Day 1
Venue: Temasek Polytechnic
MEDICAL DEVICE REGULATORY
Time
|
Topics
|
|---|
0830
|
Registration
|
0900
|
Opening
|
0915
|
The role of Industry Associations and partners in regulatory convergence and healthcare innovation
- 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
|
1015
|
Clinical trial for Innovation in Asia
- What are funding available and criteria
- Single or Multi-centre trial
- Plan and conduct of Clinical trial
- Differences between Clinical trial vs clinical evaluation
(MOU Ceremony for CIH, KUH & ARQon group)
|
1045
|
Break
|
1100
|
International Medtech Opportunities for Innovation
- Sharing on different type of collaboration opportunities internationally for medtech companies
|
1145
|
Medtech Manufacturing Set-up or Contract manufacturing Outsourcing?
- Benefit and key considerations in set-up manufacturing or outsource
- Contract manufacturing vendor selection criteria
|
1215
|
Lunch
|
1315
|
Global Harmonization of the medical device regulations
- Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia
- Definition and Risk classification of Medical Device, IVD, and Combination product
|
1345
|
APAC regulatory requirements - South Korea
|
1415
|
APAC regulatory requirements - ASEAN, Greater China
|
1445
|
Tea break
|
1500
|
MDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
- Conformity assessment routes for CE Marking under MDR
- Post Market: Vigilance, PMCF, PSUR
- Further changes eg Eudamed, Clinical Evaluation
|
1530
|
IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
- Conformity assessment routes for CE Marking under IVDR
- Post Market: Vigilance, PMPF, PSUR
- Further changes in EU eg Companion diagnostic
|
| 1600 |
US FDA regulatory requirements
- 510(k), PMA and other submissions
|
| 1630 |
Q&A (IMDS KR) & Quiz (IMDS SG) |
| 1700 |
End of Day 1 |
Day 2
Location: Temasek Polytechnic
MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT & STANDARDS
Time
|
Topics
|
|---|
0900
|
Registration
|
0930
|
Design Thinking of Medical Device Innovation
|
1000
|
Design Thinking Workshop
- Concept brainstorming & Value proposition
- Design requirements, Feasibility vs validation discussion
- Project management
|
1200
|
Lunch
|
1300
|
Quality Management System - Importance of QMS, Design to Production, Risk management
- What are the key QMS: ISO 13485, MDSAP, QSR, MDR, IVDR
- Design to production requirements
- Risk management in product lifecycle: ISO 14971
|
1330
|
Standards Adoption for Medical Device |
1350
|
Electrical and Electromagnetic testing
|
1410
|
Software validation, Usability, Software
|
1430
|
Biocompatibility
|
| 1450 |
Sterilization & Packaging |
| 1510 |
Health safety compliance eg Radiation, Wireless |
| 1530 |
Tea break |
| 1550 |
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
|
| 1750 |
Quiz |
1805
|
End of Day 2
|
Day 3
Location: Temasek Polytechnic
MARKET & SUPPLY CHAIN STRATEGY
Time
|
Topics
|
|---|
0830
|
Registration
|
0900
|
Market trend and opportunities in Medtech
|
0940
|
Medtech Marketing Approaches
- Sales Model: Subsidiary, Direct Sales or Distributor
- Product licence holding rights
|
1000
|
Quick Path for Commecialisation of IVD and Medical Device
|
1040
|
Labelling
- Labelling requirements: Product label, IFU, eIFU, Brochure
- Promotion and Advertisement
- Challenges
|
1100
|
Tea Break
|
1115
|
Intellectual Property: Patents, Trademarks, Liability
- Patenting strategies; timing and geographical
- Product trademark
- Product liability/risk after sales
|
1135
|
Code of Ethics for Medical Device Industry
- Good Ethics for Professionals in Medtech Industry
|
| 1155 |
Profession job roles in Medtech Industry
- Sharing different Medtech roles
- How to select the right candidate. What is their skillset?
- Managing resources need
|
| 1215 |
Fund raising
- Value proposition
- Pitching dos and don’ts
|
| 1245 |
Awareness on Government Funds & Support for Medtech Industry & Industry 4.0 |
1315
|
Lunch
|
1415
|
Hospital procurement
- Medical device procurement policy in hospital
|
1445
|
UDI Barcode
- What is UDI and benefit of UDI for traceability
- Global landscape on UDI regulatory requirements
|
| 1545 |
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
|
1615
|
Tea Break
|
1630
|
Commercialization and Distribution strategy
- Strategy and Considerations for Product Launch
- Investor & Collaborator approach
- Determine distribution channel
|
1815
|
Quiz
|
| 1830 |
End of Day 3 |
Day 4
Location: Temasek Polytechnic
Product Research & Development and Application Technology (R&D, Engineering)
Time
|
Topics
|
|---|
0830
|
Registration
|
0900
|
Medical Devices Development
- Function and characteristics of Electrodes and Transducers
- Design amplifiers and filters for medical applications.
- Relate the various methods of noise and Electromagnetic Interference (EMI) suppression.
- Build a Medical Device prototype of a physiological signal measurement system.
|
| 1000 |
Tea Break |
1030
|
Laboratory Practices & Medical Biochemistry
- Introduction to Laboratory Management System
- Medical Biochemistry Fundamentals
|
1130
|
Smart Wearable Healthcare Devices
The advancement of smart wearable technology and growing demand from consumers to take control of their own health has influenced the medical industry and technology companies to develop more smart wearable devices. This lecture will cover the following topics:
- What are smart wearable healthcare devices?
- Examples of smart wearable healthcare devices
Technology roadmap: accessory type, textile integrated, skin patchable, body implantable.
|
1230
|
Lunch
|
1330
|
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.
- 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.
|
1530
|
Quiz
|
| 1630 |
Tea Break |
| 1645 |
Workshop Summary |
| 1800 |
End of Day 4 |
Certification
Participants will be awarded with a Certificate of Accomplishment upon passing the assessment and upon meeting 75% of the required course attendance.
