How Small and Mid-Size OEMs Can Choose the Right Medical Device Contract Manufacturer

For small and mid-size medical device OEMs, selecting the right medical device contract manufacturer is a critical decision that can impact product quality, regulatory compliance, and long-term success. Unfortunately, many OEMs encounter a hidden challenge - most top-tier manufacturers impose annual sales minimums that smaller companies cannot meet.

This leaves many emerging or growing OEMs forced to choose between inflexible large manufacturers or less experienced partners lacking regulatory depth. But a better option exists, one that balances experience, quality, flexibility, and global reach.

What to Look for in a Medical Device Contract Manufacturer

1. Experience in Medical Device Box-Build Assembly

Not all contract manufacturers are equipped to handle the complexities of medical device box-builds. Look for a partner with years of hands-on experience in this specific area. Proven medical assembly experience ensures that the manufacturer understands:

• Precision mechanical and electro-mechanical integration
• Device-specific documentation and labeling requirements
• Final testing and validation procedures
• Regulatory submission support

This kind of real-world knowledge reduces risk and accelerates time-to-market.

2. Flexibility Without Minimums

Many large contract manufacturers only work with OEMs that commit to high annual volumes, often in the multi-million-dollar range. Small and mid-size companies benefit most from partners who do not impose annual sales minimums and are willing to:

• Support low- and mid-volume production
• Accommodate forecast variability
• Ramp up as demand grows

This flexibility allows OEMs to scale without compromising on service or support.

3. Quality and Regulatory Track Record

Medical devices must be manufactured under strict regulatory conditions. Your contract manufacturer should operate an FDA-inspected facility and maintain ISO 13485 certification, the internationally recognized standard for medical device quality management systems. A strong regulatory and quality track record shows that the manufacturer:

• Complies with FDA QSR and international standards
• Has passed regulatory audits
• Maintains proper documentation and traceability
• Understands the importance of CAPA processes

Don’t take this lightly. Regulatory failures during manufacturing can delay product launches or lead to costly recalls.

4. Willingness to Collaborate

Smaller OEMs often need more than just a supplier. They need a collaborative partner. Look for a manufacturer who is willing to:

• Assist with DFM (Design for Manufacturability)
• Offer early-stage engineering input
• Help develop or optimize test strategies
• Adapt to your systems and workflows
• Communicate proactively and transparently

The right partner will view your success as their success and stay engaged throughout the product lifecycle.

A Partner with U.S. and Asia-Based Factories

Global capability is another important factor. A contract manufacturer with factories in the U.S. and Asia gives you:

• Cost-effective volume production in Asia
• U.S.-based production for quicker turnarounds or regulatory needs
• Redundancy and resilience in your supply chain
• More options to navigate trade policy, tariffs, or shipping delays

This dual-region footprint is especially useful in today's uncertain global environment.

One Example: Sanbor Medical

Medical device contract manufacturing companies like Sanbor Medical have structured their services specifically to support small and mid-size OEMs. With FDA-inspected facilities, ISO 13485-certified systems, and factories in the U.S. and Asia, Sanbor Medical has earned the trust of both emerging innovators and leading medical device brands.

Importantly, Sanbor Medical does not require annual sales minimums, making it an ideal fit for OEMs who want quality and compliance without volume-related barriers.

Final Thoughts

Selecting a medical device contract manufacturer is about far more than cost. It's about finding a partner who offers:

• Real-world experience in medical device box-builds
• Flexibility to work with your forecast and scale
• A proven quality and regulatory foundation
• A genuine willingness to collaborate
• Global reach through factories in the U.S. and Asia

For small and mid-size OEMs, these criteria can make all the difference between a successful product launch and a costly misstep.

Ready to learn more? Contact our team today