April 16, 2024

As you read this, someone somewhere is undergoing anesthesia with the help of a product manufactured by Cadrex. And now, so is someone else. Every 0.2 seconds, someone in the world receives general anesthesia from an anesthesia delivery system made by a global medical technology company. An anesthesia delivery system is a machine that turns anesthesia from a liquid into a gas; an operator uses the machine to create a custom plan for each patient and deliver anesthesia to them. Cadrex partners with the medical technology company to provide components for one of these delivery systems, which is a mainstay in hospitals around the world.

The patient on the receiving end of this technology likely is not thinking about the various parts and processes that make up the anesthesia delivery system. They may be thinking about the education and experience of the people taking care of them: the nurse prepping them for a procedure, the anesthesiologist operating the machine, or the surgeon performing the operation. The medical workers who greet the patient in the operating room receive extensive training because there is no room for error in their profession. The same goes for the manufacturers who make medical tools, parts, and equipment.

What is Medical Manufacturing?

Medical manufacturing includes the production of surgical tools, diagnostic equipment, medical transport, implants, medical device components, and medical supplies. Whether companies offer a myriad of medical products or focus on a specialty, they look to medical contract manufacturers to assist with ensure Design for Manufacturability (DFM) of medical parts and to produce and assemble parts or components of medical equipment.

Medical contract manufacturers are not only responsible for surgical tools and hospital equipment, but they are also the minds and hands behind every product used in the medical industry. Consider the gurney used to transport a patient, the oxygen meter on the patient’s finger, or the IV bag used to hold fluids — some items are smaller than others, but they are all significant. A medical manufacturing company must be trustworthy, qualified, and made up of highly skilled experts to produce any product related to the medical industry. Details and functionality of medical tools, parts, and equipment can be the difference between life and death.

Regulatory Compliance in Manufacturing

Many medical technology and equipment companies abide by unique quality, verification, and certification requirements, and medical contract manufacturers need to understand and be able to work with these requirements. Quality standard organizations evaluate and audit a manufacturing company’s ability to follow and maintain strict quality guidelines. Manufacturers will then display their certifications to demonstrate compliance. These certifications help medical companies know which manufacturing partners are capable of delivering high-quality products.

FDA Compliant Manufacturing

Medical contract manufacturers may need to register with the U.S. Food and Drug Administration (FDA) to make certain products. With FDA compliant manufacturing, the manufacturer maintains a database with the FDA Unified Registration and Listing Systems (FURLS). This tracks the devices a manufacturer makes for its customers.

ISO Quality Management Standards

Medical manufacturing requires pinpoint accuracy, and Cadrex offers a custom quality plan for each project. Cadrex sites are ISO 9001:2015 certified, which means they meet the quality management standards set forth by the International Organization for Standardization. This certification demonstrates our ability to ensure quality and precision, and it allows our clients to know they can trust our quality control processes.

At Cadrex Westminster, our ISO 9001:2015 certification demonstrates our ability to meet quality standards for the manufacture of plastic injection molded components and assemblies. We produce a wide range of medical products at this facility, all of which undergo strict testing and meet stringent standards. Here, for example, we manufacture the top and bottom covers of a pulse oximeter finger sensor, which is placed on a patient’s finger to read their blood oxygen level. We put these parts through a crush test to make sure the plastic doesn’t crack before they are sent to the customer. At this facility, we also manufacture a component for ventilators that helps measure the flow of oxygen to the patient. The component must pass several rounds of testing before it is sent to the customer.

Cadrex Ossian is FDA registered and ISO 13485:2016 certified. ISO 13485:2016 specifies requirements for quality management systems of certain medical devices, including medical implant trials and surgical instruments. Our Ossian team uses precision CNC machining to manufacture surgical cut guides, which are used by a surgeon to cut bone at a specific angle and make way for a drill implant. It is imperative that we meet strict quality standards for medical devices and implants at Cadrex Ossian, and all our facilities.

Medical Manufacturing Processes

The capabilities and techniques used to manufacture products for the medical industry vary depending on the individual project. It helps to work with a manufacturer’s design and engineering experts, who can guide a client through the manufacturing process. Cadrex offers a breadth of capabilities, and our experts work with clients to develop solutions for highly complex parts and mechanical assemblies.

Plastic Injection Molding for Medical Parts

Plastic injection molding is commonly used in the creation of medical devices, tools, and parts. The manufacturing process involves injecting plastic material into a mold cavity, where it is then cooled and ejected as a plastic part. Cadrex has dozens of state-of-the-art plastic injection molding machines at its facilities across North America, and we also offer in-house tool design for injection molding and mechanical assembly and finishing solutions.

At Cadrex Westminster, we manufacture and assemble components for several advanced electrosurgical generators, which involve multiple capabilities. For one electrosurgical unit used for both open and laparoscopic procedures, plastic injection molding is used to make the outer shell of the generator, or bezel. Our assembly team puts brass inserts into the bezel and pad prints images onto the shell.

Precision Machining for Medical Parts

Time is always of the essence, but speed can’t take away quality. Precision CNC machining is often used in medical manufacturing to produce a high volume of precise parts repeatedly and quickly. Cadrex offers expert programming for precision CNC machining, and we continue to invest in state-of-the-art precision machining equipment, automation, and robotics.

In addition to the cut guides made At Cadrex Ossian, we also manufacture drills, rasps, and reamers that medical professionals use to drill, scrape, and shape bone. These instruments are very intricate, and manufacturers must pay close attention to detail. Skilled machinists are trained to operate precision CNC equipment to ensure quality, accuracy, and speed when producing these instruments.

Innovation in the Medical Industry

Everyone involved in the medical industry needs to be up to date on the latest trends, research, and technology in their sector, and that includes manufacturers. It’s important for a medical manufacturer to work closely with their customers, understand their needs, and exceed their expectations regarding innovation. The manufacturer should continuously invest in quality equipment that has more precise measuring, automated equipment that will increase rate and repeatability, and machines that can hit better tolerances.

Part of remaining innovative also means matching and growing with a customer when they want to improve their technology. Cadrex facilities in Ossian, Indiana; Grand Haven, Michigan; and Agawam, Massachusetts provide dozens of components for a medical device and equipment company that creates medical mobility solutions. Cadrex manufactures parts for a powered chair that emergency responders, medical workers, or caregivers use to move patients up and down stairs. To help the client stay innovative and on the cutting edge of technology, Cadrex engineers collaborated with them to create prototypes that went through multiple rounds of changes to get the design perfect before production. This helped them get to market faster and contributed to the success of the product.

A Competitive Advantage

Companies in the medical industry rely on medical manufacturers who can match their requirements, guide them through the manufacturing process, and deliver products with speed, care, and quality assurance.

At Cadrex, we offer speed to scale without compromising on quality. We invest in expert employees and innovation to provide unmatched solutions for our customers in the medical industry. Learn more about manufacturing for the medical industry at Cadrex.