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Where would you like to commercialise your healthcare product today?
Introducing
Access-2-Healthcare in a nutshell
Access-2-Healthcare helps medical technology companies gain market entry to various countries.
We execute and provide education on
• Market segment analysis and local market study
• In-country regulatory approvals, quality & trade compliance consulting
• Business due diligence - qualify business partners professionally, respectfully and objectively,
and can locally manage these business partners for you.
We support our execution with our software platforms and tools to encapsulate a unique,
comprehensive solution for your go-to-market desires.
Copyright Access-2-Healthcare 2
How did Access-2-Healthcare come about?
Our Origins
In love with the Healthcare industry, heeding the call for to make innovation available, and the drive
to contribute globally towards lowering overall healthcare costs, we created Access-2-Healthcare.
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
Copyright Access-2-Healthcare 3
Our Company Culture - Education
Access-2-Healthcare believes in education,
empowerment, and competency development.
Even if it is far more challenging to achieve,
Education has the potential to reach more people
through knowledge sharing and networking.
This integrated approach helps us to ensure our
customers get all the necessary support they need
from every aspect of commercialisation.
Copyright Access-2-Healthcare 4
Our Company Culture - Work from home
In Access-2-Healthcare, our company
embraces the increasing need for
family time, personal space, and the
opportunity to work wherever,
whenever - to deliver the best
performance ever in a fun, relaxed
environment.
All team members work from home
or anywhere deemed safe by the
company, and appropriately enjoys
the same benefits as they would in
any other company.
Copyright Access-2-Healthcare 5
Our Core Competencies
▪ Market Entry
▪ Go-to-Market Strategy
▪ Regulatory Approvals
▪ Trade Compliance
▪ Business Due Diligence
▪ Quality Consulting
▪ Business partner performance management
▪ Software Tools that enable product commercialisation
Copyright Access-2-Healthcare 6
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 Challenging
Copyright Access-2-Healthcare 7
Concept
Consulting - Value
Proposition, Market
Validation
Funding Prototype
Consulting - R&D,
Proof of Concept,
Intellectual Property
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
Copyright Access-2-Healthcare 8
Research–to-Development Consulting
Services
▪ Aid in developing proof of concept
▪ Aid in sourcing for funding
▪ Design and development consulting
Copyright Access-2-Healthcare 9
Client Company Size
small
small
small to medium
Concept Funding Prototype
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
Organisations are finding ways to establish quick and
nimble quality systems to manufacture and/or market
medical technologies, and stay 100% compliant
Copyright Access-2-Healthcare 10
Quality Consulting
Services
Being inspection-ready for your Regulator or your Notified Body
Bespoke competence development for your organisation on all of
the quality topics
How to implement Quality Planning
Establish quality resourcing and infrastructural allocation
Integrating quality and risk management into your business
processes
Copyright Access-2-Healthcare 11
Client Company Size
All
All
All
medium to large
All
CAPA, Management Review, Complaint Handling, Audits, Training and
Development, Document and Records Management, Design Control, Process
Control, Process Validation, Supplier Management
We are part of the ISO committees that writes, revises and maintains the ISO13485
and ISO14971 standards. How more expert can you get?
Concept Funding Prototype
Quality
Management
Systems
Design and
Development
Ready for
Manufacture
Business Due Diligence
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Qualify Business Partners and Manage Them Locally
Business Due Diligence
In country Business
Partner management
In country Business
Partner management
Copyright Access-2-Healthcare 12
Business Due Diligence
Services
▪ Business partner sourcing
▪ Business partner off-site background check
▪ Business partner audit and qualification
▪ Client specific in-house 4-day workshop
Copyright Access-2-Healthcare 13
Client Company Size
small to medium
small to medium
small to medium
medium to large
We check from top..
..to bottom!
Why Due Diligence?
▪ Despite attending trade exhibitions,
networking online or face-to-face,
business partnership appear to
depend on previous experience and
'feel' - is that the best way?
▪ Costs of re-establishing a business
partnership when the previous one
had failed, is a complex, lengthy, and
costly ordeal
▪ We minimise your business risks and
'restart costs'
▪ Maximises your chances of having a
positive, long-term relationship with
your business partner
Copyright Access-2-Healthcare 14
Concept Funding Prototype
Quality
Management
Systems
Design and
Development
Ready for
Manufacture
Going-to-
market
Regulatory
Approvals
Finding
distribution
channels
Product
reached
customers!
Go-to-Market Strategy
Market segment analysis
Local Market Study
Copyright Access-2-Healthcare 15
Market Validation
Our Solutions
We divide go-to-market strategy into two
levels to overcome market uncertainties:
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
Your Results
The go-to-market strategy and processes
becomes more objective and structured.
You gain local knowledge on the market
tendencies, as well as 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 $$$
Copyright Access-2-Healthcare 16
Concept Funding Prototype
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!
