Access-2-Healthcare

What Access-2-Healthcare does

Access-2-Healthcare is a Singapore-headquartered MedTech commercialization services firm founded in 2015 that physically executes end-to-end market entry and product launch activities for small and medium-sized medical technology companies. The company operates through 11 wholly-owned legal entities in Singapore, Thailand, Indonesia, Philippines, Malaysia, Taiwan, Vietnam, China, Japan, South Korea, India, Australia, Germany, and the UK, employing 32-36 team members distributed across these jurisdictions. Its service portfolio spans 15 offerings organized around the MedTech commercialization lifecycle: research-to-development mentorship, medical technology design and development, clinical site support, full-suite regulatory services, manufacturing scale-up, business due diligence, engineering prototyping, go-to-market strategy, quality and risk management systems consulting, research ethics readiness, independent license holding, supplier control support, regional sales/tech service hubs, investment referral, and the monthly MedTech Gateway newsletter.

Revenue is generated primarily through flat-fee professional consulting engagements, paid incrementally per milestone, with optional monthly or annual retainer structures; project fees range from high three-figures to low six-figures USD depending on device risk class, organizational complexity, target penetration, and tasks executed. A secondary revenue stream consists of referral fees for matching medical device manufacturers with investors, without taking equity. Customer segments span MedTech SMEs and startups (including one-person operations and non-medical companies pivoting into MedTech), larger medical device manufacturers expanding into Asia Pacific, hospital innovation departments commercializing clinician-led ideas, academic institutions, and government/trade-association funding bodies. Distribution channels are direct (enterprise field sales) supplemented by event-led demand generation at regional healthcare trade shows.

The company's competitive position rests on its physical, multi-jurisdiction presence that allows local engagement with regulators, distributors, and clinical sites, plus licensed authorized-representative capacity (notably in the EU via the German entity). Its self-funded, single-company ownership structure and stated impartiality policy (no equity, no distributor endorsements) are positioned as differentiators intended to preserve neutrality in due diligence and channel-management work. No external investors, venture capital, or private equity backing is disclosed, and there are no patents, trademarks, regulatory actions, or M&A activity on record.

Name

Access-2-Healthcare

Legal name

Access-2-Healthcare

Website

https://access2hc.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Access-2-Healthcare is a Singapore-founded, self-funded MedTech commercialization services firm (founded 2015) that operates through 11 legal entities across Asia Pacific, Europe, and Australia to physically execute end-to-end market entry, regulatory, quality, and product-launch services for small and medium medical device companies.

Ownership category

akta.pro rank

Product category

MedTech Commercialization Services

NAICS

Professional, Scientific, and Technical Services (54)

SIC

Services-Health Services (8000)

akta.pro primary industry

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

Keywords

• Medical device consulting
• Regulatory affairs services
• MedTech market entry
• Quality management consulting
• MedTech commercialization

Headquarters

HQ city

Singapore

HQ country

Singapore

HQ region

Asia

Offices14 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Professional Consulting Services: Flat service fee structure, paid incrementally over the course of the project per milestone achieved. May also consider monthly or annual retainer structure if deemed more suitable for the project. Fees range from high 3-figures to low six-figures depending on complexity of organisation, risk class of device, likely market penetration, and number of tasks executed.
2. Investment Referral: Referral fees from matching investors to manufacturers requiring investment. They sit on the side of investees (manufacturers requiring investment) and may take a small referral fee. They do not invest directly or take equity.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Access-2-Healthcare physically executes end-to-end market entry and product launch activities for medical technology companies globally. The company delivers professional consulting services spanning regulatory affairs, quality and risk management systems, business due diligence on distributors and manufacturers, engineering prototyping, clinical site support, go-to-market strategy, manufacturing scale-up, and independent license holding through its wholly-owned legal entities in 11 countries.

Product overview

Access-2-Healthcare is a professional services firm that physically executes end-to-end market entry and product launch activities for medical technology companies globally. Rather than a unified software product, the company offers a portfolio of consulting and execution services organized around MedTech commercialization. The core service suite includes Research to Development Mentorship, Medical Technology Design and Development, Full Suite Regulatory Services, Business Due Diligence, Engineering Prototyping, Go-To-Market Strategy Services, and Quality/Risk Management Systems Consulting. Supporting services include Investment Referral, Clinical Site Support, Manufacturing Scale Up, Research Ethics Readiness, Independent License Holding, Supplier Control Support, and Regional Sales/Tech Service Hubs. The company also publishes the monthly MedTech Gateway Newsletter for industry insights. Services are delivered through the company's own team members distributed across 11 countries (Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, Australia, Germany, India, Taiwan, Japan, UK, Korea) rather than through a software platform.

