Come meet the medical device experts from asia pacific
US EVENT POSTPONED:
Please be advised that the event in California, USA has been postponed.
If you would like to be notified when new dates are announced please register here
EU Event Postponed:
Please be advised that the event in Brussels, Belgium has been postponed.
If you have interest in attending a future EU event please contact us for more information.
COME MEET THE MEDICAL DEVICE EXPERTS FROM ASIA PACIFIC.
The Asia Pacific Device Summit is the world’s premier medical device conference for companies wishing to successfully launch products and magnify their impact in the Asia Pacific region.
The 2020 edition of the event attracts the industry's leading experts and authorities in Asia Pacific medical devices, research and regulatory affairs to discuss and debate the unique trends and challenges of our exciting, fast-paced industry.
BROUGHT TO YOU BY:
Successfully register medical devices in the Asia Pacific region
Optimise your revenue
Manage product distribution more efficiently
Get expert insight to inform your strategy
Gain a strong understanding of the reimbursement opportunities
Learn from experts in the field
Get best-practice tools and advice for ensuring a powerful launch
Market your products and brands effectively
Enhance regional operations
Amplify your local influence, strategic direction and cultural fit
Gain exclusive, insider information and insight into country-specific markets
In particular, the complex Chinese market
Explore ground-breaking industry research
Access the latest scientific knowledge to give your business a leg up
Share experiences, ideas and challenges
Network with regional decision makers and thought leaders
Discuss and debate the major issues in APAC
Stay ahead of the competition and keep up-to-date with industry trends and challenges
Connect with local experts from throughout the Asia Pacific
Explore business partnering opportunities for decision makers and investors
Understand the implications of the EU-MDR within the Asia Pacific marketplace
Find out how new developments impact your organisation
Learn about drug registrations in the rigorous Australia and New Zealand markets
Ensure compliance across the region
Set your company up for a healthy, long-term operation
Get the essential tools, tips and advice you need to succeed in the Asia Pacific market
USA Agenda
8:00 |
Breakfast and registration |
9:00-9:15 |
Introduction and Welcome Grant Bennett, Brandwood CKC |
9:15-10:00 |
Taking your 510(k) Down Under - Australia's Reliance model of regulation. Australia has developed a reliance model of regulation which leverages international reviews and is strong on international harmonisation. Explore TGA's streamlined Australian registration pathway for devices and IVDs already approved in US, Europe, Japan or Canada and requirements in key areas including software, UDI, clinical evidence and postmarket reporting. Terrance (T.J.) Thiel, Brandwood CKC |
10:00-10:45 |
China - managing the complexity China's NMPA continues frequent and incremental updates to regulations and practice. Clinical data remain at the forefront of regulatory review, with clinical trials mandated unless formally exempted, and a very cautious opening of the door to international clinical trial data. China is following Europe's lead on postmarket reporting and placing strict requirements on local representatives for active monitoring of postmarket feedback. We take a look at the latest developments in the Middle Kingdom and why strategy with flexibility is key to success. Jenny Lin, Brandwood CKC |
10:45-11:15 |
Morning Tea |
11:15-12:30 |
Secrets to Successful Medical Device Commercialisation in Australia Understand what makes Australia an attractive market for medical devices, gain insights into some of the key considerations for market entry and how to optimise your Australian market entry strategy for success. Kirsty Amland, Meta Medtech |
12:30-1:15 |
Considerations for Regulatory and Commercialisation Requirements in Asia Pacific: An IOL Case Study Japan's hybrid model combines detailed PMDA review of high risk devices with third party assessment of medium risk Class II devices. This presentation looks at the practical requirements for Japanese approvals. Randall May, Randall May & Associates, Inc. |
1:15-2:15 |
Lunch |
2:15-2.35 |
New Zealand rewrites the book on devices regulation New Zealand is undertaking a root and branch reform of regulation with a complete rewrite of the 1981 Medicines Act. The new legislation introduces completely new devices regulations, which accept international reviews and toughens up postmarket requirements. Terrance (T.J.) Thiel, Brandwood CKC |
2:35-3:00 |
Conducting clinical investigations in China China's formidable health care infrastructure provides many opportunities for clinical studies, but understanding the processes and local practices are essential to success. Danielle Giroud, MD Clinicals |
3:00-3:15 |
Afternoon Tea |
3:15-4:00 |
