Hasten Inc.

MARKET ACCESS & BUSINESS DEVELOPMENT LATAM

Your strategic partner for regulatory approval and commercial expansion to enter the medical device markets of Latin America and Brazil

A U.S.-based company specializing in connecting innovative international medical technologies to high-growth markets in Latin America, integrating regulatory strategy, clinical validation, and distribution management.

ABOUT HASTEN INC.

Connecting global medical innovation to Latin American markets

Hasten is a U.S.-based company specializing in market access and business development in the medical device sector, bringing innovative healthcare technologies to enter and grow successfully in Brazil and Latin America.

We combine regulatory strategy, market development, distribution management, clinical and scientific support, and local execution to connect transformative medical technologies with the markets that need them.

Built on decades of international experience in the medical sector, Hasten brings together a trusted network of regulatory experts, healthcare professionals, distributors, and commercial partners. Our current strategic focus is on Brazil and Latin America, while maintaining the international background and relationships developed over years of global operations.

From regulatory planning and market entry to distribution channel development and long-term commercial growth, Hasten acts as an extension of our partners’ teams, turning market opportunities into sustainable businesses.

Learn about our story and team

HOW WE CAN HELP

Solutions tailored to your market stage

For Global Manufacturers and Exporters

Accelerate your regulatory pathway and build your distribution network in Latin America with
an experienced and trusted local partner.

For Regional Importers and Distributors

Gain access to innovative international medical technologies with strong commercial appeal and
proven clinical validation.

For MedTech Startups and Innovators

Navigate complex regulatory environments with confidence and reduce the costs and risks
of your international expansion.

OUR SOLUTIONS

Full support across the entire market entry cycle

Premarket and Device Development

Support in preparing medical device documentation for market entry, including laboratory testing, clinical study preparation, technical validation, and compliance with local requirements.

Regulatory and Quality | ANVISA, FDA, and EU MDR

Preparation of technical dossiers and complete regulatory strategies for ANVISA, FDA, EU MDR, and other markets, ensuring full compliance with global regulated quality standards.

Distribution and Commercial Acceleration

Post-market operations through active management of distribution channels, sales strategies,
marketing support, and clinical team training to connect technologies
to leading hospitals and healthcare networks.

OUR EXPERIENCE

Decades of accumulated knowledge in the healthcare sector

30+ years

of accumulated experience in the healthcare and medical device sector.

50+ countries

reached throughout our history through international projects and partnerships.

International know-how

decades of experience in building, qualifying, and managing distribution networks.

LatAm and Brazil focus

strategic dedication and local execution in emerging Latin American markets.

KEY DIFFERENTIATORS

Risk reduction and commercial acceleration in Latin America

Multi-market regulatory expertise

Specialized guidance on the requirements of ANVISA, FDA, EU MDR, and Latin American regulatory agencies.

Clinical and scientific validation

Local clinical engagement, relationships with key opinion leaders (KOLs), and evidence-based commercial strategies.

Active distribution management

Rigorous distributor selection, goal tracking, and ongoing sales support.

Efficiency and risk mitigation

Market presence and local intelligence that reduce operating costs and accelerate time-to-market.

PRODUCTS AND TECHNOLOGIES

High-impact medical devices with businesses accelerated by Hasten

Ampcare ESP | Effective Swallowing Protocol

Advanced protocol for dysphagia rehabilitation that combines Neuromuscular
Electrical Stimulation (NMES) with targeted therapeutic exercises for muscle strengthening.

S-Protector

Surgical protection device indicated for thyroidectomies and neck surgeries, reducing thermal damage at the incision site and optimizing aesthetic and clinical outcomes.

Semmelweis Hand-in-Scan

Hand hygiene training and retraining system for healthcare professionals, based on smart technology, designed to increase adherence to and validation of protocols for preventing healthcare-associated infections (HAIs).

LEADERSHIP

Experience and connections working for your business

Our team brings together specialists in regulatory affairs, market development, and commercial management with a long track record in the international healthcare industry.

Eduardo de Melo

Eduardo de Melo

Founder/CEO

Eduardo de Melo is a healthcare executive and entrepreneur with more than four decades of professional experience and extensive expertise in business development, commercial leadership, and international expansion.

