APACMed Members’ Day 2019

26 February 2019

Singapore

亚太医疗技术协会

Agenda

• 14:00 Welcome, by APACMed Chair

• 14:10 Message from new APACMed Chief Executive

• 14:15 Highlights 2018; 2019 Plan & Calendar of Events

• 14:45 Functional Committee Updates and Q&A

• 15:15 Break and Networking

• 15:30 Functional Committee Updates and Q&A

• 16:15: Asia Pacific Healthcare & Medical Device Outlook 2019• Rhenu Bhuller, Partner & Senior Vice President, Frost &

Sullivan

Highlights 2018

APACMed in numbers:

• Current membership: 122• Member representatives: 1,000+• Five Committees. Eight Working

Groups.• Committee representatives: 250+• Secretariat headcount: 7• Board Members: 14• Events, workshops and conferences:

4,200+ delegates• Press coverage: 35+ original articles• Social media followers: 4,000+ w

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One third of APACMed members are local, Asian-headquartered start-ups

Number of member companies

Medtechstart-ups

5

• ASEAN Medical Device Committee

• New medical device law (Vietnam and Philippines)

• APEC Vietnam: Business ethics/ APEC-RHSC

• Halal certification for medical devices

• Vietnam Cybersecurity Law

• Adverse Event Reporting guidelines

• Clinical trial requirements

• NHFPC National Pricing• UDI• New QMS standards• Two-invoice system

• Price controls & trade margins

• Public procurement• New Medical

Device Regulations• New clinical

requirements

• Prosthesis list pricing• Broader Private Health

Insurance reform

APACMed: Advocacy priorities in 2018

6

Partnerships & Publications

7

Attendees: 758Speakers: 84Sponsors: 53

Rating: 87% G/VG/E

www.medtechforum.asia

The industry’s nonprofit global competition and accelerator for medical device, digital health, and diagnostic start-ups.

Our mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system.

Introducing MedTech Innovator Asia

3rd Asia Pacific Medical Device Regulatory SummitHeld in conjunction with the Asia Pacific MedTech Forum 2018

Topics included:

• Challenges in Implementation of New Regulations – Thailand, India, EU.

• Regulatory Convergence and Regional/Local Solutions – Indonesia, China, MDSAP.

• Sustainable Talent Pipeline for Regulatory Professionals – Japan, Malaysia, WHO.

• Regulations of Disruptive Innovation – Korea, Australia, U.S.

2019-20 Membership Fee revision

1. 10 tiers of memberships fees for Corporate Members to replace the current 4 tiers (USD 10K to 50K).

2. Maximum fee to increase from current USD 50K to USD 120K for the very largest companies with revenues above USD 20B.

3. In order to reduce the immediate financial impact for members, implementation will be phased over two years.

11

Welcome new APACMed Members 2019:

Plan 2019&

Calendar of Events

Key Activities 2019

• Running Activities • Asia Pacific MedTech Forum

• MedTech Innovator Asia

• Deloitte Compliance Project

• Increase in-country training of regulatory community

• Improve market intelligence – industry footprint study, investment index report, and RA intelligence with IQVIA

• New Initiatives• Build a better presence in India and China

• Expand membership drive e.g. via HK, AdvaMed conference

• Build centre of competence for education & training

• Improve Committee effectiveness (communication/collaboration)

14

Asia Pacific MedTech Forum 2019

Initiatives

• BiodesignSingapore Thought Leaders Series (pre-Forum)

• Care Continuum Showcase

• MedTech Innovator Asia

Agenda

• Medical Devices

• Digital Health

• Patient Experience

• Regulatory Summit

• Compliance & Business Ethics

Speakers

• Align Technology

• Australian Digital Health Agency

• BumrungradHospital

Connecting Leaders, Connecting Care

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MedTech Innovator Asia

• Partnership between APACMed and MedTech Innovator (US).

• USD 300K in non-dilutive cash prizes.

