与汽车行业相比，医疗设备制造商处于应用精益制造原则的早期阶段。先进的成像设备和手术设备的制造商往往进一步领先于生产大量低成本设备的公司。

“一般来说，医疗器械行业刚刚开始倾向于，”花岗岩湾全球总裁Don Penkala，一家精益制造咨询公司。“当然，也有例外。[一些]医疗器械植物[等级]我见过的最精简。“
几十年来，汽车公司一直在使用某种形式的精益，并取得了不同程度的成功。消费品制造商在20世纪90年代中期开始了他们的精益之旅。

“通过经济衰退，通过经济衰退加速了精益倡议，因为制造商必须找到降低成本和在日益监管和价格敏感市场的成本和维持质量的新方法，”Penkala说。

彭卡拉指出:“一些(医疗设备生产商)不愿采用精益，是它们所处的严格监管环境的结果。”“要进行细胞创建、团队修改、测试运行(和其他举措)以及医疗设备制造中固有的文档和报告要求的试验，就不那么容易了。”

医疗器械制造商使用了许多相同的借口，延迟了瘦弱制造的WideScale采用。“Besides the typical justification that ‘lean is for automotive manufacturers’ or ‘lean only works for Toyota,’ the most common excuse against using lean concepts is [the misnomer that it can’t] work in a highly regulated environment,” says Sammy Obara, president of Honsha Associates, an alumni association of former Toyota Motor Corp. engineers and managers.

“One company I ended up teaching lean to for several years gave me an early push back claiming that continuous improvement would make them ‘too bureaucratic,’” recalls Obara, who spent three years studying lean manufacturing principles in Toyota City, Japan, and another 10 years applying it at Toyota plants in North and South America. “They explained that for every tiny change in their process they would have to create lots of documents to obtain FDA approval and that could take a long time.”

Penkala补充说:“除了精益实施的典型挑战，比如获得承诺、理解并将原则应用到特定环境中，医疗设备行业还面临着快速的技术变革。”“(制造商通常)需要在需要精度的地方引入自动化。由于监管的原因，(人们)不愿采取改变;组件和产品的可追溯性;以及增加报告和文件要求。”