[Photo: Sarah Goehrke]

Continuing with our dive into this week’s busy RAPID + TCT in Fort Worth, Texas, the third keynote, sponsored by Materialise and held Wednesday morning, centered on point-of-care (POC) manufacturing, a topic we’ve been hearing about more frequently in the 3D printing field as of late. However, this nontraditional form of manufacturing is not new, having been used in hospitals as far back as the late 1970s, and according to a recently published white paper by SME, which hosts RAPID, over 95% of POC professionals are expecting POC manufacturing, enabled by just-in-time and on-site 3D printing, to grow.

Debbie Holton, SME’s Vice President of Events and Industry Strategy, said, “More growth is expected for medical and biomedical applications.”

Then Holton introduced SME’s Industry Manager Lauralyn McDaniel, an expert in her field who guides SME’s medical strategy. McDaniel, who conducted the organization’s first Medical Point-of-Care Manufacturing Survey, which is detailed in the white paper, also discussed a white paper onstage that was published last year regarding workforce development before announcing that SME had developed the first ever annual report to cover POC manufacturing, device manufacturers, and any medical professionals using additive manufacturing (AM) to impact their patients.

“97% of the responders expect an increase in the use of AM for medical applications,” McDaniel stated. “And they didn’t just expect an increase – over half expect more than a 10% increase in 2018. And they expect it across all the major categories of applications in medical.”

Challenges to this increase in adoption include funding and reimbursement, materials, a qualified workforce, and the regulatory environment. You can download the annual report for free on SME’s website.

Peter Leys, the Executive Chairman of Materialise, was on hand to introduce the keynote speakers, but first introduced the crowd “to somebody totally different – I would like you to meet Nathalie.”

3DPrint.com covered French citizen Nathalie Dufaut Danjon’s story in the fall, but it gave me chills to listen to Leys talk about how she, along with several members of her family, were attacked at a family wedding, and how Danjon moved past the tragedy with the help of 3D printing.

“What was supposed to be a lovely, long weekend gathering with family and friends turned into a nightmare,” Leys told the crowd. “The morning after the wedding, a heavily disturbed member of the bride’s family rushed into the hotel with a hunting rifle.”

Unlike some of her family members, Danjon escaped with her life, but spent six months in a coma before waking up to begin recovering after a bullet destroyed the anatomy of her shoulder joint and robbed her of mobility. Leys explained how Danjon visited roughly a dozen surgeons in six months in an effort to regain full mobility, and how she also “started studying.”

“She starts reading medical journals and papers…she becomes an expert,” Leys continued. “But every time she talks about these innovations she stumbles upon during her reading, and the potential of 3D printing to her surgeons, she gets the answer we’ve all heard before – 3D printing is at too early a stage, Nathalie. It’s too risky. It’s too expensive. Even 3D printing will not be able to help your complex case. It’s a gimmick.”

But Danjon persisted, and eventually Materialise Mimics 3D software was deployed to come up with a virtual, pre-surgical plan to fix her shattered shoulder. 3D printed surgical guides, and a custom 3D printed implant, were created and used, and Danjon has now regained “significant mobility” in her arm and shoulder. With the regained ability to do “simple but important” tasks again, like making the beds for her children, she also wrote and published a book, titled Shattered Dreams, about her journey.

[Photo: Sarah Goehrke]

“In some instances, probably rightfully so, patients sometimes accept a no. But in every instance, where a medical innovation is overlooked, a life is being destroyed,” Leys said. “That’s why we as an industry have to be as stubborn, strong, and determined as some of the patients that we can help – like Nathalie. That is what Mayo and Materialise are doing.”

With that, keynote speakers Jonathan Morris, MD and Amy Alexander, BME, MS, both from the nonprofit Mayo Clinic, walked onstage. The Mayo Clinic, which completes 75,000 surgeries a year and saw 1.3 million patients from 140 different countries last year, has become a major POC manufacturer for 3D printed anatomical models, and also uses virtual surgical planning (VSP) “as often as possible.”

Dr. Morris specializes in minimally invasive thermal ablation of tumors, and has used 3D printing for medical purposes since 2001, helping to develop the Mayo Clinic 3D Printing/Anatomic Modeling Laboratory, which he now co-directs, over a decade ago. Alexander, who converts 2D radiological images into 3D printed models in the Department of Radiology’s Anatomic Modeling Lab, designs and 3D prints custom surgical tools, such as cutting guides, to help improve surgical efficiency and accuracy.

“We 3D printed a lot of stuff over the years, but we really started small, and really complex,” Dr. Morris said. “Materialise has been a wonderful partner to us – we call them a lot and ask them, how can we do this, how can we make that happen?”

