3D printed anatomy being held by hands with blue surgical gloves, one side has a pen pointing to the 3D model

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

By Ryan Hess & Gary Turner

Summary

Five barriers to adopting additive manufacturing — and how to overcome them

Read time: 4 minutes

In the first two articles in this series, we discussed the differences between 3D printing and additive manufacturing and how direct digital manufacturing delivers personalized experiences.

In this third article, we examine barriers to adopting additive manufacturing and how to overcome them. Nearly all emerging technologies have barriers to mass adoption, and additive manufacturing is no different. As an emerging technology, the potential to capitalize on this market opportunity is high, with a growth rate over 20% annually.

The opportunity to deliver tremendous value is particularly high, especially in healthcare. For example, the consumer healthcare accessories industry can utilize additive manufacturing for mass customization of teeth aligners, hearing aids, orthotics and casts.

Before detailing specific barriers, it’s important to reiterate the benefits early adopters have already experienced. These include:

  • Lower start-up costs compared to traditional manufacturing

  • Faster speed to market

  • Lower inventory costs

  • Reduced waste

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.

So, what are the barriers, and how do you overcome them?

There are several challenges to adopting additive manufacturing, with applications across many industries, but we’ll use healthcare as an example. Knowing the hurdles and, more importantly, how to overcome them will help spur mass adoption of this technology that is already delivering proven results.

Barrier #1: Minding the skills gap

Mass adoption of any emerging technology in healthcare requires extensive expertise in the specific areas where it is being applied.

In healthcare, additive manufacturing engineers need to understand biomedical engineering with knowledge of anatomy, clinical intervention understanding, and the rules and guidelines of additive manufacturing. These engineers must have the skills to determine which of the wide range of 3D printing technologies and materials are best suited for specific projects. They need to account for financial issues related to volume requirements, output options, material processing considerations, the longevity of a program, and day-to-day operations. In addition, compliance, regulatory and legal departments will need to be involved.

Barrier #2: Building the right team

As with many new technologies, individuals with a specific skill set that incorporates everything are probably in short supply.

Consider building collaborative, cross-functional teams with the right people with skills in additive manufacturing, design for additive manufacturing (DfAM), anatomic modeling, biomedical engineering, and patient-centric design.

Also, consider outsourcing or partnering with experts in additive manufacturing services. Over time, the market for skills will mature, and finding individuals with all the right skills will be more pervasive.

See why RICOH 3D for Healthcare was awarded Best New Technology Solution - Orthopedics by MedTech Breakthrough Awards.

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.

How can you overcome the barriers and move your additive manufacturing program forward?

Additive manufacturing has clear benefits across multiple industries for its cost and environmental advantages. Advancing additive manufacturing in healthcare has the potential to redefine the cost/benefit structure that has plagued the industry in areas including personalized implants, orthodontics, dental models, and developing artificial tissue and models of organs to improve the quality of care for specific patients.

The possibilities of saving lives and improving health are huge without the barrier of having to mass-produce products to make solutions affordable.

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.

Learn more about additive manufacturing in our prior articles including a primer on additive manufacturing and building the new era of personalized customer experiences.

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