If you are familiar with the additive manufacturing (AM) world, you know RAPID + TCT is the premiere exhibition and conference event for AM in North America. As one of the largest and most influential AM gatherings, many of the world’s AM organizations exhibit during the event.
Over the years, the number of technical presentations and workshops has noticeably increased, and 2023 was no different. The medical and healthcare space was an early adopter of additive manufacturing, and the industry’s presence was again strong throughout this year’s edition of RAPID + TCT, including notably during the conference arm of the event.
For two days in downtown Chicago, Illinois (May 2-4), the AM community participated in more than 20 conference track healthcare-focused presentations, a pre-conference workshop on applications of 3D printing in healthcare, and four mainstage thought leadership panels specific to healthcare.
A major focus for the additive manufacturing healthcare community continues to be point of care (PoC) 3D printing. There were several panels on the topic and the conference track presentations had strong representation from the VA Office of Advanced Manufacturing, one of the leading groups using PoC 3D printing and the first hospital system to have 510(k)-cleared 3D printed devices.
One particular panel of interest for PoC discussed regulatory considerations for hospital-based 3D printing. Each panelist represented a perspective from the FDA’s Discussion Paper: 3D Printing Medical Devices at Point of Care: Ben Johnson, representing a traditional manufacturer of medical devices; Dr. Beth Ripley, representing a hospital organization with sites registered as medical device manufacturers and devices cleared by the FDA; Joseph Lipman, MS, representing a hospital with a traditional medical device manufacturer embedded within the hospital; and, Dr. Jonathan Morris, representing a hospital using AM equipment and cleared software to serve the needs of a unique patient population.
[Image courtesy of the author]
One take-away from the discussion was the idea of a medical device production system (MDPS) – a complete validated system that would produce a final device locally and operated by the hospital team – which seemed to be a clear need from these thought leaders. However, understanding the requirements from worldwide regulatory bodies is the missing piece.
Matthew Di Prima, a materials scientist with the FDA, shared his initial thoughts on an MDPS from an FDA perspective. Their concept would include a more flexible option than the Australian regulatory body has discussed, for example, where a healthcare provider could have components of a medical device production system that could be used to make multiple devices within a specific validated workflow. One main advantage of this panel-discussed concept is that users will be provided with all the pieces to make a device locally, and not have to vet or reinvent the wheel because the entire system would have been previously validated.
When making medical devices, inspection and quality control are two important pieces of the puzzle, so naturally these were topics of interest throughout the entire RAPID + TCT conference program. For instance, one technical talk introduced near-infrared spectrometers as part of 3D printing in-pharmacy quality framework for patient-specific drugs. These spectrometers could measure critical parameters, such as dose and ingredient distribution during the printing process.
Additionally, the panel, “A Review of Risk Acknowledgement and Risk Mitigation in 3D Printing Activities” touched on how to apply a risk framework when producing medical devices at different locations. The main suggestion from the panelists, especially when a healthcare organization is providing devices for themselves, was to document the thinking behind what has been decided and the risks considered in making that decision.
When thinking about what to document, it was suggested to consider that when the device and process creator leaves, what information would be needed to recreate that same device six months later? Proactively asking and answering this question will help determine what should be documented.
In order to further reduce risk for the healthcare facility, which Ricoh 3D has employed, another option is to have medical device manufacturer employees co-located in the healthcare facility. In this case, Ricoh 3D would take on the risk and regulatory burden as the medical device manufacturer and provide the 3D printing service to the hospital system in-house.
A common question that medical device professionals receive in the context of additive manufacturing is, “What materials are missing from the AM portfolio?” Because medical device regulatory strategy is largely dependent on using a predicate device and a material with clinical history, what the industry has so far works quite well (e.g., cobalt chrome, titanium and titanium alloys, and PEEK for implantable devices). However, after hearing some of the encouraging developments from the panel, “Bridging the Biomaterial & Bioprinting Gaps Facing the Industry,” that question might now be answered differently.
After many years of research (and what some might consider hype), biomaterials and cells could be the next frontier in 3D printing material development for healthcare. FluidForm, Dimension Inx, and 3D Systems Regenerative Medicine group shared exciting advancements during their panel sponsored by ARMI BioFabUSA. These milestones include the first 3D printed regenerative bone graft product clearance (CMFlex by Dimension Inx) as well as FluidForm’s novel printing method called FRESH, which embeds the printing process in a sacrificial support bath to maintain positions of the proteins and cells until they can keep their intended shape.
Katie Weimer, VP – Regenerative Medicine for 3D Systems, also shared a few interesting developments regarding a partnership with United Therapeutics Corporation on a 3D printed lung. This lung is considered the most complex item ever 3D printed, having hundreds of millions of capillaries and alveoli, which if they were strung end-to-end, would be 4,000km long.
Outside of this thought leadership panel, GE Research provided an overview of their work in ceramic additive manufacturing, biomechanics, and bone and vascular engineering to address load-bearing bone regeneration.
There were also a few new and/or expanded announcements of interest to the medical community at RAPID + TCT including (but not exhaustive):
3D Systems Healthcare introduced an update to the Kumovis R1, now rebranded as the EXT 220 MED. This newer version is claimed to be 30% faster than the previous version. The machine prints PEEK, Radel, and PPSU materials, which are important for medical implants (PEEK) and instruments.
Ricoh 3D for Healthcare received FDA clearance in early May for cardiovascular, neurological, gastrointestinal, genitourinary, and breast diagnostic 3D printed models. This is an expansion of their previously cleared craniomaxillofacial and orthopedic patient specific model service.
One technology that may be interesting to the orthosis and prosthetic (O&P) world is InkBit’s multi-material 3D printing technology. Their machine can create a multi-material output using mechanical connections. As is common with AM, design can be used to modify mechanical properties of these materials, introducing some very soft options. While the machines are quite expensive and it’s still unclear if these materials are appropriate for skin contact, it may provide new opportunities for O&P designs in the future.
InkBit Multi-Material Additively Manufactured Sample Part [Image: InkBit]
Although it was difficult to see even a fraction of everything at RAPID + TCT this year, with close to 400 exhibitors and more than 130 technical presentations, I hope this overview provided a glimpse into the top medical-focused areas.
For more information, the panels mentioned in this article can still be viewed in the SME Events app in the RAPID + TCT event section.
