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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

Location: Temasek Polytechnic (Subject to Change)

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

 

Time

Topics

0830

Registration

0900

Singapore KPMG Introduction

0915

CHALLENGES & TRENDS: Understanding the job to be done for medical technology innovation

  • Health systems are under greater pressure than ever before (reference ongoing WEF sustainable healthcare financing program)
  • Beyond the science itself, there are many challenges faced by medical technology innovators in getting their products to market at scale (reference industry footprint work)
  • Winners will be those that can effectively collaborate across public-private sector in order to make a real impact on population health (innovation case studies to be provided)
  • Feed in to panel discussion with healthcare leadership about how they see trends emerging, and potential opportunity for medical technology companies

0930

Understanding the job to be done for medical technology innovation

1030

Tea Break

1045

CUSTOMER: How to narrow your “Customer”, channel partners, and value proposition

  • Guest speakers: Local start-up with some scale, to share their learnings and to engage with the audience.

1200

Lunch Break

1300

SCALE UP: How to scale your innovation into a sustainable business

  • Guest speakers: MNC to talk about how they run their own business, as well as their interactions/experiences in dealing with start-ups.

1500

SUPPLY CHAIN: Ensuring you live up to customer expectations with supply chain and channel partnerships

  • Guest speakers from a distribution player to talk about a diversified channel strategy, as well as the tips/learnings in running an effective supply chain operation.

1600

Tea Break

1615

OTHERS: Bringing it all together

  • Panel to cover some of the themes not already covered (e.g. investment, IP, talent, government support, reimbursement).

1730

Quiz

1745

End of Day 1

1800

MEDTECH EXCHANGE NETWORKING EVENT 

(COMPLIMENTARY)

 

Organised By: ARQon, ASEANmed, SGInnovate, Temasek Polytechnic (Subject to change)
Venue: To Be Advised
Note: Refreshment will be provided



Day 2

Location: Temasek Polytechnic (Subject to Change)

PRODUCT DESIGN AND DEVELOPMENT, STANDARDS, MANUFACTURING, QMS, CLINICAL EVIDENCE

 

Time

Topics

0830

Registration

0900

Singapore Biodesign Introduction (Subject to Change)

0915

Design Thinking Process

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

0935

MedTech International Collaboration opportunities

  • Sharing on manufacturing and collaboration opportunities
  • Sharing on investment policy & business/manufacturing setup

1045

Tea Break

1100

Standards Development Organization (Subject to Change)

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

1120

Electrical, Electromagnetic testing, Usability

  • IEC 60601, IEC 61010, IEC 62366

1140

Software validation & Cybersecurity

  • IEC 62304

1200

Sterilization & Packaging validation

1220

IVD safety and effectiveness requirements

1240

Lunch

1340

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

1410

Medtech Manufacturing Set-up & Challenges

  • Bill of Material
  • Production Floor
  • Lean Cost-Effective manufacturing
  • Contract Manufacturing Sourcing
  • Vendor selection criteria and considerations
  • Expectations of the certification body

1440

Medtech Quality Assurance in Product Release and Supply chain

  • Cleanroom, Production and   Validation
  • Product release and Quality Assurance
  • Supply chain management
  • Expectations of the certification body

1510

Tea Break

1525

National Health Innovation Centre Introduction (Subject to Change)

1545

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

1615

Panel discussion: Clinical needs, plan, approval and conduct

1655

Quiz

1800

End of Day 2




Day 3

Location: Temasek Polytechnic (Subject to Change)

REGULATORY IN PRODUCT LIFECYCLE

 

Time

Topics

0830

Registration

0900

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

0930

ASEAN medical device regulatory requirements

  • Establishment registration: Manufacturer, Importer, Distributor, Authorised Representative
  • Product registration & Other access routes
  • ASEAN/SG Common Submission Dossier Template (CSDT)

1045

Tea Break

1100

Panel discussion: Regulatory barriers and strategies

  • Case studies and  sharing by MNC
  • Case studies and  sharing by SME

1130

Panel discussion: The role of Industry Associations and partners in regulatory convergence and healthcare improvement

  • The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL
  • The importance of association’s role for its stakeholder i.e. local industry and the national authorities/agencies.

1200

Lunch

1300

Asia regulatory requirements

  • Greater China, Japan, Korea

1320

Asia Pacific regulatory requirements & Reimbursement Australia & NZ

  • What is Reimbursement & technology coding being paid of

1340

Medical Device vs IVD 

  • Key highlights differences between Medical Device and IVD registration

1400

Product/Process/Label Changes

  • Managing changes and Impact
  • Regulatory intelligence news updates

1420

Post-market surveillance overview

  • What is Post Market Surveillance
  • What to report and timeline for Vigilance Reporting
  • Post-Market Clinical Follow up (PMCF)
  • Handling Complaints, Adverse Event and Field Safety Corrective Action/Recall

1440

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 certify to ISO 13485?
  • Can we use literature paper vs Clinical trial?
  • How to transit MDD/IVDD to CE MDR/IVR

1520

Tea Break

1535

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

1555

IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

  • IVDD and the New IVDR
  • Conformity assessment routes for CE Marking
  • Post Market: Vigilance, PMPF, PSUR
  • Further changes in EU e.g. Companion diagnostic

1615

CE mark regulatory requirements – Technical Documentation

  • Contents of a Technical documentation
  • Key challenges in CE approval

1635

US FDA regulatory requirements

  • 510(k), PMA and other submissions
  • Key challenges in US approval 

1655

Regulatory Controls on

  • Wireless Medical Devices
1715

Regulatory Controls on

  • Radiation (Ionizing and Non-Ionizing) Medical Devices
1735 Quiz
1800 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.

1100

Tea Break

1030

Laboratory Practices & Medical Biochemistry 

  • Introduction to Laboratory Management System
  • Medical Biochemistry Fundamentals

1315

Lunch

1400

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

Tea Break

1545

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.

1715 Centre of Excellence Tour ( HRG & AMC )

1800

Course completion

 

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

Intake Info Application Closing Date Course Duration

23 – 26 March 2021

23 February 2021

4 Days

(9 AM – 6 PM)

APPLY

Registration may be closed earlier due to overwhelming response.

 

Application Procedures

 

Click on the Apply button above to submit your application online. Registration may be closed earlier due to overwhelming responses.

 

Steps to follow in your application: 

 

Step 1 - Enter NRIC/ Passport No 

Step 2 - Select ZMZ  and course commencement date. 

Step 3 - Enter personal, qualification, employment and sponsoring details (if applicable). 

Step 4 - Applicable for 'Stackable based modular course' or 'Diploma or Post-Diploma courses' only. Select, rank your preference for the selected subject(s) and indicate the number of subject(s) you wish to take. Please note that the subject start date(s) denotes the semester start date.

Step 5 - Make declaration and submit online application

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
  • 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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