DAY 1: 18 March 2024
MEDICAL DEVICE REGULATORY & INNOVATION
Chairperson: May Ng, ARQon
Time
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Topics
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|---|
0800 - 0815
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Registration
|
0815 - 0830
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Opening & Welcome Remarks
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0830 - 0915
|
Role of Trade Associations – Driving access, innovation & collaboration
- The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL
- The importance of association’s role for its stakeholders i.e. local industry and the national authorities/agencies
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0915 - 0940
|
EU Regulatory Requirements & Strategy
- Brief Overview of Regulation & Strategy
- Case studies
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0940 - 1005
|
US Regulatory Requirements & Strategy
- Brief Overview of Regulation & Strategy
- Case studies
|
1005 - 1030
|
Innovation vs Regulation: Friend or foe?
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1030 - 1045
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Tea Break
|
1045 - 1115
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Medical software – Regulation & Strategy
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1115 - 1140
|
Use of Real-World Evidence for regulatory approval in Korea
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1140 - 1200
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Medical Device reimbursement in Korea – A MedTech company’s worst nightmare?
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1200 - 1300
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Lunch
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1300 - 1345
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Clinical Investigation for the registration of Medical Devices in Korea
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1345 - 1430
|
Global Harmonization of the medical device regulations - Jack
- Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia
- Definition and Risk classification of Medical Device, IVD, and Combination product
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1430 - 1445
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Tea break
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1445 - 1515
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MedTech in Korea – Where is it heading?
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1515- 1545
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The Startup Journey – From Concept to Commercialization and Adoption
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| 1545 - 1615 |
Startup Funding – Tips for landing it
|
| 1615 |
End of IMDS KR/SG DAY 1
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DAY 2: 19 March 2024
MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT & STANDARDS
Chairperson: May Ng, ARQon & Jack, ARPA
Time
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Topics
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|---|
0900 - 0930
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Registration
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0930 - 0950
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Design Thinking of Medical Device Innovation
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0950 - 1005
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Tea Break
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1000 - 1200
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Design Thinking Workshop:
- Concept brainstorming & Value proposition
- Design requirements, Feasibility vs validation discussion
- Project Management
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1200 - 1300
|
Lunch
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1300 - 1330
|
Quality Management System - Importance of QMS, Design to Production, Risk management, Design Control
- What are the key QMS: ISO 13485, MDSAP, QSR, MDR, IVDR
- Design to production requirements
- Design control requirements
- Elements in Design History File
- Risk management in product lifecycle: ISO 14971
|
1330 - 1350
|
Standards Adoption for Medical Device
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1350 - 1410
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Electrical and Electromagnetic testing
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1410 - 1430
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Software validation, Usability, Software
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1430 - 1450
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Biocompatibility
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1450 - 1510
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Sterilization & Packaging
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1510 - 1545
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Health safety compliance
- Equipment registration requirements for Wireless Medical Devices
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1545 - 1605
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CEO Session
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1605-1620
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Tea break
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1620 - 1820
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Workshop Regulatory Strategy
- Start-ups getting first approval in US, CE, or local country
- Regulatory strategy compliance for Technical, Clinical, Key requirements for Global approval
- Content of Technical documentation, Clinical Evaluation Report, Country Submission Dossier
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1820
|
End of Day 2
|
DAY 3: 20 March 2024
MARKET & SUPPLY CHAIN STRATEGY
Chairperson: May Ng, ARQon & Jack, ARPA
Time
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Topics
|
|---|
0830 - 0900
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Registration
|
0900 - 0930
|
Market trend and opportunities in Medtech
|
| 0930 - 1000 |
Medtech Marketing Approaches
- Sales Model: Subsidiary, Direct Sales or Distributor
- Product licence holding rights
|
1000 - 1030
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IVD Case Study - GASTROClear: The Journey from Lab to Clinic |
1030 - 1100
|
Labelling
- Labelling requirements: Product label, IFU, eIFU, Brochure
- Promotion and Advertisement
- Challenges
|
0950 - 1005
|
Tea Break
|
1115 - 1145
|
Intellectual Property: Patents, Trademarks, Liability
- Patenting strategies; timing and geographical
- Product trademark
- Product liability/risk after sales
|
1145 - 1215
|
Distributor GDP/SS620 and Post market
- When you need GDP certification
- What are the steps for GDP set-up
- Common challenges for GDP set-up in ASEAN
- GDP differences between device and pharmaceutical
- Complaint and Vigilance handling
- Expectations of the certification body
|
1215 - 1235
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Due Diligence and Valuation for Startups
|
1235 - 1335
|
Lunch
|
1335 - 1355
|
Hospital procurement
- Medical device procurement policy in hospital
|
1355 - 1415
|
Code of Ethics for Medical Device Industry
- Good Ethics for Professionals in Medtech Industry
|
1350 - 1410
|
Fund raising
- Value proposition
- Pitching dos and don’t
|
1500 - 1520
|
UDI Barcode
- What is UDI and benefit of UDI for traceability
- Global landscape on UDI regulatory requirements
|
1520 - 1605
|
CEO Session
|
1605-1620
|
Tea break
|
1620 - 1820
|
Commercialization and Distribution strategy Workshop
- Strategy and Considerations for Product Launch
- Investor & Collaborator approach
- Determine distribution channel
|
1820
|
End of Day 3
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Day 4
PRODUCT RESEARCH & DEVELOPMENT AND APPLICATION TECHNOLOGY (R&D, ENGINEERING)
Chairperson: Adrian Danker, TP
Time
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Topics
|
|---|
0830 - 0900
|
Registration
|
0900 - 1100
|
Laboratory Practices & Medical Biochemistry (Ms Cathy Sagun)
- Introduction to Laboratory Management System
- Innovating Lab Practices : A roadmap to sustainability digitalization and ISO 17025 Alignment.
|
1100-1130
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Tea Break
|
1130- 1300
|
Tour of TP , TP AMC, 3D Printing, HEC & Innovation Learning Lab (Dr Wong Yee Shan)
|
1300-1330
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Lunch
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1330 -1630
|
Microfluidics Technologies and Point of Care Systems ( Dr Fu Yi )
Microfluidic-based point-of-care systems have multiple advantages over traditional diagnostic platforms such as cost-effectiveness and shorter turnaround time. They have been increasingly used in medical and healthcare sectors.
- Fundamentals of microfluidic theories, design principles, fabrication methods and key applications.
- The technologies help in curbing COVID-19 pandemic will be introduced.
Practical session will also be conducted for the participants to produce and test a simple microfluidic device.
|
1630-1700
|
Tea Break
|
1700
|
Workshop Summary
|
1800
|
Mandatory Assessment
|
1830
|
End of Day 4 MDS SG
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Certification
Participants will be awarded with a Certificate of Accomplishment upon passing the assessment and upon meeting 75% of the required course attendance.
