Custom Manufacturing in the Medical Industry

Custom manufacturing involves designing, engineering, and manufacturing products to serve a very specific purpose. The major custom manufacturing technologies employed for the medical industry are CNC machining and 3D printing. The medical industry requires maximum quality and safety and so while these are well-known manufacturing technologies, their application in the medical industry is regulated by the ISO 13485, an ISO standard that regulates the quality of manufacturing for the medical industry.

Applications of custom manufacturing in the medical industry

Custom manufacturing is utilised in nearly all aspects of the medical industry including research, patient care, personal devices, general equipment and many more.

Personal Medical Devices (PMDs)

PMDs account for the largest percentage of custom manufacturing applications in the medical industry. This is because of the high level of customisation required for these devices. PMDs vary in material, size, and design requirements. They include implants, orthotics, prosthetics, and bionics.

General-use equipment and devices

Custom manufacturing is not used for customised products alone. The speed, scalability, and repeatability of CNC milling make it perfect for the bulk manufacture of general-use equipment and devices such as surgical devices and tools. It is also excellent for making replacement parts for medical machinery.

Prototyping

With custom manufacturing, prototypes of medical products can be created for testing, clinical trials and evaluation, sales presentations, and feedback. Both CNC machining and 3D printing technologies are excellent for prototyping.

Research

There’s very little room for error in the medical industry and so there is the need for proper research, training, and testing. Two of the major ways custom manufacturing is used to make the industry error-free are surgical planning and medical training & research.

In surgical planning, before carrying out a complicated surgery on a patient, doctors can practice with 3D printed exact replicas of the patient’s organs. This way, before they go into the actual surgery, they are already very familiar with the process and know what to expect.

Furthermore, doctors in training no longer have to rely on cadavers or animal organs to study anatomy, as highly detailed and accurate manufactured models of organs are available for training. Researchers can also use these models for research.

Materials and technologies used in medical manufacturing

Material consideration is often crucial in the medical industry. The most popular materials used in medical manufacturing are metals, thermoplastics, elastomers, and resins.

CNC Machining

For most orthopaedic implants, cobalt-chromium (CoCr28Mo6) and titanium (Ti6AL4V) are used. While titanium is less known, it is fast gaining popularity for its excellent biocompatibility. Stainless steel is used for temporary implants as it is less resistant to corrosion. Stainless steel and aluminium are utilized in the production of surgical equipment and tools.

The products from these materials and most other metal materials are made using precision CNC machining. This technology is highly accurate and can machine tolerances as tight as ±0.05 mm (±0.025 with micromachining). 5-axis milling makes possible the manufacture of very complex shapes and contours.

3D Printing

3D printing, on the other hand, is mostly used to manufacture products from plastics, resins, and elastomers. DMLS, a metal 3D printing technology, is also used for printing metal. Multicolour and multi-material polyjet printing is often used to produce artificial organs and surgical planning models from MED160.

FDM, with a tolerance of ±0.15% (±0.2 mm maximum), is a great process for prosthetics as well as surgical models. This technology works with PPSF, ULTEM, ABS M30i, and other materials. Prosthetics and bone replacements can also be made from ABS plus material using SLS 3D printing, which has an accuracy of ±0.3% (0.3 mm maximum).

Finally, with an accuracy of ±0.2 mm, DMLS can be used to print parts from 17-4PH Stainless Steel. 

Benefits of custom manufacturing in the medical industry

The following are some of the characteristics of custom manufacturing that make it perfect for the medical industry

Versatility

Custom manufacturing can cater for a wide range of requirements. From the material perspective, there are suitable processes to manufacture objects from titanium, stainless steel, ABSi M30i, PPSF, resins, or any of the numerous materials used in the medical industry.

The size requirement is another thing that varies greatly. Custom manufacturing technologies can create very tiny implants of a fraction of a millimetre, as well as a full adult prosthetic arm.

Finally, the complexity of designs for medical objects varies from very simple scalpels to very complex organs. No matter the complexity of an object, one custom manufacturing process or the other would be able to create it with speed and ease.

Customisation

The flexibility of custom manufacturing makes it the perfect solution for the customization requirements of the medical industry. Everyone’s body and medical needs are different. Custom manufacturing enables engineers to create products that match the exact needs of different patients.

Speed

Speed is important in medicine. Through custom manufacturing processes, engineers can innovate and create very quickly. For urgent or specific needs, an idea can be turned into a product in no time. At Xometry, we can turn a design, no matter how complex, into a product in just a few days.

For products that are meant for the market, the product development time is greatly reduced as prototyping is done at high speed, giving time for proper testing and feedback from stakeholders. This, in turn, ensures that properly engineered and fully functional products reach the market on time. 

Accuracy

Medical personnel can testify to the fact that little errors in dimensions can sometimes be the difference between life and death. Thankfully, CNC machining and 3D printing can produce parts with very high accuracy.

Scalability and repeatability

The manufacturing needs of the medical industry vary from one-off custom products to genetic products. Custom manufacturing offers not only speed but also scalability and repeatability for large production volumes.

Conclusion

With our network of over 2,000 vetted European manufacturers in CNC machining and 3D printing, Xometry Europe offers medical companies, hospitals, and research institutes reliable, fast, and innovative solutions to all their manufacturing needs.