level standards for medical applications
– A number of relevant screens and test methods exist, but they do not all consider the
unique requirements of medical devices applications.
– A methodical approach and commitment of resources are required,
– Ideally manufacturers in key areas of medical devices e.g. implantable should leverage
their resources and influence with the supply base to work together to define a standard
testing specification that would eliminate the need and cost of unique testing by the
OCMs
• Understanding the risk management process for medical device manufacturing is an
important point that must be considered by device manufactures and by suppliers
32
Component Specifications for Medical Electronic Products
33
Key learnings:
There is a need for component level standards for medical applications.
Understanding the risk management process for medical device manufacturing is an
important point that must be considered by device manufactures and by suppliers.
Qualification Methods for Portable Medical
Products
Project Leader: Grady White, NIST
Project Co-leader: Jack Zhu, Boston Scientific
Project
Leader(s):
Project Start:
Estimated End:
Purpose and Scope of Project Project Tasks
Status Update
Problem
Statement:
3535
Grady White, NIST
The lack of a standard methodology and qualification procedure is costing the industry. The medical electronics
industry is growing very quickly. The market is demanding quicker time to market particularly for portable medical
devices
Standard Reliability Performance Qualification Methods for Portable Devices
• This project is intended – To review existing standards and reliability performance
qualification procedures– to identify those procedures that can be applied to assessing
portable medical devices, – to identify any gaps/concerns in those procedures,– to obtain a set of procedures/recommendations acceptable to the
medical electronics industry for assessing reliability of portable medical electronic devices
3/12
11/13
• Focus on the portable medical devices, including the stand alone devices , wearable and the peripheral devices in the implantable systems.
• Leverage OEM, EMS and other expertise to identify current best practices in assessing reliability of portable electronic devices and apply them to medical applications
• An industry wide approach to qualifying the reliability performance of medical devices will enable the industry to grow faster
The project group reviewed test methods, reliability testing and standards being used in the industry.
The team is preparing a final report that will contain a review of the industry status for qualification of portable electronic medical devices, a listing
of current industry approaches and relevant standards. There will be discussion on identified gaps and recommendations on gap mitigation
procedures and next steps. End of project webinar on March 27th
Focus Area:
Nov-14TIG:
Project Members
36
Medical
Medical
Qualification Methods for Portable Devices
• What the Project Is: Develop a set of procedures/recommendations acceptable to the medical electronics industry for assessing reliability of portable medical electronic devices. An industry wide approach to qualifying the reliability performance of medical devices will enable the industry to grow faster– It will shorten the time to market and also the time to adopt and integrate new technologies into
portable electronic medical devices.– It will provide regulatory bodies with standardized criteria for acceptance of new devices or device
designs – An industry wide qualification method that is supported across the supply chain will reduce
redundant costly testing and increase confidence in the qualification procedure. • What is next for the Project:
– The team is preparing a final report that will contain a review of the industry status for qualification of portable electronic medical devices, a listing of current industry approaches and relevant standards. There will be discussion on identified gaps and recommendations on gap mitigation procedures and next steps
Standard Reliability Performance Qualification Methods for Portable Devices
37
• Anticipated project goals:– A comprehensive survey of existing reliability testing practices relevant to
portable medical devices– Identification of relevant standards and gaps or opportunities for new standards
Dissemination of results through iNEMI forums, conferences, and white papers
• Business Impact:– Clear insight for participating device manufacturers and electronic component
suppliers regarding current test methods and their limitations for particular device technologies and/or device environments
– Stimulation of standards development efforts– Harmonization of test needs and methods across the medical electronics
industry
Identify a set of procedures/recommendations acceptable to the medical electronics industry
for assessing reliability of portable medical electronic devices
Anticipated Outcomes and Benefits
38
Key learnings: • ESSENTIAL PERFORMANCE criteria must be considered throughout the fabrication process as
part of the manufacturer’s Risk Management assessment.
• A process flow that can guide the development of the qualification methods by end use
manufacturers has been identified
• Important gaps in the available standards for portable medical devices have been identified, e.g., – RF communication, interference, security
– Biocompatibility between device and body at attachment points
– Synergistic effects (multi-axis and impact mechanical loading, electrical/mechanical/environmental interactions)
Standard Reliability Performance Qualification Methods for Portable Devices
39
Review of Recent Medical symposium
Bill Bader
Medical Symposium
Co hosted with SMTA and MEPTEC
Approx 240 attendees - 49 Exhibitors - 39 speakers
Track 1: Components and Designs for Higher Density Functionalities --
Track 2: Solutions for Best-in-Class Assembly and Volume Manufacturing --
Track 3: Next-Generation Microelectronics for Changing Healthcare Markets
Keynotes:
Digital Health and the Connected Consumer
Matthew Hudes, U.S. Managing Principal, Biotechnology, Deloitte Health Sciences
What can Medical Devices Leverage from Consumer Electronics?
Chandra Subramaniam, Vice President CRDM Research & Development, Medtronic
Ensuring Quality Medical Devices Meet Regulatory Scrutiny in the Face of Industry Cost Pressures
Mike Tendick, Healthcare/Life Sciences Market Sector Vice President, Plexus
Follow up webinar for iNEMI members interested in medical electronics scheduled for Nov 5th
2014
at 11am EDT. http://www.inemi.org/events/inemi-webinar-medical-projects
Medical Symposium
Medtronic Key Note needs:
· Low Power advanced packaging
· High Reliability 3D integration
· High density batteries at low cost
· Lower power wireless with privacy and security
Other :
· Need for RF interoperability definition and appropriate standards dev.
