The added value of a partner in getting US Market Access to medical devices

Entering the US medical device market represents a significant business opportunity but also presents regulatory challenges that differ substantially from other markets. Working with the right partner can make a critical difference in bringing medical devices to American patients and healthcare providers. This article explores the distinct advantages a specialized regulatory partner brings to medical device manufacturers seeking US market access.

Understanding the knowledge gap

The company's regulatory knowledge depth often determines the need for external support. While some manufacturers maintain robust in-house regulatory teams with extensive FDA experience, others (particularly those outside the US) face unfamiliar requirements and processes.

European manufacturers are typically less familiar with US regulations than their American counterparts. This knowledge gap creates a natural need for guidance through the FDA clearance process, especially for their first submissions. Looking at European companies, we see that they have less knowledge of US regulations and seek support to guide them through the whole process.

The expertise advantage

Regulatory partners bring several forms of expertise that add measurable value:

• Procedural Knowledge. Understanding the specific documentation formats, submission systems, and review processes speeds up preparation and reduces revision cycles.
• Strategic Insight. Experienced partners recognize potential roadblocks before they emerge and can recommend effective strategies based on previous submissions.
• FDA Communication Experience. Knowing how to phrase questions, prepare for meetings, and respond to FDA inquiries most effectively improves outcomes.
• Predicate Device Selection. Identifying the most appropriate predicate devices requires deep knowledge of the FDA database and substantial equivalence principles.

Efficiency and Cost-effectiveness

While engaging external support involves cost considerations, the value proposition includes:

• Faster time to market. Professional guidance helps avoid common pitfalls that delay clearance.
• Resource optimization. Company personnel can focus on core competencies while regulatory specialists handle submission details.
• Reduced risk of rejection. Professional submissions have higher first-pass success rates, avoiding costly resubmissions.
• Tailoring support to company needs. The level of external support can be customized based on the manufacturer's internal capabilities
• Full-Service Support: Partners handle the entire submission process, from strategy development to FDA interactions.
• Gap-filling assistance. For companies with some FDA experience, partners can supplement specific areas of need.
• Review and guidance. Some manufacturers prepare submissions independently but benefit from expert review before submission.
• Training and Knowledge Transfer. Partners can build internal capability while guiding current submissions.

The importance of competence

The effectiveness of a company's regulatory team often determines the appropriate level of external support. Companies with highly competent, FDA-experienced regulatory personnel may require minimal external support, while those with less experience benefit from more comprehensive assistance.

Working with a regulatory partner offers distinct advantages for medical device manufacturers seeking US market access. The right partnership model depends on the manufacturer's internal regulatory resources, FDA experience level, and specific product complexity. External regulatory expertise provides a shorter, more reliable path to US market access for many companies, mainly European manufacturers and smaller organizations.

By carefully assessing internal capabilities against the requirements of FDA submissions, manufacturers can make informed decisions about engaging partners to maximize regulatory success and business value. This strategic approach to regulatory partnerships helps ensure innovative medical devices efficiently reach American patients while meeting all FDA requirements.

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