PHOTO: EOS NORTH AMERICA

By 2027, additive manufacturing (AM) in the medical device industry is expected to be worth $4.4 billion, with a compound annual growth rate (CAGR) of more than 16%. This staggering growth didn’t happen overnight.

During the last three decades, leaders in the medical device industry have been behind some of the most significant advancements in AM, from 3D printing human tissue to fully customized prosthetics.

Yet, many organizations focus on these major innovations instead of looking for incremental improvements, such as making current processes more efficient or consolidating parts – steps that can greatly impact their operations.

Building a sustainable and highly efficient AM production facility requires developing an end-to-end 3D printing strategy within your organization and with an experienced partner.

Additive-first mindset

Every organization’s AM strategy will be different, especially for medical device manufacturers who have significantly more oversight from more regulatory bodies than other industries.

Regardless of the end product, all businesses follow a similar AM roadmap for adoption, and the first step doesn’t involve a costly investment.

Before you can identify what to produce additively, you must have an organization-wide understanding of how the technology will impact your business – implementing 3D printing capabilities means designing for additive first, which can’t be done in a silo. Ensure you have representation from all departments, especially during the first high-level assessment, to bring in new perspectives and get buy-in from leadership throughout the organization.

AM is a complex topic, and you’ll also need to build up competencies to lay the groundwork for AM success. Most organizations find they need to bring in experts and other partners to supplement any knowledge gaps.

Start with biggest challenge

Once you have internal alignment – and before you begin production – assess your portfolio to identify the most feasible applications for 3D printing. It’s tempting to launch AM with a new product, but that makes it tough to measure success and escape pilot mode. Instead, start with narrowing down current applications that would be suitable. Evaluate each application through the lens of technical and financial requirements and advantages.

Technical fit

Industrial 3D printing enables complex structures, functional and part integration, and mass customization – all advantages for medical devices that are accountable to patient-specific needs and anatomies.

When looking for applications that are a technical fit, there are three essential criteria to consider:

Size: 3D printers are typically suited for smaller, complex components. Build chamber sizes can vary depending on the type of AM platform, but applications are not limited geometrically. Looking at your parts by size is a quick way to narrow down your list.

Materials: A range of polymer and metal materials have some clinical history. Don’t eliminate an application based on the material alone but ask if there are parts where you could use similar, if not the same, materials used in conventional manufacturing. Custom materials are available, but it’s best to start with a standard set of materials – especially those approved for medical devices.

Quality requirements: Can 3D printing fulfill the necessary criteria for any part on your list? Here’s where regulations and certifications come into play. Additionally, are there geometries, tolerances, or surfaces that must be replicated through AM?

3D-printed cervical brace
PHOTO: EOS NORTH AMERICA

Economically viable

AM isn’t a replacement for traditional manufacturing. For some applications, conventional processes remain a better option, which is why it’s vital to analyze your portfolio regarding what will create the most value and help make a business case. Use the following criteria to evaluate each product for AM.

Complexity: How complicated is it to manufacture the part traditionally? Is it even possible to manufacture using traditional methods? Do you produce it in small volumes? The more complex a build is, the more cost-effective it is to create via AM compared to traditional manufacturing. The same can be said for small and mid-sized series productions and parts with complex geometries.

Cost-per-part: Comparing AM to traditional methods is never easy. To get a comprehensive cost calculation of AM, you’ll need to consider all design and creation process steps. This analysis includes how AM will benefit everything from data preparation and part production to post-processing and quality inspection.

Value add: Any part produced additively should create value. To determine this, look at it from the perspective of product, operational improvements, and supply chain. Will AM allow you to develop patient-specific customizations? How will you benefit from limitless design capabilities? On the operational and supply chain side, look at ways you can reduce assembly steps or time to market. How beneficial will digital twins and digital inventories be to your value chain?

Once you’ve gone through these steps, assess both areas with equal importance. Look for the product with a high level of suitability to help prioritize where to start.

AM pipeline

Your first venture into 3D printing will take a lot of hard work, but time spent preparing your workforce, identifying the proof of concept, and building a business case for AM will go a long way in making subsequent product transitions easier and quicker. When you look at the pipeline with a qualification perspective in mind, you can create a quality system that can be leveraged for subsequent products without re-inventing the wheel.

A successful AM process is attainable when the right steps are taken. Working with a solutions provider with proven experience and end-to-end expertise can help kick-start your initiative and guide your entire AM journey from set-up to serial production.

EOS
https://www.eos.info

About the author: Laura Gilmour is a senior healthcare development manager at EOS North America. Connect with EOS through social media at Linkedin.com/company/EOS; Facebook.com/EOSGmbH; and @EOSNorthAmerica.