• Target: Raise USD 800K from sponsors to finance 2019 operations and awards.

• Jul-Aug 2019: Pitch events in Tokyo, Sydney, Singapore and Shanghai.

• Next steps: resourcing & engagement

17

APACMed/ KPMG Industry Footprint

Deliverables:- Database - Presentation deck- Brochure- Infographic

First time such data is aggregated for our Industry in the region

• Understanding the Market (APAC vs Global)• MedTech Contribution to Society (GDP, Number of

employees; R&D Investment) • Broader Macroeconomic & Healthcare Story

(market share; surgeries performed; demographic shifts)

• Value of Innovation (MedTech deals value & Volume; Patents filed; Number of start ups)

Investment Index Report

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WHAT?• Comparison/index of “medtech investment climate” in APAC • Working with the Asian Institute of Management• Ranks countries looking at medtech focused corporate tax rates, matching R&D

grants, hiring costs, size of domestic market, labor market, import duties, transport infrastructure, compliance, coherent government policies, regulatory complexity, etc.

WHY?• Long-term, constructive and flexible advocacy and policy-shaping tool • Shows specific areas where an individual country falls short• Significant PR/communication opportunities• Governments don’t understand why medtech investments are not coming in

WHAT’S NEXT?• Asian Institute of Management (AIM) is waiting for go-signal to start work• Start identifying possible index factors and criteria for the index (Q1 2019)• Launch the Index via press event in Manila or Singapore (Q1 2019)

Highlights : Calendar of Events 2019DATE EVENT

9 Jan Ayushman Bharat Webinar

30 Jan MedTech and Trade Breakfast Dialogue

26 Feb APACMed AGM, Q1 Board Meeting, Members Day & Networking Event

Mar Business Ethics & Compliance 101 for MedTech Start-ups

May APACMed Q2 Board Meeting cum Networking Event

May APACMed Digital Health Summit 2019

Jun MedTech Meet-up for Start-ups

Jun APACMed-Korn Ferry MedTech HR Summit 2019

Jul-Aug MedTech Innovator Asia Pitch Events (Australia, China, Japan and Singapore)

Aug MedTech Workshop for Start-ups and SMEs

Aug APACMed Q3 Board Meeting cum Networking Event

7-9 Oct Asia Pacific MedTech Forum 2019

Nov APACMed Q4 Board Meeting cum Networking Evet

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Functional Committee

Updates and Q&A

APACMed Functional Committees

Legal, Ethics & Compliance Committee

Legal/Ethics & Compliance Committee

COMMITTEE NAME: LEGAL/ETHICS & COMPLIANCE COMMITTEE

Charter The Legal/Ethics & Compliance Committee focuses on common legal/ethical & compliance issues of member companies in APAC, provides legal counsel to the APACMed Board and the Secretariat, and ensures proper governance of APACMed

Chair(s)/Vice-Chair(s) Chair: Campbell Clark (Medtronic)

Vice-Chairs: Ana Garcia Bello (Johnson & Johnson) and

David Rosenzweig (Abbott)

[Rich Hamilton (Stryker) and Benji Kwak (Zimmer Biomet) have made enormous

contributions to the work of the Committee. Rich left last year, and Benji this

year, to take on expanded roles within their respective organizations.]

No. of Individual Members

36

Working Groups (if any)

Code Revisions Communications Working Group; “Deloitte Project Working Group”

Meeting frequency Bi-Monthly

External partnerships

Association with AdvaMed, AdvaMed China, and MedTech Europe

2018 AchievementsINITIATIVE OUTCOME/ DELIVERABLE

1. APACMed governance

• Participation in all board meetings / meetings of members• Working with the Secretariat and APACMed external counsel to ensure that

