4 Considerations When Choosing Injection Molders for Medical Applications
Since the start of the COVID-19 pandemic, there has been a surge in demand for medical products. To satisfy this rapid increase, selecting the right medical injection molder to create high-quality parts and delivering them on-time is more vital than ever.
What is Medical Injection Molding?
Medical injection molding is the process of molding medical-grade resin for use in medical applications. While the molding process and secondary operations for injection molding and medical injection molding are the same and both are used to produce versatile, cost-effective and consistent parts for high-volume productions, the most notable difference between the two processes lies in the requirements.
While all medical injection molding parts must conform to regulatory guidelines, depending on the application, some medical parts will require the manufacturing process to take place in a clean room environment to control the purity of the molded parts. With injection molding as one of the most common ways to manufacture parts, how do you select the right molder for your medical applications? We’re glad you asked. To help avoid settling for close enough and achieve medical molding success, we have identified four critical considerations when choosing a medical injection molder.
1) Experience of the Molder
In every manufacturing environment, experience is one of the most valuable qualities. No matter the industry, everyone wants to have peace of mind that their manufacturer fully understands the process and will get it right the first time and every time. Experience is vital in the ability to problem-solve, overcome challenges and even detect issues before they arise.
At Sussex IM, we’re taking our level of expertise in molding, secondary processes, engineering and advanced manufacturing developed in our 44 years of business and expanding it into our new Class 8 clean room – a highly-controlled environment.
One of the most challenging aspects of molding for the medical industry is achieving the ISO 13485 certification. As the industry-standard, expected to be met by the medical community, this should be one of the first things you should look for in a medical injection molder.
Achieving and maintaining this standard of quality includes several costs – which is why not every injection molder provides medical injection molding capabilities. From clean room facilities to high-end presses, there are costs involved at every step. Quality in medical injection molding also requires specific training to develop a dedicated and capable staff, as molding for medical applications can demand a high level of detail. Meeting the quality standard is one thing, but consistently achieving this same level of quality, time and time again, is what separates a great medical molder from an average one.
At Sussex IM, quality is a requirement we strive to achieve in our entire operation. When the customer sets clear expectations with corresponding specifications, our team excels at developing tooling, automation and processes to maintain consistent and repeatable quality.
3) Product Requirements (ISO Standards, Clean Room Classification, etc.)
Before choosing a medical injection molder, the customer needs to understand what ISO class of clean room environment the product will need, if at all. Successfully communicating these specific requirements ensures that the customer will work with a medical injection molder with the correct ISO certifications necessary and capacity.
Not every medical molding application will require a cleanroom. However, as the medical device becomes more complex, it is more likely that it will require a clean room environment. A clean room is utilized to meet FDA requirements, as the controlled environment ensures that that dust and other particles do not contaminate the medical devices.
Selecting the correct clean room for your application is dependent on the level of particulate filtering required. For example, while most medical injection molding applications require a Class 8 clean room, surgical instruments or implant devices require a lower level of detectable particulate and a higher clean room level.
4) Total Cost & Lead Time
Often of the largest factors in the decision-making process, the final consideration to make is the total cost and lead time provided by the medical injection molder. While we all want to receive our parts as fast as possible, as cost-effective as possible, having a bit of flexibility in both areas is usually needed.
At Sussex IM, being cost-competitive is critical. However, our commercial strategy goes far beyond a number on a spreadsheet. Early in every opportunity, we focus and help define the difference between price and the value that we bring. Our strategy is to deliver a partner that is more than a molder; a total solutions provider. Delivering this means we are employing a variety of value-add services including, decoration, assembly, pressure/function testing, serialization, strategic inventory management, and 3PL services.
How to Make the Right Choice
We would all love to say there is a magic formula to follow that will produce successful parts every time. However, when it comes to medical injection molding, there is no specific answer that will work every time.
During the consideration process, there are factors, including specific procedures, requirements and controls to be aware of at every step. These factors, in turn, will change which manufacturing partner is correct for you.
In this industry, success happens when providers overcome challenges. To do this requires experience and perseverance. Sussex IM believes in these principles, and we exercise them in our everyday operations.
The Sussex Solution
At Sussex IM, our mission is to solve problems that satisfy consumer needs. Whether it is injection molding or medical injection molding, it all goes back to basics – investing in quality tooling, making sound long-term commitments and utilizing combined team knowledge to achieve goals efficiently.
While we know we aren’t the only provider for medical injection molding, Sussex IM is always moving forward with cutting-edge technologies and lean manufacturing. At the heart of all of our success at Sussex IM is our people. With in-house engineering and automation expertise to set us apart, we draw on experience and industry intelligence to provide the highest quality products.
Inside our phased approach, our dynamic team moves briskly, meeting your timeline with a progressive throughput. As we continue to expand into the medical market to meet customer needs, our manufacturing expertise inside our new ISO Class 8 clean room is critical to our ability to offer innovative solutions.
Ready to experience the advantage with Sussex IM? Click here to begin the conversation.