Update on ASEAN countries requirements ASEAN continues a steady expansion of the ASEAN Medical Devices Directive, with early implementation in Singapore and Malaysia now being followed by new regulations in Indonesia, Thailand and others. We look at the current progress. Brandwood CKC |
4:00-5:00 |
Nixon Library Tour: take some time to have a look around the library after a busy first day. |
5:00 - 7:00 |
Networking and Cocktails |
8:30-9:00 |
Breakfast and partner introductions Paul Smith - SBA Maryavis Bokal - Department of Commerce |
9:00-9:45 |
Be euristic, engage in globalisation of clinical data – success stories Danielle Giroud, MD Clinicals |
9:45-10:30 |
Unlock the New Opportunities in India in 2020 India's economy is now larger than France and the United Kingdom and it has launched the world's most ambitious health insurance program covering 500 million citizens. At the same new the new medical device rules will cover ALL medical devices starting April 1, 2020. How can foreign companies thrive in this turbulent market growing at over 15 percent per year? Gunjan Bagla, a seasoned India hand, leads Amritt's India medical device practice and will share a practical overview of medical device registration in India as well as his company's tips on how to succeed in India. This is an interactive session with plenty of time for your questions. Gunjan Bagla, Amritt Inc |
10:30-11:00 |
Morning Tea |
11:00-11:45 |
Australian clinical research sector update Australia has sophisticated heath care sytems and a well defined and light touch regulation of clinical trials which make it an ideal venue for early stage studies of advanced therapies. This presentation will describe the current regulatory frameworks including TGA's pilot of clinical trial audits. Stefan Czyniewski, Mobius Medical |
11:45-12:30 |
Taiwan - a predictable pathway? Taiwan's new Medical Devices Act remains stalled in parliamentary review. Meanwhile Taiwan FDA operates a unique process - driven, regulatory pathway with separate considerations of Quality Certification and product registration. It's not fast but advance planning and understanding how all the parts fit together can deliver predictable outcomes. Jenny Lin, Brandwood CKC |
12:30-1:00 |
Lunch |
1:00-1:45 |
Australian Reimbursement - Prosthesis Listing, Pricing and Evidence Australia's unique reimbursement model for implantable devices continues to be in the spotlight, with continuing reforms on pricing and scope. We look at the early steps in extension of the scheme to non-implants and the evidence required for the all important Prosthesis Listing. Sarah Griffin, Medtechnique Consulting |
1:45-2:30 |
Combination devices - medical devices incorporating medicines Brandwood CKC |
2:30-3:00 |
Afternoon tea |
3:30-4:15 |
Keynote: Global medical device regulations With so many jurisdictions each having local requirements and different cultures and practices, clear process and planning are essential to manage a global compliance portfolio. This session describes how to develop a global strategy with regulation as a key input, and how to pull it all together from half a world away. Grant Bennett, Brandwood CKC |
4:15-5:00 |
Panel discussion |
Hear from the Experts
Grant Bennett
CEO. Brandwood CKC
Grant Bennett
CEO. Brandwood CKC.
Grant joined Brandwood CKC in the later part of 2013, bringing with him experience with both the Therapeutics Goods Administration (TGA), along with a multitude of other regulatory authorities throughout Asia. Grant’s prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US headquartered multinational supplier of Professional Medical Devices.
Grant serves the wider industry through active participation in industry associations and harmonisation bodies. He is a member of both the Regulatory Affairs Expert Panel and the National Advisory Council for AusMedtech. Grant also contributes to the regulatory guidance development of the Asian Harmonisation Working Party (AHWP).
Grant has specialised expertise in requirements for Universal Device Identifiers (UDI) and direct experience in compliance with requirements of the Australian National Product Catalogue (NPC) controlled by the Australian National E-Health Transition Authority and the corresponding DHB National Catalogue for Healthcare in New Zealand.
Prior to joining the Medtech industry, Grant had extensive prior experience in accountancy, commercial software and project management. Grant’s earlier roles included support of existing clients with the implementation of their MRP systems, as well as developing process flows and detailed financial analysis/reporting, allowing businesses to better understand their business. He was also involved in the development of sales and marketing material for potential clients.
Kirsty Amland
Principal, Meta Medtech Consulting
Kirsty Amland
Principal, Meta Medtech Consulting
Kirsty has over 20 years of experience in senior commercial roles within the medical technology sector in Australia, in both multinational and start-up companies. Over the course of her career Kirsty has successfully launched many innovative medtech products that have shaped medical specialties in Australia by driving procedural change and market adoption of new technology.
