DAY 1: 25 March 2025
MEDICAL DEVICE BUSINESS DEVELOPMENT
Chairperson: May Ng, ARQon
Time
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Topics
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|---|
0800 - 0815
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Registration
|
0815 - 0915
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Opening & Welcome Remarks
|
0915 - 0945
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Global development and Harmonization of the medical device regulations
Overall regulations, directives, guidelines IMDRF, AHWP,
ASEAN MDD, EU, US, Canada, Japan, Australia
|
0945 - 1045
|
ASEAN medical device regulatory requirements
|
1045 - 1100
|
Tea Break
|
1100 - 1145
|
How to know who your real “customer” is, and the variety of ways to reach them.
|
1145 - 1200
|
Open discussion, and reflecting on morning topics
|
1200 - 1300
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Lunch
|
1300 - 1345
|
Scaling up – how to evolve your concept into a sustainable and profitable business.
|
1345 - 1500
|
Launching your product/service to market with an intentional manufacturing & supply strategy. |
1500 - 1515
|
Tea break
|
1515 - 1615
|
OTHERS: Bringing it all together to reflect on the above and other items like funding, support, human capital (panel format)
Panel to cover off some of the themes not already covered (e.g. investment, IP, talent, government support, reimbursement)
|
1615 - 1700
|
Open discussion or Workshop
|
| 1700 - 1800 |
Open discussion, afternoon wrap-up
|
| 1800 |
End of Day 1
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DAY 2: 26 March 2025
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
|
Registration
|
0930 - 0950
|
Design Thinking of Medical Device Innovation
|
0950 - 1005
|
Tea Break
|
1000 - 1200
|
Design Thinking Workshop:
- Concept brainstorming & Value proposition
- Design requirements, Feasibility vs validation discussion
- Project Management
|
1200 - 1300
|
Lunch
|
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
|
1350 - 1410
|
Electrical and Electromagnetic testing
|
1410 - 1430
|
Software validation, Usability, Software
|
1430 - 1450
|
Biocompatibility
|
1450 - 1510
|
Sterilization & Packaging
|
1510 - 1535
|
Health safety compliance
- Equipment registration requirements for Wireless Medical Devices
- Packaging reporting & Radiation
|
1535-1600
|
Tea break
|
1600 - 1700
|
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
|
1700 - 1800
|
Open discussion, afternoon wrap-up
|
1800
|
End of Day 2
|
DAY 3: 27 March 2025
Commercialization, IP and Distribution
Chairperson: May Ng, ARQon & Jack , ARPA
Time
|
Topics
|
|---|
0830 - 0900
|
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
|
UDI Barcode
|
1030 - 1100
|
Labelling
- Labelling requirements: Product label, IFU, eIFU, Brochure
- Promotion and Advertisement
- Challenges
|
1100 - 1115
|
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
|
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
|
1415 - 1500
|
Fund raising
- Value proposition
- Pitching dos and don’t
|
1500 - 1530
|
IVD Performance Evaluation studies
|
1530 - 1545
|
Tea break
|
1545 - 1700
|
Commercialization and Distribution strategy Workshop
- Strategy and Considerations for Product Launch
- Investor & Collaborator approach
- Determine distribution channel
|
1700 - 1800
|
Open discussion, afternoon wrap-up
|
1800
|
End of Day 3
|
DAY 4: 28 Mar 2025
Product Research & Development and Application Technology (R&D, Engineering)
Chairperson: Adrian Danker, Dr Wong Yee Shan, Cathy
Time
|
Topics
|
|---|
0830 - 0900
|
Registration
|
0900 - 1100
|
Laboratory Practices & Medical Biochemistry (Ms Cathy Sagun)
- Introduction to Laboratory Management System
- Sustainability
|
1100-1130
|
Tea Break
|
1130- 1330
|
AI Applications
|
1330-1400
|
Lunch
|
1400 - 1700
|
Microfluidics Technologies and Point of Care Systems
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.
Practical session will also be conducted for the participants to produce and test a simple microfluidic device.
|
1700-1730
|
Tea Break
|
1730 - 1800
|
Final Quiz
|
1800
|
End of Day 4
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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.
