All medtech manufacturing requires some level of scaling between the design and development of a product and full-scale production. It may also take place after commercial launch if demand increases significantly. Unfortunately, not all companies prepare properly for scaling, regardless of when it takes place. For example, processes used to prototype a device may not be suitable to use for manufacturing.

As such, it’s critical for organizations to keep the production environment and processes in mind during design stages. Those that do will enjoy a smooth transition from development to manufacturing and beyond. When this aspect is neglected, however, it can lead to delays and increased costs.

Strategic manufacturing partners can assist with scaling considerations. Through capabilities such as design for manufacturability, they can determine key areas that may need to be adjusted in design to accommodate scaling a product. With this in mind, Jay Gurgens, Director of Commercial Operations at Vantedge Medical, responded to a series of questions about scalability.

Sean Fenske: For the purpose of this discussion, can you start by first explaining what scalability is?

Jay Gurgens: In medical device manufacturing, scalability is the ability to reliably increase production volumes, whether transitioning from…