Mayo has partnered with big-name companies in the 3D printing industry, like Stratasys, Materialise, Formlabs, and 3D Systems, to bring 3D printing to the clinic.

“We had to figure out how to put industrial equipment inside a hospital…this requires a lot of facility work, and the vendors have been very good to us,” Dr. Morris said.

According to a 1977 study that was pivotal in developing what’s known as the Allee effect, the further away you are from your colleagues, the less productive you are as well, which is why Mayo Clinic decided to build the 3D printing center inside the hospital itself.

Dr. Morris said, “Even if it’s just three minutes down the street, to surgeons, that’s like another planet.”

The speakers asked for a show of hands in the keynote theatre to see how many people are currently working with medical 3D printing, and it was an impressive number of hands. Alexander then brought up the “long history of engineering” at Mayo, and how the multidisciplinary care already offered at the hospital “rolls right over into 3D printing….nothing changed about the type of care we were offering when adding 3D printing technology.”

“Having an engineer enroll in a clinical environment is just so different,” Alexander said. “The relationships I’m allowed to build with radiologists and surgeons are so valuable.”

Dr. Morris expounded on this, discussing the many different clinicians who were “coming and going” from the 3D printing center to pick up models for various surgeries.

The first case Mayo used 3D printing on was a difficult surgery involving conjoined twins and the need for a 3D printed liver model. A solid, well thought-out plan and ace surgical team were necessary to ensure no loss of life, and the team met and trained for months. While image processing has long been available at Mayo, and a lot of imaging was available for this particular surgery, it didn’t quite cut it.

“One of the questions we get a lot of the time in radiology is, ‘Why can’t you just look at the 2D images?’ The images are getting better, and available at the click of a button in 5 seconds,” Alexander said. “Why can’t you just use these great images?

“You can’t hold an image – you have no idea how big that is. A surgeon has to operate on this child with a severe deformity. Until the surgeon gets the life-size model in their hands, they don’t kow how to answer some of these questions.”

Dr. Morris said medical professionals are able to learn more about impending surgeries by holding and studying 3D printed models, as there are “lots of unknowns in the OR until you make an incision.”

Complex surgeries are successful because of entire groups of people working together to solve problems, and from anesthesiologists and radiologists to surgeons specializing in vascular and craniomaxillofacial, medical teams all speak different languages. That’s why 3D printed anatomical models are helpful to have, even of body parts and blood vessels nearby the surgery site, so teams can plan for both the expected and the unexpected.

“Once the doors opened on 3D printed tumor models, we never went back,” Dr. Morris said, noting that Mayo moved on with 3D printing from twins to spines to tumors.

He discussed how Mayo often works with Materialise, because its software is FDA approved, to figure out problems.

Dr. Morris said, “They’ve been an incredible partner – call them up and say, I’m stuck, can you help me?”

This is why it’s so important to collaborate with others, which the 3D printing industry does so well – we may not always know everything about  a specific topic, but we can call on someone we know who does know and can help.

Mayo first decided to bring virtual surgical planning in-house in the mid-90s, and turned to Alexander for engineering; one of the major benefits of moving to in-house clinical engineering includes operative efficiency. But there are also a lot of steps when it comes to VSP, which is “not push button,” and imaging is always the first one.

“Even showing segmentation is important, so surgeon can see differences,” Alexander explained.

“Surgeons come in and sit down, with coffee, and together we look at imaging and plan the surgery out in a low-stress environment. How is this surgeon going to resect this piece of bone and then reconstruct it in the best possible way for this patient?”

Completed parts must be properly sterilized, once they’ve been 3D printed with the proper material, and implants also have to be able to hold up under radiation.

As we’ve heard time and again, the less time spent in the operating room the better for patients, and this is why 3D printed guides are so useful during the surgery itself.

The KLS Martin Group, which often uses 3D printing for surgical purposes, also works with Mayo, manufacturing 3D printed surgical guides and plates. In one particular case study mentioned in the keynote, thoracic surgeons at Mayo used a 3D printed model from the company to help them figure out a minimally invasive surgical plan that would avoid having to cut through the patient’s ribs but would still allow them to remove all of the tumor. The patient left the hospital three days later, with no remnants of the tumor left and having spent no time in the ICU.

The hospital offers an array of different 3D printing technologies, and is currently investigating whether to add SLS to the list. Alexander also noted that their 3D printing processes include  instructions, which is “important for any clinic and surgical technology.”

“At Mayo, you’re allowed to work together with people who are all trying to do the same thing – it’s not about you, it’s only about the patient.”

That, in a nutshell, is the whole point of using 3D printing in POC manufacturing – it’s about the patient.

Stay tuned to 3DPrint.com for more of our coverage from RAPID + TCT.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below. 

[All photos: Sarah Saunders unless otherwise noted]

 

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