Medical devices, being products that directly affect human life, demand extremely high quality and safety. High-precision and reliable molds are indispensable for their manufacture. In recent years, aluminum molds, which excel in lightweightness, corrosion resistance, and thermal conductivity, have been gaining attention in the medical device field. This article introduces the importance of aluminum molds in medical devices, the required precision and safety, design and manufacturing technologies, and successful case studies.
Precision and Safety Required for Aluminum Molds for Medical Devices
Medical devices are products that affect human health and life, so extremely high precision and safety are required. Aluminum molds must also meet these requirements.
Precision
The following precision is required for aluminum molds for medical devices.
- Dimensional Accuracy: Dimensional accuracy required for part fitting and function is required. For example, high dimensional accuracy is required for syringe pistons and cylinders, and catheter insertion parts.
- Surface Roughness: The surface of medical devices is required to be smooth and clean. If the surface roughness is large, bacteria may easily adhere or the frictional resistance may increase.
- Shape Accuracy: It is necessary to accurately form parts with complex shapes. For example, artificial joints and implants have complex shapes and require high shape accuracy.
Safety
The following safety is required for aluminum molds for medical devices.
- Biocompatibility: Select materials that do not cause allergic reactions or toxicity, considering contact with the human body. For example, implants and artificial joints must be made of highly biocompatible materials.
- Sterilizability: Materials and designs that can withstand sterilization in medical settings are required. Medical devices need to be sterilized because they can be contaminated with bacteria and viruses. The aluminum mold itself must also be able to withstand sterilization.
- Burr Removal: Thorough removal is required because burrs can harm medical personnel and patients. Burrs are small protrusions that can form on the surface of medical devices and can injure the human body.
- Corrosion Resistance: It is necessary to prevent corrosion by body fluids and disinfectants. Medical devices can come into contact with body fluids and disinfectants, so they must be made of highly corrosion-resistant materials.
To Achieve Both Precision and Safety
To achieve both precision and safety required for aluminum molds for medical devices, advanced design and manufacturing technology and a quality control system are required. Specifically, the following can be mentioned.
- High-Precision Design: Utilize CAE analysis to create optimal mold structures and cooling designs.
- Precision Machining Technology: Accurately reproduce the shape according to the design drawing using high-precision CNC machining and electrical discharge machining.
- Strict Quality Control: Establish a quality control system that complies with standards related to medical devices such as ISO13485, and conduct strict inspections in all processes.
Aluminum molds for medical devices are a field that requires high precision and safety, and their design and manufacture require advanced technology and experience. However, by establishing appropriate design and manufacturing technology and a quality control system, it is possible to provide high-quality and safe medical devices.
Design and Manufacturing Technology to Achieve Both High Precision and Safety
Aluminum molds for medical devices require conflicting requirements of high precision and safety. Advanced design and manufacturing technology is indispensable to meet these requirements.
Design Stage
- CAE Analysis: CAE (Computer Aided Engineering) analysis is a useful tool for improving the accuracy of mold design and avoiding troubles. Flow analysis simulates how molten aluminum alloy flows through the mold, predicting problems such as poor melt flow and gas entrapment. Strength analysis simulates the forces applied to the mold, predicting mold strength deficiencies and deformation. Based on these analysis results, optimal mold structures and cooling designs are created to achieve high-precision and safe aluminum molds for medical devices.
- 3D-CAD/CAM: 3D-CAD (Computer Aided Design)/CAM (Computer Aided Manufacturing) are indispensable tools for precise mold design and machining program creation. 3D-CAD accurately designs molds with complex shapes, and CAM creates high-precision machining programs based on the design data. These tools streamline the entire process from design to manufacturing and enable the production of high-precision molds.
Manufacturing Stage
- High-Precision CNC Machining: CNC (Computer Numerical Control) machining is a technology that performs high-precision machining under computer control. High-precision machining of the mold body, cavities, and cores improves the dimensional accuracy of the product. Complex shapes and minute parts can also be accurately machined.
- Precision Electrical Discharge Machining: Electrical discharge machining (EDM) is a technology that uses electrical discharge to machine hard materials and complex shapes. It is used to machine minute and complex shapes and contributes to improving mold accuracy.
- Special Surface Treatment: Special surface treatments such as anodizing and coating are performed to improve the wear resistance and corrosion resistance of the mold. This extends the life of the mold and stabilizes product quality.
- Quality Control System: ISO13485 is an international standard for quality management of medical devices. By establishing a strict quality control system that complies with this standard, the quality of aluminum molds for medical devices is guaranteed and safety is ensured.
Others
- Work in a Clean Room: A clean room is a special room that can minimize the entry of particulates and bacteria in the air. By manufacturing aluminum molds for medical devices in a clean room, the cleanliness of the product is maintained and safety is enhanced.
- Deburring and Polishing: Burrs can harm medical personnel and patients. Therefore, burrs are thoroughly removed using manual work and special tools. Polishing the surface of the mold smooths the surface roughness of the product and improves quality.
- Cleaning and Sterilization: Medical devices used in medical settings require sterilization. Therefore, aluminum molds for medical devices must also undergo cleaning and sterilization that can withstand use in medical settings.
By combining these design and manufacturing technologies, it is possible to achieve aluminum molds for medical devices that achieve both high precision and safety.
Successful Case Studies of Aluminum Molds for Medical Devices
Case 1: Medical Device Housing (Cost Efficiency and Weight Reduction)
- Medical Device Manufacturer: (Specific company name unknown, but assuming a case using Taiyo Parts’ technology as an example)
- Product Name: Portable Medical Device Housing
- Challenges: Cost reduction and weight reduction of the housing. Improved productivity was also required.
