• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Ossis Medical
 

Ossis Medical

on

  • 465 views

 

Statistics

Views

Total Views
465
Views on SlideShare
465
Embed Views
0

Actions

Likes
0
Downloads
0
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003
  • GL5 CONFERENCE , 4-5 December 2003

Ossis Medical Ossis Medical Presentation Transcript

  • BRAZILIAN MARKET OVERVIEW 1
  • We will talk about… Country Market Ossis Medical Business 2
  • BRAZILIs known for its more exotics traits.. . 3
  • BRAZILbut its economic potencial is less well known... 4
  • BRAZILhas 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
  • BRAZIL’S PROFILE 1 Territory: Language: 8,511,965 miles Portuguese Federation: Population: 27 States 196,342,592 Democracy 6
  • 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
  • BRAZIL’S HEALTH ORGANIZATIONresponsabilities FEDERAL Ministry of Health: National Health Plans & Policies Management Funding and Control of the National Health Service (SUS) Agencies: ANVISA ANS 8
  • BRAZIL’S HEALTH ORGANIZATIONresponsabilities 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
  • BRAZIL’S HEALTH ORGANIZATIONresponsabilities 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
  • 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
  • BRAZILIAN HOSPITALS Brazilian Hospitals: 7,685 Public Hospitals: 2,812 Private Hospitals: 4,687 Academic Hospitals: 186 12
  • STATE OF SÃO PAULO PROFILEa 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
  • SÃO PAULO METROPOLITAN REGIONPROFILE 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
  • SÃO PAULO METROPOLITAN REGIONTOP 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
  • SÃO PAULO METROPOLITAN REGIONTOP 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
  • SÃO PAULO METROPOLITAN REGIONTOP 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
  • 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
  • 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
  • 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
  • OSSIS MEDICAL Its competence is derived from its founder’s professional experience in supplying doctors and hospitals. SALES & MKT QUALITY E IT ASSURANC 21
  • 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
  • OSSIS MEDICALMANAGEMENT TEAMSALES & MARKETING Fernando Lobato Brisolla, DDSQUALITY ASSURANCE & REGULATORY AFFAIRS Priscila Di Mase, DDSINFORMATION TECHNOLOGY Amauri Viera Bailon SALESFINANCE & ADMINISTRATION & MKT QUALITY E IT ASSURANC Celso NovaesBUSINESS DEVELOPMENT Isu Fang, Ph.D. 23
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 30