Differentiator

Problem solved

Functional benefit

Brands

• MedTech Gateway: Monthly industry insights newsletter covering medical technology developments, regulatory updates, and company news

Products and services

• Research to Development Mentorship Guidance and advisory services to help researchers and innovators navigate the journey from research concept to development and commercialization. Targeted at academic institutions, hospitals, and startups developing medical technologies.
• Investment Referral Facilitates connections between medical technology companies seeking investment and investors (family offices, angels, VCs, PE) through a curated referral network, earning small referral fees while remaining neutral.
• Medical Technology Design and Development Engineering and design services for medical technology products, including prototyping and technical documentation. For MedTech companies needing design-for-manufacturing and engineering oversight.
• Clinical Site Support Support services for clinical investigations and trials, including site selection and management through government hospital partnerships. Targeted at medical device companies conducting clinical studies for regulatory submissions.
• Full Suite Regulatory Services Comprehensive regulatory consulting covering submissions, approvals, and compliance across multiple markets including EU, US, and Asia Pacific. For medical device companies seeking market access in regulated geographies.
• Manufacturing Scale Up and Set Up Assistance with scaling up production and establishing manufacturing capabilities for medical devices. For startups and companies transitioning from prototype to volume production.
• Business Due Diligence Systematic assessment of potential business partners (distributors, manufacturers, suppliers) covering financial, quality, and operational dimensions, using a proprietary 15-page due diligence checklist.
• Engineering Prototyping Advanced prototyping services for medical technology innovations, executed through partnerships with prototyping partners in the EU, Thailand, and China.
• Go-To-Market Strategy Services Strategic planning and execution support for market entry and product launch across global markets, leveraging local insights from 11 countries.
• Quality and Risk Management Systems Consulting Consulting services for establishing and maintaining quality management systems and risk management processes for regulatory compliance, including ISO certification.
• Research Ethics Readiness Support Support services to prepare research proposals and sites for ethics committee approvals. For academic and clinical researchers conducting MedTech studies.
• Independent License Holding Services License holding services allowing clients to maintain product and import licenses through the company's legal entities in various countries as local authorized representative.
• Supplier Control Support Monitoring and support services for contract manufacturers and critical suppliers, including site visits and audits. Average on-site evaluation takes 3 days for exclusive distributors and 5 days for contract manufacturers.
• Regional Sales / Tech Service Hub

Quantifiable outcome

• Average on-site evaluation for exclusive distributor: 3 days; for contract manufacturer: 5 days
• +1 more outcomes

Named customers5 records

Segments6 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Two partnerships are on record, tiered minor.

• Engineering Prototyping Partners (EU, Thailand, China)minorStrategic or Co-development PartnerPartnerships for scaling up engineering prototyping services, based in EU, Thailand, and China. These partnerships extend their prototyping capabilities beyond their core consulting services.
• Clinical Investigation Partners (Government Hospitals)minorStrategic or Co-development PartnerClinical investigation partners via government hospitals for conducting clinical trials and studies required for regulatory submissions.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Asia Actual: Asia Actual is a direct peer offering MedTech regulatory, quality, and commercialization services across Asia, with a comparable operating model of helping Western medical device companies achieve in-country approvals and distribution. It competes head-to-head for the same APAC market-entry mandate.
• Pacific Bridge Medical: Pacific Bridge Medical is a direct peer that assists medical device and pharmaceutical companies with regulatory and market-entry support across Asia. It overlaps strongly with Access-2-Healthcare's regulatory affairs and APAC go-to-market offerings.
• RQM+: RQM+ is a direct peer specializing in regulatory affairs, quality compliance, and clinical trial services for medical device manufacturers. It competes for the same MedTech regulatory and quality management mandates across global markets.
• China Med Device: China Med Device is a direct peer focused on helping international medical device companies obtain NMPA approval and commercialize in China. It overlaps specifically with Access-2-Healthcare's Shenzhen-based China entity on regulatory and in-country representation work.

Broad incumbents

• Emergo by UL: Emergo (now part of UL Solutions) is a broader incumbent providing global medical device regulatory, quality, and in-country representation services. It offers overlapping EU/US AR, Asia regulatory, and quality system consulting, but as part of a much wider UL portfolio rather than an APAC-only specialist.
• NAMSA: NAMSA is a broader medical device-focused CRO offering regulatory, quality, and testing services. It is comparable to Access-2-Healthcare's clinical site support, regulatory affairs, and quality management consulting offerings.
• IQVIA: IQVIA is a broad incumbent contract research and consulting organization that includes regulatory affairs and commercialization services for MedTech and life sciences clients. While much larger and broader, it overlaps on global regulatory and market-entry mandates.
• Frost & Sullivan: Frost & Sullivan is a broader strategy consulting and market intelligence firm with a deep healthcare and MedTech practice covering APAC growth advisory. It competes on the go-to-market strategy and due diligence layers of Access-2-Healthcare's service stack.
• L.E.K. Consulting: L.E.K. Consulting is a broader strategy consulting firm with a global healthcare practice advising MedTech clients on market entry, commercial due diligence, and go-to-market strategy. It overlaps with Access-2-Healthcare on the strategic advisory layer rather than execution.

Emerging players

• Alira Health: Alira Health is an emerging player providing MedTech and pharma advisory, regulatory, and clinical evidence services globally with an active APAC footprint. It overlaps with Access-2-Healthcare on the commercialization and regulatory consulting layer for MedTech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/access2hc
• LinkedInlinkedin.com/company/access-2-healthcare
• Xx.com/Access2HC

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Access-2-Healthcare