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Development of 18 Quality Control Gates for Additive Manufacturing of Error Free Patient-Specific Implants.
Daniel Martinez-Marquez1, Milda Jokymaityte2, Ali Mirnajafizadeh3
1School of Engineering, Griffith University, Gold Coast, QLD 4222, Australia. daniel.martinezmarquez@griffithuni.edu.au.
Materials (Basel, Switzerland)
|September 27, 2019
Summary
Additive manufacturing (AM) enables complex patient-specific implants. This study developed an integrated 18-gate quality control procedure to meet evolving medical standards and regulations for AM implants.
Area of Science:
- Biomedical Engineering
- Materials Science
- Manufacturing Engineering
Background:
- Additive manufacturing (AM) allows complex, patient-specific implants for bone reconstruction.
- Evolving medical standards and customer needs necessitate robust quality control for AM implants.
Purpose of the Study:
- To develop an integrated quality control procedure for additively manufactured patient-specific implants.
- To synthesize and adapt best practices from three AM companies and existing literature.
Main Methods:
- Exploration of production and quality control aspects in three AM companies.
- Synthesis and adaptation of industry best practices and literature, including FDA guidelines and ASTM standards.
Main Results:
- Development of a comprehensive, 18-gate integrated quality control procedure.
- Identification of critical success factors: R&D investment, advanced quality control technology, and a quality improvement culture.
Conclusions:
- The integrated procedure prepares the AM industry for stricter medical regulations.
- Strategic investments and a strong quality culture are vital for companies in the AM patient-specific implant sector.
