Manufacturing

Diversifying Into Medical Device Molding

Many injection molders currently serving markets that are slumping are beginning to recognize the value of diversification, and the mantra of many has become, “I want to get into medical molding.” It’s easier said than done.

The medical industry, while it may look a stable, high-volume segment, is a tough market to enter. The barriers are primarily regulatory, and Good Manufacturing Practices (GMPs), clean rooms, and the high cost of compliance restrict many molders from gaining entry.

A major misconception in the molding community is that big money is to be made in medical devices, however, the reality is that the pricing pressures are just as heavy in medical as in automotive or consumer products.

While molded components for nearly all markets require quality, on-time delivery, and best cost, meeting those requirements in medical device molding is much different from other markets because of compliance issues. The overall company culture requires a different mindset for employees who need to understand the medical device manufacturing business.

Molding medical device or healthcare products tends to require more resources.

The goal of the medical part designer should be to provide a part that combines maximum functionality with minimum complexity. Some of the important principles as enlisted below, when overlooked results in increased mold costs, a defective final product, or premature part failure.

What Are OEMs Looking For?

Because of the tight-tolerance, highly regulated, and critical nature of components manufactured, various factors are being evaluated by OEMs in determining which outsourced manufacturers will be used, including:

• Product reliability

• Proven ability to assist in medical device design

• History of strong performance and financial health

• Product performance in the marketplace Cost

• Value-added capabilities, including assembly, packaging, and sterilization, among others

• OEMs are looking for manufacturers largely dedicated to medical with full production and clean room capabilities and systems in place to adhere to stringent regulatory and quality requirements

Challenges For Global Medical Device OEMs

Competition Driven Challenges

• Keep designing and making innovative products

• Keep designing and making new versions of existing products

• Do both of the above at reduced cost

Contract Manufacturing Partner Eelated Challenges

• Global designing and manufacturing capabilities

• Global regulatory capabilities

• Communication barriers

• Cultural differences

• Fluctuating currencies

• Regulatory processes

• Experience in designing and developing medical devices in a regulated environment

• Capabilities across all classes of devices

• Certifications: ISO 13485, ISO 9001, etc.

• Registrations: U.S. FDA, CDSCO, etc.

• Flexibility

• Global footprint

• Proven track record

Medical Component Manufacturing : Some Important Developments

Micro-Moulding

New medical technologies are driving demand for smaller plastic components and hence micro-injection moulding has evolved as a technology for the mass production of minute - intricate polymer and composite components for medical applications Hot Runner Moulding.

Medical products require thin wall components that can be moulded in large volume, to the tightest tolerances and at a very reasonable cost and hence in some cases economics justify hot runner moulds.

All Electric Injection Moulding

The process is said to offer lowest energy cost, extreme reproducibility, narrow processing window for thin walled component in engineering polymers, prolonged accuracy and instant repeatability, high uptime, smaller short size utilization, low emission, water saving, noiseless environment need, clean room necessity etc.

Automation of Medical Device Moulding

There are a variety of elements in the molding process that can be automated.
Material Handling : Part Removal
Mold Setting : In-Line Assembly
Process Data Input : Packing / Boxing
Quality Control : Production Analysis
The Degree to which a project can be automated depends upon: Part Design, Quality Demands, Run Length, Economics Normally, higher levels of quality will justify higher levels of automation.