APACMed complies with its corporate obligations

2. Advice and support to the other functional committees

Engagement of members of the Committee to support the work of the other

functional committees, including MoUs negotiated by the Regulatory

Committee

3. APACMed Code of

Ethics

• Following the elimination of direct sponsorship, working with member

companies to resolve questions and concerns

• Publicizing the Code changes with impacted stakeholders

4. “Deloitte Project” Working with Deloitte to develop a platform to enable HCPs to access educational grant funding

5. GMTCC Presented at the GMTCC meeting in Paris in May

5. APEC BusinessEthics Forum

Participation in the Forum in Tokyo in July

6. APACMed Compliance Meeting

Organized a compliance meeting for members, following the 2018 MedTech Forum, Singapore

2019 Plans

STRATEGIC PRIORITY / INITIATIVE

OUTCOME/ DELIVERABLE by when

1. APACMed governance

Participation in all board meetings / meetings of members – as scheduled

2. Advice and support to the other functional committees

Engagement of members of the Committee to support the work of the other

functional committees / have representatives attend meetings of other

functional committees – as required

3. APACMed Code of

Ethics

• Monitor adherence to the Code

• Address practical challenges arising out of the elimination of direct

sponsorship

• Work to align the Code with other regional codes of ethics

4. “Deloitte Project” Considerable work is still required to complete Phase 1 of the Project, and then

to move to Phase 2

5. APACMed Compliance Meeting

Organize a compliance meeting of industry associations, as part of the 2019 MedTech Forum, Singapore

Regulatory Affairs Committee

Regulatory Affairs CommitteeCOMMITTEE NAME: REGULATORY AFFAIRS COMMITTEE

Charter • Promote regulatory convergence in collaboration with government agencies, industry associations, academia and other stakeholders;

• Build and support a strong regulatory workforce for MedTech industry and regulators, and drive capacity building initiatives in partnership with various stakeholders;

• Advocate for policies promoting patient access to innovative technologies that advance patient outcomes.

Board Sponsor Andrew Frye (Baxter)

Chair/Vice-Chairs Chair: Dominik Reterski (Medtronic)

Vice-Chairs: Miang Tanakasemsub (Alcon); Jason Guo (Abbott)

No. of Individual Members 190+ individual members from 38 Corporate members companies (accounting for 93% of APACMed Corporate membership)

Working Groups China CoE, Indian Sub-continent CoE, Southeast Asia CoE,Regulatory Intelligence WG, IVD WG, Capacity Building task force

Meeting frequency Monthly call, quarterly townhall, annual regulatory summit

External partnerships AMDC, AHWP, APEC-RHSC, CIMDR, IMDRF, Duke-NUS CoRE, GMTA

FUNCTIONAL COMMITTEE UPDATES:

Board Sponsor: Andrew Frye (Baxter)

Chair: Dominik Reterski (Medtronic)

Vice Chairs: Miang Tanakasemsub (Alcon); Jason Guo (Abbott)

Secretary: Victoria Qu (Abbott)

China CoE

Chair: Guo Ye (BD); Secretary: Liu Xiaoyi (Johnson & Johnson)

Vice-Chairs: Pan Shi (B. Braun); Wang Yuhong (Smith & Nephew)

Southeast Asia CoE

Chair: Priscilla Koh (Johnson & Johnson)

Vice-Chair: Terry Song (Boston Scientific) Secretary: Kenneth Cheong (ConvaTec)

Indian Sub-Continent CoE

Chair: Kirti Arora (Boston Scientific)

Vice-Chairs: Asok Kumar (Johnson & Johnson); Latika Vats (Medtronic)

In Vitro Diagnostic (IVD) Working Group

Chair: Adelheid Schneider (Roche); Vice-Chair: Lai Pai Lin (Siemens)

Regulatory Intelligence (RI) Working Group

Chair: Max Sakurai (Johnson & Johnson); Secretary: Dacia Su (Abbott)

Vice-Chair: Rhoel Laderas (Baxter)

