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The Quest to Solve Additive Manufacturing Challenges

By Rob Meyer

Orthopaedic device companies and their suppliers face a host of critical challenges when implementing and adopting additive manufacturing (AM), or 3D printing.

Companies of all sizes seek to ensure ROI with AM while simultaneously staying abreast of a convoluted, confusing and unclear regulatory path. AM users are constantly managing supply chain expectations, quality control, design considerations, purchasing decisions and much more. Despite these challenges, we believe AM brings transformational potential to the medical device industry.

The exciting future of the technology in the orthopaedic space cannot be understated.

What used to take weeks, or even days, to manufacture now only takes a matter of hours with the technological innovations of AM. Getting products to market sooner can add up to millions of dollars in extra revenue. But with these innovations brings questions. Best practices surrounding the technology are being discussed globally by ORTHOWORLD® customers every day.

These discussions include, but are not limited to, the following topics:

AM Implementation and Advancement for OEMs. Conversations around AM often center on aspects of cost, speed, advanced designs and clinical outcomes. Our highly-regulated, patient-facing industry demands quality — of the process, machine and finished product. Device companies implementing or exploring the use of AM must consider how quality applies to the technology. It’s a question that must be answered whether you’re utilizing additive in-house or exploring outsourcing options.

Enhancing Design through Engineering and Manufacturing Collaboration. Unlike conventional manufacturing, AM requires design and manufacturing teams to work closely together very early in the design phase process. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make AM work for you. We highly recommend developing pre-established best practices when working with both external and internal suppliers.

Powder Considerations. AM is no different from any other manufacturing method in that your part is only as good as the quality and type of materials selected. When choosing materials for orthopaedic AM applications, several factors must be considered. There are various metal powder options to consider when implementing AM. It is imperative companies choose the correct option to meet their manufacturing goals.

Mechanical Test Methods. Medical devices fabricated from additively manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Staying current on the various test methods for characterizing AM devices is critical, as is understanding the differences between testing AM devices and devices fabricated with traditional machining methods.

Developing a Roadmap for Regulatory Guidance and Standards. FDA published its guidance on AM technical considerations late last year, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said the 38-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the AM narrative. With that being said, regulatory concerns are often voiced by ORTHOWORLD® customers. Few topics have dominated our conversations with device companies, suppliers and surgeons like AM has in recent years. In that vein, clearer guidance is desired. We expect the questions we’ll field from industry and our customers alike will evolve as companies experience successes and failures with AM technology.

Supplier Relationships. Amidst the rising popularity of AM, OEMs that want to bring the process in-house must have deep knowledge of and a strong business case for the technology in order to truly adopt it. Many OEMs outsource use of the technology until they’re able to demonstrate the expertise needed and can justify the volume to purchase machines. Still, the need remains for partners who can assist throughout the product development lifecycle. There are many suppliers that will work with OEMs as a trusted partner to guide you down the winding AM path

As orthopaedic companies invest millions in AM, the need has never been greater to identify the tools, expertise and knowledge requited to fully realize the technology’s benefits. Enter OMTEC®, the Orthopaedic Manufacturing & Technology Exposition and Conference, which takes place June 12-14 in Chicago.

OMTEC® 2018 features the GE Additive Tech Center, a one-stop-shop where all of your questions about AM can be answered in a practical, conversational and straightforward manner. Education, discussion and insight will be provided by more than 20 AM experts in a thought-provoking, timely and critical one and a half day seminar.

In short, this is the must-attend AM conversation of the year.

Rob Meyer is ORTHOWORLD's Senior Editor. He can be reached by email.