Healthcare Engineering Group, Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough LE11 3TU, UK.
Philos Trans A Math Phys Eng Sci. 2012 Aug 28;370(1973):3924-49. doi: 10.1098/rsta.2011.0049.
Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice-extreme levels of repeatability and reliability-demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.
工程创新在医疗保健领域的应用对人们的生活产生了重大影响。市场增长由人口统计学决定。良好制造规范的法规和要求——极高的可重复性和可靠性要求——需要高精度的工艺和测量解决方案。使用活生物材料的新兴技术增加了复杂性。本文介绍了一些工作成果，展示了活材料的精密自动化制造，特别是用于治疗再生医学的人类干细胞群体的扩增。本文还描述了用于精密工艺设计和改进的质量工程技术，并确定了此类治疗的制造技术和测量系统发展的要求。
