Injection Molding in the Medical Device Industry
The molding press has become the control center of the manufacturing cell, linking auxiliary equipment, material handling, and other equipment together in the machine controller. That has been a constant evolution since 1989.
Injection molding is commonly used to manufacture medical parts in large quantities with reliable consistency. Understanding all the variables of injection molding and their impact on successful processing is particularly important for medical device manufacturers, who require tight tolerances and unique performance requirements. Equipment design, material performance, process variables, and part design specifics all contribute to the performance quality of any injection-molded medical part.
Medical injection molders consumed just over 664 million lbs (310,000 tons) of resin in 2009 and rose to an estimation of 693.5 million lbs (350,000 tons) in 2010, as per Mastio & Company’s study.
Growth rates through 2012 averaged 4.4%, which is quite strong compared to most other businesses currently, but certainly not as robust as what was anticipated a few years ago.
The medical molding business is less susceptible to economic swings than most other industries. Despite the weak economic condition in 2009, molders have seen an uptick in their business.
However, medical molders are also feeling pressure from hospitals to lengthen the life of their products. Some hospitals spend as much as $1 million on heat testing, so one can produce parts that can withstand the myriad of sterilization procedures used throughout the world.
Medical Injection Molding (MIM) is more than a plastics process. The medical molding process goes well beyond a machine, mold and material. Important factors of MIM are quality control capabilities and operational controls. Quality system compliance is one of the foremost requirements for medical molding. Many molders are using some version of the ISO quality system.
Medical OEMs are looking for total solutions from their molding partners in areas such as part and tool design, prototyping, and part qualifications/validations, among other things (which Eastek International can most definitely do). Some molders are investing more resources into research and product development, believing that new products will define the future of the medical supply business.
Competition is becoming stiffer as more international molders enter the market. The FDA regulations and rigorous product approval processes put in place by OEMs make this a difficult market to enter. Reluctance on part of the OEM to switch once a molder has been approved because of the red tape involved also acts as an entry barrier. MIMs tend to be highly automated and equipped with clean rooms and controlled processing environments. Resins utilized are chosen because they meet FDA standards for clarity, durability, purity, and strength. (For some applications, resins must be able to withstand gamma radiation or other sterilization processes without changes in color, dimensions, or physical characteristics.)
Some Factor Affecting MIM Market
Some other factors that have affected the market of medical injection molded products are:
- Pressure on pricing
- Mergers in medical device industry (OEM)
- Increasing length of life by hospitals due to reduce cost of incineration of used products
- Higher needs for better sterilization resistance
- Stiffer competition from international market
Some Facts on Medical Device Molding
Medical Device Molding is a significant portion of the total medical device market. With a population over 300 million, the USA is the third largest country in the world, behind China and India.
By 2018, the forecast is that revenues will reach $1.45 billion, fueled by a compound annual growth rate of 5.2%.
Medical technology applications place high demands on injection molding machines and the production line. Top performance can only be achieved with sophisticated technology and detailed process know-how.
- Several factors are driving the global plastics medical market including:
- Improved sterilization techniques,
- A shift towards disposable device’
- The development of enhanced plastic materials.
- The characteristics of today’s materials:
- Chemical Resistance
- Light Weight
- Design Flexibility
All of which make plastics an ideal choice for medical applications.