Infection Control and Prevention Company Defines Winning US Market Entry Strategy

Client Challenge

A European infection prevention and control company sought to expand a portfolio of wound care and antiseptic products into the US market. The portfolio included several novel disinfectant platform-based products spanning multiple regulatory categories in Europe, including medical devices, drugs, and cosmetics.

The client’s primary challenge was to define the optimal US market entry strategy amid significant regulatory uncertainty. In the US, this type of products sits at the intersection of drug and device classifications, while this novel disinfectant platform itself is not currently approved as an API, complicating regulatory pathways.

The approach to this challenge also needed to extend beyond regulatory considerations alone. The selected pathway would directly influence development costs, time to market, reimbursement potential, pricing, and overall commercial viability. The client therefore needed an integrated regulatory and commercial strategy to ensure that proposed pathways were both FDA-feasible and commercially attractive.

The client selected Alira Health for its combined expertise in US drug and device regulation, deep understanding of healthcare market access dynamics, and specialized Center of Excellence in infection control and fluid management. Most importantly, Alira Health demonstrated the ability to deliver a fully integrated regulatory and commercial approach aligned to the client’s strategic objectives.

Our Approach

The Alira Health team proposed a two-pronged approach combining regulatory affairs and commercial development expertise to address both dimensions of the challenge simultaneously.

This approach was selected because regulatory and commercial decisions are interdependent. Regulatory classification influences evidence requirements, timelines, and cost and market access dynamics determine whether those investments are justified. By running both workstreams in parallel and continuously aligning them, the team ensured that regulatory strategies were commercially viable, and commercial strategies were regulatorily feasible.

Critical steps

• Kick-off and alignment: Defined strategic objectives for US expansion and collected and reviewed existing EU data and documentation
• Regulatory classification analysis: Evaluated each product’s intended use, mechanism of action, and claims, benchmarked against FDA precedents and similar products, and identified potential classification scenarios and associated risks
• Development pathway definition: Designed regulatory roadmaps (e.g., 510(k), De Novo, NDA), defined clinical and non-clinical requirements, and outlined FDA engagement strategies
• Commercial and market access analysis: Conducted primary and secondary research (clinicians, payers), assessed reimbursement pathways and pricing benchmarks, and evaluated market positioning and competitive landscape
• Integrated scenario modeling: Combined regulatory and commercial insights into 2–3 strategic scenarios, modeled ROI and investment implications, supported decision-making on portfolio prioritization
• Final strategic recommendations: Delivered clear, actionable recommendations for US entry and facilitated decision-making workshops with stakeholders

Outcomes

The solution was fully aligned with the client’s expectations because it simultaneously delivered clear regulatory pathways for all products, provided commercial validation of each pathway, and enabled informed prioritization and investment decisions.

The client received deliverables including the definition of regulatory classification and pathways for the portfolio of products, cost and timeline estimates for US development, key risks and mitigation strategies, and scenario-based ROI models to guide decision-making.

Additionally, the project fostered alignment across internal stakeholders (regulatory, commercial, leadership), a robust business case for US expansion, increased clarity on portfolio prioritization and sequencing, and strengthened confidence in discussions with potential US partners.

Key Success Factors

The client was highly engaged throughout the project, with continuous collaboration and feedback loops, multiple alignment meetings and workshops, and adoption of the final recommendations for strategic decision-making.

One key success factor was true integration of regulatory and commercial expertise. Alira Health’s ability to combine regulatory, market access, and commercial development into a single, coordinated approach ensured that all recommendations were both feasible and commercially meaningful.  

Another contributing factor was Alira Health’s deep therapeutic and market expertise. Our dedicated Center of Excellence in infection control and fluid management enabled rapid understanding of the portfolio, competitive landscape, and US care settings.

Finally, a strong understanding of the US ecosystem was essential. Alira Health’s expertise in FDA pathways, reimbursement systems, and healthcare delivery models allowed the team to translate complex regulatory decisions into clear business implications.