While additive manufacturing (AM) has the potential to radically change health care, enabling greater customization and design innovation, many companies hesitate to use AM due to the complexity of FDA regulations. Learn how your AM strategy can inform your path to regulatory approval.
Additive manufacturing (AM) has the potential to deliver radical change to the health care landscape. AM technologies allow for the systematic addition of materials to form a final product, as opposed to subtractive manufacturing, where material is removed to form the product. This is more than just a mere change of how a product comes to be; instead, it introduces new possibilities for the entire health sector. AM can introduce entirely new abilities for:
- Manufacturing at the point of use. AM disrupts the traditional supply chain, allowing for goods to be produced closer to the point of use at the time of need, which limits material waste, economies of scale, and lead times.1 This feature is particularly relevant in health care, where demand can be unpredictable, and patients’ health can even be impacted by longer shipping and wait times.
- Greater customization. AM allows for mass customization at the point of use. Devices can be tailored to a patient’s exact anatomy,2 which can improve the patient experience and patient outcomes.
- Innovation in design. AM provides designers freedom to create manufactured works with fewer constraints, removing limitations on design imposed by the limitations of traditional manufacturing methods in assembly and manufacture.3Limitless design achieved through AM can support new medical innovations and improve patient care.
- Cost-effective, quality solutions. AM can be profitable at much lower scales of production than traditional manufacturing techniques. This can enable life sciences and health care professionals to utilize devices or tools whose economies of scale may previously have made them impractical. With the rising costs of health care, AM solutions can provide patients with affordable solutions, while achieving quality standards at or above those realized using traditional manufacturing methods.
- Ethical research and development (R&D). Drugs and disease models can be tested on 3D-printed tissues instead of on animals or humans.
Despite these potential benefits, many companies and organizations are hesitant to incorporate AM due to a lack of understanding of potential applications and US Food and Drug Administration (FDA) regulations. While these companies are likely familiar with FDA regulation, navigating the new elements added by AM can seem daunting. For example, how can you preapprove a customizable medical device made by AM since it changes each time it is made for a different patient?
While AM does introduce some unique considerations, they are by no means insurmountable. In order to be competitive and deliver greater innovations, companies should be fully aware of how they can use AM while navigating FDA regulations. This article provides an introduction to the regulatory issues around AM in health care and shows how companies can use their strategy for AM to inform their path to regulatory approval.
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