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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

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

  • IEC60601, IEC61010

1410

Software validation, Usability, Software

  • IEC62304, IEC62366

1430

Biocompatibility

  • ISO10993
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.

Course Schedule/Apply

Intake Info Application Closing Date Course Duration

To be advised

NA

4 days

9.00am – 6.00pm

Classroom-based learning

Registration may be closed earlier due to overwhelming response.

 

For Corporate training, click here.

Course Fees

Fees Type Course Fees
(w GST) 
Singapore Citizens
Full Course Fee / Repeat Students S$2,033.00
Aged 40 and above / SME-sponsored S$229.90
Aged below 40 S$609.90
Non-Singapore Citizens
Full Course Fee / Repeat Students S$2,052.00
Singapore Permanent Residents / Long-Term Visit Pass Plus (LTVP+) Holder S$615.60
SME-sponsored (Singapore Permanent Residents) / Long-Term Visit Pass Plus (LTVP+) Holder) S$235.60

SkillsFuture Credit Approved. For more details, please click here


With effect from 1 Jul 2020, the Workforce Training Scheme (WTS) will be replaced by the Work Support Scheme (WSS), for more information, please visit:
https://www.wsg.gov.sg/programmes-and-initiatives/workfare-skills-support-scheme-individuals.html

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 4
    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.