Regulatory Consulting
License holdingPost Market Surveillance
outsourcing
Copyright Access-2-Healthcare 17
Market Entry, Regulatory Consulting
Services
Product Registration - project-based or turnkey solutions
Training for product development teams on Regulatory Integration
Assessment and implementation of regulatory processes
Training and consulting on customs clearance through Trade Compliance
training courses
Copyright Access-2-Healthcare 18
Client Company Size
All
All
All
All
Regulatory approval capabilities in
Singapore, Malaysia, Indonesia, Philippines, Australia, China, Taiwan,
the EU, and the US
and sync with your supply chain team for trade compliance
Legal Entities - One Company, One Trusted Brand
▪ Access-2-Healthcare physically own company entities that are legally able to maintain
your product/import license for you.
▪ Wholly owned legal entities in Singapore, Malaysia, Thailand, Indonesia, Philippines,
Australia, Germany by end of 2017.
▪ Access-2-Healthcare uG (Germany) also a licensed European Union Authorised
Representative (EU AR), fully compliant to MDD 93/42 and EU MDR/IVDR, complete with
full post market surveillance capabilities
Distributor
A
Access-2-
Healthcare
Foreign
Manufacturer
Distributor
B
License holder
Distributor
A
Foreign
Manufacturer
Distributor
BLicense holder
Copyright Access-2-Healthcare 19
Concept
Consulting - Value
Proposition, Market
Validation
Funding Prototype
Consulting - R&D,
Proof of Concept,
Intellectual Property
Quality
Management
Systems
Establishment
Training / Assessment
Remediation
Design and
Development
Mentorship / Consulting
Ready for
Manufacture
Business Due Diligence
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
Business Due Diligence
In country Business
Partner management
In country Business
Partner management
License holding
Post Market Surveillance
outsourcing
Copyright Access-2-Healthcare 20
Software Tools to aid Commercialisation
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?
http://www.access2hc.com/soft-cost-of-business-partnership.html
Worldwide Regulatory Agency Websites
Can't seem to find a country regulatory authority's contact?
Here‘re their websites
http://www.access2hc.com/soft-resource-portal.html
Copyright Access-2-Healthcare 21
Commercialisation Tools - 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
Copyright Access-2-Healthcare 22
http://partners.access2hc.com/
Commercialisation Tools - 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
256-bit encrypted, 2-factor authentication file transfer
web application for your confidential documentation.
Closed system, FDA CFR Part 11 capable, with the
necessary anti-virus scan and storage backup
Copyright Access-2-Healthcare 23
Copyright Access-2-Healthcare 24
Contact: helpme@access2hc.com

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Access 2-healthcare Company Introduction- English - Apr 2017

  • 1. Where would you like to commercialise your healthcare product today? Introducing
  • 2. Access-2-Healthcare in a nutshell Access-2-Healthcare helps medical technology companies gain market entry to various countries. We execute and provide education on • Market segment analysis and local market study • In-country regulatory approvals, quality & trade compliance consulting • Business due diligence - qualify business partners professionally, respectfully and objectively, and can locally manage these business partners for you. We support our execution with our software platforms and tools to encapsulate a unique, comprehensive solution for your go-to-market desires. Copyright Access-2-Healthcare 2
  • 3. How did Access-2-Healthcare come about? Our Origins In love with the Healthcare industry, heeding the call for to make innovation available, and the drive to contribute globally towards lowering overall healthcare costs, we created Access-2-Healthcare. 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 Copyright Access-2-Healthcare 3
  • 4. Our Company Culture - Education Access-2-Healthcare believes in education, empowerment, and competency development. Even if it is far more challenging to achieve, Education has the potential to reach more people through knowledge sharing and networking. This integrated approach helps us to ensure our customers get all the necessary support they need from every aspect of commercialisation. Copyright Access-2-Healthcare 4
  • 5. Our Company Culture - Work from home In Access-2-Healthcare, our company embraces the increasing need for family time, personal space, and the opportunity to work wherever, whenever - to deliver the best performance ever in a fun, relaxed environment. All team members work from home or anywhere deemed safe by the company, and appropriately enjoys the same benefits as they would in any other company. Copyright Access-2-Healthcare 5
  • 6. Our Core Competencies ▪ Market Entry ▪ Go-to-Market Strategy ▪ Regulatory Approvals ▪ Trade Compliance ▪ Business Due Diligence ▪ Quality Consulting ▪ Business partner performance management ▪ Software Tools that enable product commercialisation Copyright Access-2-Healthcare 6
  • 7. 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 Challenging Copyright Access-2-Healthcare 7
  • 8. Concept Consulting - Value Proposition, Market Validation Funding Prototype Consulting - R&D, Proof of Concept, Intellectual Property 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 Copyright Access-2-Healthcare 8
  • 9. Research–to-Development Consulting Services ▪ Aid in developing proof of concept ▪ Aid in sourcing for funding ▪ Design and development consulting Copyright Access-2-Healthcare 9 Client Company Size small small small to medium
  • 10. Concept Funding Prototype 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 Organisations are finding ways to establish quick and nimble quality systems to manufacture and/or market medical technologies, and stay 100% compliant Copyright Access-2-Healthcare 10
  • 11. Quality Consulting Services Being inspection-ready for your Regulator or your Notified Body Bespoke competence development for your organisation on all of the quality topics How to implement Quality Planning Establish quality resourcing and infrastructural allocation Integrating quality and risk management into your business processes Copyright Access-2-Healthcare 11 Client Company Size All All All medium to large All CAPA, Management Review, Complaint Handling, Audits, Training and Development, Document and Records Management, Design Control, Process Control, Process Validation, Supplier Management We are part of the ISO committees that writes, revises and maintains the ISO13485 and ISO14971 standards. How more expert can you get?
