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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
MediHeroes
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: Zoom

MEDICAL DEVICE REGULATORY & INNOVATION

 

Time

Topics

0830

Registration

0900

Joint opening speech: Malaysia & Singapore 

0930

Journey of Medical Device: R&D/Design/Manufacturing/sterilization/Logistic/Commercial/Industry 4.0

0950

MedTech International Collaboration opportunities

  • Sharing on manufacturing and collaboration opportunities

1010

Global Regulatory strategy & FAQs

  • Start-ups getting first approval: What to do?
  • What is Medical Device File, Technical File, and Design History File? 
  • Which country first: US, EU or SG?
  • Is it a must to have/certify to ISO 13485?

Can we use literature paper vs Clinical trial?

1030

Break

1040

Global development and 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, Drug and Combination product

Product lifecycle from research to commercialization

1100

ASEAN medical device regulatory requirements

  • Establishment registration: Manufacturer, Importer, Distributor, Authorised Representative
  • Product registration & Other access routes

Common Submission Dossier Template (CSDT)

1130

Asia regulatory requirements

  • Greater China, Japan, Korea
  • Key highlights differences between Medical Device and IVD registration

1200

Lunch

1300

Quality Management System - Importance of QMS in Design, Development, Manufacturing, Storage, Distribution (ISO13485:2016, MDSAP, USQSR, SS620 GDPMDS)

  • Why need QMS?
  • What are the key QMS and differences: ISO/EN ISO 13485:2016, MDSAP, US QSR, EU MDR/IVDR
  • Common industry challenges for QMS set-up and maintenance

How is risk management use in product lifecycle

1345

IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

  • IVDD and the New IVDR - most important changes
  • Timelines of IVD Regulation
  • Conformity assessment procedures
  • Challenges for Manufacturers

Guidance documents CE process & timeline

1430

MDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

  • MDD and the New MDR, Other related Directives e.g. Combination products
  • Conformity assessment routes for CE Marking
  • Post Market: Vigilance, PMCF, PSUR 

Further changes e.g. Eudamed, Clinical Evaluation

1515

US FDA regulatory requirements

  • 510(k), PMA and other submissions

Key challenges in US approval 

1600

Quiz

1700

End of Day 3 IMDS MY/ End of Day 1 IMDS SG



Day 2

Location: Temasek Polytechnic

MEDICAL DEVICE DESIGN & DEVELOPMENT, STANDARDS & CLINICAL

 

Time

Topics

0830

Registration

0900

Singapore Biodesign Introduction

0920

Design Thinking Process

  • Concept brainstorming & Value proposition
  • Early validation through feasibility
  • Project management

0950

Standards Development Organization 

  • Introduction 
  • Why Adoption of Singapore Standards (SS) and if different from ISO Standards

1020

Electrical, Electromagnetic testing, Usability

  • IEC 60601, IEC 61010, IEC 62366

1045

Break

1100

IVD safety and effectiveness requirements

RNA standards Singapore

1130

Software validation & Cybersecurity

  • IEC 62304

1200

Lunch

1300

Sterilization & Packaging validation

1330

National Health Innovation Centre Introduction 

1400

Developing a clinical strategy

  • What is clinical investigation/research
  • When this is needed for medical devices
  • How to plan and conduct clinical investigation properly
  • What are the differences between clinical investigations and clinical evaluation?
  • What are the differences for medical device, IVD and pharmaceutical clinical Investigation

1430

Panel discussion: Clinical needs, plan, approval and conduct

1530

Quiz

1700

End of Day 2




Day 3

Location: Temasek Polytechnic

CUSTOMER LANDSCAPE & GO-TO-MARKET STRATEGY FOR MEDTECH INDUSTRY

 

Time

Topics

0830

Registration

0900

Opening and Welcome Speech

0915

Opening remarks by the instructor to set the scene/agenda + Poll 1

0930

The sustainability of our health systems, and implications for medtech companies + Poll 2

1000

DSTM approach for aligning to the “job to be done” principles in successful medtech ventures

1045

Break

1100

How to know who your real “customer” is, and the variety of ways to reach them.

1145

Open discussion, morning wrap-up + Poll 3

1200

Lunch

1300

Scaling up – how to evolve your concept into a sustainable and profitable business

1345

Supply chain and traceability of medical device in hospital

1430

Break

1500

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)

1600

Open discussion, afternoon wrap-up + Quiz

1730 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.

1030

Laboratory Practices & Medical Biochemistry 

  • Introduction to Laboratory Management System
  • Medical Biochemistry Fundamentals

1230

Smart Wearable Healthcare Devices 

The advancement of smart wearable technology and the 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.

1330

Lunch

1430

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.

1600-1800

Medtech Career Insights

 

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

APPLY

Registration may be closed earlier due to overwhelming response.

 

For Corporate training, click here.

Course Fees

Fee Type Item Total Fees (w GST)
Full Course Fee S$2033.00
SG Citizens aged 39 & below / Permanent Residents S$609.90
SG Citizens aged 40 & above / SME-sponsored SG Citizens & Permanent Residents S$229.90

SkillsFuture Credit Approved. For more details, please click here



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

Lecturer/Trainer Profile

Course Contact

  • 67881212 (Mondays – Fridays, 9.00am – 5.00pm)
  • 8.30am – 6.00pm (Mon – Thu)

    8.30am – 5.30pm (Fri)

    Closed on Sat, Sun & Public Holidays

    Due to Safe Management Measures, our office is currently closed.

    Please call or email us your enquiry.

    Thank you for your patience and understanding.

  • Website: https://www.tp.edu.sg/tsa
  • Temasek SkillsFuture Academy
    Temasek Polytechnic
    East Wing Block 1A,
    Level 3, Unit 81
    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.

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