5. BRAZIL
has a very solid financial sector
2011 (USD) Total Assets
Itau 38.4 billion
Bradesco 31.1 billion
Brasil 28.9 billion
Santander 27.1 billion
Caixa Econômica 10.6 billion
5
6. BRAZIL’S PROFILE
1 Territory: Language:
8,511,965 miles Portuguese
Federation:
Population: 27 States
196,342,592 Democracy
6
7. BRAZIL’S PROFILE
2 GDP: US$ 2,5 Billion
GDP Growth:
2012: 1.50%(est)
Reserves:
US$373.147M
Trade Partners:
USA
China MORE ABOUT BRAZIL CONSULT:
EU http://www.weforum.org/documents/GCR0809/in
dex.html
Mercosul
7
8. BRAZIL’S HEALTH ORGANIZATION
responsabilities
FEDERAL
Ministry of Health:
National Health Plans &
Policies Management
Funding and Control of
the National Health
Service (SUS)
Agencies:
ANVISA
ANS
8
9. BRAZIL’S HEALTH ORGANIZATION
responsabilities
STATE
Local Health Policy
Public Health Coordination &
Control
Policies following Federal
Directives
Monitoring of Hospitals,
Industries, etc...
Funding of Public Health
initiatives
Operation of Public Hospitals
Dibursement of SUS funds to
Municipalities
9
10. BRAZIL’S HEALTH ORGANIZATION
responsabilities
MUNICIPAL
Public Health Operations
Monitoring of activities
related to public health
(Vigilancia Sanitaria), such
as Pharmacies, Medical
Offices, etc...
Operation of Public Hospitals
Other:
Philantropics Hospitals
10
11. BRAZIL’S PRIVATE HEALTH
Health Insurance Plans(HIP):
First plans in the 50s
21.4% of the Population has HIP(42 M)
27% has Individual Plans(11,5 M)
73% has Corporate Plans(30,5 M)
78.6% depend on SUS(154 M)
HIPs regulated & controlled by ANS
1749 Plans in accordance with ANS
13 Major Plans responds for 81,13%
Individual
11
13. STATE OF SÃO PAULO PROFILE
a world called São Paulo
Capital: São Paulo
Population: over 40 million
20.37% of Brazil
Area: 95,384 sq miles
11% of Brazil
GDP: 31% of Brazil
MORE ABOUT THE STATE OF
SÃO PAULO CONSULT:
http://www.saopaulo.sp.gov.br/en/conhecasp
13
14. SÃO PAULO METROPOLITAN REGION
PROFILE
Third largest Metropolitan Region in the
World
Population: 19,777,084
Territory: 3,108 sq miles
GDP:
57.3% of the State of São Paulo
19.4% of Brazil
Hospitals: 1,759
MORE ABOUT SÃO PAULO METROPOLITAN
Private Hospitals: 1,252 REGION CONSULT:
http://en.wikipedia.org/wiki/Greater_Sao_P
aulo
14
15. SÃO PAULO METROPOLITAN REGION
TOP HOSPITALS
Israelita Albert Einstein: 9 de Julho:
Beds: 500 Beds: 250
Surgeries Rooms: 67 Surgeries Rooms: 14
Accredited Doctors: 6,000 Accredited Doctors: 3,000
Collaborators: 5,600 Collaborators: 1,500
Units: 7 Units: 1
15
16. SÃO PAULO METROPOLITAN REGION
TOP HOSPITALS
Alemão Oswaldo Cruz: Sirio Libanes:
Beds: 239 Beds: 300
Surgeries Rooms: 13 Surgeries Rooms: 20
Accredited Doctors: 2,467 Accredited Doctors: 4,000
Collaborators: 1,415 Collaborators: 4,500
Units: 1 Units: 1
16
17. SÃO PAULO METROPOLITAN REGION
TOP HOSPITALS
Santa Catarina: São Luiz:
Beds: 306 Beds: 803
Surgeries Rooms: 24 Surgeries Rooms: 49
Accredited Doctors: 5,000 Accredited Doctors: 11,000
Collaborators: 1,837 Collaborators: 4,800
Units: 1 Units: 3
17
18. OSSIS MEDICAL
MAIN GOAL
To be the most successfull
and the best structured
distributor in the Brazilian
market for biomaterials
MISSION
To be an ethical, responsible
healthcare enterprise that
guarantees the safety and quality
of its products and that sees its
growth coming from the
satisfaction of its clients
18
19. OSSIS MEDICAL
OPERATIONS
Safety in the handling of
products, compliance
with Brazilian regulatory
issues and operations
efficiency.A solid IT
infrastructure
guarantees secure
processes and total
product traceability, from
arrival to final use.
