Medical device assembly tends to be more error prone  than other discrete manufacturing sectors such as consumer electronics and home appliances, due to smaller lot sizes. First time yields remain between 60 to 85%, and manual-assembly related quality issues (human errors) are a major contributor to these poor yields. Emergency manufacturing requirements, such as recent needs to scale ventilator manufacturing for COVID-19 patients, cause yield and quality to be significantly worse.
Overall, the opportunity to improve quality costs for the medical devices industry is $4.75-$6B a year. In fact, costs of a single non-routine quality event, like a major recall, have been as high as $600M in medical device companies.
These stricter quality requirement imply an increased need to mistake-proof manual assembly processes in medical devices manufacturing. Our RetroActivity platform assists these manufacturers in three ways:
1. Enforcing compliance to a clearly defined Bill of Process.
2. Empowering lean engineers by providing them with continuous time and motion studies which facilitate root cause analysis and error tracing.
3. Providing data-driven training programs for operators that emphasize common errors.
These capabilities have been shown to yield 10% improvement in first-time yield and 60% reduction in manual-assembly related quality issues within 2 weeks.
 The Business Case for Medical Device Quality. McKinsey Center for Government. (link