iNEMI Medical Electronics Workshop Case Studies Medical...

ELECTRONICS

MANUFACTURING

SERVICES

© 2008 Sanmina-SCI Corporation. Sanmina-SCI is a trademark of Sanmina-SCI Corporation.

All trademarks and registered trademarks are the property of their respective owners.

iNEMI Medical Electronics Workshop

Case Studies – Medical EMS Technology Solutions

Gelston HowellSenior Vice President, Medical Division

May 5, 2010

Sanmina-SCI Confidential


Medical EMS Outsourcing Today – Setting the Stage

Medical EMS: History and Current Status

Trends and Case Studies in Medical EMS

Opportunities for Medical Industry Collaboration


$67 B $67 B$64 B

$66 B

$79 B

$88 B

$102 B

$114 B

$121 B

$100 B

$138 B

$40 B

$60 B

$80 B

$100 B

$120 B

$140 B

$160 B

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Global Top 10 EMS Companies: Annual Revenue

EMS Company Revenues, Trends

EMS Company Revenue, latest quarter

Foxconn / Hon Hai $33B

Flextronics $6.9B

Jabil $3.9B

Celestica $1.8B

Sanmina-SCI $1.6B

Plexus $570M

Benchmark $540M

Outsourcing & electronic EMS revenues are

growing, and generally follow broad

economic trends…

Recession, banking crisis

Dot Com bust, recession


Vertical Integration

Systems Design and Manufacturing Target End-marketsComponent Manufacturing

pcb fabrication pcb assembly

backplanes cables

memory modular solutions optical modules

precision machining enclosures

Market Focus

communications Industrial and semiconductor

personal and business computing aerospace and defense

enterprise computing and storagemedical systems

multimedia automotive

Contract Manufacturers, Business Model

EMS Company Services: Design, Components, Integration, Test, Logistics


Capability

Product Design: Circuit Design, Plastics

Validation and Verification

Packaging: Design & Sub-contracting

Manufacturing & Sustaining Engineering

Order Fulfillment Possible, done for other similar

products…

Example: Product for

Detecting Ear Infections

Relationship

Smaller Medical Device Company with less

design and manufacturing resources

Company looking for complete design,

validation, manufacturing and packaging

solution

Medical EMS: Products & Services


Medical EMS: Products & Services

Nuclear/PET & CT Table Design & Mfg

Capability

Nuclear Medicine, CT Gantries & Tables:

Complete systems in production

Mfg in U.S., Europe, Mexico, China

Full design & engineering of tables – 40 page

statement of work and product specification

Example: Large Imaging

Systems Design & Mfg.

Relationships

Large Medical OEM’s – 15 year relationships

with EMS companies

Large Medical OEM’s comfortable with full

outsourcing business model, including product

design

Nuclear Medicine System Manufacturing


San Jose, CA

Guadalajara, Mexico

Huntsville, AL

Örnsköldsvik, Sweden

Fermoy, Ireland

Ma’alot, Israel

Shenzhen, China

Singapore/Batam

Medical EMS – Global Footprint

Medical Electronic Product Manufacturing: 20 Years

Focused, Separate Medical Division – 8 Years

Dedicated Medical Facilities: 18 with 13485-2003 certification

Focus: Finished Medical Electronic Products

Separate, FDA QSR Compliant Medical Quality System

Kunshan, China

Chennai, India

Penang, Malaysia

Tatabanya, Hungary


Ultrasound

Blood Glucose Meters

Portable

Monitoring

Dermatological

Laser Systems

Blood Separators

CT & Nuclear Medicine

Middle Ear

Infections

In Home

Monitoring Cosmetic &

Therapeutic

Respiration

Systems

Mobile / Portable Large Systems

Blood/Molecular

Diagnostics

Patient Tables

Devices, Disposables

Implanted Products

Devices and

Disposables, including…

RF Urinary Incontinence

RF Bowel Therapy

GERD Disposables

Electronic Drug Injectors

Other Injection Devices

Patch Products

…..

Medical EMS: Finished Products

Finished Products, In Production Today

20K – 1M units/year 1000 – 5000 units/year 50 – 2000 units/year 5000 – 1M units/year


Medical Division: Quality System

Complete, Electronic DHR’s Shared between all plants. Data appended for returns/RMA’s

Parametric Data Data, reports available real time to Customers via secure web

portal

Serial Number, Location & Status Part Number, Revision and Shop Order NumberRMA # captured in the Original Unit History

ECO # captured in the

Original Unit History

Subassemblies removed &

added as required

Record Failure

Records

Defect

Date & Time stamp, Operator,

& Process Step

Component Traceability – attached to

Top level Unit History


Rapid Transfer: Blood Handling Equipment

Multi-procedural apheresis platform Continuous AutoTransfusion System Sterile Packaging Platform for red blood

cells and plasma

Customer requested a rapid transfer of complex, legacy products to createmanufacturing space for the next generation of their products.

EMS company sent a team of 16 people to the customer site for 3 months.

Manufacturing, test and supply chain managed by EMS company.

Many cost reductions, documentation and supply chain enhancements made.


Mobile / Portable Product Example

High Volume Medical Product…

- fully automated assembly, calibration and test in two plants

- team of automation engineers…

- packout, bulk and in-store packaging for multiple customers

- 3M units per year, for some products


CT and NM Repair

Spares, Service, Hubbing, Logistics

NM Camera Repair CT Repair

EMS Companies Providing…

DHF Maintenance

Sustaining Engineering

Component Obsolescence

PCBA Spares / Repair (350 PN’s)

Complex FRU Re-Engineering


Mobile / Portable “Core” Medical Large System

Personal Health Monitoring

Patient Monitoring

Diagnostic ImagingSurgical Camera Assembly

Asia Medical Device Manufacturing

Medical EMS: Production in Asia


Reduce cost by 50%, Add Blue Tooth, IR, Ethernet & Functional Tester

Product Re-Design for Cost Reduction

Old Product: New Product:

- 3 circuit boards - 2 circuit boards

- 4 primary plastic parts - 2 plastic parts

- 3 shields - 0 shields

- copper tape - no copper tape

- 23 screws - 5 screws


Trends: Medical Outsourcing

Medical Electronics/Mechanical COGS on a decreasing trend:

- VLSI & Commoditization are outpacing the ability of Medical OEM’s toadd product features that mitigate normal price erosion.

Medical Electronics Companies Seeking a “Total Manufacturing Solution”

- Product Design, Regulatory Management, Supply Chain, Manufacturing, Product Sustaining Engineering and Lifecycle Support

Emerging Countries: Medical Company Acquisitions and Sales

- Medical OEM’s making a number of acquisitions in emerging countries

- OEM’s often seeking a product for a specific country region,manufactured in that region due to tariffs and trade agreements

Ultrasound


Discussion: Working Group Charter

Challenges today with OEM and EMS business engagements

- Engineering Engagements: Scope of Work

- Engineering Engagements: Design vs. R&D Programs

- e.g. product development vs. the real time solution of

core technology or new science

- Manufacturing Service Agreements: Common issues arising

from “fixed price” agreements

- e.g. underabsorption of manufacturing costs due to

delays caused by material shortages, ECO’s,

etc..

ELECTRONICS

MANUFACTURING

SERVICES

© 2009 Sanmina-SCI Corporation. Sanmina-SCI is a trademark of Sanmina-SCI Corporation.

All trademarks and registered trademarks are the property of their respective owners.


Case Studies – Medical EMS Technology Solutions

Gelston HowellSenior Vice President, Medical Division

May 5, 2010

iNEMI Medical Electronics Workshop Case Studies Medical...

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