How additive manufacturing will make personalized medical devices affordable

Additive manufacturing will make personalized medical devices affordable. As 3D printers have become more accessible and manufacturers innovate new materials for medical applications, the industry is delivering patient-specific orthotics, prosthetics, dental devices and more.

But adoption has not yet hit an inflection point, and material science innovation of new skin-safe and biocompatible materials will spark an increase in personalized healthcare via 3D printing. Medical device makers and facilities must understand the potential of these new materials and incorporate them into device design.

3D printing in medical applications
Aside from printing metal for implants, there are two main types of 3D printing relevant for medical applications: Stereolithography (SLA) and Selective Laser Sintering (SLS). SLA has dominated the healthcare industry for its ability to produce high-accuracy, isotropic, and watertight prototypes and end-use parts with fine features and smooth surface finish. In addition, biocompatible materials are already available for SLA 3D printers, enabling medical device designers and manufacturers to create custom devices that improve care with end-use and surgical devices. Designed to meet the need for sterilization and skin-contact, these materials are available in several colors, such as black, white, clear, or amber, which are validated for different uses, including long-term skin or short-term mucosal membrane contact.

With its performance and range of available materials, SLA 3D printing has historically been the go-to for medical device makers.

Now, SLS 3D printing is rising. This method uses a high-power laser to sinter small particles of polymer powder into a solid structure based on a 3D model. This makes it a popular choice for manufacturers in other industries because of its low cost per part with high productivity, ideal for rapid prototyping and creating end-use parts. New skin-safe materials for SLS printers that will enable the medical industry to reap the benefits of this 3D printing type.

Before coming to market, these 3D printing materials are tested to meet ISO standards for irritation and skin sensitization so they can be used in custom-made medical applications, such as prosthetics, medical appliances, bolus devices, sports equipment, orthotics, wearable accessories and more. The ISO standards represent a biological and clinical evaluation of materials’ safety, and it provides instruction material preparation for medical device applications with skin contact. There are several different standards, durations, and endpoints for different skin exposures, such as in silico or in vitro methods, so it’s important that device engineers, facilities, and manufacturers understand uses for each material – and, by extension, 3D printing methods – for their application.

With SLA and SLS 3D printing for medical applications, device makers have more options for custom-made parts for medical care. Understanding the properties of these medical materials and capabilities of various 3D printing applications ensures that facilities and manufacturers choose the right path for point-of-care 3D printing, prototyping and end-use patient-specific part creation.

New materials enabling innovation
There’s a direct correlation between material innovation and medical adoption of 3D printing. All new medical technologies must comply with regulatory standards to ensure patient safety, and additive manufacturing leaders are beholden to these standards. The 3D printing industry creates materials with medical and dental requirements to enable innovation and new applications for 3D printing. For example, dental labs and practices use a mix of materials to create custom crowns and bridges, implants, dentures and more, easily and at a lower cost.

Development of new medical-grade materials is critical to expanding access to point-of-care manufacturing for healthcare professionals. The manufacturing process for healthcare materials includes ISO 13485 certified and FDA-registered facilities, and testing for ISO 10993 and USP biocompatibility and sterilization compatibility. Even with many SLA and SLS materials on the market, continued research and development supports personalized healthcare adoption.

When new materials are developed with safety and healthcare applications in mind, additive manufacturing innovation and adoption can advance. Not only is this increasing the opportunities for personalized healthcare, it can also set the stage for a more agile medical supply chain while improving surgery, trainee education, and patient engagement for years to come.

What’s next for 3D printing innovation
A variety of 3D printing workflows and materials for medical applications will move healthcare forward, equipping researchers, surgeons, radiologists, device engineers, dentists and orthodontists with the tools to provide patients with personalized, precision healthcare.

In addition to providing patient-specific devices and new medical device innovations at a lower cost, these materials can also help reduce risk and increase agility in the medical supply chain while improving surgery, trainee education and patient engagement for years to come.

For example, the pandemic sparked a rare, fast response in the industry as healthcare facilities innovated and collaborated to respond and deliver urgent patient care. Early 3D printing adopters were using the technology to create patient-specific surgical guides and anatomical models, advanced prosthetics, medical devices and more. When nasal swab shortages hit, existing 3D printers and a skin-safe material enabled a nimble response with a Covid-19 nasal test swab design created collaboratively by USF Health, Northwell Health, and Tampa General Hospital, and printed on Formlabs 3D printers. This quick action was possible through the collaboration and pre-existing materials for medical applications that were ready for use.

This nimble response shows how healthcare leaders can utilize medical 3D printing and these materials to create more nimble supply chains to be ready for the next crisis. It’s a case study in how global healthcare facilities can collaborate to save lives.

To move forward, medical device designers and manufacturers must embrace 3D printing and educate themselves about the technologies and materials available for healthcare applications. As new skin-safe materials are developed, the possibilities increase for providing patient-specific care at a lower cost.

Beyond improving patient care, material innovation and growing 3D printing adoption in healthcare will enable providers, facilities, and manufacturers to become nimbler and respond to crises and patient needs faster than before. Medical Design & Outsourcing