taller: emprender en electrónica 25 de noviembre, 2008 medical devices.pdf · 2017. 4. 23. ·...
TRANSCRIPT
-
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