Guest Column | July 10, 2015

Top 5 Criteria For Choosing A Medical Contract Manufacturer

By KMC Systems

If you're a medical device company in search of a medical contract manufacturing partner, consider two or three prospective medical outsourcing partners and conduct a comparative analysis based on these important considerations.

1. Choose a medical manufacturer with relevant technological expertise
Determine the specific expertise and proven abilities of each medical contract manufacturer. Research the products that they’ve commercialized, ask for customer testimonials or permission to contact an existing customer. It is important to select a medical contract manufacturing partner with proven experience in the specific technologies that your project requires. This ensures that the engineering and development teams who develop, design manufacture and test your product will have the technical expertise needed.

2. Do they offer sustaining engineering for medical devices?
Look for a medical contract manufacturing partner who can provide comprehensive sustaining engineering and consulting for medical devices throughout the entire production process. Sustaining engineering is comprised of many different skills and is essential to a continuous supply of high quality product to the user. Here are a few areas to consider when looking for sustaining engineering support:

  • Continuous improvement program for product quality and cost.
  • Parts obsolescence management with design support.
  • Post launch compliance support (i.e. RoHS, WEEE, REACH)
  • Support for field returns, repairs, and feature upgrades.
  • Support for field maintenance kits, and spares

3. Consider supply chain management when choosing a medical manufacturer.

The materials cost of medical device manufacturing is a significant portion of the finished product. Many times, materials cost approaches 80 percent of the cost of the finished good. It follows that medical supply chain management for the components and services needed to manufacture your medical product is paramount. Evaluate the methodologies and techniques that the medical contract manufacturer utilizes to manage their vendors. Ask about their MRP systems and vendor quality control programs and how they are integrated. Understand the buying power that they may be able to offer in order to procure the required materials at lower prices without sacrificing quality or delivery timeframes.  

4. Don’t settle for less than a robust and proven quality management system
Assess the robustness and track record of a medical product outsourcing partner’s quality management system. Look for a demonstrated record of compliance with processes for traceability and documentation on device history records, reports on calibration procedures and test data – all of which will help with FDA and ISO 13485 compliance. Perform a quality system audit of prospective outsourcing manufacturers before agreeing to a partnership. Assessing the robustness and reliability of the medical device contract manufacturer’s quality system is important for large OEMs when determining quality systems alignment. It's essential for smaller start-up OEMs that rely on the certified quality system of a medical device contract manufacturer before their own quality systems are in place.

5. Talk cost of finished goods and pricing models up front
Of course, cost plays into the decision-making process. Experienced medical contract manufacturers use a formula-based pricing model that estimates the cost of targeted raw materials, assembly, test and labor as well as the expected cost of finished goods before the product is designed. Ask about pricing models and the methods by which a potential partner determines the finished goods cost in the beginning. This discussion not only establishes your budget and any flexibility therein but it can also uncover any issues of cost uncertainty.

Comparing prospective medical manufacturing companies based on these five criteria should narrow your focus and put your medical manufacturing project on the path to success.