RA Committee Leadership

2018 Achievements (1/4)

FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOMES

1. Seat at table to represent industry at regulatory harmonization/convergence platforms:

• IMDRF• APEC-RHSC• AMDC• AHWP• WHO

• Contributed to the 13th and 14th IMDRF meetings in Shanghai and Beijing as GMTA member and engage with regulators in key economies in March and Sept;

• Attended APEC- RHSC meetings on behalf of industry coalition in Singapore and Brisbane to drive medical device PWA roadmap and core curriculum in Feb and Aug;

• Co-organized AMDC meetings, striving for AMDC preferred partnership by closely engaging AMDC Chair and ASEAN Secretariat throughout the year; position letter in April and pitch to 9 ASEAN countries in Dec;

• Participated and co-organized AHWP annual meeting as official liaison member in KL in Oct;

• Attended the WHO Global Forum on Medical Device in Visakhapatnam, India in Dec.

2018 Achievements (2/4)FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOMES

2. Advocate on key regulatory changes as preferred industry partner

• Position letters submitted in India CDSCO:⁻ Comments to CDSCO on public notice regarding medical devices as drugs in

Section 3 (b) (iv) of DCA 1940 (Jul 2018)

• Position letters submitted in China Ministry of Justice and NMPA:⁻ Draft Amendments to Decree 680 (24 Jul 2018)⁻ Provisions for Import Medical Device Agents (2 Sept 2018)⁻ Guidance documents for post market surveillance including the Periodic Risk

Assessment report (Dec 2018)

• Position letters submitted to Vietnam DMEC:⁻ Decree 36 Amendments (June 2018)⁻ Meeting minutes based on 26 July face-to-face meeting in Hanoi (Aug 2018)⁻ Draft letter to the Government Office (Aug 2018)

• Position letters submitted in Philippines FDA:⁻ IVD Draft AO (Oct 2018)⁻ Meeting minutes based on 13 Nov face-to-face meeting in Manila (Nov 2018)

• 13 meetings with MedTech regulators (1 Australia, 2 China, 1 Indonesia, 1 India,

1 Japan, 1 Korea, 1 Malaysia, 1 Philippines, 1 Singapore, 2 Thailand, 1 Vietnam);

• Invited by regulators to attend 3 expert consultation meetings (2 China, 1

Philippines).

2018 Achievements (3/4)FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOMES

3. Drive capacity building projects and enhance visibility & credibility

• Completed the 10-month project on MedTech regulator competency

framework jointly with AHWP and Deloitte; successfully obtained input

on 97 competencies from 13 AHWP member regulators:

⁻ Chile

⁻ Chinese Taipei

⁻ Hong Kong SAR of China

⁻ Indonesia

⁻ Kingdom of Saudi Arabia

⁻ Malaysia

⁻ People’s Republic of China

⁻ Philippines

⁻ Republic of Korea

⁻ Sultanate of Oman

⁻ Tanzania

⁻ Thailand

⁻ Vietnam

⁻ & APACMed member companies!

• Co-organized one-day training for 60 ASEAN regulators and one-day

training for 100 industry participants in Dec 2018 in Bangkok, jointly

with Thai FDA and AMDC.

2018 Achievements (4/4)FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOMES

4. Build the unique dialogue platform for members to engage with WHO, regulators, trade associations, academia, etc.

• Organized the most highly rated regulatory Summit with speakers and

participants from:

⁻ the World Health Organization (WHO)

⁻ 6 national regulatory authorities (Indonesia, Japan, Korea, Malaysia,

Singapore, Thailand)

⁻ 3 regional harmonisation initiatives (AHWP, AMDC, APEC-RHSC)

⁻ 9 Industry Associations (from all over APAC region and beyond)

⁻ 2 academic partners (Duke-NUS CoRE, Duke Margolis Center for

Health Policy).

