Access 2-healthcare company introduction deck - english - may 2018

Medical Technology. End-to-End Market Entry. Asia Pacific.
May 2018
Introducing
Access-2-Healthcare

Access-2-Healthcare in a Nutshell
Access-2-Healthcare provides end-to-end consulting support for medical technology
companies and start-ups to gain market entry in various countries, especially in Asia Pacific
We execute the work and provide competency development on:
 Go-to-market strategy, and local market study
 In-country regulatory approvals, quality systems & trade compliance consulting
 Business due diligence to qualify business partners such as distributors, manufacturers,
service providers, and locally manage these business partners on your behalf
Copyright Access-2-Healthcare 2

Who Looks For Us? – Our Customer Segments
 Medical Device Companies for market
expansion into Asia Pacific
 Medtech Spin-off / Start-up companies
for market launch through EU and USA
 Improvements to the processes for
market entry
• Remediation for quality / regulatory
• Switching distributors, contract
manufacturers
• Mentorship of start-up during product
development

What we are not…
We are not a network of partnerships
We are not a distributor
We don’t do sales at all
We don’t recommend distributors or manufacturers
We don’t provide customer leads

What we are…
 Single point of
contact
 Multi country, multi
function consulting
company
 Integrated
services, end-to-
end market entry
Provide Knowledge,
Ability to Discern
Trust Deliver
New market segments
Gain market share
Maintain market share
 Faster, smoother
market entry,
market launch
 Resolve
problems
existing in Asia
Pacific markets

Our Company Profile
PRODUCT EXPERTISE
All categories of medical devices, including large
diagnostic imaging, sterile/single use devices, invitro
diagnostics, homecare, implants, combination device
with drug, software-based medical devices
FUNCTIONAL EXPERTISE
Strategic market analyses, in-country regulatory
approvals including CE marking, FDA approvals,
quality compliance, logistics, due diligence to qualify
business partners
COMPANY Access-2-Healthcare
FOUNDED 2015
OWNER Ee Bin LIEW
CAPITAL Self-funded
TEAM SIZE 12 members in 8
countries

Our Owner Profile
Ee Bin Liew
• Entire career in the medical device industry with large multi-national companies going from product development to
manufacturing, operations, and product commercialization in different countries, including regional executive
management and leadership roles of multi-cultural teams and organizations, up to 19 countries within Asia Pacific
• One of few individuals in the world to have the practical experience in various medical device environments and
functions (R&D, production, operations, commercial) in Medical Devices.
• Global leadership in regulatory harmonization efforts, worked closely with high level management in many
Regulatory Agencies across the globe > 12 years.
• Currently volunteering and representing the Asian Harmonization Working Party (AHWP) as the Technical
Committee WG7 Co-Chairman for the past 7 years, and the ISO TC210 Industry Liaison member.
• Many years of experience in the FDA QSR Parts 820, 803, 806, ISO 9001, and is way ahead in the forefront of the
key Standards development for the medical device industry, working directly in the drafting committees of ISO
TC210, WG1, Joint ISO/TC 210-IEC/SC 62A, and WG6 for ISO13485, ISO14971, ISO/TR24971 and ISO/TR20416
– one of the few in the world with this combination of expertise.
• Attained the Singapore Professional Certification in Management Consultancy (PMC No. 10815) in 2017.

Our Physical Entities - Global Coverage
REGION CITY, COUNTRY COMPANY NAME YEAR
ESTABLISHED
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

Why Access-2-Healthcare?
It is for you, and for me
Every time we go to the hospital or the clinic,
the top 50 medical technology and
pharmaceutical companies dominate our
quality of care and pricing.
If we don’t help the smaller players who are
trying out new technology or new business
models, our healthcare cost is never going to
change
We lend our immense expertise and
resources to give the small/medium sized
medical technology companies a chance
… and to give you and I a chance
Our Vision
Enable access to healthcare globally,
and contribute to lowering overall
healthcare cost
Our Mission
Help medical technology partners gain
market entry to provide people
with safe, effective and affordable
healthcare around the world

Unique Value Proposition
One company
with one
owner
Swift, confident
decision
making
Same company
ownership for
all countries
100%
commitment
and dedication
to executing
the project
Complete
coverage of
medical device
technologies,
even the most
innovative of
devices
Local experts
in-country
complete
knowledge of
market,
regulatory,
trade
compliance
No taking of
equity, shares
or revenue
Service fees by
milestones for
a clear and
transparent
business model

