Assembling Medical Devices with the highest reliability

Leading medical training equipment manufacturer deploys Retrocausal

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:

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. Click here

Use Cases:

Precise Sequence Following

Due to regulations and ISO certification requirements, operators are often required to precisely follow a standard sequence of steps, and avoid batch assembly. Pathfinder, both with and without its projector integration has been deployed to encourage such compliance, and led to near 100% compliant results.

Tiny Devices

Pathfinder has been deployed on assembly of very small medical devices that can be sent inside the human body or transplanted into it. In these settings, Pathfinder is used with highly magnifying cameras including with microscopes, while the operator performs assembly also aided by magnifying glasses. We have also provided integrations with highly specialized instruments to achieve validation of certain steps. In a certain deployment where scrap rate was 30% and per unit cost in 1000s of dollars, customers were able to bring down scrap rate to under 5%.


Pathfinder has also been used when liquids and chemicals are involved in the assembly process. We are able to provide guidance on how to make computer vision validation work when transparent glassware is utilized in the assembly process; and help deploy digital Poka Yoke systems for these use cases as well.

Kit Packing

 It is critical to include all required components when kitting medical products e.g. Tourniquets, Shunt Kits, Stents, Perfusion Cannulas, and Catheters. In many cases, these kits are opened in emergency situations, and the medical practitioner cannot afford to have parts missing from the kits. Returns in these situations are not only bad for the bottom line in the short term, but the reputational costs of missing parts in Kits can be catastrophic. Pathfinder has been deployed in several medical Kit Packing use cases with success.