3D Printing Positioned to Address Issues that have Prevented Wide Adoption of Microneedle Drug Delivery

(Amherst, NH) – The promise of commercial microneedle drug delivery has been on the horizon for more than a decade. Like other compelling medical device innovations such as noninvasive glucose monitoring, the potential of the technology has yet to be realized due to the inability to solve the issues of reliable product performance from unit to unit and across a wide user population.

To fully address the unmet need these technologies represent, any successful solution must meet the requirements of patient self-administration, a set of use cases that include ease-of-use, reliability, consistent performance from patient-to-patient and dose-to-dose and minimal side effects. With only a few exceptions, microneedle drug delivery devices designed for patient self-use have not met these criteria, resulting in only a handful of drug-device products reaching the market.

Recently, developers have been turning to 3D printing as a way to create microneedles with the precision and repeatability that is needed to overcome the limitations of current production approaches. 3D printing – as known as additive manufacturing – is a family of almost a dozen methods that create three-dimensional structures from precise data sources such as CAD files to exact dimensions and spatial layouts. This methodology is the foundation for the repeatability and precision that has been missing in most legacy microneedle production approaches and which makes the technology well-positioned to break through the limitations that have gated the large-scale production of devices for the general population.

Another important aspect of additive manufacturing relative to legacy microneedle methods is the initial publication of guidelines that represent what may be considered as standardization. Legacy approaches have been proprietary and specific to the producer, making comparisons between and among microneedle devices extremely difficult if not impossible. The issuance of final guidance by the FDA in the first quarter of 2018 is designed to instill best practices in device manufacturers considering or using 3D printing. The document takes into account the range of additive manufacturing processes that might be used in a particular design. It also addresses the need to document the multiple software programs that may be used at various stages of the process.

3D printed microneedle drug delivery is detailed in a new and comprehensive report researched and written by Greystone Research Associates. The report – 3D Printed Microneedle Drug Delivery: Technology, Products, Markets, Players and Forecasts - analyzes additive manufacturing technology for microneedles and the current landscape for 3D printed microneedles. The report includes analysis of competitive factors, therapeutic markets, supply chain factors, and the product activities of sector participants.

More information is available at http://www.greystoneassociates.org

Source: Greystone Research Associates

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

Contact:

Mark Smith
Greystone Research Associates
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Amherst, NH 03031 USA
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www.greystoneassociates.org

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