Forming an Overview of Medtech’s Manufacturing Landscape

Ray Products, a custom plastics manufacturer, recently conducted its annual thermoforming industry survey. The results have shed light on some insightful trends, specifically in the medical device manufacturing industry. For instance, medical device manufacturers are 14.7 percent more likely to use domestic manufacturing than other plastics manufacturing customers. This is consistent with recent years. Though once standard to outsource this work overseas, the quality and delivery challenges has kept companies from realizing the promised savings of offshore outsourcing. This has forced many manufacturers to bring the business back to the United States.
 
One of the biggest differences highlighted in the survey between medical device manufacturers and those in other industries was the intense emphasis on quality. This was apparent in the demand for prototypes before starting production. Nearly 94 percent of those surveyed in the medical device industry purchased a 3D-printed or additive-manufactured prototype before starting production, compared to 87 percent of those in other industries. And 100 percent of engineers in the medical device industry required a prototype prior to a project being released to production, compared to 89.5 percent of engineers in other industries.
 
But before we take a deep dive into the survey results and trends, let’s go over who participated in the survey.
 
Who Was Surveyed?
The survey was given to professionals who hold a range of roles in a variety of industries. Roughly 25 percent of respondents are currently working in the medical device manufacturing industry. Of those respondents, 50 percent were engineers and the rest were equally divided between industrial design, manufacturing, quality, purchasing, and administrative roles.
 
As to the size and frequency of the work:
 

• 61.5 percent of medical device respondents worked on 1-5 plastics manufacturing projects in the last year
• 19.2 percent worked on 5-10 projects
• 7.7 percent worked on 10-15 projects
• 11.5 percent worked on 15+ projects

 
The breakdown of the number of projects completed in the last year was fairly consistent with that of other industries.
 
In addition to the heavy emphasis on quality, two of the primary differentiators between the medical device and non-medical device manufacturers were related to the processes of choosing a vendor and the selected manufacturing process.
 
Choosing a Vendor
As stated previously, the medical device manufacturing industry’s emphasis on quality was made abundantly clear in the survey results. When those in purchasing were surveyed, the medical device respondents said that quality was the most important factor when selecting a vendor (as compared to cost, delivery, and payment terms). In other industries, cost was seen as just as important as quality.
 
When all of the medical device respondents were asked about the most important factors in choosing a plastics manufacturer, the top factors were quality and communication. Respondents were also asked how much they valued a supplier’s understanding of their manufacturing line and its challenges. While 100 percent of medical device engineers said it’s critical, only 33.3 percent of other industries agreed.
 
Selecting the Manufacturing Process
When it comes to selecting the right manufacturing process, there are different criteria depending on the industry you’re working in. The number of individuals involved in the decision-making process may also vary by industry. For instance, of the industrial designers who were surveyed, 100 percent in the medical device industry said they have significant influence when selecting the manufacturing process used for designs as compared to 58.8 percent in other industries.
 
While each manufacturing process has its pros and cons, some—like injection molding and thermoforming, which includes vacuum forming and pressure forming—have proven to be more successful for medical device manufacturing. While 75 percent of medical device engineers have designed a pressure-formed part, only 52.6 percent of engineers in other industries have. And medical device manufacturing companies as a whole are 15.4 percent more likely than other types of manufacturers to use pressure forming. In terms of the processes used by medical device manufacturers, the breakdown is below.
 

• Injection molding: 23.5 percent
• Vacuum forming: 15.7 percent
• Sheet metal: 12.7 percent
• Urethane castings: 11.8 percent
• Pressure forming: 7.8 percent
• Reaction injection molding (RIM): 6.9 percent
• Structural foam molding: 3.9 percent
• Fiberglass: 1 percent
• Other: 1 percent

 
Why Pressure Forming?
Though thermoforming and injection molding are both great options for medical equipment manufacturing, thermoforming is increasingly becoming the process of choice for a number of reasons. First, the lower tooling cost means the process is less expensive when producing small to medium runs of parts. It’s also almost twice as fast. And because thermoforming allows for a wide variety of materials, finishes, colors, and material thicknesses, it often doesn’t require additional painting or finishing. When creatingenclosures, housing, covers, and cases for medical devices, the parts can come out of the mold with a textured class A surface finish. Some materials even offer built-in antimicrobial resistance.
 
Thermoforming is also great for medical equipment because it allows for a large variety of parts. With thermoforming, manufacturers can create much larger parts, more complex shapes, pieces with vents or louvers, and pieces that require tighter tolerances.
 
As the advantages of thermoforming continue to be shared, it is expected that the medical device manufacturing industry will increasingly adopt the process. According to Ray Products’ survey, almost 66 percent of survey respondents working in the medical device manufacturing industry believe they will be taking on the same amount or more thermoforming projects in the next year.
 

---

Jason Middleton is vice president for sales and development at Ray Products, a custom heavy gauge thermoforming manufacturer founded in 1949 and located in Ontario, California. With more than 15 years of plastics manufacturing industry experience, Middleton plans and executes successful pressure forming and vacuum forming projects for clients in a wide range of industries.