Medical device assembly tends to be more error prone [1] 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.

[1] The Business Case for Medical Device Quality. McKinsey Center for Government. (link)