Medical Device School

Temasek Polytechnic and ARQon (Asia Regulatory & Quality Consultancy) are launching the Medical Device School program to provide an ideal opportunity to MEDTECH INDUSTRY PROFESSIONALS to gain a comprehensive overview of medical devices lifecycle, from research and development stages to commercialization.

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:

Supported by:

Community Partners:

  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Asia Regulatory and Professional Association (ARPA)
  • Agency for Science, Technology and Research (A*STAR) Singapore Biodesign
  • Biomedical Engineering Society (BES), Singapore
  • British Standards Institution (BSI)
  • European Enterprise Network (EEN)
  • Informa Knect365 Medical Device Training International (MDTI Online training)
  • Institute of Engineers, Singapore (IES) Biomedical Engineering Technical Committee
  • Industrial Technology Research Institute (ITRI), Taiwan Republic of China
  • Intellectual Property Intermediary (IPI)
  • Jurong Town Corporation (JTC)
  • National Healthcare Innovation Centre (NHIC)
  • NUS Enterprise
  • SGInnovate
  • Singapore Manufacturing Federation’s MedTech Industry Group (SMF’s MTIG)
  • Singapore Manufacturing Federation’s Standard Development Organization (SMF’s SDO)
  • Singapore Manufacturing Federation’s GS1 (SMF’s GS1)
  • TUV Rheinland
  • TUV SUD
  • Underwriters Laboratories (UL)
  • National Additive Manufacturing Innovation Cluster (NAMIC)

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.

Course Outline

DAY 1: TUESDAY, 1 OCTOBER 2019
LOCATION: ASPIRATION ROOM, MATRIX BUILDING, BIOPOLIS

MEDICAL DEVICE REGULATORY AFFAIRS

Time Topics Speakers
0830 Registration  
0900 Opening

• Wong Kia Ngee, Temasek Polytechnic
• May Ng, ARQon

0915

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

• Jack Wong, Asia Regulatory and Professional Association (ARPA) /Allergan
0945

ASEAN medical device regulatory requirements
• Establishment registration: Manufacturer, Importer, Distributor, Authorised Representative
• Product registration
• Other access routes

• May Ng, ARQon
• Regulators

1045 Tea Break  
1100 Panel discussion: ASEAN regulators

• Audrey Lee, Invisalign Singapore
• ASEAN Regulators

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 stakeholders i.e. local industry and the national authorities/agencies.

• Duc, Edward LifeSciences
• Jacqueline Monteiro, Regulatory Affairs Professionals Society (RAPS).
• Preecha Bhandtivej, ASEANMed

1200 Lunch  
1300

Asia regulatory requirements (registration and testing)
• China

Asia regulatory requirements (registration)
• Taiwan ROC

• Su Ping, TUV Rheinland
• Dazhi (ex-CFDA/NMPA) ARQon China
• Albert Li, Industrial Technology Research Institute (ITRI)

1345

Asia regulatory requirements
• India

• Sharad, Johnson & Johnson
1405

Asia regulatory requirements
• Japan

 
1430

Asia Pacific regulatory requirements & Reimbursement
• Australia & NZ
• What is Reimbursement and the Technology coding being paid of

• Ruth Shennan, Device Technologies
1500

Product/Process Changes
• Managing changes and Impact

• Yenny Anggoro, Stryker
1520

Asia regulatory requirements – Differences Medical Device, IVD
Key highlights differences between Medical Device and IVD registration

• Nashata Isa, Qiagen
1540 Tea Break  
1555

MDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
• MDD and the New MDR, Other related Directives for Combination products
• Overview of Conformity assessment routes for CE Marking
• Post Market: Vigilance, PMCF, PSUR
• Further anticipated changes in EU eg Eudamed, Clinical Evaluation

• Moira Lim, TUV SUD
1615

IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
• IVDD and the New IVDR
• Overview of Conformity assessment routes for CE Marking
• Post Market: Vigilance, PMPF, PSUR
• Further anticipated changes in EU eg Companion diagnostic

• BSI Group
1635

CE mark regulatory requirements – Technical Documentation
• Contents of a Technical documentation
• Reviewing the Essential requirements
• The use of relevant standards

• Jocelyn Reyes, TUV Rheinland
1655

US FDA regulatory requirements
• 510(k), PMA and other submissions
• US QSR Quality system and inspections

