SME Examines Point-of-Care Manufacturing Enabled by 3D Printing

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Patient holding her heart model used by physicians at Nicklaus Children’s hospital to aid in planning for her double aortic arch surgery. [Image: Stratasys]

Point-of-care (POC) is a nontraditional form of manufacturing. The just-in-time creation of things like 3D printed surgical instruments and guides, anatomical models, scaffolds, and prosthetics based on patients’ personal medical imaging data at the place of their care all fall under the POC umbrella.

Nonprofit organization SME is dedicated to supporting the manufacturing industry in all its many facets, including POC manufacturing, and one of the ways it does so is by hosting events for the industry, such as the RAPID + TCT conference that we’re looking forward to attending next month in Fort Worth, Texas.

POC manufacturing is the topic of a white paper SME recently published, titled “Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing,” which you can download for free here. According to the paper, over 95% of POC professionals are expecting POC manufacturing, enabled by on-site 3D printing, to expand.

Healthcare providers work in an environment that is always changing, whether it’s due to regulations and policies or advancing technology, like 3D printing, which is helping to improve things for patients. It’s more and more common these days for surgeons to use tools like 3D printed models or virtual planning services to work out a surgical plan ahead of time, so they can safely get their patients off the operating table faster, and at less cost. These models can also help surgeons give patients a more clear idea of what their surgery will entail.

Anatomical model of conjoined McDonald twins with guides developed via virtual surgical planning for separation and then 3D printed. [Image: 3D Systems]

The SME white paper states that nearly half of the healthcare provider executives questioned for SME’s first Medical Point-of-Care Manufacturing Survey said that one of their organization’s top three priorities over the next five years is making the patient experience better. 3D printing in hospitals can help make this a reality, as it offers multiple benefits to patients and physicians alike, including reduced costs and improved patient outcomes.

“Early success stories show the benefits of POC manufacturing which are driven by increased accessibility to the technology by innovative clinicians and enabling greater interdisciplinary collaboration. These advantages lead to a number of positive effects, from reducing operating room times to lower readmission rates. Often these benefits directly translate to cost-savings for the institution,” the white paper states about the benefits of POC manufacturing.

“Another advantage of implementing 3D printing in a POC setting is that clinicians can regularly visit the manufacturing lab and provide iterative feedback during the process of anatomical modeling. This team approach successfully blends expertise in biology, engineering and 3D printing.”

There are several different types of POC manufacturers, including both for-profit and non-profit hospitals, contract manufacturers that work with hospitals, government hospitals or hubs, like the VA system, and university engineering departments that work with hospitals.

SME’s white paper shows that the most popular application when it comes to POC 3D printing is, unsurprisingly, anatomical models by a wide margin, followed by prototyping and then tooling, fixtures, and molds. The vast majority of POC manufacturers – over 80% – do indeed use 3D printed anatomical models for surgical planning; this application is followed by training and patient education.

Dr. Jane Matsumoto and Dr. Jonathan Morris, co-directors of Mayo Clinic’s 3D Printing Lab, work with biomedical engineer Amy Alexander to prepare files for 3D printing.

There are some barriers to POC 3D printing manufacturing, such as setting up proper quality control and regulations.

“With the concept of making medical devices at a hospital, everyone needs to understand that the regulatory process is complex,” said Joseph Lipman, MS, Director of Device Development, Hospital for Special Surgery (HSS) in New York, in the white paper. “There are a number of steps outside of manufacturing like cleaning and sterilization, which need to be validated. It’s not so simple.”

To learn more about about point-of-care manufacturing, including case studies, capital investment needs, and the applications expected to grow the most this year, you can download SME’s new white paper for free.

POC manufacturing will also be the focus of the RAPID + TCT keynote on Wednesday, April 15th. Register here if you want to hear Dr. Jonathan Morris, MD, and biomedical engineer Amy Alexander explain how the Mayo Clinic, which 3D prints between 500 and 700 anatomical models annually, has embraced its important role as a POC manufacturer to improve patient care. Additionally, RAPID + TCT’s Medical Manufacturing Innovations Program (MMI) will be expanding the focus on medical 3D printing at the event.

Join the discussion of this and other 3D printing topics at 3DPrintBoard.com, or share your thoughts below.

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