Kirsty is known for her strategic insight, commercial acumen and product launch expertise. Combining these strengths with her deep market knowledge and experience, has resulted in her strong track record of developing and executing on targeted strategies that deliver on financial and strategic goals.
She holds an MBA from the Australian Graduate School of Management and a Bachelor of Science (Hons) in International Business from St. Louis University, USA.
Jenny Lin
Regulatory Consultant, Brandwood CKC
Jenny Lin
Regulatory Consultant, Brandwood CKC
With over 5 years of research experience on molecular biology, microbiology, immunology and biomedical engineering in both academic and clinical setting, Jenny joined the Brandwood CKC team in 2016 with her extensive knowledge in medical science. Her prior role as a patent engineer at an intellectual property law firm also brings in hands-on experience in relevant sectors within the healthcare industry.
Jenny has achieved significant regulatory approvals for medical devices and in vitro diagnostics in multiple markets, including Australia, New Zealand, China, Taiwan and other Asian Pacific countries. She also has first-hand experience in project management throughout product development phases and registration cycle, e.g., provision of regulatory strategy, development of technical files, coordination of lab testing, regulatory and importation support for clinical trial, on-site consultation with regulators, and postmarket compliance. As a bilingual consultant (English and Chinese), Jenny also supports direct communications between clients and their subcontractors in the greater region of Asia countries for quality compliance.
Terrance (TJ) Thiel
Consulting Operations Manager / Principal Consultant, Brandwood CKC
Terrance (TJ) Thiel
Consulting Operations Manager / Principal Consultant, Brandwood CKC.
Terrance has over 20 years of experience in the medical technology field in industry and academia. He has lived and worked in the United States and Australia. He offers a global framework for regulatory requirements from experience in regulatory affairs, compliance and advocacy.
He has provided discussions and regulatory training with academia and industry to provide better understanding on the ever-changing regulatory landscape.
Terrance has acted as a SME for numerous quality system regulations and ISO standards, including ISO 13485 (Medical Device Quality Systems), ISO 9001 (Quality Systems), ISO 14971 (Risk Management), ISO 14155 (Medical Device Clinical Trials) and IEC 62366 (Medical Device Human Factors Engineering). He has also provided due diligence activities for company acquisitions regarding target’s business viability, quality system status and regulatory position. Terrance also maintains a current Regulatory Affairs Certification through the Regulatory Affairs Professional Society (RAPS).
Luis Jimenez
Vice President of Business Development. Brandwood CKC
Luis Jimenez
Vice President of Business Development. Brandwood CKC.
Luis Jimenez serves as the Vice President of Business Development for Brandwood CKC. His experience includes operations, quality control in cGMP manufacturing, regulatory affairs for manufacturing, design engineering, technology transfer and project management within a start-up and large corporations such as Johnson & Johnson and Express Scripts. Luis’s background includes Chemical Engineering, Cum Laude with focuses on Computer Science and Economics, and an MBA with Academic Excellence. His trajectory in diverse health-related companies and experience building a class III medical device bio-tech company from the bottom-up provides him with hands-on experience in solving the challenges of navigating regulatory approvals. Luis is passionate about entrepreneurship and regulatory and serves as the 2020 President for the Orange County Regulatory Affairs Group (OCRA).
Sarah Griffin
Director, Medtechnique Consulting
Sarah Griffin
Director, Medtechnique Consulting
Sarah has more than 25 years experience in the medical technology sector including health economics, health insurance, health policy and legislation, medical finance and reimbursement systems and government relations. Sarah’s strengths lie in her strategic approach to market access and the creation of effective reimbursement and health economic strategies. She is a registered lobbyist and an expert in preparing complex reimbursement submissions. She has assisted many medical technology companies to gain market access for innovative technologies.
She has filled senior and international roles with St Jude Medical, MBF and Mercy Health Services in the United States. Sarah received her B.App Sc (Physio) from the University of Sydney and a GradDip in Health Economics and Policy from Monash University. She is currently a member of the Medical Technology of Australia’s Reimbursement Sub-Committee and a member of the AusBiotech Health Economics Expert Panel.
Danielle Giroud
Founder, CEO. MD-Clinicals
Danielle Giroud
Founder, WMDO & MD-Clinicals.
With over 30 years of experience, Ms. Giroud is founder of the World Medical Device Organization, an independent professional organization dedicated, to serving the professional development and educational needs of medical device professionals. Since 2013, Mrs Giroud also founded MD-CLINICALS, a 100% medical device dedicated full service CRO with main activities in the Asia Pacific region and Europe. Mrs Giroud is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) task force.