19
20. OSSIS MEDICAL
Continuous improvement, with objectives and
goals for new products, processes and services
and the efficient use of existing resources.
Rigorously applied Quality Assurance,
engaging collaborators in the Company’s
mission.
Ossis’ Quality Assurance system complies with all
requirements of RDC-59.
20
21. OSSIS MEDICAL
Its competence is derived from
its founder’s professional
experience in supplying doctors
and hospitals.
SALES
& MKT QUALITY
E
IT ASSURANC
21
22. OSSIS PROFILE
Experience in opening market ( Exclusive distributor for
BonAlive Biomaterials Ltd. )
Credibility with hospitals, health plans and physicians.
Know-how to introduce new products on the market.
Close relationship with the following specialties:
Orthopedics, Traumatology, Osteomyelitis experts, Bone
tumor experts, spine, CMF, etc.
www.ossis.com.br 22
23. OSSIS MEDICAL
MANAGEMENT TEAM
SALES & MARKETING
Fernando Lobato Brisolla, DDS
QUALITY ASSURANCE & REGULATORY AFFAIRS
Priscila Di Mase, DDS
INFORMATION TECHNOLOGY
Amauri Viera Bailon
SALES
FINANCE & ADMINISTRATION &
MKT
QUALITY
E
IT ASSURANC
Celso Novaes
BUSINESS DEVELOPMENT
Isu Fang, Ph.D.
23
24. OSSIS MEDICAL STRATEGY
PRODUCTS:
Distributing Biomaterials ( Ossis’
focus )
Total focus on chosen Supplier
Expand to other lines of the
chosen Supplier
GEOGRAPHICAL:
São Paulo Metropolitan
Region
State of São Paulo
Country wide distribution
network
24
25. OSSIS MEDICAL STRATEGY
MARKETING:
Top Private Hospitals and
Surgeons
HIPs
University Hospitals SALESMAN
SURGE
ONS
Seminars & Conferences
National publications
SALES FORCE:
Recruit experienced HIP
salesman through HOSPIT
AL
agressive compensation
Intensive training
Technical support
25
26. OSSIS MEDICAL STRATEGY
TI INFRASTRUCTURE:
Control of operations
Traceability
Cost controls
Supply chain management
BI to support marketing and operations
PRODUCT REGISTRATION:
Complete documentation of process to
avoid call for clarifications
Tight cooperation with Supplier to
shorten approval time
Project management to speed up
registration
Constant follow-up of the approval
process 26
27. APPROVAL PROCESS SCHEDULE
Factory Inspection by ANVISA ( Norm since 2010 )
RFA (Request for Approval) Preparation: 30 days
Presentation of RFA to ANVISA
Analysis by ANVISA
Legal term: 90 days
Actual term: over 150 days
This can be shortened by legal measures
ANVISA may ask for clarifications
Answer has to be presented in 30 days
There is no legal limit on the number of clarifications
The average term from presentation to final approval: 5 months
27
28. PRODUCT REGISTRATION
All medical products have to be approved by ANVISA(the
Brazilian FDA).
Product approval needs detailed and complete
documentation of the manufacturing process, step by
step, from design to final delivery to the consumer,
including all quality control steps.
Has to be shown that the product is safe, effective, and all
existing arguments should be presented in order to
avoid questioning by ANVISA(which is usual).
The request for approval(RFA) documentation should be
able to show complete knowledge of the product and
of the manufacturing process.
28
29. PRODUCT REGISTRATION
ANVISA is known as a very rigorous agency, comparable to
its sister agencies in Japan and Korea.
A complete and well assembled RFA can shorten the
approval time.
OSSIS will supply the check list of the necessary
documentation.
Besides the basic information like user instructions, photos,
technical drawings and clinical data, other data like
mechanical tests, quality certificates, materials specs and
etc… may be asked for.
29
30. SOURCES
Instituto Brasileiro de Geografia e Estatística(IBGE):
www.ibge.gov.br
Banco de Dados do Sistema Único de Saúde(DATASUS):
www.datasus.gov.br
Conselho Regional de Medicina de São Paulo(CREMESP):
www.cremesp.org.br
Agência Nacional de Vigilância Sanitária(ANVISA):
www.anvisa.gov.br
Ministério da Saúde:
www.ministeriodasaude.gov.br
Agência Nacional de Saúde Suplementar:
www.ans.gov.br
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