Alira Health

Alira Health
Case Study | Regulatory Strategy

Medtech Company Creates an Early Go-to-Market Strategy for Its Breakthrough IVD Solution

Client Challenge

An innovative startup was developing a breakthrough in-vitro diagnostic (IVD) solution aimed at improving cardiac disease diagnosis, risk stratification, and, potentially, better tailor treatment according to patients’ characteristics.

The client needed support to create an early go-to-market strategy for the novel IVD solution to prepare for product development and successful launch in key European countries and the United States (US). The client wanted a full and comprehensive understanding of the market landscape and dynamics, regulatory processes, pricing and market access, the current state of cardiovascular clinical practice, and commercial strategies.

The client selected Alira Health for this project based on the company’s capabilities and internal cross-functional synergies to strategically combine different areas of expertise, including clinical, regulatory, market access, and commercial.

Our Approach 

The Alira Health team assessed the market, product value proposition, and client capabilities to develop a comprehensive and pragmatic early-go-to-market strategy with relevant scenarios for next steps.

Specifically, the Alira Health team:

  • performed an in-depth assessment of the addressable market, including possible product positioning, market potential, and likely adoption rates of the novel IVD technology within targeted European countries and the US. Applying a multidisciplinary approach, the team analyzed the IVD regulatory landscape to identify potential gaps, outlined the steps for implementation, and identified the most appropriate strategic path for the specific IVD solution.
  • integrated a strategic pricing and market access assessment through a continuous synergic and cross-functional approach, identifying potential price and reimbursement scenarios, barriers, and mitigation strategies.
  • identified promising commercialization roadmaps and strategies for the client to maximize the value of the IVD solution, in line with their company objectives and milestones. The team also recommended potential capabilities, resources, and timelines required across different commercialization models and scenarios.

All findings and recommendations were shared and discussed with the client across frequent touchpoints and brainstorming sessions. The value proposition of the IVD solution was also summarized into an ad-hoc pitch deck for potential investor/partner engagement.


With Alira Health’s help, the client gained a comprehensive understanding of the actions needed in the next four to five years to launch their product, considering their goals, milestones, and internal capabilities. The Alira Health team provided a report containing a comprehensive understanding of the market landscape, regulatory processes, pricing and market access dynamics, and commercialization strategies. The project helped increase the client’s awareness of the challenges and requirements involved in bringing their IVD product to market. The project also equipped the client with a powerful business case and pitch deck for investor, partner, and stakeholder conversations. This strengthened their position with a clear rationale and justification for their product development and commercialization strategy, making it easier to garner support and resources internally and externally.

Key Success Factors 

The Alira Health team developed and clearly summarized all the relevant factors which will affect the future commercialization of the IVD product, providing a checklist of every aspect that this innovative startup must consider for a successful launch. The client greatly appreciated the Alira Health team’s methodology, including regular opportunities to engage and ask questions.

Key success factors included:

  1. Alira Health’s expertise across different healthcare segments integrated within the project which allowed the team to efficiently tailor solutions for the client.
  2. frequent interaction and discussion with the client, enhanced by the team’s listening skills and prioritization of the client’s needs.
  3. the Alira Health team’s ability to plan the ideal commercialization strategy for the client.
Business Impact
The client gained a comprehensive understanding of the actions needed in the next few years to launch their product and an awareness of the requirements involved in bringing their IVD product to market. The project also equipped the client with a powerful business case to garner support and resources internally and externally.
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