Concept Funding Prototype
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

Concept
Clinical workflow definition
and improvement
Business Model Development
Funding Prototype
Consulting and
mentorship on
prototyping
Advanced Prototyping
via Strategic Partners
Quality
Management
Systems
Design and
Development
Mentorship / Consulting
Outsourced Software Testing
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Research–to–Development Consulting

Research–to–Development Consulting
 Improve value proposition to source for funding
 Clinical workflow definition and improvement
 Business Model Development
 Consulting and mentorship on advanced prototyping
 Industrial Design - Assess the product attributes
according to market suitability.
 Usability – Early adoption of IEC62366, HFE. Perform
gap analysis for product usability testing,
 Standards - Identify the relevant standards and
regulatory requirements during prototyping
 Design and development mentorship
 Definition and collation of design input
 Design control processes
 Design Transfer / Design for Manufacturing

Partnerships – Advanced Prototyping,
Usability
Manufacturing Consortiums
(Super Factories) - Sumida, Minato,
Taisho Prefectures
Advanced prototyping
Advanced prototyping
Usability test lab
Rangsit University
Incheon
National
University
 Advanced Prototyping, used for
 Usability Tests (HFE and IEC62366)
 Animal Trials
 First-in-Human Trials
 Usability Test Lab
 Normative and Summative Evaluations

Outsource Your Software Testing
 Access-2-Healthcare provides outsourced
software validation and verification services
for medical technology companies
• All Software as a Medical Device (SaMD),
including mobile applications for medical
purposes
• All embedded software within medical devices
• Enterprise Resource Planning (ERP) systems
 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

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
Software
Testing
Process
All of our expert
software testers
communicates through
the encrypted gateway
and are DISconnected
from the Internet.

Quality
Management
Systems
- Establishment
- Training
- Assessment
- Remediation
Design and
Development
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Quality Consulting
We are part of the drafting committee in ISO for ISO13485 and
ISO14971 Standards, practical experience in medical
technology manufacturing and commercial environments.
How more expert can you get?

Quality Consulting
Help organisations
establish quality
systems from
scratch
Assess the quality
compliance of the
organisation
Work closely with
organisations on quality
remediation projects
Help organisations to be
inspection-ready for your
Regulator or your Notified Body
Provide bespoke
competence
development for your
organisation on all
quality topics
Guide organisations on
how to implement
Quality Planning,
establishing quality
resourcing and
infrastructure allocation

Quality
Management
Systems
Design and
Development
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Market segment analysis
Local Market Study
Go-to-Market Strategy
Market Validation

We interconnect the 5 Key Elements of a Go-to-
Market Strategy
Market
Segment
Reimbursement Regulatory
Pathway
Intellectual
Property
Clinical
Activities
Which market should you go to?
• Analysis of current data combined
with local market data to identify and
properly validate your product’s
market segment
How do you make that market
successful?
• Specific market studies performed
by local team members just for you.
Gain real local market insights. The 2-
step process reduces risk of
unnecessary and excessive costs –
you save money $$$

Quality
Management
Systems
Design and
Development
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Regulatory strategy
In country execution
Trade compliance consulting
Finding
distribution
channels
Product
reached
customers!
License holdingPost Market Surveillance
outsourcing
Regulatory Consulting
We are at the management level of the AHWP, engage with
the IMDRF, well at the forefront of global regulatory
developments. Our in-country RA teams have the hands-on
experience to get your product approved smoothly

Our Regulatory Services
Develop Regulatory
strategy for various
countries
Technical File audit /
DHF audit
Remediation
Compile technical file
/ dossiers for
submission for
various countries
Translate technical
documentation to
local language
Submission of
technical file online
or in-person to local
regulatory authority
File Product change
notifications
Manage input
requests from
until final approval
Holding and renewal
of local license
Adverse Event
Reporting / Product
Recall Management
Trade compliance
consulting

Document
Preparation
Screen the
technical dossier
submission is as
clean as it gets,
for a smooth
approval.
The Design
History File and
other
deliverables are
thoroughly
checked prior to
submission
Pre-
Submission
Some country
regulations
require local
product testing,
or local clinical
trials, or foreign
factory pre-
qualification.
Manage all these
time-consuming
activities
smoothly and
locally
Submission
•Compile your
technical file to be
submitted online or
our in-person to local
•Translated to local
language if necessary
•Double-audited prior
to the ‘Submit’
button
Post-
Submission
Respond to input
requests from the
Prepare additional
documents as
requested by the
authority
Manage the timelines
till license approval
License
Approval
•Renewal of
license if required
•Manage product
and license
changes as part of
lifecycle
management
Post-
Market
Compliance
•Manage the post
market
surveillance
communication
with regulators
•Adverse event
reporting
•Product recall
management
How We Process your Regulatory Approvals
Turnkey pricing

