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Medical Technology Market Entry in Asia Pacific
- 1. Medical Technology | End-to-End Market Entry | Asia Pacific April 2019 Introducing Access-2-Healthcare
- 2. Medical Device Launch & Market Expansion in Asia-Pac Improved Business Transparency and Infrastructure Someone that actually DO the work, instead of just talking about it! Copyright Access-2-Healthcare 2 Many efforts lead to nowhere Why Access-2-Healthcare was Established ? OPPORTUNITIES CHALLENGES PROBLEMS NEEDS b Great Economic Growth, Relatively Politically Stable Improved Education; Improved English proficiency Distance Long lead time to market Complex Regulations Very Different Market Segments and Pricing strategies Unable to find reliable help Underwhelming sales results Integrated knowledge of In-country market segmentation, Regulations, Intellectual Property, and reimbursement A stable and consistent partner to collaborate and trust
- 3. Copyright Access-2-Healthcare 3 Access-2-Healthcare physically executes end-to-end market entry and product launch activities to help overcome various challenges faced by medical technology companies globally We provide Consulting Solutions o On-the ground execution o Competency development o Long-term Mentorship Who we are and What we do We Share Our Experience with large MNCs and the Medical Device Industry :
- 4. Our Company Profile Copyright Access-2-Healthcare 4 Origins Year founded : 2015 Investment Self-funded Country Physical Entities Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, Australia, Germany, India Organisation 12 Team Members - strategic marketing, quality, regulatory, channel management, due diligence functions Single company ownership for all country entities; not a network Complete coverage of medical technologies Our own team members for a consistent, professional experience No taking of equity from start-ups Unique Value Proposition Access-2-Healthcare in a nutshell :
- 5. Medical Device Manufacturing Product Development Product Life Cycle Management Manufacturing (MFG), Operations, Distribution MFG division transfer, MFG line transfer Process Validation planning and execution Design & Development, Strategic Sourcing Product Life Cycle Management Supplier Management Medical Device Sales, Service, Distribution Regional Executive management 19 countries with local country direct-reporting Regulatory and Quality In-depth market knowledge Turnkey Project Management Greenfield MFG plant commissioning Connected with the senior management of many Regulatory Agencies and Ministries of Health across the globe > 12 years. Represent the Asian Harmonization Working Party (AHWP) Technical Committee WG7 Co-Chairman for the past 7 years, and the ISO TC210 Industry Liaison member. Directly involved in standards development for the medical device industry -drafting committees for ISO13485 quality systems, ISO14971, ISO/TR24971 risk management, ISO/TR20416 post market surveillance Expert application knowledge FDA QSR Parts 820, 803, 806, ISO 9001. Company Ownership Company Establishment, Business Development, Operations Geographical Expansion Government and Trade Relations 1999 2009 2015Current Our Owner’s Profile Liew Ee Bin Copyright Access-2-Healthcare 5
- 6. Our Customer Segments ▪ Medical Device Companies for Market Expansion into Asia Pacific • First time in APAC market – go-to- market strategy, regulatory approvals • Sourcing or switching distributors or contract manufacturers in the region and need due diligence • Hold product license in-country through authorised representation • Improvements to market entry processes such as remediation for quality / regulatory, oversights to operations, warehousing Copyright Access-2-Healthcare 6 Who Looks For Us? ▪ MedTech Spin-off / Start-up Companies for Market Launch through EU and USA • Mentorship of start-up during product development from quality systems, design & development, • engineering prototyping, design-for- manufacturing, production line set-up • technical file building, regulatory approvals, HTA and reimbursement ▪ Convert non-Medical Device Company to Launch MedTech Products • Market segment assessment according to the company’s competencies • Develop MedTech product portfolio • Convert existing manufacturing sites to produce medical device ▪ GPO, Hospital Procurement, Investors with MedTech Sourcing Needs • MedTech feasibility assessment • Help targets with product launch, market expansion or market entry 60% 20% 5% 5%
