AMS 2025: Enabling & Scaling 3D Printing in Healthcare, Part 2 – 3DPrint.com

There were many reasons to be excited about this year’s Additive Manufacturing Strategies in New York City, from panels on venture capital, private equity, and M&A to the popular CEO roundtable. But I was most looking forward to the session on healthcare, which was absent from AMS 2024. According to AM Research, the 3D printed medical device market is expected to reach $16.5 billion in revenues by the year 2034. The technology has had a major impact on healthcare, from improved accessibility to prosthetics and lower development costs to more innovation in advanced medical devices and enhanced patient outcomes. So I was eager to hear from the experts at the event.

In part two of my healthcare write-up, I look at patient-centric devices and the policy landscape for AM in healthcare.

Patient-Centric 3D Printed Solutions Redefining Cancer Care

First-time AMS attendee Rajan Patel, the CEO of medical device company Kallisio, shared that he was “very impressed and inspired by all the stories.” He was there to share a success story.

“I’m discussing an actual application where we took additive manufacturing, listened to the clinicians, and worked with partners to get the product out to the marketplace.”

A brief background: Patel said that the MD Anderson Cancer Center in Texas wanted to change cancer care by providing patients with necessary treatment, but without harmful side effects. Often, cancer patients will lose their hair during radiation or chemotherapy, but another side effect is oral mucositis, which Patel said is “like a sunburn in your mouth.” It causes painful inflammation and ulcerations, which makes talking and eating difficult, and can even delay the patient’s cancer treatment.

“Close to 20% of the patients have to be treated for this, and it’s almost one-third the cost of a typical cancer treatment.”

MD Anderson was looking for a way to treat cancer that wouldn’t cause patients to suffer the excruciating side effect of oral mucositis. By working with Kallisio, they found the solution in a 3D printed medical device called Stentra: an FDA-approved, patient-specific radiation therapy device.

First, the patient undergoes an intraoral optical scan, and the design is created from that imaging. Once placed in a patient’s mouth, this custom oral stent pushes the patient’s tongue away from the tumor, which is where the radiation is aimed. This reduces the chance of developing oral mucositis, and has the added benefit of a more focused radiation therapy dose, which Patel says “also allows you to save money on the dosing itself.” Plus, Kallisio can deliver this patient-specific solution within 72 hours.

Scaling is the part that Kallisio worked on with MD Anderson, as this product does have to be regulated; as Patel said, “If you are a hospital and want this product, you can’t just take a 3D printer and make it.” The company partnered with Ricoh for the manufacturing and Materialise for the software.

“We’re a design house. We worked with physicians to design this product. But without these partnerships, it wouldn’t have happened,” he explained. “We can scale our technology with these partnerships.”

Are we sensing a theme yet? Collaboration continues to be key if we want our products to succeed in this industry, especially in highly-regulated sectors like healthcare.

The 3D printed Stentra device is a true medical success story. It’s available on the market, and Patel said that Kallisio is already working on its next two products.

Policy for AM Healthcare

The final panel in this session focused on the need for certification, advocacy, and reimbursement systems. Moderator Mark Burnham, the Director of Policy for Additive Manufacturing Coalition, first asked his panelists where additive manufacturing is at in healthcare today, and where it’s going in the near future, in terms of the impact on health, costs, and patient outcomes. Lexi Gormley – Clinical Applications Specialist, Additive Manufacturing, Ricoh USA, said AM is important for patient-specific applications, and that, while there’s still a long way to go, bioprinting applications is where the industry is heading.

“To get there, we need good policies implemented for bioprinted organs,” she said. “How do we make sure it’s a safe product to implant into a person?”

Unsurprisingly, Ankush Venkatesh, Intrapreneur, Additive Manufacturing, for Glidewell Dental, said that AM in the dental industry has “led the pack in many ways, like volume and speed of adoption,” and that he is most excited about the point-of-care aspect—about 50% of dentists have an intraoral scanner, which is often the first step to digitizing a clinic. Louis-Philippe Broze, co-founder and CEO of 3D design automation software firm Spentys, said we need more successes like the dental industry to show the power of AM, to “demonstrate the value to the market and make sure it goes to the next level.”

When asked about the impediments to the expansion of AM in healthcare, Venkatesh said that in a dental clinic, there’s often a certain expectation of what these machines will do. To meet these expectations and achieve ROI, modification and education is often needed, and none of this is helped by “OEMs and machine makers making false or misleading promises.” Broze brought up a “lack of harmonization” between the United States and the European Union, and said that “all the networks preaching to their local governments” should be sharing the same message.

Gormley noted that 3D printed anatomic models, and other medical AM technology, are not fully reimbursable.

“It’s our role to show the value in it, and why it should be reimbursed, and why it’s better than the current practice,” she explained. “If you’re talking point-of-care facilities, that’s a large investment for a hospital, so you have to convince them why.”

Just as Alexander mentioned in the earlier panel, you often need to make physicians aware that the technology even exists, and what it can do. Gormley went a step further by saying we need to let them know exactly why reimbursement should happen, like just how much OR time or blood the technology is saving.

Burnham wanted to know what—if we get past the impediments and regulations—excited the panelists about AM in healthcare. Broze noted that, while “the sky is kind of the limit,” not everyone is well-intentioned, so those regulations aren’t necessarily a bad thing.

“From a regulatory point of view, I think what’s needed more is a sandbox, where we can demonstrate the value,” he said. “You don’t want to create the whole framework and wait for the applications to come. We need to be pragmatic, given the space to innovate, while making sure patients are safe.”

Because Ricoh believes in democratizing additive manufacturing, Gormley was hopeful that the technology can spread to various hospital systems. That way, it can get to the people who need it but not otherwise have it, like patients who live in rural areas who would normally have to drive hours for treatment. Venkatesh is aiming for high-quality, same-day dentistry so patients won’t need multiple appointments; plus, it’s more profitable for the clinician as well.

The panelists also discussed the importance of certification, with Gormley stating that tracking 3D printed medical devices from start to finish can also bring about innovation—if something goes wrong, you can go back, find the problem, and make it better. This will also show insurance companies that you are making a safe, consistent, and repeatable product, which will make them more likely to reimburse you.

Burnham closed the session with his own call to action for healthcare workers: talk to members of Congress, and your community, about the availability of 3D printing, even if it’s not reimbursed yet.

“Once doctors understand that these are tools available to them, you’ll have a huge impact on the level of interest.”

Venkatesh asked him how we in the industry can best reach out to the policymakers. Burnham said the best thing to do is contact your local representatives, and mentioned that whenever he’s seen these representatives or their staff at trade shows, they often say they had no idea what AM is capable of creating.

“Everyone has a member of Congress, two senators. Invite them to your facility to see what you do. Tell them your narrative. From your patient’s perspective, from your small business perspective. You have an amazing story to tell.”