US FDA regulatory requirements
• Warning letters and key lookout

 
1725

Regulatory Controls on Radiation & Wireless medical device

 
1745

Global Regulatory strategy & FAQs
• Start-ups getting first approval
• Manufacturer penetrating Asia
• Manufacturer transitions to CE MDR/IVR

• May Ng, ARQon
• Heikki Pitkanen, Lean Entries Finland

1815

Quiz

 
1830

End of Day 1

 

DAY 2: WEDNESDAY, 2 OCTOBER 2019
LOCATION: NTU ALUMNI CLUB (NTU@ONE NORTH)

MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT SYSTEM
MEDICAL DEVICE CLINICAL & PERFORMANCE EVALUATION

Time Topics Speakers
0830 Registration  
0900

Singapore Biodesign
• Singapore Biodesign introduction

• Mark Chong, Agency for Science, Technology and Research (A*STAR)  Biodesign

0915

Quality Management System - Importance of QMS and Risk management
• Why need QMS?
• What are the key QMS: ISO/EN ISO 13485:2016, MDSAP, US QSR, EU Conformity
• How risk management fits with the product life-cycle, ISO 14971:2012

• Eamonn Hoxey, Association for the Advancement of Medical Instrumentation (AAMI)
0945

Quality Management System - Design Control
• Design control requirements
• Elements in Design History File
• Expectation of the certification body

• May Ng, ARQon

1015

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

• Mark Chong, Agency for Science, Technology and Research (A*STAR)  Biodesign/NTU
1045 Tea Break  
1100 SDO Introduction

• Standard Development Organisation (SDO)

1115

Electrical and Electromagnetic testing
IEC60601, IEC61010

• Underwriters Laboratory (UL)

1135

Software validation
IEC62304 and Usability IEC62366

• Industrial Technology Research Institute (ITRI)
1155 Cybersecurity & Data Protection • TUV Rheinland
1215 Biocompatibility IEC10993 • Li Yang, TUV SUD
1235 Sterilization & Packaging validatio • Eamonn Hoxey, Association for the Advancement of Medical Instrumentation (AAMI)
1255 Lunch  
1355

Quality Management System - Production, Warehousing & Distribution
• Cleanroom, Production and Validation
• Product release and Quality Assurance
• Supply chain management
• Expectations of the certification body

 

1425

Medtech Manufacturer’s Quality Management System Set-up (ISO13485:2016, MDSAP, USQSR)
• When you need QMS certification
• What are the steps for QMS set-up
• Common industry challenges for QMS set-up

• Teo Siow Thing, ARQon
1455

Medtech Manufacturing Set-up & Challenges
• Bill of Material
• Production Floor
• Process validation IQ/OQ/PPQ
• Lean Cost-Effective manufacturing
• Other Key considerations

 
1525

Medtech Outsourcing Contract Manufacturing
• Contract Manufacturing Sourcing
• Vendor selection criteria and considerations
• Factor for success collaboration

• Colin Chong, ARQon US
1545

Medtech Manufacturing and Collaboration opportunities
• Sharing on manufacturing capabilities and investment policy

 
1625 Tea Break  
1640

NHIC Introduction

• Teo Cher Hwa, National Health, Innovation Centre, Singapore (NHIC)
1655

Developing a clinical strategy
• What are the differences between clinical investigations and evaluations?
• What are the differences for medical device, IVD and pharmaceutical clinical investigation
• Designing your clinical investigation
• Understanding the importance of GCP & ISO 14155

 
1725

Panel discussion: Clinical needs, plan, approval and conduct

 
1815

Quiz

 
1830

End of Day 2

 

DAY 3: THURSDAY, 3 OCTOBER 2019
LOCATION: ASPIRATION ROOM, MATRIX BUILDING, BIOPOLIS

MARKET & SUPPLY CHAIN STRATEGY

Time Topics Speakers
0830 Registration  
0900 Market trend and opportunities in Medtech

 

0920

Medtech Market Access: Barriers & strategies
• Market strategy and Considerations for Product Launch

• Alok Mishra, Value Addition

0940

Medtech Marketing Approaches
• Sales Model: Subsidiary, Direct Sales or Distributor
• Product license holding rights

Medtech Business One-Stop Service platform
• MedtechBOSS eNetwork

• Shikharesh Das, Ontogenix
• David Lee, MedtechBOSS

1010

Healthcare software/apps & E-commerce
• Online sales of medical device, Software for clinical service, Software/apps for healthcare lifestyle. Are these product/service and its provider being controlled?
• Personal-use importation
• SMA eMarket

