Imagine a world where, instead of a physical warehouse full of actual products collecting dust on a shelf, you have an entire digital warehouse of design files for those products available at your fingertips. Suppose this digital warehouse also exists in the cloud. In that case, you can access design files from anywhere with an Internet connection instead of only at a warehouse that could be anywhere from a few to several hundreds of miles away. Instead of having to wait for a part or piece to be delivered, you can manufacture the part in almost no time, on site, while meeting regulatory requirements. This scenario isn’t far-fetched, and it is becoming today’s reality through industrial 3D printing, otherwise known as additive manufacturing (AM).

There is an urgent need to design new medical devices that are reliable and can be efficiently mass manufactured with 3D printing. (Credit: EOS)

Implications for Industry

AM isn’t a new process. Industrial-grade 3D printers have existed for decades, but only in the last few years has the technology advanced to a place where it can rival traditional manufacturing processes in terms of production quality and value. These advancements have also opened new possibilities for the medical design industry. It is now possible to combine multiple components into one 3D printed part, create stronger elements that are lighter weight, and even bring new ideas to life that were previously too complex to manufacture because of traditional manufacturing limitations. The medical industry has only just begun to scratch the surface of what is possible with AM.

Titanium’s material characteristics make it ideal for many high-performance medical applications that require biocompatibility. (Credit: EOS)

That could change in the not-too-distant future, however. We may look back in hindsight one day at the coronavirus pandemic as a tipping point for adopting and utilizing AM. The pandemic has already exposed weaknesses in supply chains that AM can help remedy through localized manufacturing. The scenario described earlier with the creation of digital warehouses is already gaining momentum as a way of producing lower-volume components or products on-demand. Organizations with AM capabilities were also able to offset shortages in vital PPE for frontline workers.

Longer term, the pandemic’s economic impact may pave the way for a period of innovation and advancement in medical design. While it may sound counterintuitive, there has been a lot of consolidation across the industry recently, with larger organizations acquiring smaller or midsized ones. This is coupled with temporary industry slowdowns as fewer people elect to get procedures, and R&D personnel have more time to think about future use-cases for 3D printing. These factors will even lead to increased innovation from companies identifying new and exciting ways to leverage the technology. And the organizations that don’t already have an AM mindset in their operations will find themselves playing catch up.

Are You AM Ready?

Successfully implementing and using AM requires more than plugging in a machine, downloading some software, and hitting print. Additive manufacturing necessitates medical design professionals to think differently — to think additively.

Although AM is an agile and adaptive technology, it’s important to remember it isn’t intended to replace conventional processes. Instead, it is another tool in your manufacturing toolbox. For instance, take the custom orthoses and prostheses industry. They help provide better mobility and improve recipients’ livelihood, but every patient has different needs and anatomies.

With traditional manufacturing methods, like casting and molding, producing custom prostheses and orthoses requires a high level of human involvement and is costly and time-consuming — not to mention that patients in rural areas may have to travel long distances on multiple occasions to get properly fitted or for adjustments.

For these applications, 3D printing offers virtually limitless design possibilities and superior customization with quicker turnarounds. The result is a device perfectly adjusted to a patient’s specific needs. There is less waste generated for the manufacturer, and in some cases, the devices are ready to be fitted in as few as 10 days.

Having an end-to-end manufacturing process with the flexibility to produce in whatever method makes the most sense for each product is incredibly beneficial and strengthens your entire value chain. Getting to this point, though, where additive technology is fully integrated, is quite difficult. The process is more complicated than most people realize, and many organizations fail to go beyond the pilot stage. On top of it, the medical device industry has significant oversight to deal with, making it even more challenging to reach its full potential.

Emergency use authorizations have been pivotal during the pandemic, but these are exceptions. Under normal circumstances, manufacturing and design processes are all well documented and understood, ensuring that the manufacturer is making the same safe and effective device every time.

As manufacturers start to think about a future beyond the pandemic, creating a low-risk AM pipeline becomes more about shifting the way you think and identifying gaps in your operations that the technology can solve. Here’s where a knowledgeable AM partner can teach you what you need to know so you can apply it to the next product in your pipeline. They’ll help assess your AM readiness, minimize risks in investments, and optimize competitive advantages.