Stefan Czyniewski
Principal & Clinical Director, Mobius Medical
Stefan Czyniewski
Principal & Clinical Director, Mobius Medical
Stefan is a founding member of Mobius Medical graduating from the University of Sydney in 2000. Stefan joined a small private orthopedic practice as a research assistant focusing on partial hip and knee replacement prosthetics, autologous chondrocyte implantation and metal toxicity studies associated with orthopedic implants. In 2003 Stefan joined the clinical team a Laboratoires Fournier as a Clinical Research Associate and Data Manager based at the National Health and Medical Research Council (NHMRC) Clinical Trial Center. During this time Stefan worked on a large multi-center international Phase III pharmaceutical study, the FIELD study. In 2006 Stefan moved into medical device trials at Ventracor assisting the company in obtaining CE Mark for their Left Ventricular Assist Device the Ventrasist. Stefan was promoted to Clinical Affairs Manager in 2008 and left Ventracor in 2009 to team up with other medical device experts to create Mobius Medical.
As a co-founder and Principal at Mobius Medical Stefan has a passion for clinical trials developing a core understanding of numerous therapeutic areas. Stefan’s key focus is on business development, liaising with clients, clinical strategy, clinical study design, clinical operations and data management of medical device and pharmaceutical clinical trials. Stefan is currently completing a MBA at The University of Sydney and in his spare time enjoys skiing and diving.
Paul I. Smith
Economic Development Specialist & District International Trade Officer, US Small Business Administration
Paul I. Smith
Economic Development Specialist & District International Trade Officer, US Small Business Administration
Paul Smith is an accomplished professional with twenty-five years experience in business development. His career encompasses both the private and public sectors. His experience includes sales management, direct marketing, export promotion, and matchmaking, for markets worldwide. As an Economic Development Specialist and District International Trade Officer for the U.S. Small Business Administration, Mr. Smith is responsible for outreach to the business community for the Santa Ana District office. His expertise focuses on International Relations, High Tech industries & Native American outreach. He works closely with private industries, trade associations, state / federal Agencies and local chambers to promote international trade.
Randall May
Randall May & Associates, Inc.
Randall May
Randall May & Associates, Inc.
Randall May has been providing consulting services to the medical device industry for more than 25 years. He is currently President and Principal Consultant at Randall May & Associates, Inc., a consulting firm established with the goal of supporting medical device companies achieve regulatory compliance with strategic regulatory and quality system consulting services directed toward both US and international product registrations.
Client companies represent many major medical specialties, including urology, cardiology, general surgery, dental and ophthalmology.
After serving honorably in the United States Marine Corps, Randall received his education in Business and Mathematics from California Community Colleges and was educated as a Mechanical Engineer with an emphasis on fluid-thermal system from California State Polytechnic University at Pomona. Randall is an ISO 13485:2016 Lead Auditor
Randall is active in US politics and calls Yorba Linda, California home.
Gunjan Bagla
CEO, Amritt Inc
Gunjan Bagla
CEO, Amritt Inc
Gunjan Bagla is CEO of Amritt Inc which specializes in the medical device market in India. Gunjan’s team in India conducts market research with Indian physicians and hospitals, finds and selects distribution partners in India, manages the registration and regulatory processes in India for its global clients. Amritt clients include BD (Becton Dickinson), Cardiovascular Systems, Covidien/Medtronic, Hollister, J&J, Roche Diagnostics, Sawbones and many more.
Gunjan writes about the Indian medical ecosystem for Medical Device Online. He is known for his 5-star rated book, “Doing Business in 21st Century India”, published by Hachette and for his articles about India in the Harvard Business Review. He has an MBA with honors from Southern Illinois University and a Mechanical Engineering degree from the Indian Institute of Technology Kanpur. Gunjan lives in Malibu, California and can be reached at https://www.linkedin.com/in/gunjan/ or https://amritt.com/industries/medical-device-india/
The Asia Pacific Device Summit is for anyone wishing to:
Whether you’re looking for additional support for your operations in the Asia Pacific marketplace or are seeking an introduction to local medical device registration, the 2020 Asia Pacific Device Summit is an essential event for your organisation.
The event will provide you with an unrivalled opportunity to explore and evaluate how your organisation can plan, implement and obtain successful product registration in the Asia Pacific region.
USA Location
The Nixon Library
18001 Yorba Linda Boulevard
Yorba Linda, California 92886
Register your interest.
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