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Taller: Emprender en Electrónica25 de Noviembre, 2008

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  • Taller:

    “Emprender en Electrónica”

    25 de Noviembre, 2008

  • CCC is a medical device company, focused in the design, testing and manufacturing of medical systems including:

    • active implantable medical devices

    • programmer systems

    • battery chargers

    • patient wands

    • leads

    About us

  • History

    1950’s 1960’s 1970’s 1980’s 1990’s 2000’s

    October 8, 1958

    Arne Larsson

    received the world's

    first implantable

    pacemaker

    (manufactured by

    Elema-Schönander )

    at the Karolinska

    Institute in

    Stockholm, Sweden.

    February 3, 1960

    Dr. Fiandra performed

    the first successful

    pacemaker chronic

    implant at CASMU,

    Montevideo. The

    pacemaker was also

    manufactured by

    Elema-Schönander .

    1970

    Dr. Fiandra found CCC, to

    design and manufacture

    pacemakers.

    1998

    CCC starts offering

    medical devices design

    services for third parties

    1996

    Design of

    ASIC for CCC

    pacemakers

    2000’s

    Several devices

    designed and

    manufactured by CCC

  • People & Facilities

    • Employees: 130

    – Engineers: 50

    • Facility surface: 2000 m2

    – Class 100.000 clean area: 132 m2

    – Class 10.000 clean area: 12 m2

    • Location: Montevideo, Uruguay

  • Quality System

    • ISO 9000:2000 (BSI)

    • ISO 13485:2003 (BSI)

    • FDA 21 CFR Part 820 (QSR) compliance

    • CE Mark of TEROS pacemakers and ALUS Programming System

    • CE Mark and IDE for several customer’s devices

    Near future:

    • 2009 Q1: GMP facility authorized by the FDA

  • Business Units

    Pacemakers Engineering

  • Pacemakers Unit

    • Products:

    – TEROS pacemakers

    – ALUS Programming System

    – LD PACE II for Cardiomioplasty

    – Leads

    – Pacemakers System Analyzers

    – Circuits & Parts

    • Markets: Uruguay, European Community, Dominican Republic, Argentina, Russia, India and China.

  • Engineering UnitCCC designs and manufactures active

    implantable devices and complete medical

    systems for third parties.

    Our capabilities include:

    • Product design and development

    • Breadboard and prototypes building

    • Small series manufacturing

    • FDA and CE documentation

  • Medical System Components

    IPG Leads

    Programmer

    System

    PSA

    Patient

    wand

    Battery

    charger

    Logger

  • Design Areas

    • Electronics

    • Firmware

    • High-level software

    • Mechanical design

    • ASIC design

    • Leads and encapsulation

    • Communications

    • System integration

  • De

    ve

    lop

    me

    nt

    Intr

    od

    uc

    tio

    n

    Gro

    wth

    Ma

    turi

    ty

    Time

    Pro

    du

    ct

    Lif

    e c

    ycle

    Design & Manufacturing Outsourcing

    Idea / Concept

    Research

    Design / Development

    Small Production

    Prototype / Product

    Large Production

    Design / Development

    Prototype / Product

    Small Production

  • Design Process

    Specification

    Idea /

    Concept

    DesignPrototype /

    ProductVerification

    Small

    Production

    Validation

    Design Review

    Technology

    Transfer

    Large

    ProductionResearch

  • Development Platform• Communication module

    • Sensing modules

    • Pacing modules

    • Wireless battery recharge module

    • Impedance measure module

    • Accelerometer module

    • FW download module

    • RTC module

    • Neurostimulator for research

  • Development Platform

    Customer

    Therapy

    Pacing

    Module

    Communication

    Module

  • Application Fields of Systems

    Developed by CCC

    • Heart Failure

    • Obesity

    • Diabetes

    • Neurostimulation

    • Blood pressure control

    • Foot drop correction

    • Urinary incontinence

    • Patient monitoring

  • Customers & Markets

    • Customers: medical devices start-up companies:

    – They own the therapy IP (developed in house or

    licensed from research centers, Universities, etc.)

    – Usually in early stage (proof of concept, early animal

    research, future clinical trials)

    – Funded by VC firms, angel investors or corporations

    – Exit strategy: IPO or buyout

    • Markets: niches in USA, Israel and Canada

  • How do we find our customers?• References: the most important source. A satisfied

    customer is the best marketing promotion.

    • Networking: entrepreneurs, investors, researchers.

    • Conferences:

    – Investing conferences: investors and entrepreneurs in the

    same room

    – Technical conferences: research of today, development of

    tomorrow

  • How do we find our customers?

    • Sources of information:

    – Specialized publications

    – VC investing reports: PE Hub, PWC MoneyTree, etc.

    – Patents search: USPTO site

    – Internet search

  • CCC Competitive Advantage

    • CCC offers a turn-key solution:

    – Our customers give us a requirements document, and

    we deliver a product ready for implantation

    • Fast development

    • Flexibility to customer needs

    • Almost 40 years of experience in implantable

    medical devices

  • Q&A