Sean Fenske, Editor-in-Chief03.14.18
Additive manufacturing has already made a significant impact in the area of medical device manufacturing, but what we’ve experienced thus far could merely be the tip of the iceberg. I’ve spoken to members of the industry about what I foresee coming to the healthcare technology scene. That is, an era where patient scanning and additive manufacturing technologies are employed directly by healthcare professionals (not necessarily an OEM) within the hospital environment. The goal of such a scenario would be to enable the use of patient-specific medical technologies that can be created virtually on-demand at the point of care.
Not surprisingly, I’m hardly alone in having such a vision for the future of healthcare. SME (formerly the Society of Manufacturing Engineers) recently published a white paper (Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing; download for free at www.sme.org/POC) that shared the results of its first-ever Medical Point-of-Care Manufacturing Survey, which inquired about this trend. They found that more than 95 percent of point-of-care (POC) professionals expect to see an expansion of POC manufacturing enabled by additive manufacturing and 3D printing. Further, 69 percent stated they had used 3D printing for three years or more. Perhaps hardly a vision of the future, but rather a very active trend that’s pervasive in healthcare. Then again, as far as I saw, the white paper didn’t reveal the total number surveyed; the actual number of those completing the survey could have been relatively small.
Still, other results provided interesting insights into the trend. While it’s not so surprising to see that 71 percent of respondents stated they used POC 3D printing for “anatomical models,” I was intrigued by the other end of the spectrum. Survey results indicated that 13 percent used the technology for “resorbable patient-matched implants, including scaffolds” and “non-resorbable patient-matched implants,” while 6 percent said they used it for “bioprinting.” While still small in comparison, those are fairly big numbers for a technology in its relative infancy in terms of where it could be headed.
The white paper further revealed that in 2016, 99 hospitals in the U.S. had a centralized 3D printing facility. This was courtesy of a chart provided by Materialise, so that number could be substantially higher. Further, the white paper shared that 16 hospitals out of the top 20 as ranked by U.S. News and World Report have implemented a medical 3D printing strategy. Again, relatively small in comparison to total number of hospitals and healthcare facilities in the U.S., but certainly impressive figures.
This leads into one of the points of disagreement I’ve encountered when discussing this topic with others within the industry. I’ve been told the biggest obstacle to the growth of this healthcare trend is tied directly to liability. “The hospital will never take on that amount of liability,” I’ve been told flatly. Well, do the results of the SME survey counter that criticism? Is liability not nearly as much a barrier to growth as some apparently think? It’s a worthwhile and interesting debate for certain; one I’d love to have with a 3D printer supplier, a hospital supervisor (or perhaps one of their lawyers), and the doubters I’ve encountered.
Another factor to consider is the design of the devices and technologies that will be able to be printed on-demand at the point of care. Who will be providing these “blueprints” or more apropos, CAD files, that a hospital can use? Actually, on second thought, would a CAD file even be employed? If the advantage of this technology is to better enable personalized healthcare in the form of a patient-specific device, a static design would be far too rigid. Rather, a software program would need to be written and sold to the hospital that could then be used in conjunction with patient imaging scans. The software would need to output a custom solution in the form of an implant, stent, tissue, bone, or eventually, functional organ, that could be implanted into a patient. Looking back at the results of the survey, this “futuristic” vision may not be as far off as it seems.
Alas, with this path, another challenge emerges—the U.S. Food and Drug Administration (FDA). Undoubtedly, point-of-care manufacturing would gain the attention of the government agency, and I can’t imagine it would be too enthusiastic about the prospect. Arguably overtasked already with maintaining a watchful view of the entire medical device manufacturing industry, adding 3D-printing-capable healthcare facilities would not do the FDA any favors.
Unfortunately, I’m out of room for this topic in this letter, but not out of ideas and questions. That’s why I’ve already reached out to my co-host, Mike Drues, who joins me for every episode of the Mike on Medtech podcast (http://bit.ly/mpomike). We’ll address some of the points already mentioned here while also delving into the regulatory topic in more detail in our next episode in March. Be sure to listen!
Not surprisingly, I’m hardly alone in having such a vision for the future of healthcare. SME (formerly the Society of Manufacturing Engineers) recently published a white paper (Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing; download for free at www.sme.org/POC) that shared the results of its first-ever Medical Point-of-Care Manufacturing Survey, which inquired about this trend. They found that more than 95 percent of point-of-care (POC) professionals expect to see an expansion of POC manufacturing enabled by additive manufacturing and 3D printing. Further, 69 percent stated they had used 3D printing for three years or more. Perhaps hardly a vision of the future, but rather a very active trend that’s pervasive in healthcare. Then again, as far as I saw, the white paper didn’t reveal the total number surveyed; the actual number of those completing the survey could have been relatively small.
Still, other results provided interesting insights into the trend. While it’s not so surprising to see that 71 percent of respondents stated they used POC 3D printing for “anatomical models,” I was intrigued by the other end of the spectrum. Survey results indicated that 13 percent used the technology for “resorbable patient-matched implants, including scaffolds” and “non-resorbable patient-matched implants,” while 6 percent said they used it for “bioprinting.” While still small in comparison, those are fairly big numbers for a technology in its relative infancy in terms of where it could be headed.
The white paper further revealed that in 2016, 99 hospitals in the U.S. had a centralized 3D printing facility. This was courtesy of a chart provided by Materialise, so that number could be substantially higher. Further, the white paper shared that 16 hospitals out of the top 20 as ranked by U.S. News and World Report have implemented a medical 3D printing strategy. Again, relatively small in comparison to total number of hospitals and healthcare facilities in the U.S., but certainly impressive figures.
This leads into one of the points of disagreement I’ve encountered when discussing this topic with others within the industry. I’ve been told the biggest obstacle to the growth of this healthcare trend is tied directly to liability. “The hospital will never take on that amount of liability,” I’ve been told flatly. Well, do the results of the SME survey counter that criticism? Is liability not nearly as much a barrier to growth as some apparently think? It’s a worthwhile and interesting debate for certain; one I’d love to have with a 3D printer supplier, a hospital supervisor (or perhaps one of their lawyers), and the doubters I’ve encountered.
Another factor to consider is the design of the devices and technologies that will be able to be printed on-demand at the point of care. Who will be providing these “blueprints” or more apropos, CAD files, that a hospital can use? Actually, on second thought, would a CAD file even be employed? If the advantage of this technology is to better enable personalized healthcare in the form of a patient-specific device, a static design would be far too rigid. Rather, a software program would need to be written and sold to the hospital that could then be used in conjunction with patient imaging scans. The software would need to output a custom solution in the form of an implant, stent, tissue, bone, or eventually, functional organ, that could be implanted into a patient. Looking back at the results of the survey, this “futuristic” vision may not be as far off as it seems.
Alas, with this path, another challenge emerges—the U.S. Food and Drug Administration (FDA). Undoubtedly, point-of-care manufacturing would gain the attention of the government agency, and I can’t imagine it would be too enthusiastic about the prospect. Arguably overtasked already with maintaining a watchful view of the entire medical device manufacturing industry, adding 3D-printing-capable healthcare facilities would not do the FDA any favors.
Unfortunately, I’m out of room for this topic in this letter, but not out of ideas and questions. That’s why I’ve already reached out to my co-host, Mike Drues, who joins me for every episode of the Mike on Medtech podcast (http://bit.ly/mpomike). We’ll address some of the points already mentioned here while also delving into the regulatory topic in more detail in our next episode in March. Be sure to listen!