· Incremental work on characterizing flexure for bendable applications, reliability testing etc.
· Measurements and test method for peel test of flexible/wearables
· Health data analysis tools and techniques (big interest of MSEI)
· Medical industry access to key players throughout the supply chain on advanced
miniaturization
· Medtronic panel discussion item ( Mark Ricotta Medtronic) – Definition of aligned
miniaturization elements looked at from a system integration standpoint – Implications are scaling
in size is well aligned of all critical system pieces and parts. Not useful to just shrink one part or
package.
43
Discussion topics - inputs
• 3D integration
– For implantables
– For portables
• Industry Test Vehicle development
– Interconnect testing
– RF module in the mixed band with 3D technologies e.g. Embedded components
Areas of common interest - inputs
•Biocompatibility
•Environmental regulations
•Supply chain readinessMaterials
•Integrity of supply
•Counterfeit
•Long life time of products
•Liability
Supply chain
•Interoperability
•Data SecurityCommunication
Reliability
• Impact of changes in Europe. e.g. common parameters for assessment of suppliers.
• UDI – how should we do this?
• Do we need regulators involved and when
• Need to be aware of the AMMI & UL std work -
•Types of testing & standards
•Consumer reliability vs. Medical requirements
•Software
45
Potential Long term Future Technical Projects - Inputs
• 3D Heterogenous Packaging:
– Need for test vehicles and components to investigate miniaturization for electronic devices with RF and sensoring. and processes. A working group
needs to be formed with participation from all industry segments that seek miniaturization of their electronics. This group can help drive development
of multiple test vehicles to compare multiple technology options (First an Interconnect vehicle which can then lead to a Functional demonstration of a
Sense/Control/low power RF 3D package for medical applications.
• Discrete Component initiative:
– Continuation of the High Density/High Rel ultra-dense capacitor work already in progress w. iNEMI support on the “Component specifications for
medical products” project. In particular, this effort will need to investigate alternatives to Ta/MLCC capacitors due to leakage concerns impacting
portable and implantable electronics.
• Cleanliness:
– New: Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?
• Development of low profile, compact miniaturized passives
• Development of higher density, miniaturized connectors -> 4K I/O in 1 inch. Too nichy?
• Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative, high
resolution serialization, other?). How to implement to UDI (Unique Device Indicators)
• Supply Chain
– How to be prepared for more stringent assessment of supply chain for medical applications as being driven in Europe.
45
Key Potential Projects AreasPre standards work
Critical areas where there are insufficient medically-specific standards to guide manufacturers & their supply chains:
– RF performance: protocol security, broadband signal response, wireless charging, unintentional coupling, wireless coexistence, and body area networks are all subtopics that require industry/government collaboration to develop standards
– Biocompatibility/biostability: current standards lack accelerated tests to evaluate long term issues
– MRI: guidance on design to ensure device compatibility with rapidly evolving MRI tool capabilities
– Damp heat: acceleration models are needed for non-hermetic devices
– Synergistic effects (multi-axis and impact mechanical loading, electrical/mechanical/environmental interactions)
Enable low power Miniaturization / 3D Heterogeneous Packaging:
– Need for test vehicles and components to investigate miniaturization for electronic devices including RF and sensing
– Need for low power
Supply chain
– How to handle the Traceability gap. A useful outcome would be a white paper covering best practices in component traceability (administrative, high resolution serialization, other?).
– How to implement the UDI, particularly in miniaturized devices (Unique Device Indicator)
– How to enable the Integrity of supply chain for medical applications so that it meet the assessment criteria of regulators and notified bodies
Manufacturing related
– Cleanliness on Components/PCB’s due to dirt/FM on boards. How to qualify and maintain supply chain cleanliness?
– Development of low profile, compact miniaturized passives
– Incremental work on characterizing flexure for bendable applications, reliability testing etc
– Measurements and test method for peel test of flexible/wearables
46
Review of 2015 Initiative Process
Project Selection/Initiation
• Projects must be beneficial to all project participants.
– Pre Competitive in Nature. Not core IP development
– Level Playing Field at End Game desirable
– Benefits of shared R&D Desirable and Needed
– Works when supply chain players are not vertically oriented
– Development of knowledge and data not otherwise doable by individual companies or
firms.• Requires design, assembly, test, modeling, characterization, stress testing (or subset of above)
• Requires subset of industry leaders to agree on best known practices with end goal of
stakeholder alignment.
• Can result in industry organized standards or white papers.
– Preparing inputs for members survey at the end of the year to identify projects of interest
and critical mass to lead them.
iNEMI Project Process Flow
Initiative raised
• Member company/Workshop/Survey output
• Committee members/Project teams
• Roadmap gaps/Technical plan/Research priorities
Planning
• Facilitated by iNEMI staff/Identify leaders
• Develop statement of work & project statement agreement
• Approve by iNEMI Technical Committee
Project execution outputs
• Knowledge/ results for the project team members
• White paper/Industry survey report
• Common specification/Recom-mendation on standard
• Presentation/paper at conference/Project report/webinar
Potential Project Area
• Need leaders
• Need participants
Actions and Next steps
• Review the inputs
• Identify potential project areas
• Input need by Dec 10
• Discuss with iNEMI and determine if the critical mass is there to
1. Develop a project plan (iNEMI Initiative phase – 1-3 months)
2. Commence a collaborative project to deliver on indentified need (typically 8-10 iNEMI
member team, project length typically 12-18 months)
52
www.inemi.orgEmail contacts:
Grace O’Malley
Bill Bader
David Godlewski