Seven Pitfalls to Avoid When Using a Contract Manufacturer to Build Your Medical Device

Partnering with the right contract manufacturer (CDMO) can make or break your product’s success. During the most recent webinar, CEO Matt Hanks and Co-founder Dan Purvis provided valuable insights into seven critical pitfalls to avoid when working with a CDMO. These takeaways are essential for medical device companies looking to navigate the complexities of high-volume commercialization. Here’s a recap of the key points.

1. Finance: Understanding Costs and Constraints

The financial aspect of working with a CDMO often presents challenges, especially for startups. Matt Hanks emphasized the importance of thoroughly understanding your bill of materials (BOM), including second- and third-tier supply chain costs. Knowing these details helps you evaluate transparency in pricing.

Key questions to ask your CDMO:

• How do you arrive at my price?

• What value are you bringing to the table in terms of made versus bought components?

• How do you prove with objective evidence that you can successfully manufacture my device?

Balancing your minimally viable product (MVP) with your unique selling position (USP) is also critical. While it’s tempting to perfect every feature, focusing on getting your product to market quickly can save resources and accelerate impact.

2. Quality: Building in Excellence from the Start

Quality should never be an afterthought. High regulatory requirements make selecting a CDMO with robust quality systems vital. Dan Purvis highlighted the importance of compliance with standards such as ISO 13485, IEC 60601, and FDA Part 820.

Essential tips:

• Partner with a CDMO experienced in your specific device category.

• Audit their quality management system and assess their professionalism.

• Ensure traceability and material control with integrated ERP systems.

As Matt Hanks noted, “Quality is cheapest the first time,” underscoring the value of proactive planning to avoid costly rework.

3. Improvement: A Culture of Continuous Progress

Manufacturing is either improving or regressing. Choosing a CDMO with a clear focus on lean manufacturing practices such as 5S, Gemba, and Kaizen. A strong culture of improvement not only boosts efficiency but also ensures resilience in the face of challenges.

Questions to ask:

• What continuous improvement processes do you practice?

• How does your team provide feedback for process optimization?

• Can you share examples of resolving line problems quickly and effectively?

4. Supply Chain: Ensuring Stability and Scalability

“A medical device is only as good as the parts it’s made of,” warned Purvis. Supply chain disruptions can derail even the best-laid plans, so it’s critical to work with a CDMO that prioritizes supplier qualification, performance monitoring, and risk mitigation.

Key recommendations:

• Analyze minimum order quantities and lead times to optimize delivery.

• Proactively address obsolescence in electronic components.

• Maintain transparency in supplier challenges to enable joint problem-solving.

5. Cybersecurity: Protecting Your Device and Data

With new FDA cybersecurity guidance in place as of September 2023, ensuring compliance is non-negotiable for medical devices with software components. Strong cybersecurity measures in both manufacturing and embedded product security is essential in 2025 and beyond.

Key considerations:

• Disable automatic updates on manufacturing floor computers to preserve process capability.

• Incorporate cryptography, shared secrets, and FOTA (firmware over the air) in your device design.

• Verify that your CDMO is ISO 27001 compliant and has a proactive security strategy.

6. Design for X (DFX): Building for Success

The easiest medical device to manufacture is one designed with manufacturing in mind. “DFX” refers to design for manufacturability, test, obsolescence, and scalability. Dan emphasized early collaboration with your CDMO to streamline production and testing processes.

Critical tips:

• Align your design team with your manufacturing partner from the start.

• Simplify wherever possible to achieve “good enough” for market entry.

• Plan for scalability to avoid bottlenecks as demand grows.

7. Test: Unifying Strategies Across Development and Production

Behind every successful medical device is a robust testing strategy. Your contract manufacture should be advocates for unifying test systems from the development phase through to manufacturing. Automated testing becomes essential at high volumes to ensure repeatability, scalability, and accuracy.

Key questions:

• When do you consider automated over manual testing?

• Can you demonstrate existing automated test systems and explain who built them?

• How is test data stored and made traceable?

Final Thoughts

Partnering with a CDMO is a complex yet critical decision for medical device companies. By addressing these seven pitfalls—finance, quality, improvement, supply chain, cybersecurity, DFX, and testing—you can position your product for success while mitigating risks.

As Matt and Dan concluded, building a collaborative, transparent, and improvement-focused relationship with your CDMO is key to achieving your ultimate goal: changing lives through innovative medical technology.