- 7. Our Clientele and Project Progress Copyright Access-2-Healthcare 7 0 10 20 30 40 50 60 70 80 2015 2016 2017 2018 Completed Projects vs. Validated Leads - Global Completed Projects Qualified Leads at end of Year Smoothen Product Launch Speed Up Market Expansion Reduce Business Risks Improve Margins Provide Expertise, Education Share Industry Knowledge Medical Device companies from the US, EU, Israel, Russia, Asia Pacific – sized from seed funding to 1 billion USD. MedTech start-ups as small as one person! Medical device regional distributors in Singapore Hospitals in South-East Asia for healthcare innovation management Academia (universities, polytechnics, institutes) in Asia Pacific for competency development Assistance to funding agencies, trade associations, government agencies How have we grown so far? > 50 projects completed > 30 currently active in 2019
- 8. Our Ways of Working Copyright Access-2-Healthcare 8 ▪ Neutral, unbiased party ▪ Strong advocate of business compliance ▪ Maintain a zero-level Conflict of Interest policy ▪ Service and Referral fee structure Guide companies to own the process instead of depending on recommendations and introductions Client information is strictly confidential No direct sales for any client product By project milestones, in a clear and transparent pricing model, very flexible payment scheme
- 9. Concept Funding Quality Management Systems Design and Development Ready for Manufacture Going-to- market Regulatory Approvals Finding distribution channels Product reached customers! Product Commercialisation is Hard Work Copyright Access-2-Healthcare 9 Prototype
- 10. Research to Development Mentorship ▪ Design Inputs Guidance ▪ Standards Compliance ▪ Regulatory Strategies Copyright Access-2-Healthcare 10 Improve Tech Licensing Opportunities and Tech Transfer : Key Opinion Leaders Clinical Test-bedding Healthcare Economics MedTech Innovation Research and Development Commercial Targets Hospital Workflow ▪ Clinical Workflow Definition and Improvement ▪ Business Model Development Improved Value Proposition for Fund Raising ‘Al Dente’ Right amount of Technical documentation Sufficient flexibility for foreground IP
- 11. Design and Development to Product Launch Copyright Access-2-Healthcare 11 Specially for MedTech Start-Ups and Companies Diversifying into MedTech : Medical Device Usability gap analysis Provide design recommendations to achieve IEC62366 Usability Test Lab in Korea for Normative and Summative Evaluations Medical Device Usability Identify the relevant standards and regulatory requirements during prototyping Medical Device Standards Design & Development Mentorship Definition and collation of Design Input Design for Manufacturing; Strategic Sourcing Design Output ; Technical File establishment Production Specifications; Design Transfer Line-for-Line Documentation Reviews
- 12. Engineering Prototyping, Usability, Standards Used for ▪ Usability Tests (HFE and IEC62366) ▪ Animal Studies ▪ First-in-Human Trials With Our Medical Device Engineering Partners : ▪ Conceptualisation in partnership with client ▪ Industrial Design experts from Singapore, Japan, US, Thailand - Assess the product attributes according to market suitability. ▪ Medical Device usability and clinical design considerations ▪ Supported by local manufacturing for components; tight tolerances and quality control MedTech Engineering and Advanced Prototyping Copyright Access-2-Healthcare 12
- 13. Help You Establish Your Manufacturing Line Turnkey Manufacturing Solutions ▪ Building and Construction ▪ Factory facility and environmental assessment ▪ Technology Transfer; Strategic Sourcing, Process Development ▪ Equipment Installation; Commissioning ▪ Process Validation; Control Plan ▪ Quality systems and Certification ▪ Hand-over to Client Manufacturing Line for a Service ▪ Process Development ▪ Equipment Installation; Commissioning ▪ Process Validation; Control Plan ▪ Quality systems and Certification ▪ Process equipment maintenance; Servicing ▪ Flat monthly fee; Annual term ▪ Exit within 3 months upon client initiation – Clean and Simple! Provide us the facility and we do the rest! With Our Building, Facility and Engineering Partners : Copyright Access-2-Healthcare 13
