As the clear aligner industry experiences global growth, more brands are looking to expand beyond their home countries. But with global opportunity comes global complexity. From navigating different regulatory systems, managing logistics and crafting localised marketing strategies. Going global requires thoughtful planning and execution.
This blog post will dive into the core pillars of successful global expansion for clear aligner businesses.
Understanding Local Regulatory Requirements
Medical devices including clear aligners are subject to strict regulations that vary from one region to another. Failing to address these regulations can either stall market entry or lead to non-compliance penalties.
Key Regulatory Bodies:
- U.S. – Food and Drug Administration (FDA)
- Asia-Pacific – National agencies such as NMPA (China) and CDSCO (India)
- MENA – SFDA (Saudi Arabia), JFDA (Jordan), etc.
- Australia - Therapeutic Goods Administration (TGA)
Common Requirements:
- Clinical evidence and biocompatibility data
- Local authorized representatives/agents
- Unique Device Identifiers (UDI) and proper labeling
- Country-specific language and instructions for use
- Appropriate Quality Management System
For more information, read our blog post about regulatory requirements
Avoid Literal Translation, Localize Instead
Localization goes beyond translating content, it’s about understanding the culture, the market and the behaviour of doctors and patients in each region.
Key Tactics:
- Adapt marketing visuals and tone to fit the culture of each market
- Offer customer service in local languages to break communication barriers
- Understand the role of the general dentists vs. orthodontists in aligner treatments in each market
- Ensure sales coverage in key areas to build relationships with high-potential clinics and early adopters
Tailor Your Go-To-Market Strategy
When entering a new market, your go-to-market strategy should focus on building relationships and trust among doctors in the region. Success depends on how effectively you position your brand, communicate your USP’s, and support doctors in integrating clear aligners into their practice.
Key Components include:
- Market Segmentation: identify the right doctor persona for your brand, understand their pain points, motivations and readiness to adopt clear aligners. For more information, read our blog post on Market Segmentation
- Education and training: provide localized onboarding and clinical support to build confidence.
- Brand positioning: highlight your unique value propositions. It could be clinical precision, support, speed of delivery, or ease of use.
- Sales enablement: equip local sales teams with the tools and resources such as marketing materials, visual aids, and scripts tailored to each market
- Launch Events and Market Presence: Announce your presence with launch events, hands-on workshops, and local networking opportunities to build buzz and show commitment to the market from day one.
Consider The Role Of Local Distributors
In some markets, partnering with a local distributor can be a practical way to accelerate market entry. Distributors often bring existing relationships, market knowledge and on-ground presence that can help drive early adoption and brand visibility.
However, success with distributors depends on:
- Clear alignment on brand messaging
- Training on your clinical and commercial model
- Regular communication and accountability
Conclusion
International expansion can bring great opportunities but it requires more than just shipping your product to another country. Success can highly depend on taking the time to understand each market, adapt your offerings, and build meaningful relationships with local stakeholders. With the right planning and partnerships, your clear aligner brand can grow globally delivering smiles to people everywhere.
