In-House vs. Outsourcing: How to Choose a Clear Aligner Provider

Clear aligners have revolutionized the orthodontic industry, providing a more discreet and convenient alternative to traditional braces. As the demand for clear aligners continues to grow, businesses and entrepreneurs seeking to enter the market face a crucial decision: Should they establish an in-house manufacturing facility or outsource their clear aligner production to a reliable provider? In this blog post, we will explore the key aspects and tips to consider when choosing between in-house manufacturing and outsourcing for clear aligners. Additionally, we will address frequently asked questions to provide you with a comprehensive understanding of this dynamic market.

In-house manufacturing

1. Create a business plan

As with any business, you'll need to create a solid business plan. This plan should include your financial projections, marketing strategies, and goals for growth. It's also important to research the competition and understand the regulatory environment in your region to successfully position yourself in the market.

2. Obtain regulatory approvals

Manufacturing a customized medical device requires obtaining medical device clearances in your selected jurisdiction. Adding to that, before applying for regulatory clearance, your facility must be ISO certified for medical device manufacturing. Establishing compliance takes significant time and oftentimes hundreds of thousands of dollars in fees.

3. Set up a factory and buy the needed equipment 

Setting up an in-house production facility requires a significant investment in equipment, including 3D printers, thermoforming machines, and many other machinery, in addition to building your manufacturing management software. The cost of these machines can easily run into the hundreds of thousands of dollars, and you'll also need to find a suitable location for your factory as well as set up your supply chain, human resources and shipping logistics. Time is also an important factor, and setting up a factory can take up upwards of a year or two.

4. Choose or build a dental software program

To create clear aligners, you'll need a dental software program that can design digital treatment plans and feed those STL files into your 3D printer. There are several software programs available in the market, and while they can be expensive, they're essential for producing high-quality aligners. Developing that software in-house is costly and takes upwards of a year to develop, requires high salaries and a dedicated technology team to perform regular maintenance and updates. 

5. Treatment Design

To truly scale your clear aligner brand, you would need a digital treatment planning team, preferably led by a clinical team of orthodontists, to design treatment plans for doctors or directly for patients. 

6. Establish your packaging

Once you've produced your clear aligners, you'll need to package them in a way that's appealing and functional. Your packaging should protect the clear aligners from damage during shipping and display your brand in a professional manner. The packaging, clear aligner case, and any accessories also need to be regulatory compliant for the different requirements of the country of distribution. You can choose to design and produce your packaging in-house, or outsource it to a packaging company. 

7. Start promoting your business

Once you've set up your production facility and established your business plan, it's time to start promoting your business. This can include hiring a sales and marketing team, attending trade shows, and networking with potential clients. It's important to have a clear message about what sets your business apart from the competition as well as a well-studied go-to-market strategy. 

What Are The Benefits of Outsourcing Clear Aligner Production

Outsourcing clear aligner production offers numerous benefits for businesses looking to enter the clear aligner market. Here are some key advantages:

1. Cost Savings

Outsourcing can provide substantial cost savings compared to in-house production. By partnering with an experienced clear aligner manufacturer, you can leverage their expertise, economies of scale, and efficient processes to minimize production costs. This includes reduced expenses on equipment, raw materials, labor, and facility maintenance.

2. Quality and Expertise

Professional clear aligner manufacturers specialize in producing high-quality aligners. They possess the necessary knowledge, experience, and cutting-edge technology to ensure precise manufacturing, accurate fit, and superior product quality. With their experience, you can confidently deliver clear aligners that meet or exceed industry standards, leading to improved patient satisfaction and outcomes.

3. Faster Time to Market

Outsourcing enables you to accelerate your time to market, allowing you to introduce your clear aligner brand quickly and efficiently without the time needed to set up an in-house manufacturing facility and obtain the necessary regulatory clearances, which can take upwards of two years. Established manufacturers have streamlined processes, optimized workflows, and dedicated resources, enabling them to produce clear aligners in a timely manner. 

4. Scalability and Flexibility

As your clear aligner business grows, outsourcing provides scalability and flexibility. Manufacturers can easily accommodate fluctuations in demand, whether you need to ramp up production during busy periods or scale back during slower times. This scalability allows you to meet customer needs promptly and efficiently without the burden of maintaining excess capacity.

5. Access to Latest Technology and Innovation

Partnering with a clear aligner manufacturer grants you access to the latest advancements in technology and innovation. Manufacturers continually invest in research and development to enhance their manufacturing processes, materials, and software. By leveraging their capabilities, you can stay at the forefront of the industry, deliver cutting-edge products, and maintain a competitive advantage without the extra cost.

