The Significance of Medical Device OEMs Turning to Thermoforming

For many years, plastics have played a crucial role in our daily lives. From commercial products to consumer electronics and everyday items, plastics are ubiquitous, and their impact is evident everywhere. As a result, plastic components are widely used in the medical industry as well. Over the years, the production of medical-grade plastics has been a steadily growing industry. Injection molding, vacuum forming, and line bending are some examples of the techniques used by plastic manufacturers to produce medical devices.

The Rising Popularity of Thermoforming in Medical Devices

Thermoforming technology for medical devices has also joined this list of techniques. In recent years, thermoforming has garnered increasing attention. The use of thermoforming technology to manufacture medical-grade devices has even become the new norm, and the reasons are clear. The primary reason for the increased use of thermoforming is that it is one of the most efficient technologies for plastic production while also meeting the strict requirements for medical-grade component manufacturing.

Market Growth of Thermoformed Medical Devices

A recent research report indicates that the market size for sterile medical packaging devices using various thermoformed medical devices will grow from $26.55 billion in 2015 to $35.07 billion in 2020. The market is expected to continue growing at a compound annual growth rate (CAGR) of 5.72%. Based on the growth in sales of thermoformed medical devices, one can conclude that thermoforming is the preferred choice for medical device OEMs.

Basics of Plastic Thermoforming

In medical component thermoforming, thermoplastic sheets are heated to the desired temperature and formed into molds, typically achieved by applying external force. When thermoplastic sheets are heated to a specific temperature, they soften to a moldable state. The softened sheets are then shaped by vacuum or pressure. This way, the sheets take on the desired product shape, which stabilizes upon cooling. This technology is commonly used in the production of medical components for manufacturing hollow parts.

Seven Key Reasons for the Importance of Thermoforming in Medical Components

Thermoforming is a Fast Production Process
The process is generally straightforward, allowing for shorter turnaround times for parts. This is a critical aspect when dealing with important components like those used in medical applications.

It Offers Design Flexibility
While other technologies have their clear advantages, thermoforming indeed provides a wide range of design flexibility, enabling medical OEMs to produce large quantities of plastic components.

It Facilitates the Production of Both Large and Small Medical Parts
This method can also be used to manufacture multi-section devices. As a result of the first two factors, the variability in product size increases. Thermoforming can also improve the efficiency of manufacturing larger and more complex medical devices by producing subcomponents for larger tools.

Size Stability and Precision
Compared to other technologies, thermoformed plastics can manufacture parts with stricter tolerances. This presents a clear advantage for medical devices.

It Requires Minimal Tooling and Post-Processing
Another benefit is the increased production efficiency. By reducing post-processing steps, production costs are typically lowered.

It is a Cost-Effective Process
Higher production rates combined with minimal tooling and post-processing positively impact overall costs. Medical devices indeed have stricter tolerances and requirements, meaning any cost savings are highly beneficial.

FDA-Approved Materials for Medical Device Production
Materials such as PETG, APET, and HIP can be effectively shaped into desired forms through thermoforming. Therefore, thermoforming is a compatible production method, provided the appropriate materials are selected. Fortunately, many materials required for medical device production are compatible with plastic thermoforming.

Types of Medical-Grade Plastic Thermoforming Technologies

When manufacturing medical components, there are several different types of thermoforming technologies. Let’s take a look at an overview of these types:

Vacuum Thermoforming:
In this technique, softened thermoplastic sheets are exposed to a vacuum, creating suction that molds the sheets into the desired shape. This forms components within a vacuum chamber or mold. This technique is particularly suitable for forming hollow medical components.

Pressure Thermoforming:
In this technique, pressure is used as the forming force. The softened thermoplastic sheets are pressed using a punch or shear equipment. This causes the sheets to bend, curve, and form into plastic medical components. This technique is suitable for both hollow and solid medical parts.

Dual-Sheet Thermoforming:
In this technique, two sheets of potentially different thermoplastic materials are formed using the thermoforming process. This technique is used to manufacture hollow medical components.

Examples of Thermoformed Medical Devices

– Medical electronic device housings
– Housings for imaging equipment such as MRI, CT scans, X-rays, etc.
– Components for hospital beds
– Sterile packaging
– Ward panels
– Medical trays, surgical

Why Use Thermoforming for Medical Devices and Components?

Custom thermoforming provides an economical and attractive solution for manufacturing high-quality, large, and aesthetically pleasing housings, panels, trays, lids, and sidewalls. Thermoformed medical devices offer lower-cost tooling for the production of large components and shorten time-to-market, which is often critical in the medical device field. Topthermoforming’s thermoformed plastic components can be combined with metal sheet components to leverage the advantages of both materials for your products. Topthermoforming has the expertise, engineering support, and established experience to meet your needs for customized thermoformed medical devices. We take pride in providing impartial, process-independent advice and a variety of production techniques suitable for high-mix/low-volume, low-mix/high-volume, and everything in between.