The cost-effective and efficient quality control in the one-stop additive manufacturing of orthopedic medical devices is also an important part of contract manufacturers delivering value to customers.
Here, we will share the efforts of orthopedic implant contract manufacturer Croom Precision Medical (CPM) in additive manufacturing implant production and quality control, as well as the complete additive manufacturing process chain solution they use.
Traceability of implants throughout the additive manufacturing cycle
Croom Precision Medical, a contract manufacturer of orthopedic implants, is committed to providing orthopedic medical devices such as femoral implants, tibial implants, acetabular cups, and shoulder joint replacement implants. Cooperating clients include ZIMMER BIOMET, DePuySynthes (under Johnson & Johnson) and other famous orthopedic medical device companies.
Croom Precision Medical uses advanced technology and advanced equipment to ensure production efficiency and provide high-quality products. Among the manufacturing equipment invested by CPM, powder bed laser melting metal additive manufacturing equipment has become an important part of it. According to CPM, the investment in additive manufacturing technology has enabled them to win more market shares in East Asia and North America in the international market.
Since medical devices are closely related to patient health and quality of life, it is essential that strict quality procedures should be adopted during and after implantation to achieve the safety and effectiveness of medical devices. As an orthopedic medical equipment manufacturer, CPM hopes to maintain the consistency and reliability of product quality. CPM operations include ISO 9001, ISO 13485 and ISO 14001 certified integrated management systems (IMS). To prove compliance with standards, CPM must maintain manufacturing transparency and traceability at every stage of the manufacturing process.
CPM has introduced additive manufacturing (3D printing) technology since 2007 and has more than 10 years of experience in additive manufacturing and material research and development. In 2017, CPM invested in multiple selection laser melting 3D printing equipment for the production of FDA approved implants. Materials that CPM can perform additive manufacturing include titanium, stainless steel, and Inconel materials.
CPM invested in the RenAM 500M additive manufacturing system and used it in the production of titanium orthopedic medical devices. Renishaw's additive manufacturing system uses the selective laser melting process to produce complex structures in one manufacturing process, such as manufacturing acetabular cups with a lattice structure. CPM has begun to evaluate a lattice structure with a spiral pattern. According to Renishaw, the final implant has undergone rigorous CPM quality testing and exhibits excellent density and Young's modulus values.
The design of orthopaedic implants is still developing rapidly. In recent years, orthopedic manufacturers have incorporated more and more novel and complex structures into implant design to improve implant performance and life through design. Metal 3D printing technology is also an important manufacturing method for achieving such innovative implants, and manufacturing such structures with traditional manufacturing techniques is extremely challenging and not always economically feasible.
In addition to achieving innovative design through 3D printing technology, maintaining the consistency, reliability, and traceability of additive manufacturing products is also an important factor for manufacturers to enhance their competitiveness.
CPM tests the chemical, mechanical and morphological properties of implants. Although these tests are critical to measuring the mechanical and chemical consistency of the implant, they can be time-consuming and increase the cost of a single implant. CPM hopes to change this way and reduce the cost of manufacturing a single piece.
Renishaw`s in-process control software provides CPM with the necessary information to prove the quality of the additive manufacturing implants. The information includes component construction reports to post-processing, so CPM can achieve 3D printed implants throughout the manufacturing cycle. Traceability.
In order to improve the quality and consistency of parts, CPM also chose Renishaw as a partner for precision metrology, and also adopted Renishaw's technology in the testing and part verification after manufacturing.
Medical is one of the leading industries where additive manufacturing technology can be applied and developed, and there is still much room for growth in the future. CPM regards Renishaw as a strategic partner to promote the progress of additive manufacturing technology. In the next few years, CPM will continue to use the expertise gained from the rigorous development process and work closely with orthopaedic medical device customers and medical device regulatory agencies to promote the development of additive manufacturing technologies and support the advancement of medical technologies .
Globally, the commercial transformation of 3D printed acetabular cups and spinal implants (especially fusion cages) has achieved remarkable results. Typical 3D printed acetabular cup products worldwide. The commercialization of 3D printed acetabular cups started as early as 2007.
Since 2019, the commercial transformation of China's orthopedic 3D printed implants has shown an obvious acceleration trend. The driving force behind it is the development of additive manufacturing design and manufacturing solutions. Orthopedic medical devices and medical institutions have made innovations. The efforts of medical regulatory agencies to guide technical review, product approval, and standards jointly promoted by industry associations and the orthopedic industry chain.