Medical Device AM Experts Tackle Quality, Software and Hiring

In 2009, researcher Justin Ryan discovered firsthand the limitations of a quality management system (QMS) based on a Microsoft Excel spreadsheet. At the time, he was working in the 3D printing lab at Phoenix Children’s Hospital.

“We were trying to track everything on the patient side and then we tried to track the 3D printing consumables and the 3D printing itself and the maintenance of the machine,” he recently told attendees at the MD&M West 2021 conference in Anaheim, California. “So we started to develop. And we had an Excel sheet with over 100 columns and it was no longer pragmatic.

At MD&M West 2021, Justin Ryan from Rady Children’s Hospital, Cambre Kelly from Restor3d, and Sean McEligot from Mayo Clinic have covered a wide range of topics related to the use of additive manufacturing for the development of end-use devices.

Ryan commented as a panelist for a discussion on AM for the development of end-use devices. He left the hospital in Arizona and is currently director of the Helen and Will Webster Foundation 3D Innovations Lab at Rady Children’s Hospital in San Diego.

More than a decade after the spreadsheet-based quality management system at Phoenix Children’s, Ryan said leadership and support for the quality aspect of his business was still lacking from regulators and suppliers. of software.

“We’re looking to see what the FDA says in this conceptual framework when it becomes more than just a concept, what kinds of QMS specifically do we need to put in place? ” he said. “This could still be developed in-house, as there is always this software mismatch meeting our specific needs as a manufacturer of hospital service points. “

The United States Food & Drug Administration released a guidance document in 2017 on 3D printing, but it did not include point-of-care manufacturing like that performed in hospitals, the FDA researcher said. Matthew DiPrima in a separate interview.

Sean McEligot, who is section chief of medical device research and development at the Mayo Clinic and who also spoke on the MD&M West conference panel, said his site had also developed its system for managing the disease. quality because the standard software is designed for large-scale applications. manufacture and not the “onesies” and “twosies” they make.

That should change, however, since Mayo acquired a titanium printer. Its intention is to go beyond the manufacture of anatomical models and laboratory instruments to manufacture custom 3D printed titanium implants for the patient. The U.S. FDA told Mayo it would be a medical device maker if that happened.

“As we look to become a registered device maker and audit likelihood, we’ll need to improve our game and focus more on making sure everything, every ‘i’ is pointed and every ‘t’ ‘is crossed out. “, did he declare.

Special segmentation software required

Quality management is just one of two shortcomings that software vendors can help developers of end-use devices.

They also need more options for FDA certified segmentation software.

These applications allow a user to segment the data in a CT or MRI DICOM file, separating surrounding tissue from bone, for example, and choose only the information needed for a 3D printing STL file.

“There are very few players in the game right now,” said panelist Cambre Kelly, vice president of research and technology at device maker Restor3d. “So hopefully we’ll start to see new packages and new features coming out in the next couple of years. “

In the meantime, Restor3d has started to consider writing some software in-house for its very specific workflows, she said.

Moderator Gaurav Manchanda, director of medical market development at 3D printer manufacturer Formlabs, said: “I think there are three vendors with [FDA] Approved Packages for Medical Models for Diagnostic Use – Materialize, 3D Systems, Synopsis is the latest, with more to come.

Ryan agreed with Kelly on the need for more segmentation software vendors.

“Certainly, from a hospitals point of view, I hope we will see more software that produces more competition and the prices go down,” he said. “.

The panel looked at the topic of finding the right people to use the software and printers to create new options for limb rescue and reconstruction, in the case of Restor3d, and the separation of the Siamese twins, that McEligot and his colleagues argued in Mayo, among other more frequent uses. .

“I actually went on Reddit and tried to hire a software engineer that I could teach 3D printing,” Ryan said. “I wanted a software engineer to learn how to operate machines but provide us with new resources,” for example, virtual and augmented reality.

He said the desired skills for potential hires include 3D printing and basic engineering design principles, including CAD and segmentation.

“It would be great to come out of a radiology technology school to know how to do 3D segmentation in a very efficient and high level way,” he said. “We see steps towards this space. “

Kelly said it was a huge benefit if the candidates had been exposed to the various software packages used by Restor3d for anatomical modeling.

“You even need to know what tools are available and at their disposal to be able to really get down to it,” she said. “Same thing on the print.

McEligot said his Mayo lab is fortunate to be associated with the Mayo Department of Radiology, where biomedical engineers are experts in using segmentation software. Its challenge is to hire to be a full-fledged medical device company.

“I would like a double major in mechanics and biomedical [engineering], “he said.” They would come with these SolidWorks skills (CAD-CAE software from Dassault Systèmes) or something equivalent, and then, as with medical device companies, this is an on-going training. ‘use. “

This OTJ training includes software for biocompatibility, sterilization, 3D printing, image analysis and segmentation.

Right now, one of McEligot’s best employees is an intern.

“He was running a 3D printing lab at the University of Wisconsin-Madison and took over the AM facility with a storm, and that brings us all kinds of new and great ideas,” he said. “So talent comes from everywhere. “

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