The development phase of a medical device is a fantastic time, when a napkin sketch can be crafted into a working prototype, enabling a doctor to hold and manipulate the device. However, if the product cannot be reliably and repeatably produced at scale, it’s not going to be successful. It’s critical a novel design can be produced in the necessary volumes.

To help ensure this transition between development and manufacturing can take place seamlessly and without raising red flags in the production environment, design for manufacturability (DFM) needs to be incorporated. Making the necessary revisions early, before design freeze, to confirm manufacturability results in an elimination of surprise costs and time-to-market delays.

To help further illustrate the value of DFM early in the product lifecycle, John Lipari, Chief Commercial Officer at PrecisionX Group, addressed several questions about the topic. In the following Q&A, Lipari defines DFM, offers an overview of the advantages realized from its use, and explains the importance of early manufacturing partner involvement.

Sean Fenske: Design for manufacturability (DFM) is often mentioned but not always explained. What is DFM within the context of medical device development?

John Lipari: DFM in medical isn’t a checklist; it’s a conversation that has to start the moment a device is being sketched. Done right, the design engineer, manufacturing partner, and…