5. Regulatory Intelligence sharing with members and partners

• 5 regulatory newsletters

• 1 townhall meeting

• 2 meetings with Board sponsor

• 1 Board meeting update

• 6 Core leadership meetings

• 22 CoE/WG meetings/calls

• 5 GMTA meetings/calls

2019 Plans (1/3)

FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOME/ DELIVERABLE by when

1. Represent MedTech industry of Asia Pacific and promote regulatory convergence by striving for/maintaining seats at table with regulatory harmonisation/convergence platforms:

• IMDRF• APEC-RHSC• AMDC• AHWP• WHO

• Continue to actively participate and influence as GMTA member at IMDRF meetings and strive to become the co-organizer for IMDRF meetings in March and Sept 2020 in Singapore, building credibility among regulators and industry from 10 key markets;

• Drive the pre-marketing review reliance initiative among ASEAN economies towards better harmonization and promote better access in collaboration with AMDC; co-organize the 8th ASEAN Medical Device Committee meeting together with PH FDA and PAMDRAP in July 2019 in Philippines as well as AMDC trainings in Singapore in Q4.

• Promote harmonization by continually leading AHWP technical session and capacity building initiatives with regulators from 30 member economies in Q4 in Oman;

• Monitor the progress of Medical Device PWA roadmap through association peers and academia partners at APEC-RHSC with 21 member economies in Feb and Aug.

2019 Plans (2/3)

FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOME/ DELIVERABLE by when

2. Build and support a strong regulatory workforce for MedTech industry and regulators, and drive capacity building initiatives in partnership with stakeholders

• Publish the white paper and run webinar on MedTech regulator

competency framework in Q1;

• Design and deliver trainings and workshops in India and ASEAN

countries in Q2/Q3;

• Enhance partnership with WHO, harmonization platforms,

academia and association peers in capacity building.

3. Closely monitor and

proactively advocate in

countries for regulations and

standards that promote

patient access to innovative

technologies advancing

patient outcomes

• Engage with regulatory authorities and monitor major changes in APAC markets;

• Advocate proactively through CoEs/IVDs in collaboration with peer associations as knowledge partner (more details in the following slides).

2019 Plans (3/3)

FUNCTIONAL COMMITTEE UPDATES:

INITIATIVES OUTCOME/ DELIVERABLE by when

4. Strive for regulatory intelligence thought leadership

• Share monthly intelligence updates with members;

• Produce thought leadership pieces in prioritized areas (such as Digital Health regulations, IVD performance evaluation, etc.) .

5. Continue to build our annual Regulatory Summit as a branded high-level platform for dialogues on regulatory issues among multiple stakeholders

• Closely work with APACMed members to build the agenda for regulatory summit;

• Proactively engage with regulators, policy makers and other stakeholders to ensure a high quality and impactful dialogue on key policy and regulatory issues in APAC and beyond.

Cluster 1 – Mature Markets(Japan, Korea, Australia, Singapore )

Priorities: Multilateral engagement; Digital health; Local partnership

Key Initiatives:

➢ Presence at IMDRF meetings and participation in working items as GMTA member;

➢ Apply to be the Sub-champion under APEC-RHSC to drive capacity building with

regulators and industry from 21 economies and top universities;

➢ Apply to be the Co-chair of the newly established working group for capacity building

under AHWP to engage regulators from 30 economies;

➢ Strive for Regulatory Intelligence thought leadership in Digital Health, UDI,

performance evaluation, etc.;

➢ Monitor WHO guidance documents on Model List of Essential IVDs (EDL),

nomenclature, and priority medical devices (PMD); influence as a GMTA member;

➢ Forge closer ties with local industry association and explore the needs of setting up

new working groups in these markets.

Cluster 2 – Emerging Superpowers (China, India)

Priorities: Trust building; Compliance; Targeted campaign

Key Initiatives:

China

➢ Explore the option of setting up China Representative Office under the new

Foreign NGO law to enable more proactive advocacies;

➢ Influence major new regulations, guidance documents, and standards

(Overseas clinical data acceptance, MAH and domestic agents; overseas GMP

inspection, post-marketing surveillance guidance) by partnering with multi-

stakeholders in China;

➢ Continue to sponsor CIMDR meeting as the co-organizer.

