As the medical robotics industry continues to advance, considerations surrounding the selection of the thermoforming or injection molding process play an important role in ensuring the safety, efficacy, and reliability that development teams work so hard to realize and refine.
Given the complexity and cost of attaining FDA approval for a medical device, companies want to maintain that initial manufacturing investment for as long as possible before the inevitable redesign and resubmittal process. Therefore, your enclosure manufacturing process selection should consider startup cost vs materials vs anticipated growth of product sales.
In the thermoforming process, a plastic sheet is heated and drawn over (male tool), or into (female tool) a mold to form a rigid shape. This process is assisted by pulling a vacuum from the underside, and optionally adding pneumatic pressure on the top side. The excess sheet material is then trimmed off and, if necessary, sc…