Steps for Implementing 3D Printing

As noted, bringing on industrial 3D printing is more than investing in a machine. It’s a complete and fundamental shift in how you do business and operate. Your organization will have a unique journey and goals, but the steps below, outlining the absolute necessities for embarking on a successful implementation, are similar for everyone.

Shifting your approach. Industrial 3D printing is a change strategy. Similar to any digital transformation, it involves a rethinking of your design process, manufacturing philosophy, and supply chains, as well as an organization-wide commitment.

The most crucial first step is to look inward at your challenges or pain points and develop strategies to help you reach your desired end goals. At this stage, you’ll start to identify AM knowledge gaps, understand your opportunities and risk/benefit ratios, and begin to take on an additive-first mindset. Keep in mind that your needs will be determined by preexisting structures and products within the company.

Creating a Business Case. Justifying the financial side of AM is complicated. The machines can be pricey, and when the cost-per-part of 3D printed products is compared to those manufactured via a traditional method, the AM prices tend to look much higher on the surface. But this perspective doesn’t consider lower minimum quantity orders, simplified supply chains, patient- or user-customized application, or reductions in waste, among other efficiencies enabled by 3D printing.

When you first approach AM as a viable solution, it may be tempting to start with a net-new product offering. But, without a previous part to compare it to, it becomes almost impossible to measure your success. A better approach is to go back to one of the problems you identified and ask yourself, can I solve it in a new way with 3D printing?

The Mecuris Cervical Orthosis is built using PA 2200, a polyamide with color added. (Credit: EOS)

One example may be in the long tail of the product portfolio. Are there end-of-life products or spares with low order quantities? Switching to parts designed with additive in mind allows you to avoid large stockpiles of low-need parts, minimizing costs without losing supply chain robustness. Another area you could focus on is the other end of the spectrum, at the beginning of a part’s life. Are there components you can redesign for a better fit or function or to decrease costs? You might find that going forward with a design for AM not only helps with prototyping and initial pilots but throughout the product life cycle.

Regardless of the business problem you’re trying to solve, you want to start with the most complicated process, not the simplest, and get the process right before moving on. Conduct due diligence, and don’t cut corners. This will make every subsequent product transition more straight - forward because you’ll already have the right steps in place for success.

Building Cross-Functional Teams. A product development engineer working on a design and then throwing it over to the manufacturing team to figure out how to make it a reality doesn’t work with 3D printing. No one can create AM applications in a silo. All sides need to have input during all stages of the design and manufacturing process.

This organizational arrangement is common in the software development world, where it’s referred to as a team of teams. In this approach, teams include people from various areas of your business who have in-depth knowledge of AM and can work together fluidly. They can still operate in their normal hierarchies but must have the flexibility built in to work cross-functionally regardless of titles or roles. This setup enables an agile and open work environment that plays off their strengths and expertise, allowing you to pull in people as needed.

Boosting Education and Knowledge. Even if your team has the skills needed to get your first 3D printed product off the ground, there’s value in continuing to learn about the technology. Further training and education open up opportunities, and those opportunities become competitive advantages.

Most companies EOS has worked with have continued to grow and evolve and build upon their groundwork. And because they made an initial commitment to AM years ago and focused on building internal knowledge throughout their organization, they’re already several evolutions deep into their 3D printing integration.

Rethinking Medical Device Manufacturing

In preparing your organization for 3D printing, you’re also preparing for the holistic benefits of the future of manufacturing. Think of AM as part of a bigger workflow — a workflow that the entire manufacturing universe is shifting toward, especially after the current health crisis. Is it a magic pill? No, but manufacturers should take the noise and chaos happening in the industry now as an opportunity to do things differently so they are better prepared and positioned for improved manufacturing systems in the future.

This article was written by Fabian Alefeld, Additive Minds Manager for EOS, Pflugerville, TX. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the March, 2021 issue of Medical Design Briefs Magazine.

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