Access 2-healthcare Company Introduction Deck - English - feb 2018

Where would you like to commercialise your medical technology today?
February 2018
Introducing Access-2-Healthcare

Access-2-Healthcare in a Nutshell
Access-2-Healthcare helps medical technology companies gain market entry to various countries.
We execute the work and provide competency development on:
• Go-to-market strategy, market segment analysis 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
We support our execution with a variety of in-house software applications and platforms to
encapsulate a unique, comprehensive solution for all of the go-to-market needs in the medical
technology industry.
Copyright Access-2-Healthcare 2

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

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 marketing, lmarket analyses, in-country
regulatory approvals including CE marking, quality
compliance, logistics, due diligence to M&A level
COMPANY Access-2-Healthcare
FOUNDED 2015
OWNER Ee Bin LIEW
OWNER
PROFILE
17 years in medical technology
industry – manufacturing, R&D,
commercial, regulatory / quality,
global multinational companies
TEAM SIZE 12

Global Coverage
REGION CITY, COUNTRY COMPANY NAME YEAR
ESTABLISHED
SOUTH EAST
ASIA
Singapore Access-2-Healthcare (Head Office) 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
EUROPE Hamburg, Germany Access-2-Healthcare uG (EU AR) 2017
AUSTRALIA / NEW
ZEALAND
Melbourne, Australia Access-2-Healthcare Australia Pty Ltd 2017

Customer Segments
 Small-Medium Size Enterprises (<4 Billion
USD revenue) for market expansion into
various countries
 Spin-off / Start-up companies for market
launch
 Improvements to the processes for
market entry
• Remediation for quality / regulatory
• Switching distributors, contract
manufacturers
• Mentorship of start-up during product
development

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
Improve Product
Value Proposition,
Market Validation
Funding Prototype
Improve Proof of
Concept
Quality
Management
Systems
Design and
Development
Mentorship / Consulting
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Research–to–Development Consulting

Research–to–Development Consulting
Services
 Improve value proposition to source for funding
 Clinical workflow definition and improvement
 Business Modelling
 Consulting and mentorship on prototyping
 Industrial Design - assess the product attributes
according to market suitability.
 Usability – early adoption of IEC62366, HFE and
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
Client Company Size
Small
Small
Small to Medium

Software Testing
 Access-2-Healthcare remote software
validation and verification services for
medical technology companies
 This service aims to ease the pain of
medical technology companies in
sourcing resources for software testing
 Ensure companies can 100% fulfil all
requirements for Software Validation &
Verification in the medical device industry
Quicker to launch your
product in the market
Significantly reduce
challenges during regulatory
approvals
Improves product safety for
the end users
Your
Results

What Software Can We Test?
• All Software as a Medical Device (SaMD), including
mobile applications for medical purposes
• All embedded software within medical devices
• Enterprise Resource Planning (ERP) systems
Agile Development or Waterfall (V)-models

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
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

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'

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

Integration of 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 the market segment
How do you make that market
successful?
• Specific local market studies
performed by local team members
just for you. Target on the expected
users or key opinion leaders to gain
real local market insights

Which market should you go to?
How do you make that market successful?
 You gain local knowledge on the market tendencies, customs, culture,
behaviours, that are critical to market success
 With the market validation, your product is much more accepted
when launched
 The two step process potentially reduces risk of un-necessary and
excessive investment – 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. Out in-country RA teams have the hands-on
experience to get your product approved smoothly

Our Regulatory Services
Develop Regulatory
strategy
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

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

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

Concept
Improve Product
Value Proposition,
Market Validation
Funding Prototype
Improve Proof of
Concept
Quality
Management
Systems
- Establishment
- Training
- Assessment
- Remediation
Design and
Development
Mentorship / Consulting
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

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 - feb 2018

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Access 2-healthcare Company Introduction Deck - English - feb 2018