Science Technology Innovation system regarding the Thai Healthcare and Medical Industries

Transcription

1 Science Technology Innovation system regarding the Thai Healthcare and Medical Industries EU-Thailand Cluster Cooperation 6 September 2017 Hotel SO Sofitel Bangkok Assoc. Prof. Dr. Somchai Chatratana National Science Technology and Innovation Policy Office 1

2 National Science Technology and Innovation Policy Office The agricultural, industrial and service sectors of Thailand can compete successfully in the world market and the quality of life of Thai people is improved inclusively due to modern science technology and innovation policy and systematic implementation 1. Strong Foundation of STI system: STI reform, STI Ecosystem, STI database 2. Innovative Industry Platform: 6 industry sectors, SML enterprises, Science Diplomacy 3. New Economic Growth Engines: Food Innopolis, Startups Thailand, Mobility of Talents 4 Learning Organization

3 Innovative Industry Platform: 6 industry sectors, SML enterprises WiL L E n t e r p r i s e RDI/ ITAP M E n t e r p r i s e ITAP S E n t e r p r i s e Science Diplomacy Target Industry Clusters 1. Food Agro Bio industry 2. Health/Medical Device industry 3. Smart Devices / Robotics industry 4. Digital industry 5. Creative Culture / Services industry 6. Energy / Environment industry 1. Smart farmers, small agro-business, decision support system for farmer, PLANT BREEDING 2. Medical Device, BIO- Pharmaceutical 3. Smart factory, IoT, Cyber physical system, Industrie 4.0, Design for Engineering and Manufacturing, Sensors, 4. Open government, Open Data, Big Data, Analytics, API 5. Smart tourism, Service for senior people 6. Electric Vehicles industry Product Environment Footprint, Rail system industry 3

4 Plan of Operation: Health/Medical Device industry Collaborate with major stakeholders on the development of policy, ecosystem, development plan for the medical, health and biomedical industries, such as: National Plan and Policy on the medical device Rules and regulations governing medical and health products. Standard, testing and quality system for medical and health products Transfer of technology Technology assistance for SMEs Technology Fund for SMEs to support: R&D, clinical research, certification, sart-ups. 4

5 Outputs : Policy Issues Innovative Industry Consortium: Medical Device Industry Focus group meeting of private sectors to develop strategic plan (Demand Driven) Plan of operation on Research and Development on Medical device will be developed and proposed to the cabinet. 20 Year- National Plan for Medical Device Drafting Working Group includes representatives from : Food and Drug Authority, National Social and Economic Development Board, Office of Industrial Economics, National STI Policy Office. Ministry of Public Health will propose the National Plan for Medical Device to the cabinet for approval in October

6 (1 st Draft) Strategic Plan for Research and Innovation : Medical Device Industry: May/04/17 Application Ageing Society Non Communicable Diseases Handicaps Emergency Medicine Cancers Value added Product Group Translational Research Standard Clinical Studies Branding R&D Knowledge Diagnostic Kits Proof of Concepts Technical 1.Marketing 2. Value 3 Customer 4 Venture 5 Business plan Dental Medical Implants Cardiovascular Devices Orthopedic Active Medical Devices Devices CT / Laser Aesthetic Lithotripter Medical Software Prototype Pilot Production Production - Physical / Biological - GMP - CE MARK /Environmental Testing - ISO CSDT - Validation /Clinical - Process Validation Trial New Products Platform Technology - Bio/Composite Material Technology - Protein /Enzyme Technology - Cell / Tissue Culture Technology - 3D Printing - Smart Sensor - Medical Imaging - Hardware/ Software Design - Smart Electronics - Sterilization / Packaging - Automation - Medical Devices Cyber Security Supporting Measures Promotion of local products Promotion of R&D in Medical Device ASEAN Market International Collaborations Manager ADTEC BOI Dept. of Medical Device Control : FDA NIA DITP Dept. of Industry Promotion 6

7 National Plan for Medical Device ( ) (Draft) Medical devices manufactured in Thailand are of high standard, good quality, reasonably priced and accessible by people and government health offices. Medical device industry in Thailand is innovative, competitive and sustainable. FIVE-YEAR 1. Develop and promote medical device industry and manufacturers. 2. Improve medical device regulation system on the basis of inclusive participation of stakeholders 3.Develop human resource and infrastructure to support research, development, certification and regulation of medical device industry 4. Promote utilization of locally produced medical device with respect to safety and cost 7

8 National Plan for Medical Device ( ) (Draft) Strategy 1. Development of market for products that respond to local needs and export market. 2. Improvement of the quality and the standard of medical device according to international standard 3. Development of efficient regulation system 4. Development of mechanism and system for reasonable and safe usage of medical device 5. Strengthening the research, development and industrialization 6. Development of science and technology workforce for medical device industry 7. Development of integrated database for the research, development, regulation, promotion and usage 8. Establishment of an intermediary which is responsible for driving, coordinating and implementing of plans and projects derived from the strategy 8

9 Past activity:consultation on product registration for ASEAN Market Collaboration among STI, ITAP, and ADTEC Guidance on the preparation of a product registration application for medical devices using the ASEAN Common Submission Dossier Template (CSDT). 9

10 Past activity:consultation on product registration for ASEAN Market 24 companies participated in the project Products include: medical consumables; Hemodialysis solution, medical furniture, LASER machine, etc. Project cost : 13.5 MBaht ( 0.4 MUSD) for seminar, preliminary visits and subsidy for consultation fees (up to 50%) Project duration: 18 months (May 2016-September 2017) 10

11 Further promotion and assistance related to medical device industry 1. Support SMEs to achieve conformed electrical design with knowhow to select correct electrical and electronics components and material for casing Non-conforming material for Casing : Bended and burnt during ISO test Non-conforming AC adapter 2. Support SMEs on biocompatibility test on material used in manufacturing medical devices Non-conforming material according to ISO (biocompatibility) leads to redesign 11

12 Further promotion and assistance related to medical device industry Aesthetic LASER 3. Support and promote local test labs to be able to validate medical software and active medical device with embedded software I. Training the trainers II. Support SMES to be able to comply with ISO III. Lab test accreditation for ISO Medical and surgical bed Electrical controlled adjustable dental chair Software Validation Required: Software and circuits for command, control and display (logic test and black box test) including warning must be validated (Risk management) 12

13 Further promotion and assistance related to medical device industry 4. Support more testing laboratories to be accredited for bio-safety and electrical safety testing I. Electrical safety testing (IEC , ) II. Bio-safety testing (biocompatibility) ISO (biocompatibility) 13

14 Standards related to Medical Device ISO 14971: Risk management IEC 62366: Usability IEC 62304: Software lifecycle IEC : Electrical devices Issue : How to determine the process which leads to Certification according to standard? Software validation includes process, controlled document for verification.

15 Further promotion and assistance related to medical device industry 5. Train more experts to consult, design and recommend for components selection in the prototype development and production process I. Compliance Engineers II. Consultants III. Auditors 15

16 16 End of Presentation THANK YOU