Throughout his career, he has held leadership positions at companies such as CryoConcepts, Masimo, Wolters Kluwer Health, Stryker, Kimberly-Clark, Sanofi Pasteur, and Akzo Nobel, developing markets and distribution networks in Latin America and other regions of the world.

He also took part in the creation of the Brazilian Chamber of Laboratory Diagnostics (CBDL), contributing to the organization and strengthening of the laboratory diagnostics sector in Brazil.

He is the founder of Hasten and serves as Vice President of International Sales at CryoConcepts. His work connects medical technology companies with partners and commercial opportunities, integrating market entry strategy, channel development, and collaboration with clinical and regulatory teams.

A Brazilian based in the United States, he combines knowledge of local markets with global experience to expand access to healthcare technologies.

🌐 Languages: Portuguese (native), English, and Spanish.

Max Bernardes

Max Bernardes

Corporate Vice President

MedTech Executive | Biological Safety, Feasibility & Regulatory Specialist

25+ years of leadership driving customer success for global CROs and top testing laboratories.  Specialist in market authorization, regulatory compliance, and biological safety for medical devices across the US, Europe, LATAM, and Asia.

Currently serving as Business Development Manager at NAMSA for Latin America and VP of Premarket Business at Hasten Inc. with a team operating strategically throughout Latin America and the Caribbean, from offices in Brazil, Mexico, and Costa Rica.

Core Expertise:

  • Global Regulatory Mastery: FDA, ANVISA, MDR-EU, ISO, ASTM, GMP, GLP, GCP.
  • Strategic Leadership: Managing multidisciplinary tech-commercial teams for biocompatibility, functionality, and clinical trials.
  • Technical Authority: ISO International Commission Member; expert in clean-room validation, sterilization, and critical process control.

📍 Based in São Paulo | Serving South & Central America and the Caribbean.

🌐 Languages: Portuguese (native), English, and Spanish.

Luciana Gil

Luciana Gil

Head of Business Operations

Corporate Operations Management | Governance, Administrative Efficiency & C-Level Support

Over 20 years of solid trajectory leading corporate operations and delivering high-level executive advisory to Boards and global leadership across multinational and national enterprises. Specialized in operational governance, administrative workflow optimization, industry event management, and budgetary and logistical structuring to enable business operations with efficiency and compliance.

Currently serves as Head of Business Operations at Hasten, overseeing corporate process management, partner relations, and the strategic operational governance to support business expansion and foster cross-functional alignment across departments.

Core Expertise:

  • Governance & Operational Efficiency: Continuous optimization of administrative and operational processes and workflows.
  • Budget Management & Strategic Negotiation: Thorough vendor research focused on cost-effectiveness and strict expense control (OPEX).
  • Events, Travel & Commercial Support: Organization of trade fairs, congresses, and corporate travel, alongside strategic operational support for Commercial and Marketing teams.

📍 Based in Rio de Janeiro | Supporting Global & Corporate Operations.

🌐 Languages: Portuguese (native), English, and Spanish.

Marcelo Contijo

Marcelo Gontijo

Regional Sales Manager

Business Development, Commercial Strategy & Account Management

Professional with solid experience in commercial management and business development, specialized in market expansion, strategic account management, and building long-term relationships. Proven track record in defining and executing sales strategies, identifying new business opportunities, and driving sustainable revenue growth across regional markets.

Core Competencies:

  • Regional Commercial Strategy: Development and execution of sales plans, goal setting, market analysis, and identification of growth opportunities.
  • Account Management & Client Relations: Strategic key account management, building commercial partnerships, and leading high-value negotiations.
  • Business Development: Prospecting, market expansion, new lead generation, and development of strategic channels and partners.
  • Commercial Leadership: Managing and developing sales teams, monitoring performance, setting KPIs, and steering strategies to achieve business results.
  • Performance & Revenue Growth: Pipeline management, sales forecasting, commercial metrics analysis, and revenue growth strategies to increase market share.

📍 Based in São Paulo | Regional reach across all Brazilian states.

Bring your product to Latin America

Talk to our specialists and find out how we can support the entry and growth of your business in emerging markets.

Talk to Hasten on WhatsApp

Direct support from specialists in medical devices and Latin American markets.

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