3D printing processes — which use digital models to create physical devices out of materials like plastic — present a great opportunity for medical device manufacturers and allow for the fabrication of cheap, custom-fit devices as needed by patients and physicians.
However, 3D printing technology is still relatively new and has only recently been adopted in the manufacturing side of the medical device industry — meaning manufacturers are still adapting to some remaining difficulties. 3D printing can be a huge benefit for device makers, but there are some downsides to working with the technology that manufacturers should consider.
Here are three pros and three cons to 3D printing for manufacturers of medical devices.
3 PROS OF 3D PRINTING MEDICAL DEVICES
1. PERSONALIZED MEDICAL DEVICES AND PATIENT-SPECIFIC IMPLANTS
3D printing can create medical devices and implants that are tailor-made for a patient’s specific physiology — or even a specific surgery — making it potentially more effective than a mass-produced device. Customized, surgery- and patient-specific 3D-printed tools and implants are already being used in knee surgery, where surgeons at Yale Medicine have found that they speed up recovery and reduce patient pain levels.
With the emergence of this novelty technology, a few manufacturers are already developing their own patient-specific medical devices. Some significant developments in patient-specific medical devices include external prosthetics, orthopedic implants and customizable airway stents.
2. JUST-IN-TIME MANUFACTURING APPROACH TO ON-DEMAND DEVICES
The speed of 3D printing means it’s possible for manufacturers to quickly create devices in response to patient demand. Traditional implants can take weeks to design and manufacture, especially if they need to be customized for a patient. 3D printing is already being used to cut down the time needed to create bone implants to as little as possible.
Combined with the possibility of personalized medical devices, the just-in-time approach enabled by 3D printing could result in on-demand personal devices. These components could be a better fit for patients than the devices they may have needed to wait for in the past.
The speed and flexibility of this approach could help to reduce waiting times for patients and lower the chances of complications that may occur as a result of delayed or unavailable medical devices.
3. RAPID MEDICAL PROTOTYPING
3D printing is often cheaper — and sometimes faster — than standard manufacturing methods, which means manufacturers can rapidly design, print and test medical device prototypes.
Some medical device companies already use 3D printing to rapidly develop and test drug delivery devices, like inhalers and injectors. These devices need to be both comfortable and easy to use. Often, manufacturers can only tell if a design is truly ergonomic and built for human use with repeated testing.
Traditional design and manufacturing methods may need weeks to produce a new prototype. With 3D printing, it’s much quicker to iterate on previous designs — 3D technology allows a prototype to be designed and printed in a few days.
3 CONS OF 3D PRINTING MEDICAL DEVICES
1. 3D PRINTING PROCESS IS NOT ECO-FRIENDLY
3D printing is intensive in two resources — plastic and energy. If a medical device manufacturer is wanting to go lean — or otherwise cut back on energy used or emissions produced — 3D printing will make those plans harder to follow.
Manufacturers can reduce this waste, and 3D printing itself isn't necessarily wasteful. For example, because 3D printing uses only the materials that end up in the finished product — no material ends up on the factory floor — it is, in some respects, less wasteful than traditional manufacturing. And the plastic used in 3D printing can often be recycled.
But plastic and high energy use aren't good for the environment no matter how you slice it. Medical device manufacturers wanting to work with 3D printing will have to either accept these environmental costs or look for an alternative.
2. LIMITED OPTIONS OF 3D PRINTING MATERIAL
There’s a limited amount of materials that can be used in 3D printing. Composite devices — or devices that require special, non-printable materials or components — may be difficult or impossible to 3D print without cutting some corners.
New materials for 3D printing are, however, being announced all the time. For some manufacturers, the right materials may be just a few months or years out of reach. But some materials, like fabrics, are going to be difficult or impossible to print. In cases like these, manufacturers may need to rely on traditional manufacturing methods — either partially or entirely.
3. INCONSISTENT QUALITY OF 3D-PRINTED OBJECTS
3D printers don't always produce top-of-the-line results. 3D-printed objects can vary slightly in dimensions, and some level of design noise — like texture or bumps when a surface needs to be smooth — may be introduced in the manufacturing process. In such cases, the noise and irregularities would need to be machined out by a worker before the parts would be allowed to come into contact with patients.
If a design error causes a 3D printer to make the same mistake on a set of several hundred devices, manufacturers will need to commit a significant amount of extra labor to fix those mistakes. These post-labor costs can cancel out the money a manufacturer may have saved by switching to a 3D printing process.
Some experts in operations management believe that this drawback is enough to keep 3D printing from becoming competitive anytime soon.
It should be said, however, that this problem isn’t guaranteed. New 3D printing technology will likely improve the quality of 3D-printed devices — if only gradually. And better familiarity with 3D printing techniques may also improve the initial quality of 3D-printed devices, although it's unlikely that devices will make their way from production to consumer without any extra labor involved.
BENEFITS AND DOWNSIDES OF 3D PRINTING MEDICAL DEVICES
Medical device manufacturers can benefit from 3D printing in a number of different ways. This technology allows for cheaper production costs, patient-specific devices and a just-in-time manufacturing approach.
Manufacturers should, however, be aware of the current downsides of 3D printing technology before investing too heavily. 3D printers are energy-intensive, limited in functionality compared to some traditional manufacturing methods, and not always able to produce devices that are exactly to spec. 3D printing has many benefits to offer medical manufacturers, but the method may not be an outright upgrade over standard manufacturing techniques.