A Deep Dive into Needle Manufacturing—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
Needles are intertwined with the vision of healthcare. They are often associated with the delivery of vital medications, therapies, and vaccines to prevent and treat disease. But their use goes far beyond that role. Further, just as varied as the applications for which they are indicated, so too are the design options and considerations.
 
There are a number of factors that must be addressed prior to the successful manufacture of a needle. In addition, the manufacturing firm must have expertise in numerous capabilities to ensure a clean, smooth, sharp needle that perfectly suits the intended application. Finding such an organization that meets with all of these requirements is not a simple task.
 
Fortunately, Argon Medical Devices Inc. is such a company. Better still, for the following Q&A, its Sr. Director of Engineering, Sojan Abraham, took time to share his insights on this complex process. Abraham responded to inquires involving the critical factors that need to be considered in manufacturing a needle, the challenge involved, and future demands.
 
Sean Fenske: For what types of applications are needles being used?
 
Sojan Abraham: There are a variety of applications in which needles are being used within the healthcare space that go well beyond traditional drug delivery. Just a few examples include soft tissue biopsies, ENT, reinforced anesthesia needles, guidewire introducer needles, bone access, and Tuohy needles.
 
Fenske: Does the application dictate the design and manufacturing processes used for the fabrication of the needle?
 
Abraham: Yes, the end use heavily dictates the end design of the device. It influences the desired sharpness and shape of the bevel—blunt, match ground, Chiba, Franssen, double diamond, or trocar. The end use will also dictate the hub configuration and retention strength to the needle.

Fenske: What are the challenges involved with needle manufacturing? Why can’t just anyone fabricate them?
 
Abraham: There are unique challenges in the fabrication of the needle that prevents just any company from being able to accomplish the task. Handling small parts, cleaning, etching, grinding, blasting, cutting, polishing, laser marking, and over-molding the hub to the needle make up the majority of the required capabilities a company must have for needle manufacturing. In addition, it’s critical to know how to properly protect the needles during shipment to the end user to prevent defective product. Further, ongoing machine maintenance is a must to ensure the equipment is capable of producing the required results. The combination of the high level of technical expertise that’s required along with the significant capital investment serves as a barrier to entry for many organizations.
 
Fenske: What’s driving future needle manufacturing? What are the companies providing needles to healthcare asking of companies like you?
 
Abraham: Just like so many areas of healthcare, the demand for new functionality is always increasing. One such request is for a flexible needle that maintains the same characteristics as a standard needle. Needles are also following the trend toward miniaturization in healthcare. We’re being asked to manufacture smaller needles, even down to 27 gauge. Further, from the regulatory aspect, there’s pressure to achieve cobalt levels of less than 0.1%.
 
Fenske: Are there opportunities to leverage the techniques used to manufacture needles for other medical device areas? Can the expertise be used for other applications?
 
Abraham: Absolutely. I previously mentioned many of the processes involved with needle manufacturing. But more specifically, there are several that align very well with the needs of the medical device manufacturing industry for other applications. These include stainless steel injection molding (MIM), automation and high volume throughput, and laser marking
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Abraham: Flexibility is a critical attribute. As a contract manufacturing partner to medical device companies, we must be able to adapt to a high mix of product due to tip configuration, length, and gauge.
 
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