Which Countries Do We Cover?
Market Product Registration License Holding /
Authorised Representative
Licensed
Warehouse
Post Market
Surveillance
EU CE Marking, Clinical Evaluations EU AR (Germany) 
USA US FDA 510k, PMA, De Novo US Agent 
Australia ARTG listing, full conformity
assessment pathway
Sponsor 
Singapore Full, Abridged, Expedited
pathways
Registrant 
Malaysia Full, Expedited pathways GDPMD certified AR  
Thailand Licensed, Notified, General device Licensed Importer  
Indonesia All device classes IPAK (active, non active)  
Philippines Registerable Devices, filing of
Notification of Exemption
LTO  
Vietnam All device classes Licensed importer  

Legal Entities - One Company, One Trusted
Brand
 Access-2-Healthcare physically owns business entities that are legally able to maintain
your product / import license.
 We have physical warehouses, and resources for product importation to the country
 One single company ownership for all entities – single point of contact, same quality of
service
Distributor
A
Access-2-
Healthcare
Foreign
Manufacturer
Distributor
B
License holder
Distributor
A
Foreign
Manufacturer
Distributor
BLicense holder

License Holding - Key Value Proposition for
SMEs
1. Separate and de-couple legal from business responsibilities
2. Importation continues regardless of business status - not impact end-
customer, protect market share and access to healthcare
3. Better performance management of business partners
4. Able to concentrate on finding more sales/marketing talent to
maximise market coverage
5. Very flexible financing schemes and operational arrangements to
ease the market entry investment

Post Market Surveillance Support - Key Value
Proposition for SMEs
1. Remove regulatory burden from both distributor and manufacturer
• Error-free reportability decision making
• Accurate form filling
• Expert Advisory Notices, product recalls management eases legal and
regulatory stress
2. No unnecessary disruption of business by regulatory authorities
3. Ensure successful inspection results by regulatory authority

Surrogate your QA RA Function
Can’t find good resources? Why not use the best!
Access-2-Healthcare can ‘become’ your QA RA function for a period of time, and even train your staff
Improve your Global RA QA function
 Strategic planning and resourcing for medtech
companies at HQ level, follow through till
implementation.
 Improve any kinks (if any) in the regulatory/supply chain
handshake in terms of master data, labeling, shipping
documents and regulatory certificates.
 Training of key QA RA knowledge, including new hires
Strategic Planning, Execution of QA RA in Asia Pacific
 Provide up-to-date regulatory requirements and updates, as they are
gathered locally, and from our long-standing network with the regulatory
authorities. Accuracy in interpretation.
 Contact and communicate with Asia Pacific distributors on the current
license and licensing status
 Consider the license holding model that we provide for countries that
are large or geographically spread out or have high volume sales, to
separate the business and regulatory/legal risks.

Here’s how it works
Medical Device company that runs on a distributor model for more than 100 countries, suddenly lost their only
RA staff, due to scarcity of talent around the HQ. We help to ‘become’ the HQ RA for 6-9 months to establish
transparent processes to the licensing process and status downstream, as well as the handhold with other
functions, and ‘buys some time’ for the company to source for RA talent, provide training and get up to speed.
Case Study 1
Medical Device startup had reached a stage in the product development and company maturity to establish a
quality system, but they have no resources or time for implementation, thus we help to provide guidance and
direction, as well as some ground level work to represent the QA RA function until the startup had gained some
traction commercially and ready to hire. We also help to train the incoming QA RA and provide an efficient
handover.
Case Study 2
Regional distributor was having challenges in regulatory approvals in Asia Pacific and have had issues with
communicating with the prinicipals (manufacturers). Provided guidance, training, and establish strategy on
improving communication with principles and gain complete clarity of regulatory approval progress in the
country, thus improving the time to market.
Case Study 3

Quality
Management
Systems
Design and
Development
Ready for
Manufacture
Business Due Diligence
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Business Due Diligence and Local Partner
Management
In country Business
Partner management
In country Business
Partner management

Why Do You Need Due Diligence?
“I am are about to award exclusivity of my company products, branding
to a distributor, how should I select the most suitable one?”
“My core is in R&D, I don’t know how to manufacture nor do I want to
manufacture, how do I select the most suitable contract manufacturer?”
We do not provide recommendations – because no one’s pocket can
hold a curated bunch of partners for all different medical devices.
We Trust the Process

