With the ever changing environment in the medical device market, companies face continuous pressure to make their products smaller, lighter, more portable and of course, less costly. Epec has over 60 years of experience in working with medical customers and the stringent requirements that go along with medical devices. We will be presenting a webinar that outlines some new technologies and techniques that can help companies achieve all of their product goals. Please join us for our upcoming product webinar for more information on how Epec can help you with all your medical device needs.

1.  DELIVERING QUALITY SINCE 1952.
Medical Device Webinar
Product Design For
Medical Devices
05.31.13

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Q&A
 Questions?
– Enter any questions you may have
in the Control Panel.
– If we don’t have time to get to it, we
will reply via email.

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60+ Year History
 Experienced supplier to the medical industry.

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Our Products
Battery Packs Flex & Rigid-Flex PCB’s User Interfaces
Fans & Motors Cable Assemblies Printed Circuit Boards

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Electronics in Medical Devices
 Electronics Play a Major Role in Medical Devices

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Scope
 Medical Device Introduction
 Objective
 Case Studies
– PCB’s – High Tech Features
– User Interfaces
(Touch Panel/Membrane Switch)
– Flex & Rigid Flex PCB’s
– Custom Battery Packs
 Closing

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Introduction
 Electronic Medical Device industry has unique
characteristics that other industries do not.
– Wash down/waterproof requirements
– Backup Power
– Voltage Spikes
– Portability
– Durability/Longevity

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Regulatory Environment
 FDA requirements (510k notification, etc.)
 GMP/cGMPs (Good Manufacturing Practices)
 Quality Management Systems (QMS)
 ISO Certification (9000, 9001, 9002, 13485…)
 EMC, EMI, IEC 60601 Compliance,
 CSA/UL registration
 Clean Room Requirements
 DOT/IATA Compliance
 The final product, the
individual components and the
manufacturers may be required
to have many different approvals.

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Today’s Objective
 Discuss the newest PCB technologies to help medical
device manufacturers understand the benefits and the
challenges
 Review some specific case studies for medical device
manufacturers on:
– User Interfaces
– Flex and Rigid Flex Printed Circuit Boards
– Custom Battery Packs

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PCB Technologies – Medical Devices
 Tight Lines and Spaces
– Defined as less than 5 mil
– Used to do more with less
– High Density Interconnect PCBs (HDI
PCBs). Can include laser microvias, blind
and buried vias, sequential lamination
and many other hi tech features
 Solder Mask Via Plugging
– Purpose:
– BGA design where vias are commonly
found in very close proximity to the BGA’s
SMD pads.
– The concern is that during assembly,
solder will wick away from the intended
pad and flow down the via.
– Also prevents anything getting into the
holes during device operation.
– Special Ink used for via fill

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PCB Technologies – Medical Devices
 Via-In Pad
– Standard “dog bone” land pattern to transfer
signal from the BGA to a via that passes signal
to other layers, vias can be drilled directly into
the BGA pads.
– Vias are then filled with conductive or non-
conductive fill.
 Conductive vs Non-Conductive Via Fill
– Conductive
– Used when heat or a large amount of current
needs to be carried from one side of the board
to another
– Non-Conductive
– Prevent solder or other contaminants from
entering the via
– Provides support for the via pad

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What to Watch out for in
These Technologies?
 Process Challenges in Production
Solder Balls Etching Defects

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How to Avoid These Problems?
Etching Problems on Fine Lines
Laser Direct Imaging
– High quality exposure of fine lines and
spaces down to at least 50 microns and
below if possible
– Ability to compensate dynamically for
material dimension changes in order to
overcome variance in panels form the
same batch
– To be able to achieve tight registration
tolerance over the whole area of PCB
panels.
Significant Investment
– $250 - $500K

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How to Avoid These Problems?
Solder Balls On Filled Vias
Vacuum & Air Assisted
Filling Equipment
– Panel is placed inside the machine and
vacuum is drawn inside the chamber
– Compressed air is used to force the
material into a designated head and then
through the via holes
– All vias can be easily filled without any
voids utilizing the vacuum
– Excess material is removed by squeegee
system
Significant Investment
– $250 - $300K
Screen
Filled
SolderballShrinkage

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Touch Screen
 Application:
– Infusion pump interface.
 Customer Requirements:
– Reduce user interface area.
– Add functionality beyond limits of membrane switch.
– Incorporate new technology.
 Action:
– Resistive touch screen (pressure).
– Polyester with clear hard-coat.
– Revised electronics and modified enclosure.
 Summary:
– Expanded functionality while maintaining a high
level of reliability and durability.

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Membrane Switch
 Application:
– Home medical vascular compression device.
 Customer Requirements:
– Display impact protection.
– Optimize display readability.
– LED battery level indicator.
 Action:
– Incorporated Lexan behind display window.
– Anti-glare hard-coated polyester graphic overlay.
 Summary:
– Membrane switch was most cost effective solution to meet limited functionality
requirements and reliability and durability.

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Medical Communication
Rigid – Flex Circuit
 Customer Requirement:
– High density interconnect with high speed signal
integrity
– Severe packaging and PCB real estate restrictions
– High reliability requirement
 Solution:
– Rigid – Flex Circuit (4 layers)
 Features / Benefits:
– Controlled impedance circuits for high speed
communications
– Two sided component assembly
– EMI and RF shielding
– Reduced number of interconnects for improved
reliability
– IPC 6013 Class 3 manufacturing & IPC 2223C
design specification materials & construction

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CT Scanner Flex Circuit
 Customer Requirements:
– High Density / Reliability Interconnect
– Tight localized packaging restriction
– High degree of flexibility
– Multiple insertions / removals due to
calibration and service requirements
– Low weight
 Solution:
– 1 Layer high density flex circuit
 Features / Benefits:
– Combination Coverlay / LPI Solder mask and
FR4 Stiffened component areas for high
reliable assembly processing
– Epoxy strain reliefs (stiffener to flex) to prevent
damage during removal cycles
– IPC 6013 Class 3 manufacturing

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 Application:
– Portable Bodily Fluid Warmer for Military Vehicles
 Customer Requirements:
– Current SLA design
– Needed to reduce the size and weight by 50%
– Improved Performance
 Solution
– Redesign to Lithium Iron Phosphate
SLA Battery to Lithium Conversion

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 Create a Scope of Work – Vendor Managed
 Understand the timing around the process
– Prototypes
– UL/CE
– UN DOT Approval
 Long Term Challenges
– End of Life Cells
– Is it compatible?
– Should we dual approve?
– Next generation IC’s?
 What to watch out for?
How does it work?

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Things to ask at the beginning.
 Does the vendor have the “right” relationships
Does the vendor have the
proper or “approved”
manufacturing facilities

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Design Centers & Technical Support
 Battery Pack & Power Management – Denver, CO
 User Interfaces – Charlotte, NC
 Fans & Motors – Wales, UK
 PCB’s – New Bedford, MA & Shenzhen, China
 Flex & Rigid Flex – Toronto, Canada
 Cable Assemblies– Boston, MA
 Our Engineering and Design teams are ready to
help our customers create world class and cost
effective product solutions.

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Thank You
Check out our previous webinars at www.epectec.com.
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