India

➢ Work with other associations to advocate for acceptance of international

standards (FICCI, CII, AdvaMed, AAMI, and MTaI);

➢ E-campaign for CDSCO officials about lessons learned in other countries,

leveraging the regulatory intelligence updates.

Cluster 3 – Other Emerging Markets(Thailand, Vietnam, Malaysia, Philippines, Indonesia, Myanmar,

Cambodia, Laos, Sri Lanka, Bangladesh etc.)

Priorities: In-country visits; Knowledge partner; Capacity building

Key Initiatives:

➢ Continue to bond with policy makers through in-country visits;

➢ Strive for long-term partnership with AMDC to better shape policies; AMDC meetings

and trainings in ASEAN countries;

➢ Keep influencing the drafting and implementation of new regulations particularly

when threatening industry and impeding patient access (i.e. Halal certification issues);

➢ Contribute as a knowledge partner for government agencies by providing regional

benchmarking insights;

➢ Position papers on IVD performance evaluation, shelf life, and Research Use Only

(RUOs) products, grouping, etc.

Thank you! Any questions?

Government Affairs Committee

Government Affairs CommitteeCOMMITTEE NAME: GOVERNMENT AFFAIRS COMMITTEE

Charter • Improve patient ACCESS to medical technologies in Asia Pacific region• Promote INNOVATION in the development health-related policies and

programs in Asia Pacific region • Foster COLLABORATION among industry stakeholders in Asia Pacific region• Serve as a KNOWLEDGE PLATFORM for government affairs and capacity-

building for member companies

Board Sponsor Harvinder Singh (Abbott)

Chair(s)/Vice-Chair(s) Chair: Shakilla Shahjihan (Abbott)

Vice-Chairs: Hitendra Joshi (B. Braun), Lars Jandt (Fresenius),

Rajeev Nandan (Alcon), Marius Van Den Berg (BTG) - Head of Market Access

Working Group

No. of Individual Members 30 individuals across 19 member companies

Working Groups (if any) Market Access Working Group

Meeting frequency Leadership call every two weeks; Committee meeting approximately 1x/month, Last meeting 19 Feb

External partnerships GMTA, ISPOR, AdvaMed, MedTech Europe, Asian Institute of Management, International Alliance of Patient Organizations

2018 Achievements

ISSUES OUTCOMES/ACHIEVEMENTS

INDIA – Price controls and regulations of medical devices as drugs (ACCESS and INNOVATION)

Submitted APACMed position to NITI Aayog on the trade margin control proposals and APACMed position to CDSCO on the devices as drugs regulation; Participation in India-based WHO events to build ties with IN government

MALAYSIA AND INDONESIA – Halal standards/regulations for medical devices (ACCESS and INNOVATION)

Provided multiple position papers/letters to draft halal

standards in MY; Through AMMI, engaged with MY

government officials; Engaged with Eurocham Indonesia,

Jakarta-based ASEAN Secretariat; Monitoring ID halal

draft implementing regulations

VIETNAM - Decree 36 delays and problems +

Centralized tenders + Cybersecurity Law (ACCESS

and INNOVATION)

Following multiple APACMed letters and visits, VN

government via DMEC eventually agreed to again delay

implementation of Decree 36 allowing industry more time

to comply; Monitoring centralized tenders issue;

Submitted APACMed letter opposing data localization rules

under Cybersecurity Law

MARKET ACCESS WORKING GROUP (ACCESS and INNOVATION)

Formed the MAWG under the leadership of Marius Van Den Berg of BTG to focus on market access, reimbursement and pricing issues