- 14. Quality and Risk Management Consulting Help companies establish quality systems from ground up Guide companies to implement Quality Planning, quality resourcing and infrastructure allocation Assess the quality compliance of the company top-to- bottom Work closely with organisations on quality remediation projects Prepare companies to be inspection-ready for your Regulator or your Notified Body Provide bespoke competence development for your company on all quality and risk management topics Copyright Access-2-Healthcare 14 New Company / Start-Up Existing Company Medical Device or Non Medical Device We co-drafted ISO13485 and ISO14971 with the ISO Committee Workgroups We are also good at this: US FDA QSR Personally trained by the co-authors of the GMPs, Preambles, QSITs MDSAP Co-reviewed IMDRF guidelines Attain ISO 13485 / MDSAP certification ISO14971 compliance Pass FDA inspections without findings,
- 15. Develop Your Go-to-Market Strategy Copyright Access-2-Healthcare 15 Market Segment Reimbursement Regulatory Pathway Intellectual Property Clinical Activities Which market should you go to? Help you collect current data + local market data to analyse and properly validate your product’s market segment How do you make that market successful? Perform product-specific market studies performed by our in-country team members - Gain real local market insights Include Key-Opinion-Leader (KOL) Sourcing : This 2-step process reduces the risk of unnecessary and excessive costs – you save $$$
- 16. Regulatory - Which Countries Do We Cover? Market Product Registration License Holding / Authorised Representative Licensed Warehouse Post Market Surveillance EU CE Marking, Clinical Evaluation, Notified Body Sourcing EU AR (Germany) USA US FDA 510k, PMA, De Novo, Exemptions US Agent Australia ARTG listing, full conformity assessment pathway Sponsor Singapore Full, Abridged, Expedited pathways Registrant Partner Warehouse Malaysia Full, Expedited pathways GDPMD certified AR Thailand Licensed, Notified, General medical device Licensed Importer Indonesia All medical device classes IPAK (active, non active) Philippines New Regulations CMDR. CMDN License-to-Operate (LTO) Vietnam Import Licensing, all medical device classes Licensed importer India AERB, PNDT, Product Registration, Labeling Authorised Representative Copyright Access-2-Healthcare 16 Including Reimbursement When Applicable :
- 17. In-Country Authorised Representation ▪ Access-2-Healthcare geographical footprint are legally able to maintain your product / import license. ▪ We have physical warehouses, and resources for product importation to the country Distributor A Access-2- Healthcare Foreign Manufacturer Distributor B License holder Distributor A Foreign Manufacturer Distributor BLicense holder Copyright Access-2-Healthcare 17 Single Point-of-Contact; Same Quality of Service ▪ High-value products, capital equipment that ships direct to the medical facilities ▪ Large or distributed geographies, and needing multiple channels to grow ▪ Regulatory framework only allows single authorised representative / importer ▪ Software-only medical devices Most suited for: Standard Distributor Model License Holding : De-risking
- 18. Potential candidates Business Partner (Distributor, Manufacturer) Shortlisting Off-site background check Off-site and On- site audit Risk assessment and mitigation Due Diligence Complete Business Due Diligence Copyright Access-2-Healthcare 18 Access-2-Healthcare’s Scope for Business Due Diligence Minimise Your Business Risks and ‘Restart Costs' Client’s Scope Business Relations & Network Pricing & Margins
- 19. Post Launch In-Country Management Post Market Surveillance Support • Management Product Traceability by Distributors • Regulatory reporting to Competent Authorities Operations Hub • Product Delivery • Supplier Controls Regulatory Hub • Collate regulatory requirements in various countries • Audit documentation for accuracy • Supply to distributors • Manage and follow up till approval • Up-to-date in-country regulatory updates Copyright Access-2-Healthcare 19 Be Your Eyes, Ears and Legs in the Region : We collaborate together to assess the Return of Investment with you Enhance Your Regional Presence
