Jump to Section

Course Overview

This course will provide MedTech (Medical Technology) industry professionals a chance to receive a quick yet comprehensive overview of the medical devices lifecycle, starting from research and development stage to commercialisation. It will also include market strategies, opportunities and challenges in the manufacturing and distribution of MedTech devices. Participant will also gain valuable insights from industry experts’ sharing, such as advanced technologies in medical devices, the global regulatory landscape (including the new CE MDR/IVDR enforcement by May 2020/2022), design, testing and requirements for product safety, etc. The course would also provide opportunities for like-minded MedTech professionals in exploring potential business collaboration.

 

 

Key Benefits 

 

  • Gain valuable insights and experiences from the key respected speakers in the field to apply to your work/decision and preventing common mistakes. 

  • Gain a comprehensive understanding on global regulatory landscape and latest updates including the new CE MDR/IVDR enforcement by May 2020/2022. 

  • Discover the design, testing and standards requirements for product safety. 

  • To explore the advanced technologies in medical device. 

  • To hear about the market strategies, opportunities and challenges in the manufacturing and distribution. Networking with Medtech partners and industries, for potential collaboration.

Organiser:

ARQon
Temasek Polytechnic

Supported by:

ASEANMed
ARPA

Who Should Attend

Medtech companies’ Management, CEO, Investor, Start-up, MNC, Manufacturer, Distributor, Regulatory, Government Affairs, Quality, R&D Engineer, Legal, Clinical, Marketing and Sales professionals.

What You'll Learn

DAY 1: 18 March 2024

MEDICAL DEVICE REGULATORY & INNOVATION

Chairperson: May Ng, ARQon

Time

Topics

0800 - 0815

Registration

0815 - 0830

Opening & Welcome Remarks

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

 

0915 - 0940

EU Regulatory Requirements & Strategy

  • Brief Overview of Regulation & Strategy
  • Case studies

 

0940 - 1005

US Regulatory Requirements & Strategy

  • Brief Overview of Regulation & Strategy
  • Case studies

 

1005 - 1030

Innovation vs Regulation: Friend or foe?

1030 - 1045

Tea Break

1045 - 1115

Medical software – Regulation & Strategy

1115 - 1140

Use of Real-World Evidence for regulatory approval in Korea

1140 - 1200

Medical Device reimbursement in Korea – A MedTech company’s worst nightmare?

1200 - 1300

Lunch

1300 - 1345

Clinical Investigation for the registration of Medical Devices in Korea

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

 

1430 - 1445

Tea break

1445 - 1515

MedTech in Korea – Where is it heading?

1515- 1545

The Startup Journey – From Concept to Commercialization and Adoption

1545 - 1615

Startup Funding – Tips for landing it

1615

End of IMDS KR/SG DAY 1



DAY 2: 19 March 2024

MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT & STANDARDS

Chairperson: May Ng, ARQon & Jack, ARPA

Time

Topics

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

  • IEC60601, IEC61010

 

1410 - 1430

Software validation, Usability, Software

  • IEC62304, IEC62366

 

1430 - 1450

Biocompatibility

  • ISO10993

 

1450 - 1510

Sterilization & Packaging

1510 - 1545

Health safety compliance

  • Equipment registration requirements for Wireless Medical Devices

 

1545 - 1605

CEO Session

1605-1620

Tea break

1620 - 1820

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

 

1820

End of Day 2

 

 

DAY 3: 20 March 2024

MARKET & SUPPLY CHAIN STRATEGY

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

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

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



Day 4

PRODUCT RESEARCH & DEVELOPMENT AND APPLICATION TECHNOLOGY (R&D, ENGINEERING)

Chairperson: Adrian Danker, TP

Time

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

Tea Break

1130- 1300

Tour of TP , TP AMC, 3D Printing, HEC & Innovation Learning Lab (Dr Wong Yee Shan)

1300-1330

Lunch

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

 

 

Certification

 

Participants will be awarded with a Certificate of Accomplishment upon passing the assessment and upon meeting 75% of the required course attendance.


For more information on course fee / schedule, or to apply,

Course Contact

  • 67881212
  • Monday - Thursday: 8:30am - 6:00pm
    Friday: 8:30am - 5:30pm
     
    Closed during lunchtime, 12:00pm - 1:00pm
    and on weekends and public holidays.

  • https://www.tp.edu.sg/tsa
  • Temasek SkillsFuture Academy (TSA)
    Temasek Polytechnic
    East Wing, Block 1A, Level 3, Unit 109
    21 Tampines Ave 1
    Singapore 529757

     

  • Temasek Polytechnic reserves the right to alter the course, modify the scale of fee, amend any other information or cancel a course with low enrolment.