Outsourcing with Eon Dental

Outsourcing clear aligner production through Eon Dental’s white-label solution, Eon One, offers compelling advantages. It allows businesses to focus on their core competencies, eliminates the need for significant upfront investments, ensures access to cutting-edge technology, and provides comprehensive support throughout the manufacturing and commercial process. By choosing Eon Dental as a partner, businesses can confidently enter the clear aligner market, deliver exceptional products, and position themselves for long-term success. If you want to learn more about how clear aligners are manufactured and how Eon Dental does it, read our blog post “how clear aligners are manufactured.”

How to Choose the Perfect Clear Aligner Provider: Key Aspects and Tips

When choosing the perfect clear aligner provider, several key aspects and tips should be considered to ensure a successful partnership. Here are some essential factors to evaluate:

1. Expertise and Experience

Look for a clear aligner provider with a solid track record and industry experience. Assess their portfolio and client testimonials to gauge their expertise in producing high-quality aligners. An experienced provider is more likely to understand the nuances of clear aligner manufacturing and deliver superior results.

When looking for a clear aligner provider, it’s crucial to consider their expertise not only in aligner manufacturing but also in achieving commercial success. Examine their track record, industry experience, and proficiency in areas like aligner production, quality control and go-to-market strategies. Assess their portfolio and client testimonials to gauge their expertise in producing high-quality aligners while effectively navigating their ability to manage business complexities. An experienced provider with a strong foundation in both aligner manufacturing and commercial strategies is more likely to produce superior results and meet your business needs.

2. Quality Standards & Compliance

Quality is paramount when it comes to clear aligners. Verify that the provider adheres to stringent quality standards and possesses necessary certifications. A reliable provider will have robust quality control processes in place to ensure consistent and precise clear aligner production.

3. Customization Options

Consider whether the provider offers customization options to align with your brand and patient needs. This includes the ability to incorporate specific design elements, logos, and packaging customization. A flexible provider will enable you to create a customized and branded clear aligner solution.

4. Clinical and Technical Support

Comprehensive clinical and technical support is a vital part of choosing a clear aligner provider. Evaluate the level of support offered by the provider, including treatment planning assistance, training, and troubleshooting. Strong collaboration and communication with the provider's support team can enhance your overall commercial success and clinical outcomes.

5. Pricing Structure and Cost-Effectiveness

Compare pricing structures and assess the provider's cost-effectiveness. Consider volume discounts for larger orders and whether the pricing aligns with your budget and profit margins. It is crucial to strike a balance between cost and quality to ensure a sustainable and profitable business model.

6. Collaboration and Communication

Effective collaboration and communication are vital for a successful partnership. Evaluate the provider's responsiveness, willingness to address concerns, and open lines of communication. A transparent and collaborative relationship will foster trust and help overcome any challenges that may arise.

7. Shipping and Logistics

Consumers are increasingly looking for fast and timely deliveries. An efficient provider will be able to provide timely and accurate shipping and logistics services that ensure express delivery to all your target markets. 

By carefully evaluating these key aspects and tips, you can find the perfect clear aligner provider that aligns with your business goals, delivers high-quality products, and supports your success in the clear aligner industry. Remember to conduct thorough research, seek recommendations, and engage in discussions with potential providers to make an informed decision.


How big is the clear aligner market?

The clear aligner market has experienced significant growth in recent years and is projected to continue expanding. According to market research reports, the global clear aligner market was valued at over $2 billion in 2020, with a compound annual growth rate (CAGR) of approximately 20% from 2021 to 2028. ( clear%20 aligners%20market,teeth%20into%20the%20proper%20 positions.)

How do I differentiate myself from other competitors in the market?

Setting yourself apart from other competitors is crucial for long-term success. To achieve this differentiation and effectively grow your brand, you need to employ various strategic techniques and practices. Here are some key strategies to help you:

  • Market Research: Start by understanding the competitive landscape and market needs. This involves conducting market research, competitor analysis, and staying informed about consumer preferences.
  • Identity Market Gaps: Once you have a solid grasp of your industry and target audience, look for gaps in the market that your brand can fill. These gaps represent opportunities for differentiation.
  • Value Proposition Development: Articulate your value propositions and unique selling points that highlight what makes your brand distinct to valuable customers.
  • Messaging Hierarchy: Develop a clear messaging hierarchy that conveys your brand’s story and value. Ensure consistent messaging across all touch points and communication channels to solidify your positioning in the market.
  • Marketing and Promotion: Develop a strategic marketing plan that leverages various channels to reach your target audience and communicate your value proposition and unique selling points.
  • Feedback and Improvement: Stay updated on all industry trends and regularly assess feedback and use it to make improvements on your product offerings.

What's the relative regulations for clear aligners and complementary products?

Regulations for clear aligners and complementary products can vary by country or region. While it is essential to consult local regulatory authorities for specific requirements, clear aligners are classified as medical devices and subject to regulations specific to medical devices in each jurisdiction. Eon Dental is compliant with the medical device regulations of the countries we distribute to and has a dedicated compliance and regulatory department to help clients navigate the regulatory landscape of their selected markets.

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