Potential
candidates
Business
Partner
Shortlisting
Off-site
background
check
Off-site and On-
site audit
Risk
assessment
and mitigation
Due
Diligence
Complete
We check from top..
..to bottom!
We minimise your business risks and 'restart costs'
Access-2-Healthcare’s scope

Is all this worth the money?
“We are on a budget, and during the first year we invest and
don’t make much”

We Provide Cost Analysis Tools to Help You
 Due Diligence Execution
• Meant for screening exclusive distributors, sub-distributors, OEMs, contract manufacturers, service
providers
• There are business and financial risk if no due diligence
• “What do I stand to gain if I spend this money for due diligence?”
 License Holding
• Exclusive distributor vs. separating the legal/regulatory
• Risk of losing distributor and re-starting
• 3 scenarios calculation – when should you utilize license holding?
 Mentorship and Resourcing Surrogate QA RA
• “For the same cost, you cannot hire this level of expertise”
• Fuss free, no overheads

Quality
Management
Systems
- Establishment
- Training
- Assessment
- Remediation
Design and
Development
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Regulatory strategy
In country execution
Trade compliance consulting
Finding
distribution
channels
Product
reached
customers!
Present in Every Step of Product
Commercialisation
Market segment analysis
Local Market Study
In country Business
Partner management
In country Business
Partner management
License holding
Post Market Surveillance
outsourcing
Clinical workflow definition
and improvement
Business Model Development
Consulting and
mentorship on
prototyping
Advanced Prototyping
via Strategic Partners
Mentorship / Consulting
Outsourced Software Testing

Cost of Business Partnership Calculator
Cost of Business Partnership Calculator
Have you ever wondered how much it actually can cost when
your company is trying to find a business partner to
commercialise in the market?

Partners Portal
An online platform that provides a NO-cost, low-risk option for sourcing and
connecting with prospective business partners
Accessible can be used and accessed anywhere in the world
Swift search function is quick and easy-to-use
Safe company details are only accessible by your connections
Relevant all users verified to be a registered company, in the healthcare industry
Key Features of Partners Portal
Explore market expansion possibilities with business partners

Secure Portal
One of the oft-forgotten, marginalised aspect within compliance is data security. We provide
a simple yet comprehensive solution to address the areas of data transfer that we believe to
be medium-high risk to a healthcare company. Simple. Swift. Secure. Secure Portal.
Coming Soon!
Key Features of Secure Portal
 file transfer web application for your confidential documentation.
 256-bit encrypted (AES)
 Two-factor authentication
 Closed system
 FDA CFR Part 11 capable
 Anti-virus scan
 Daily Storage backup
– File Sharing Made Secure

Validated Portal
• Leveraging on our validated server, we have now shared this resource
with you. Providing a validated environment to host your software as
a medical device, or any medical/pharmaceutical software platform
 ISO27001 certified datacentre
 Compliant to the Federal Data Protection Act (FDPA) in
Germany and the General Data Protection Regulation (GDPR)
in the EU.
 Hardware, O/S completed IQ, OQ, and PQ, according to
ISO13485, FDA QSR, Title 21 CFR Part 11
 Microsoft or Linux O/S platform
 24/7 customer support
contact us to learn more
about the technical
specifications and
uptime guarantee
Coming Soon!

Complaints Portal
• We have a fully FDA CFR Part 11/HIPAA/GDPR compliant online portal to
have alleged reportable complaints entered and processed for error-free
reporting to the regulatory authorities
Coming Soon!
Why? 3 key Reasons
1. alleviate the challenges of complaint reporting due to the
increasingly remote nature of people in organisations
2. Ensure timeliness, competency and consistency in
decision making for reportability determinations
3. ensure regulatory compliance in marketed countries if
they are regulated

How it works
Reportable
Complaint?
Enter or import
the data
Run through
our global
decision tree
and find out if
complaint is
reportable or
not
Converts the
online form into
the necessary
regulatory
forms for
complaint filing
and reporting
Translated as
necessary by
certified human
translator
Track the
communication
with the
regulatory
authority and
with the
manufacturer
Produce all the
necessary
reports for
quality
management
review such as
the trending for
product failure
modes,
reporting
decisions
Integrate the
data with the
CAPA system,
the design
control and
manufacturing
processes

Contact: helpme@access2hc.com

Access 2-healthcare company introduction deck - english - may 2018

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Access 2-healthcare company introduction deck - english - may 2018

Similar to Access 2-healthcare company introduction deck - english - may 2018 (20)

Recently uploaded

Recently uploaded (20)

Access 2-healthcare company introduction deck - english - may 2018