Design and engineering are hugely important functions — but their labors won’t bear much fruit if their work can’t be translated into the manufacturing environment.
Johnson & Johnson learned this the hard way, and its various medical device divisions came together to develop a technology transfer process, Paul DeCosta, director of R&D for Ethicon, told attendees at the Medical Design & Manufacturing East show in June. By technology transfer, DeCosta does not mean the transfer from one industry to another, but from design and engineering to manufacturing.
The team developed a list of technology transfer best practices. Each point is called a “CTQ,” or “critical to quality.” At the high level, there are six CTQs: ensuring new technology is ready for manufacturing, having robust product and process development, executing launches well, having proper governance and metrics, getting the organization ready, and having a robust supply base.
Each of the six CTQs has many sub-CTQs. These include assessing which products are most likely to be ready for manufacturing soon; ensuring that customer, design, and process requirements are aligned and compatible; determining which issues have the potential to cause a recall; developing and monitoring a list of deliverables at each stage of development; designating clear and defined roles and responsibilities; and integrating suppliers into the process early.
“Technology transfer needs to be a priority, or else you’ll have headaches,” DeCosta said. “It’s not just a technical process. It’s a process you need to monitor, track, and continuously improve.”
– Erik Swain
