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Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
Product Design For Medical Devices Webinar
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Product Design For Medical Devices Webinar

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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. …

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.

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  • 1.  DELIVERING QUALITY SINCE 1952.Medical Device WebinarProduct Design ForMedical Devices05.31.13
  • 2. 2Q&A Questions?– Enter any questions you may havein the Control Panel.– If we don’t have time to get to it, wewill reply via email.
  • 3. 360+ Year History Experienced supplier to the medical industry.
  • 4. 4Our ProductsBattery Packs Flex & Rigid-Flex PCB’s User InterfacesFans & Motors Cable Assemblies Printed Circuit Boards
  • 5. 5Electronics in Medical Devices Electronics Play a Major Role in Medical Devices
  • 6. 6Scope 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
  • 7. 7Introduction Electronic Medical Device industry has uniquecharacteristics that other industries do not.– Wash down/waterproof requirements– Backup Power– Voltage Spikes– Portability– Durability/Longevity
  • 8. 8Regulatory 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, theindividual components and themanufacturers may be requiredto have many different approvals.
  • 9. 9Today’s Objective Discuss the newest PCB technologies to help medicaldevice manufacturers understand the benefits and thechallenges Review some specific case studies for medical devicemanufacturers on:– User Interfaces– Flex and Rigid Flex Printed Circuit Boards– Custom Battery Packs
  • 10. 10PCB Technologies – Medical Devices Tight Lines and Spaces– Defined as less than 5 mil– Used to do more with less– High Density Interconnect PCBs (HDIPCBs). Can include laser microvias, blindand buried vias, sequential laminationand many other hi tech features Solder Mask Via Plugging– Purpose:– BGA design where vias are commonlyfound in very close proximity to the BGA’sSMD pads.– The concern is that during assembly,solder will wick away from the intendedpad and flow down the via.– Also prevents anything getting into theholes during device operation.– Special Ink used for via fill
  • 11. 11PCB Technologies – Medical Devices Via-In Pad– Standard “dog bone” land pattern to transfersignal from the BGA to a via that passes signalto other layers, vias can be drilled directly intothe 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 currentneeds to be carried from one side of the boardto another– Non-Conductive– Prevent solder or other contaminants fromentering the via– Provides support for the via pad
  • 12. 12What to Watch out for inThese Technologies? Process Challenges in ProductionSolder Balls Etching Defects
  • 13. 13How to Avoid These Problems?Etching Problems on Fine LinesLaser Direct Imaging– High quality exposure of fine lines andspaces down to at least 50 microns andbelow if possible– Ability to compensate dynamically formaterial dimension changes in order toovercome variance in panels form thesame batch– To be able to achieve tight registrationtolerance over the whole area of PCBpanels.Significant Investment– $250 - $500K
  • 14. 14How to Avoid These Problems?Solder Balls On Filled ViasVacuum & Air AssistedFilling Equipment– Panel is placed inside the machine andvacuum is drawn inside the chamber– Compressed air is used to force thematerial into a designated head and thenthrough the via holes– All vias can be easily filled without anyvoids utilizing the vacuum– Excess material is removed by squeegeesystemSignificant Investment– $250 - $300KScreenFilledSolderballShrinkage
  • 15. 15Touch 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 highlevel of reliability and durability.
  • 16. 16Membrane 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 functionalityrequirements and reliability and durability.
  • 17. 17Medical CommunicationRigid – Flex Circuit Customer Requirement:– High density interconnect with high speed signalintegrity– Severe packaging and PCB real estate restrictions– High reliability requirement Solution:– Rigid – Flex Circuit (4 layers) Features / Benefits:– Controlled impedance circuits for high speedcommunications– Two sided component assembly– EMI and RF shielding– Reduced number of interconnects for improvedreliability– IPC 6013 Class 3 manufacturing & IPC 2223Cdesign specification materials & construction
  • 18. 18CT Scanner Flex Circuit Customer Requirements:– High Density / Reliability Interconnect– Tight localized packaging restriction– High degree of flexibility– Multiple insertions / removals due tocalibration and service requirements– Low weight Solution:– 1 Layer high density flex circuit Features / Benefits:– Combination Coverlay / LPI Solder mask andFR4 Stiffened component areas for highreliable assembly processing– Epoxy strain reliefs (stiffener to flex) to preventdamage during removal cycles– IPC 6013 Class 3 manufacturing
  • 19. 19 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 PhosphateSLA Battery to Lithium Conversion
  • 20. 20 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?
  • 21. 21Things to ask at the beginning. Does the vendor have the “right” relationshipsDoes the vendor have theproper or “approved”manufacturing facilities
  • 22. 22Design 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 tohelp our customers create world class and costeffective product solutions.
  • 23. 23Thank YouCheck out our previous webinars at www.epectec.com.Stay Connected with Epec Engineered TechnologiesFollow us on our social media sites for continuous technical updates and information:

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