 
1040

Hospital procurement
Medical device procurement policy in hospital

 
1100 Tea Break  
1115

Legal: Patents, Trademarks & Liability
• Patenting strategies; timing and geographical coverage
• Product trademark
• Product liability/risk after sales

 

1135

Code of Ethics for Medical Device Industry
• Key points in Code of Ethics policy for a medtech company

• Fiona Goh, Zimmer Biomet

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’t

• NUS Enterprise
1235

Awareness on Government Funds & Support

• SME Centre
1255 Lunch  
1310

Labelling
• Labelling requirements: Product label, IFU, brochure
• Promotion and Advertisement
• Challenges

• Kelvin Koh, Terumo

1330

UDI Barcode
• What is UDI and benefit of UDI for traceability
• Global landscape on UDI regulatory requirements

• Liew Wai Leong, Singapore Manufacturing Federation’s GS1 (SMF’s GS1)
1350

Post-market surveillance overview
• What is Post Market Surveilance
• What to report and timeline for Vigilance Reporting
• Post-Market Clinical Follow up (PMCF)
• Handling Complaints, Adverse Event and FSCA

• Joanna Koh, MDNet
1410

Quality Management System Set-up & Challenges for Importer & Distributor SS620, GDPMD in ASEAN
• 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

• Terry Song, Boston Scientific
• Stephen Hsu, Boehringer Ingelheim

1440

Quiz

 
1500

End of Day 3

 
1600

MEDTECH EXCHANGE NETWORKING (COMPLIMENTARY)

LOCATION: AUDITORIUM, MATRIX BUILDING, BIOPOLIS
ORGANISED: ASEANMed, ARQON, TEMASEK POLYTECHNIC, SG INNOVATE

 

DAY 4: FRIDAY, 4 OCTOBER 2019
LOCATION: TEMASEK POLYTECHNIC

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

Time Topics Speakers
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.

• Mr Siew Loong, Temasek Polytechnic
• Mr Qian Xijun, Temasek Polytechnic

1015

Tea Break

 
1030

Genetic Engineering & Tissue Engineering
• Methods to produce different genetically modified organisms (GMOs)
• Applications of genetic engineering in biotechnology
• Laboratory management, quality assurance, laboratory automation, statistical methods and safety regulations practised in laboratories..

Stem Cells and Tissue Engineering
• Concepts of tissue engineering, stem cells, biomaterials and a review on extracellular matrix, followed by topics on cell-cell and cell-matrix interactions at both the theoretical and experimental levels

Clinical Chemistry
• Pathophysiological changes in disease and the application of clinical chemistry concepts for the diagnosis, prognosis, monitoring and screening of diseases •

• Dr. Ismail Muhamad Hanif, Temasek Polytechnic

1145 Lunch  
1245

3D Printing Technologies and Applications

• Mr Lee Khim Yong, Temasek Polytechnic

1345

Microfluidics Technologies and Applications

• Dr Fu Yi, Temasek Polytechnic
1445

DISCOVERY AI
• Benefit of AI in healthcare

 
1515

Quiz

 
1530

Tea Break & Travel to Manufacturing site

 
1630

Visit to JTC Medtech Hub’s manufacturing sites:
• Medical device: Implant and 3D printing
• IVD

• Osteopore
1730

Travel back to MRT

 
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 Fee Payable after Funding:

Course Description

Course Fee (with GST)

Full Course Fee $2033.00
Singapore Citizens aged 39 years old and below / Singapore Permanent Residents $609.90
Singapore Citizens aged 40 years old and above / SME-Company sponsored Singapore Citizens & Singapore Permanent Residents $229.90
Workfare Training Scheme (WTS)* $134.90

* Eligible participant must be Singapore Citizen of 35 years and above with monthly salary not more than $2000 per month. Applicants are required to submit a soft copy of his/her WTS letter to tsa@tp.edu.sg.
Please refer to www.workfare.sg  for more information on WTS

Speakers' Profile

Enquiries & Application

Submit on-line application via:
https://form.gov.sg/#!/5d3e9ed33a99e100129c5cd9

Temasek SkillsFuture Academy
Temasek Polytechnic
East Wing Block 1A, Level 3, Unit 81
21 Tampines Avenue 1
Singapore 529757

Opening Hours
8.30 am to 7.00 pm (Mon to Fri)
Closed on Sat, Sun & Public Holidays

Contact Details
 6788 1212
tsa@tp.edu.sg
  http://www.tp.edu.sg/tsa

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