- Solutions: Adopted aluminum molds using the die casting method. Used ADC12 material and maximized the use of the patented manufacturing method.
- Results: Achieved 80% cost reduction. Improved productivity (170 units per month). Contributed to weight reduction of the housing. [1, 2]
Case 2: Mouthpiece for Endoscopes (Reflecting Customer Needs and Market Competitiveness)
- Medical Device Manufacturer: Kei S.M. Corporation
- Product Name: Mouthpiece for Endoscopy
- Challenges: Improving safety and convenience during endoscopy. Product development that reflects customer needs.
- Solutions: Developed products reflecting customer feedback. Built a system that can quickly respond to small-lot production using aluminum molds.
- Results: Achieved market success and improved safety and convenience during endoscopy. [3, 4]
Case 3: LED Illuminated Plastic Retractor (Improved Visibility and Response to Medical Needs)
- Medical Device Manufacturer: Yasui Co., Ltd.
- Product Name: LED Illuminated Plastic Retractor (koplight)
- Challenges: Improving visibility in medical settings. Responding to the needs of medical settings through collaboration with doctors.
- Solutions: Developed an LED illuminated plastic retractor through collaboration with doctors. Aimed to provide high-quality and inexpensive products using aluminum molds.
- Results: Realized an innovative product that improves visibility in medical settings. [5, 6]
Case 4: High-Precision Well Tips (High-Precision Molding and Quality Improvement)
- Medical Device Manufacturer: Okada Alloy Co., Ltd.
- Product Name: Microchannel Chips, High-Precision Well Tips
- Challenges: High-precision molding of microchannel chips, etc. Accuracy of ±0.5mm was required.
- Solutions: Adopted aluminum molds using high-precision molding technology, mold casting, and V-process.
- Results: Produced products with an accuracy of ±0.5 mm. Contributed to improving the quality of medical devices and enhanced its reputation in the industry. [7, 8]
Source:
[1] Taiyo Parts Co., Ltd. (URL: http://www.taiyoparts.co.jp)
[2] Taiyo Parts Co., Ltd. (URL: http://www.taiyoparts.co.jp)
[3] Kanagata Shimbun. (URL: http://kanagata-shimbun.com)
[4] NC Network. (URL: http://ja.nc-net.or.jp)
[5] Kanou Group. (URL: http://www.kanougroup.co.jp)
[6] Japan Science and Technology Agency. (URL: http://md-network.pj.aist.go.jp)
[7] NC Network. (URL: http://ja.nc-net.or.jp)
[8] Okada Alloy Co., Ltd. – YouTube Channel. (URL: https://www.youtube.com/watch?v=D55Xfl29kYc)
Successful Case Studies of Aluminum Molds for Medical Devices
Case 1: Medical Device Housing (Cost Efficiency and Weight Reduction)
- Medical Device Manufacturer: (Specific company name unknown, but assuming a case using Taiyo Parts’ technology as an example)
- Product Name: Portable Medical Device Housing
- Challenges: Cost reduction and weight reduction of the housing. Improved productivity was also required.
- Solutions: Adopted aluminum molds using the die casting method. Used ADC12 material and maximized the use of the patented manufacturing method.
- Results: Achieved 80% cost reduction. Improved productivity (170 units per month). Contributed to weight reduction of the housing. [1, 2]
Case 2: Mouthpiece for Endoscopes (Reflecting Customer Needs and Market Competitiveness)
- Medical Device Manufacturer: Kei S.M. Corporation
- Product Name: Mouthpiece for Endoscopy
- Challenges: Improving safety and convenience during endoscopy. Product development that reflects customer needs.
- Solutions: Developed products reflecting customer feedback. Built a system that can quickly respond to small-lot production using aluminum molds.
- Results: Achieved market success and improved safety and convenience during endoscopy. [3, 4]
Case 3: LED Illuminated Plastic Retractor (Improved Visibility and Response to Medical Needs)
- Medical Device Manufacturer: Yasui Co., Ltd.
- Product Name: LED Illuminated Plastic Retractor (koplight)
- Challenges: Improving visibility in medical settings. Responding to the needs of medical settings through collaboration with doctors.
- Solutions: Developed an LED illuminated plastic retractor through collaboration with doctors. Aimed to provide high-quality and inexpensive products using aluminum molds.
- Results: Realized an innovative product that improves visibility in medical settings. [5, 6]
Case 4: High-Precision Well Tips (High-Precision Molding and Quality Improvement)
- Medical Device Manufacturer: Okada Alloy Co., Ltd.
- Product Name: Microchannel Chips, High-Precision Well Tips
- Challenges: High-precision molding of microchannel chips, etc. Accuracy of ±0.5mm was required.
- Solutions: Adopted aluminum molds using high-precision molding technology, mold casting, and V-process.
- Results: Produced products with an accuracy of ±0.5 mm. Contributed to improving the quality of medical devices and enhanced its reputation in the industry. [7, 8]
Source:
[1] Taiyo Parts Co., Ltd. (URL: http://www.taiyoparts.co.jp)
[2] Taiyo Parts Co., Ltd. (URL: http://www.taiyoparts.co.jp)
[3] Kanagata Shimbun. (URL: http://kanagata-shimbun.com)
[4] NC Network. (URL: http://ja.nc-net.or.jp)
[5] Kanou Group. (URL: http://www.kanougroup.co.jp)
[6] Japan Science and Technology Agency. (URL: http://md-network.pj.aist.go.jp)
[7] NC Network. (URL: http://ja.nc-net.or.jp)
[8] Okada Alloy Co., Ltd. – YouTube Channel. (URL: https://www.youtube.com/watch?v=D55Xfl29kYc)
