Who’s up for a challenge? Moving additive manufacturing forward

Barrier #3: Ensuring regulatory compliance

By its very nature, healthcare is a regulatory-intensive industry. Medical devices, tools, and processes must undergo rigorous testing before being permitted by the FDA for sale and general use.

While the regulatory focus remains on the physical output from the manufacturing process, there are considerations unique to additive manufacturing that need to be addressed to ensure the continued safety and effectiveness of the printed part, whether it is a one-off, mass-customized, or mass-produced product. Some of these considerations include:

• Part placement within the build

• Part orientation

• Feed stock material recycling/variability

• Printed material mechanical properties

• The effects of post-processing

The assessment must also include the upstream digital processes utilized to generate the CAD and machine files.

Barrier #4: Navigating complex go-to-market processes

In addition to hiring the right people with medical backgrounds and proven track records in securing FDA and insurance approvals, organizations can consider collaborating with medical companies or research organizations on specific additive manufacturing projects. This helps fill the skills gap in highly specialized areas to help prevent risks and to keep progress on track.

Barrier #5: Ensuring consistent output, reliability, and support

Adoption of additive manufacturing can be limited by process factors that affect your ability to consistently provide reliable products at expected levels of service. These can include the environmental conditions of factories across geographies and the lack of reliable network production locations.

While additive manufacturing technologies are maturing, some products suffer from reliability issues. These challenges can also extend to technical service and support as well as supply chain issues preventing the delivery of the right quality of raw materials.

Today, no single company can deliver everything needed to launch additive manufacturing in healthcare into the mainstream.

Instead, look for partners, collaborators, medical organizations, and raw materials providers that all share the common goal of advancing this technology with the highest levels of reliability and support.

As the industry develops, new AI technologies and machine learning algorithms will help improve the quality of products, scalability of the processes, and make steady progress against today’s challenges.

Right now, we’re just scratching the surface of the value additive manufacturing can deliver. While there is still hard work to be done to improve processes and deliver higher levels of quality and reliability, the companies that do this right, first, will have a distinct advantage over competitors — regardless of their industry.