6 Key Takeaways from our Going Global MedTech Webinar

As MedTech companies expand their reach across international markets, establishing a strong R&D framework and strategic partnerships is essential for sustainable success. 

In a recent MHA Baker Tilly webinar, industry leaders shared insights on how MedTech companies can manage regulatory compliance, funding, and the R&D-to-commercial transition effectively. Here are the key takeaways for optimising MedTech expansion.

1. Engage Regulators Early and Leverage Expert Guidance

Early and proactive engagement with regulators is essential for smooth market entry, especially when navigating complex environments like the US and Europe. Initiating conversations with regulatory bodies such as the FDA and MHRA early on provides MedTech firms the opportunity to understand country-specific requirements and avoid costly delays. Given the nuances of compliance, working with experienced advisors—either full-time or through consultancy—can help organizations stay aligned with regulatory expectations and enhance credibility with investors.

Key Takeaway: Engage with regulators at the start and use experienced partners to guide you through region-specific compliance requirements.

2. Build a Compelling Economic Case to Secure Funding

Crafting a robust economic case is essential to attract both public funders and private investors. MedTech companies should focus on demonstrating clear value for healthcare systems, particularly for institutions like the NHS, by combining clinical evidence with economic insights. This focus on cost-effectiveness can help appeal to both insurers and government agencies, which are increasingly focused on budget impact and long-term value. Preparing these value propositions early, backed by clinical data, positions companies to engage effectively with both investors and healthcare stakeholders.

Key Takeaway: Develop a strong, evidence-backed economic case early in the R&D process to meet the needs of both healthcare funders and investors.

3. Prioritise Effective Data Management from Day One

Effective data management is crucial for R&D success, particularly when transitioning from preclinical to clinical phases. Implementing mature data standards and ensuring data integrity from the outset is highly important. Attempting to retrofit data practices later can introduce risks and inefficiencies, as regulators and non-clinical stakeholders expect clear, reliable evidence of compliance and quality.

Key Takeaway: Adopt rigorous data management standards early in development to streamline compliance and support transparent reporting to stakeholders​.

4. Strategise Resource Allocation and Partner Engagement

Maximising value during R&D often requires a flexible resource strategy that balances cash flow with high-impact engagement. Adopting a phased approach—using part-time consultants for early-stage milestones and expanding to full-time roles as the project grows—can be an effective way to manage resources while attracting the right expertise. Additionally, engaging Key Opinion Leaders (KOLs) early can provide critical insights and credibility in regional markets, further enhancing the market entry process.

Key Takeaway: Implement a scalable resource model to optimize costs and engage regional KOLs for insights into market-specific challenges and opportunities​.

5. Optimise Tax and IP Management for International Growth

Expansion across borders involves tax complexities that companies must address proactively. Early tax planning, including exploring R&D incentives, can optimise cash flow while maintaining compliance. Similarly, understanding where to house intellectual property can have long-term financial benefits, especially if jurisdictions offer favourable tax treatments or strong IP protections.

Key Takeaway: Strategically plan international tax and IP management to maximise R&D value and support long-term growth goals​.

6. Develop an Exit Strategy from the Outset

Planning for eventual exits, such as IPOs or acquisitions, provides a roadmap that can align R&D milestones with investor expectations. Mapping out multiple exit points and “thinking big” to keep doors open for future opportunities is very significant. Such planning reassures investors and ensures the organizstion’s strategy remains flexible and responsive to market changes.

Key Takeaway: Establish exit strategies early and align them with R&D milestones to keep investors engaged and maintain flexibility for growth​.