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You are here: Home / Nerac Insights / Articles / The Regulatory Environment for 3D Printing in the Healthcare Field

The Regulatory Environment for 3D Printing in the Healthcare Field

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By Erica Kramer, Ph.D., Nerac Analyst,
Originally Published: January 19, 2017

The global 3D printing healthcare market is projected to grow to $2.3B by 2020, with medical and surgical centers expected to be the dominant end user segment. External wearable devices are expected to account for the largest market segment as a result of an aging population with increasing rates of osteoporosis, amputations, hearing loss, and dental problems.

Despite the exciting scientific advances and promising market outlook there are a number of factors which may impede market growth, including the high cost of advanced 3D printers, copyright and patent issues, biocompatibility concerns, limited technical expertise, and significant regulatory and reimbursement challenges. As with any medical device, it is critical that regulatory strategy is carefully considered early in the product development lifecycle.

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