By Sean Fenske, Editor-in-Chief
 
The pandemic generated drivers of change that will have long-lasting effects on the medical device manufacturing supply chain. From increased interest in reshoring to a more concerted effort to be aware of secondary and third tier component sources, medtech OEMs and their service providers are still adjusting to the new dynamics to ensure they are better prepared for future challenges.
 
This supply chain transformation has resulted in a reassessment of service providers to ensure these companies are best suited to fulfill the needs of their customers. When it comes to injection molding, however, are these medical device firms certain of what attributes they should truly value and how they can make a quality determination? Figuring out how to best identify a quality supplier can be a challenge by itself.
 
To help with this effort, John Faulkner, vice president of sales and marketing at BMP Medical, responded to several questions around this topic. Focusing on injection molding service providers for medtech, he provides suggestions on questions to ask, how to evaluate a current supply partner, and how they customer/supplier dynamic has changed.
 
Sean Fenske: What trends are driving injection molding for medical devices today? What are the “hot” demands from the industry?
 
John Faulkner: First, there is a growing demand for smaller and more intricate medical devices, enabling less invasive procedures that deliver better patient results. Second, we are seeing a growing need for more disposable components and devices to minimize the risk of infections. Third, there is an increasing demand for medical solutions geared toward in vitro diagnostics.
 
Fenske: For companies seeking an injection molding partner, what recommendations do you have for what they should be seeking or what questions should they ask?
 
Faulkner: There are a variety of questions that should be posed to a potential partner. Some of them include:

1. Do they have the needed injection molding technology and in-house resources and capabilities to get your product to market?
2. Do they have a minimum project volume?
3. What quality management systems are in place?
4. What is their new product development process?
5. Who will be my primary contact?
6. What measures will be put in place to ensure product consistency?
7. How will our intellectual property be protected?

 
Fenske: For existing relationships with an injection molder, how should a medical device company assess the quality of the arrangement?
 
Faulkner: The medical device company should evaluate the quality of the arrangement by considering how the injection molder manages feedback, addresses complaints, reports to regulatory authorities, monitors processes, ensures product consistency, implements corrective and preventive actions, follows up on these actions, handles changes that may impact the quality management system (QMS), pursues continuous improvements, and adapts to new or modified regulatory requirements.
 
Fenske: Is the injection molding relationship still a transactional-based exchange or has it evolved into a real partnership between two companies? Or is this part of assessing the quality of the arrangement?
 
Faulkner: The injection molding relationship has transformed into a collaborative and strategic partnership, driven in large part by the increasing need to mitigate risks. It requires both parties to actively contribute to the identification and mitigation of potential risks throughout the production process.
 
Fenske: What did the pandemic and subsequent supply chain issues reveal about injection molding relationships? Were the warts exposed and/or the true value elements revealed?
 
Faulkner: The pandemic and subsequent supply chain issues exposed vulnerabilities in injection molding relationships. It emphasized the need for supplier diversification, building out a robust supply chain resilience plan, rethinking warehouse inventory space, and further prioritizing open strategic collaboration. It also emphasized the need for adopting new technological advancements and revisiting long-term business plans.
 
Fenske: What remains as the most challenging aspects of a relationship with an injection molding company for a medical device firm?
 
Faulkner: Establishing a relationship with an injection molding company poses various challenges for a medical device firm. Initially, there is a significant upfront investment required for mold fabrication, prompting the medical device firm to assess whether this process is optimal for their initial lower production volumes during certain phases of the product launch. Some injection molders may only accommodate minimal volume runs. Additionally, the industry has experienced an increase in the cost of raw materials. Furthermore, it’s crucial to acknowledge that molds have a finite shelf life, even with proper maintenance. Therefore, careful consideration must be given to the entire shelf life of a product before it reaches its end.
 
Click here to find out more about BMP Medical >>>>>