  • 12. Concept Funding Prototype Quality Management Systems Design and Development Ready for Manufacture Business Due Diligence Going-to- market Regulatory Approvals Finding distribution channels Product reached customers! Qualify Business Partners and Manage Them Locally Business Due Diligence In country Business Partner management In country Business Partner management Copyright Access-2-Healthcare 12
  • 13. Business Due Diligence Services ▪ Business partner sourcing ▪ Business partner off-site background check ▪ Business partner audit and qualification ▪ Client specific in-house 4-day workshop Copyright Access-2-Healthcare 13 Client Company Size small to medium small to medium small to medium medium to large We check from top.. ..to bottom!
  • 14. Why Due Diligence? ▪ Despite attending trade exhibitions, networking online or face-to-face, business partnership appear to depend on previous experience and 'feel' - is that the best way? ▪ Costs of re-establishing a business partnership when the previous one had failed, is a complex, lengthy, and costly ordeal ▪ We minimise your business risks and 'restart costs' ▪ Maximises your chances of having a positive, long-term relationship with your business partner Copyright Access-2-Healthcare 14
  • 15. Concept Funding Prototype Quality Management Systems Design and Development Ready for Manufacture Going-to- market Regulatory Approvals Finding distribution channels Product reached customers! Go-to-Market Strategy Market segment analysis Local Market Study Copyright Access-2-Healthcare 15 Market Validation
  • 16. Our Solutions We divide go-to-market strategy into two levels to overcome market uncertainties: 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 Your Results The go-to-market strategy and processes becomes more objective and structured. You gain local knowledge on the market tendencies, as well as 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 $$$ Copyright Access-2-Healthcare 16
  • 17. Concept Funding Prototype 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! Regulatory Consulting License holdingPost Market Surveillance outsourcing Copyright Access-2-Healthcare 17
  • 18. Market Entry, Regulatory Consulting Services Product Registration - project-based or turnkey solutions Training for product development teams on Regulatory Integration Assessment and implementation of regulatory processes Training and consulting on customs clearance through Trade Compliance training courses Copyright Access-2-Healthcare 18 Client Company Size All All All All Regulatory approval capabilities in Singapore, Malaysia, Indonesia, Philippines, Australia, China, Taiwan, the EU, and the US and sync with your supply chain team for trade compliance
  • 19. Legal Entities - One Company, One Trusted Brand ▪ Access-2-Healthcare physically own company entities that are legally able to maintain your product/import license for you. ▪ Wholly owned legal entities in Singapore, Malaysia, Thailand, Indonesia, Philippines, Australia, Germany by end of 2017. ▪ Access-2-Healthcare uG (Germany) also a licensed European Union Authorised Representative (EU AR), fully compliant to MDD 93/42 and EU MDR/IVDR, complete with full post market surveillance capabilities Distributor A Access-2- Healthcare Foreign Manufacturer Distributor B License holder Distributor A Foreign Manufacturer Distributor BLicense holder Copyright Access-2-Healthcare 19
  • 20. Concept Consulting - Value Proposition, Market Validation Funding Prototype Consulting - R&D, Proof of Concept, Intellectual Property Quality Management Systems Establishment Training / Assessment Remediation Design and Development Mentorship / Consulting Ready for Manufacture Business Due Diligence 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 Business Due Diligence In country Business Partner management In country Business Partner management License holding Post Market Surveillance outsourcing Copyright Access-2-Healthcare 20
  • 21. Software Tools to aid Commercialisation 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? http://www.access2hc.com/soft-cost-of-business-partnership.html Worldwide Regulatory Agency Websites Can't seem to find a country regulatory authority's contact? Here‘re their websites http://www.access2hc.com/soft-resource-portal.html Copyright Access-2-Healthcare 21
  • 22. Commercialisation Tools - 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 Copyright Access-2-Healthcare 22 http://partners.access2hc.com/
  • 23. Commercialisation Tools - 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 256-bit encrypted, 2-factor authentication file transfer web application for your confidential documentation. Closed system, FDA CFR Part 11 capable, with the necessary anti-virus scan and storage backup Copyright Access-2-Healthcare 23