2019 Plans

STRATEGIC PRIORITY/ INITIATIVE OUTCOMES/ DELIVERABLES

ACCESS - Market Access Working Group Facilitate and support initial work areas:• HTA process in Japan • Value based technology assessment by NECA in Korea• Price disclosure in Australia• New Office of Health Technology Assessment (OHTA) (MSAC,

PBAC and prosthesis list) in Australia• Moon care in Korea• ISPOR International Initiatives on the Assessment of the Value

of Medical Technologies

INNOVATION - Investment Index Finalize and launch the APACMed Investment Index

ACCESS AND INNOVATION - Thought-leadership in Med Tech Policy

Policy advocacy and preparation of letters and position papers on

various GA issues;

COLLABORATION - Stakeholder

Engagement and Visits Program

• Plan and organize visit to Indonesia post-election

• Participate in critical GA stakeholder meetings

COLLABORATION – GA Knowledge

Platform and Capacity-Building Activities

• Continue to organize webinars, workshops and events on GA

topics following earlier ones on Ayushman Bharat and

Medtech & Trade

Communications Committee

Mission and Role

Mission: Help bring the APACMed mission to life by providing strategic counsel to APACMed Secretariat & Functional Committees on all areas of communication

Role: • Advise APACMed, as an Association, on its Communication

Strategy and formulation of tactical plans• Provide strategic communications guidance to Functional

Committees and Secretariat on specific activities and projects

Board SponsorAnna Maria Braun,

Member of the Management Board, B. Braun Melsungen

Chair/Vice-Chair(s)

Chair: Joanna Ng, Regional Head, Corporate Communications,

Asia Pacific, B.Braun

Vice-Chairs:

- Richard Sumich, Head of Communications & Public Affairs,

Johnson & Johnson

- Jasmine Chng, Corporate Communications Director, Align

Technology

No. of Individual Members 23 members

APACMed Communications Advisory Committee

Future role and involvement for the Communications Advisory Committee

The Communications Committee will provide guidance and feedback to theSecretariat, who will take the lead to develop clear, targeted strategies and plans toachieve APACMed’s overarching communication objectives.

Articulatethe economic and

social contributions of the MedTech industry

Create awareness and understanding of the Medtech industry’s

position on key topic areas

Raise the profile and the reputation of

APACMed

Examples• Thought Leadership• Advocacy Initiatives• MedTech Forum and other events• Issues Management• Support and Amplify Cross-Committee Initiatives

Medical Affairs Committee

Medical & Clinical Affairs Committee Mission and Charter To facilitate therapy awareness and patient access to guideline-directed

medical devices and diagnostics.

Board Sponsor Graham McLean, President Asia Pacific, Stryker

Chair/Vice-Chairs Chair: Makoto Sugita (J&J)Vice-Chairs: Eng Hooi Sian (B Braun)

Hsien-Hsien Lei (Medtronic)

2018 → 2019 potential action plans

➢ Chair changed: Laurent Metz → Makoto Sugita➢ Accomplishment: Registry white paper published➢ Potential activities:

• Implementing registries as our next step: Asia-based registries in collaboration with clinical professional societies

• Collaboration with RA Committee: 1) the use of foreign clinical data (ex. In Philippines for IVD), 2) how to conduct clinical trials using new digital technologies including AI, 3) how to utilize RWE for registrations

• Collaboration with Legal Committee for improving Compliance, Patient Safety, Clinical Trial Data Transparency, etc.

• Conducting webinars on RWE, new statistical approach, etc.➢ We need to have a committee meeting under new members to decide the

direction.

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Asia Pacific Healthcare & Medical Device Outlook 2019

Rhenu Bhuller, Partner & Senior Vice President

Thank you!

Contact details:

Asia Pacific Medical Technology Association (APACMed)

2 Science Park Drive, Ascent Tower A

#02-03, Science Park I

Singapore 118222

Tel: +65 6816 3180

E-mail: info@apacmed.org

URL: www.apacmed.org

Follow us on social media:

@APACMed