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“American Innovation Forum” March 31 st, 2008

“American Innovation Forum” March 31 st, 2008. History. On February 3, 1960, Dr. Orestes Fiandra performed the first effective pacemaker implant to a human being in the world. In 1970, Dr. Orestes Fiandra founded CCC, to develop and manufacture pacemakers.

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“American Innovation Forum” March 31 st, 2008

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  1. “American Innovation Forum” March 31st, 2008

  2. History • On February 3, 1960, Dr. Orestes Fiandra performed the first effective pacemaker implant to a human being in the world. • In 1970, Dr. Orestes Fiandra founded CCC, to develop and manufacture pacemakers. • So up to date this means 48 years working with implantable medical devices in Uruguay and 38 years of experience in manufacturing.

  3. Products: TEROS pacemakers ALUS Programming System Leads Circuits & Parts We sell in Uruguay to the FNR and export to few countries. Our pacemakers have the CE mark. We are not interested in expanding our exports. Today sales of pacemakers represent less than 10% of the total sales. Development of this sector is not a priority. Pacemakers

  4. Today CCC is mainly an engineering company dedicated to the development and manufacturing of medical systems including active implantable devices.

  5. Current Main Business Lines • Contract design and low scale manufacture: CCC designs and manufactures medical systems including implantable devices for third parties. • Know how transfer: CCC sells know-how for implantable devices manufacturing. • IP licensing: CCC sells licenses to other companies to use some of its technologies.

  6. Design and Manufacture under Contract It is our main business. Our customers are companies that conceived an original method to treat a disease that implies using a new active implantable device. They contract us to design the device and complementary accessories according to their requirements and to manufacture the needed units for animal experiments and clinical trials.

  7. Design and Manufacture under Contract • Customers: companies that conceived a treatment for any disease involving the use of an active implantable device. • They contract us to : • design the device and its accessories, • build breadboards, prototypes and small series, • elaborate the documentation required for regulatory purposes.

  8. Expertise Areas • Electronics • Firmware • High-level software • Mechanical design • ASIC design • Leads and encapsulation • Communications • System integration

  9. Implantable Medical System Patient wand ID Leads Programmer System Logger PSA Battery charger

  10. Implantable Devices (ID) They have two main functions: • Applyinga therapy, usually by delivering electrical signals to some organs or tissues. • Monitoring relevant parameters or signals in order to avoid risks to the patient or to optimize his treatment. They usually are capable of measuring and analyzing electrical and mechanical physiological signals. They transmit this information (monitoring function) or use it as input data for the therapy.

  11. Development Platform • Communication protocols and modules • Sensing modules • Pacing modules • Wireless battery recharge module • Lead impedance measurement modules • Accelerometer modules • FW download module • RTC module

  12. Validation Large Production Design Review Technology Transfer Small Production Verification Specification Design Prototype / Product Design Process Customer Idea / Concept Research

  13. Application Fields of Some Systems Developed by CCC • Heart Failure • Obesity • Diabetes • Neurostimulation • Blood pressure control • Foot drop correction • Urinary incontinence • Patient monitoring • Sleep apnea

  14. Implantable Systems Market • 5 big companies: • share more than 98% of the market (mainly pacemakers and ICDs). • design and manufacture their products but do not act as contract designers or manufacturers. • buy patents and technology from small companies in the field or eventually buy the companies. • Start –up companies created to check the feasibility of treating a disease using an implantable device implementing a therapy conceived by themselves: • few per year, mainly from US, Israel and Canada • without capacity to develop and manufacture the devices

  15. Implantable Systems Market • To develop and produce the systems, they usually have two options: • hiring independent persons or companies (for example, electronics and mechanical designers, contract manufacturers, etc.) with expertise in one or several tasks necessary to develop and produce the system, • contracting CCC, which is the single company working as contract designer and manufacturer with the capability of developing and manufacturing (in small quantities) the whole system. • The quantity of implantable devices developed per year for the start up companies grew significantly in the last two years but it is still very small. • CCC designs more than the 50% of these devices.

  16. Know-how Transfer and IP Licensing • CCC signed agreements involving the transference of its implantable devices manufacturing know-how to companies from India and from US. • CCC sold licenses to use some protocols and modules that it developed to some start ups that opted by developing their devices themselves.

  17. Strengths and “Uruguay factor” • Which are CCC`s competitive strengths? • Single source → Single responsibility • Speed and lead times compliance • Experience and very good references • Is being located in Uruguay a disadvantage? • Yes, to sell pacemakers and at the beginning to sell projects. This has been reverted now. • Conference calls, Internet, etc. allow good and cheap communications. • Components supply is not a problem. • It is an advantage in order to hire highly qualified personnel and a difficulty to get specialized consultants.

  18. Certifications • ISO 9000:2000 (BSI) • ISO 13485:2003 (BSI) • CE Mark for design and manufacture pacemakers and accessories • CE Mark for TEROS family pacemakers • CE Mark for ALUS Programming System • CE Mark for several customers devices

  19. FDA • IDE for several implantable devices designed for our customers • Quality System compliance with FDA 21 CFR Part 820 (QSR) Near future: • 2008 Q2: GMP facility authorized by the FDA • 2008 Q3: PMA of an implantable device designed and manufactured by CCC.

  20. People & Facilities • Number of Employees: 125 • Number of Engineers: 45 • Facility surface: 2000 m2 • Class 100.000clean area: 132 m2 • Class 10.000 clean area: 12 m2

  21. Our People

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