- 20. Concept Funding Quality Management Systems Design and Development Ready for Manufacture Going-to- market Regulatory Approvals Finding distribution channels Product reached customers! Present in Every Step of Product Commercialisation Copyright Access-2-Healthcare 20 Prototype Comprehensive Range of Solutions : - Establishment - Training - Assessment - Remediation Clinical workflow definition and improvement Business Model Development Consulting and mentorship on Design and Development Advanced Prototyping via Strategic Partners Mentorship / Consulting Outsourced Software Testing Business Due Diligence Regulatory strategy In country execution Trade Compliance Market segment analysis Local Market Study Business Due Diligence In country Business Partner management In country Business Partner management License holding Post Market Surveillance Manufacturing Line as a Service
- 21. what to do, which segment; areas to leverage company’s competency and resources health/wellbeing and MedTech; to create streamlined and sustainable product portfolio for the right existing platforms, applications, tools, devices for the potential gaps in the solutions Provide technical guidance on the product development team to create the right product for the right market segment Market Definition and Technology Scouting Product Development Sharpen Your Market Senses Clarify and Develop Your Product Category Strategy Help You Select for the ‘Right Tech” Develop your Design Inputs Strengthen Company’s Unique Selling Point Market Distribution Bespoke Consulting On-site and Best-in-Class Support : MedTech Regulatory Pathway Clinical Evaluation MedTech Certifications Health / Wellness Help Create Your Healthcare Division Copyright Access-2-Healthcare 21
- 22. Copyright Access-2-Healthcare 22 COUNTRY X – UAT – SIT – DOCUMENTATION(MANUAL) Secure Server (Germany) Gateway En/decrypt Gateway HAMBURG – INPUT FROM CLIENT – UNIT TEST/CODEREVIEW – DOCUMENTATION VERIFICATION PC PC INPUT PC SCAN USB USB Gateway VALIDATION PC CLIENTS INTERNET SRS SDDS CODE Legend: SRS = Software RequirementsSpecification SDDS = Software DetailedDesign Specification UAT = User Acceptance Test SIT = System IntegrationTesting Outsource Your Software Testing Software as a Medical Device| Mobile Apps For Medical Purposes | Embedded Software ▪ Access-2-Healthcare provides outsourced software validation and verification services for medical technology companies ▪ Ease the pain of medical technology companies in resourcing for software testing ▪ Ensure companies can 100% fulfil all requirements for Software Validation & Verification in the medical device industry Quicken the launch of your product to market Significantly reduce challenges during regulatory approvals Improves product safety for the end users
- 23. Regulatory Framework Development Copyright Access-2-Healthcare 23 We Have Helped Develop Asia’s Regulations : Train Medical technology, standards, regulatory review criteria WriteGuidance documents for the authority and industry Execute Processes and operations within the regulatory authority MonitorKey process indicators for management ▪ We Work On-Site Training and consulting sessions for regulators, anywhere in the world ▪ No Cookie-Cutting Writing guidance documents the way to meet your country’s needs ▪ Practical Guidance, Advice on Agency Operations Processing pre-market assessment, post market surveillance, and regulatory control of distributors, service providers and manufacturers to protect public health Trained by ex-Regulators and MedTech Experts
- 24. Access-2-Healthcare Around the World Copyright Access-2-Healthcare 24 REGION CITY, COUNTRY COMPANY NAME YEAR ESTABLISHED BUSINESS ACTIVITIES MARKET ENTRY PRODUCT LAUNCH SOUTH EAST ASIA Singapore Access-2-Healthcare (HQ) 2015 Bangkok, Thailand Access-2-Healthcare Thailand Co. Ltd 2016 Jakarta, Indonesia PT Akses Kesehatan Indonesia 2016 Capiz, Philippines Access-2-Healthcare Services 2017 Selangor, Malaysia Access 2 Healthcare Sdn Bhd 2017 HCMC, Vietnam Access-2-Healthcare Vietnam CO Ltd 2018 EUROPE Hamburg, Germany Access-2-Healthcare uG (EU AR) 2017 AUSTRALIA / NEW ZEALAND Melbourne, Australia Access-2-Healthcare Australia Pty Ltd 2017 ASIA Mumbai, India Access-2-Healthcare India Pty Ltd 2019 Global Coverage and Business Scope :
- 25. Copyright Access-2-Healthcare 25 Contact: helpme@access2hc.com