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Safety

May 9, 2024 by Newsdesk

As the demand for patient-specific implants continues to grow beyond the ability of manufacturers to keep up, healthcare leaders like Mayo Clinic and the U.S. Veterans Administration  are busy making plans to establish their own facilities and start 3D printing metal implants on-site.

Currently, the most common healthcare use cases for additive manufacturing are developing anatomical models to help patients understand their upcoming procedures and customizing surgical instrumentation.

All signs point to a future in which healthcare organizations will be manufacturing devices at the point of care (POC). That means that hospitals will soon be the newest members of the medical device manufacturing (MDM) industry, a proposition with real institutional and infrastructure challenges. “After all, this is not what healthcare facilities are really set up for,” says Severine Valdant, chief commercial officer for QuesTek Innovations, a leading materials engineering firm, and a founding member of the AddUp medical advisory board. “It takes a different way of thinking for a hospital.”

The AddUp Medical Advisory Board was established in 2023 in order to provide the company with nonbiased, holistic perspectives on the application of metal 3D printing technologies for healthcare. Severine Valdant provides her unique perspective as a leader in the development of medical devices and 3D printing. Before joining QuesTek, she led the transformation of Oxford Performance Materials into an additive manufacturing leader, helping it become the first company to receive FDA approvals for 3D printed polymeric implants.

Key stakeholders recognize value of 3D printing

Even with the challenges that additive manufacturing brings for healthcare organizations hoping to leverage 3D printing at the point of care, the concept is gaining widespread acceptance among healthcare executives and other key stakeholders.

  • OEMs are making big advances. “If printer manufacturers can deliver an all-in-one solution, it makes it much less difficult to implement AM at the point of care and we’re not that far away,” says Valdant. The good news is that companies like AddUp are bringing new printers to the marketplace that can be easily integrated with other established systems and processes.
  • The FDA is on board. “In fact, they see a lot of value in POC manufacturing and they’re working with players on the healthcare and OEM side to figure out what regulations or guidelines are needed to make it happen.”
  • Surgeons are enthusiastic about the possibilities. “I’ve talked to a lot of them and they’re pretty excited about the etools, but we need to be careful that they don’t stop being doctors and become engineers,” Valdant continues.
  • Administrators play a key role. “They’re the big decision makers. If we bring AM to the point of care, they need to see a good ROI.”

Future Applications

The future of healthcare is personalized medicine and POC manufacturing will play an important role. We expect that there are many new uses cases on the horizon that will push the boundaries of the technology and broaden its possibilities. These include advances in the just-in-time manufacture of single-use, procedure- and patient-specific instrumentation to replace traditional systems at affordable costs.

The sweet spot for future applications of POC AM will be procedures for which there is not a convenient or effective off-the-shelf implant option—including complex surgeries for knee, hip, and pelvis reconstructions; spine surgeries; and tumor modeling for cancer patients.

In addition, AI and machine learning will soon enable the automation of workflows and speed production of patient-specific implants, improving development times from as long as 18 months to a matter of days. This is expected to improve patient outcomes exponentially, while also reducing operative times and the need for additional corrective surgeries.

The Right OEM

POC manufacturing will need to be an effective partnership between healthcare facility and OEM. “I think we’re a lot further ahead than we were 10 years ago, because collaboration between the two is happening,” Valdant continues. “With our deep knowledge of the medical market and a solution that is very efficient and integrated, AddUp will be a great partner on the OEM side.”

Filed Under: Medical, Safety, Uncategorized

March 5, 2024 by AddUp

Across all of manufacturing, safety should be a top priority. That certainly holds true in the much newer world of metal additive manufacturing. In our realm, the majority of risks come from using metal powder – both in its raw form and the condensate byproduct it produces during the melting process. Using a fine feedstock, with the smallest particles being on the order of 1 micron, allows for fine features and other design freedoms but also presents most of the safety risks we face in Powder Bed Fusion. Michelin launched AddUp to drive the future of Powder Bed Fusion, and here we will look at their influence in improving the safety features on the newest fleets of machines.

Metal powder in it’s raw form is a hazard to the touch and through the air. Some particles are fine enough that human skin does not serve as a barrier, so the powder acts as a vessel for heavy metals to work their way inside the body. Finer particles also hang in the air for longer, where it becomes possible to enter through the lungs. With employee and customer safety always being front-of-mind at AddUp, the design of any 3D Printer being used in their facilities had to mitigate these health risks for their employees.

The question shifts to How can you minimize operator exposure to powder without sacrificing any functionality on the machine? AddUp’s answer is the Autonomous Powder Module, the powder handling system on the Form Up 350. The main components in the APM are the Glovebox, Hopper, Sieve Unit, and Feeding System, all of which are kept inert. Powder is loaded through the glovebox of the APM and is transferred via vacuum suction to the Hopper, which has a capacity of 59L. Prior to a build, powder will move from the Hopper and through the Sieve, with the Feeding System providing the sieved powder to the interior of the Form Up’s build chamber.

After the build completes the operator vacuums the remaining powder with an interior nozzle, sending that material back to the Hopper where it can be used for the next build. The APM contributes to maintaining a safe environment by separating the operator from the powder and keeping the powder away from oxygen at all times.

The single most dangerous product of Powder Bed Fusion is the condensate formed during the melting process. Condensate is flammable, an explosion risk, and readily reacts with oxygen – with the worst case scenario being when Titanium is the base material. A common solution is paper filters, but those must be serviced and replaced by a human. These filter changes are a source of many of the safety incidents. That risk inspired AddUp to move away from paper filters and partner with Herding Filtration. With the Herding system, fumes are collected in the Fluid Module and dispensed into a metal dust bin (both of which are kept inert). In addition to the condensate, Calcium Carbonate is used to passivate the hazardous substance and inhibit any sort of reaction. Swapping out the dust bin is a simple process that takes 1-2 minutes, and is much safer than changing a filter. Dust bins are replaced about twice a month, depending on machine usage, and the remainder of the Fluid Module can go multiple years without being serviced.

Powder management may be the most important aspect of safety in Metal AM, but other machine features can encourage a safe workplace as well. As the industry grew and expert users arose, their feedback was used to incorporate ideas that addressed their pain points. AddUp made cleaning the interior of the build chamber easier by incorporating multiple access doors. This allows for the entirety of the inside to be wiped down and thoroughly cleaned without uncomfortably stretching for the back corners. Similarly, the laser lenses are removable so that they can be cleaned outside the machine. From a software perspective, oxygen setpoints and alarms are set during creation of the build file so that they can be customized to alert the operator of any potential issue, or shut down if it becomes a safety issue.

As with any promising new technology, Metal Additive Technology has extremely enticing benefits. The industry is constantly trying to extract all they can from these machines without putting anyone at risk. Machines and processes should all be designed with safety in mind, but even advanced safeguards don’t replace responsible operators, proper PPE, and an appropriate facility setup. Watch the video below to see how we’ve integrated safety into the AddUp Solution Center in Cincinnati, Ohio.

Features of the FormUp 350

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Filed Under: Safety, Workshop

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