The healthcare industry is an enormous sector, and additively manufactured medical applications can be anything from pharmaceuticals to surgical guides, from trays for DNA testing to implants. For this installment of our #AMapplications series, we will focus on life-saving medical applications, additively manufactured and approved for use.
Complexities are Advantages
One of the first industries to adopt additive manufacturing (AM) is the medical industry. It started with hearing aids and the understanding that AM enables mass-produced yet highly customized products. In hearing aids, where each device needs to fit an individual’s anatomy, AM is a perfect fit, and companies like Sonoma can testify to that. Medical implants have different requirements, the implications regarding achieving the right fit are critical, therefore the production of medical devices, especially life-saving ones such as implants is a highly complex process. The long lists of complexities include regulatory standards and the individuality of each patient, taking into account the delicate point in which a foreign material is inserted into the body. At the same time, the specifications of an implanted device call for in-depth research in form, safe and clean production processes, material compatibility, and human anatomy. Yet where complexity exists, AM can often provide an answer.
Simulating Bone Structure
One of the complexities when designing implants is designing an object that won’t be rejected by the body. This has to do with biocompatible materials but also shape. AM enables designing complex mesh structures that simulate the porosity of bone structure. The porosity and the surface texture achieved by AM facilitate osseointegration (from Latin: bone + make whole). Which in simple terms means the connection between living bone and the artificial implant. Just a couple of weeks ago at Formnext, 3D Systems presented an additively manufactured Tibial tray as well as hip cups and spinal implants emphasizing osseointegration (below in corresponding order).
Time is more than Money
Another important factor that affects the healing process is time, time spent before surgery and the duration of the surgery itself. We know the development process and production of an AM part can drastically cut lead time and development costs. But in healthcare, the shortened time doesn’t only cut costs but it can actually affect the outcome of the procedure. Even anatomical models and surgical guides can improve healthcare greatly. Just having an accurate model of the organ or bone prior to surgery or the customized tool can reduce unknown variables and unnecessary surprises, by that improving care and minimizing the time on the operating table. Less time on the operating table equals fewer complications, fewer risks. The endoCupcut (below), for example, is a tool designed to reach better results during hip cup replacement surgeries. The tool allows for more precise cutting without adding unnecessary damage to the surrounding bone. “Then look a bit wider, into the full ecosystem of the medical environment. Surgical guides for jaw reconstruction…can save up to 150 minutes of operation time, which saves a lot of money and patient operation time too. Customized implants are better implants, as patients can stay less time in the hospital,” says Stefan Leonhardt, one of two Managing Partners at Kumovis.
As mentioned above, Medical AM applications require regulation, in these applications, micron-level accuracy, and contamination-free environments are essential needs. It’s not just about the hardware but the entire process, including quality assurance of the process, the material, and additional post-processing phases such as sterilization. Yet even though the development process is anything but simple, the rewards are great, both financially and medically. According to IDTechEx the size of the opportunity presented by 3D printing in the medical industry will exceed $8.1 billion by 2029. Setting aside the economic calculations, customized implants such as the custom fit implant and the cranial implant exhibited by Trumpf at Formnext (below), are not just good business, they are life-saving (up top additively manufactured spinal cages by Trumpf).
The first 3D printed titanium cranial implant (using ARCAM technology) was approved by the FDA in 2016, the same year the FDA has granted approval for 85 additively manufactured implant devices, including in emergency situations. The number since has been slowly rising and medical device manufacturers are adopting AM for both standard and customized orthopedic implants. Even though regulation is rigorous, the AM ecosystem has been engaged in creating and enforcing regulations and standards across a number of industries such as aerospace and automotive. We have seen numerous instances where the needs brought up by a certain sector drive development across the ecosystem, be it in hardware or software solutions, that ensure repeatability and specific needs. Kumovis, for example, has a new Clean Room 3D Printer, integrating cleanroom specifications within the machine itself, meaning facilities that do not have a clean room can still reach clean room standards. Another example where a complexity turns into an advantage with AM.
More to Come
The existing life saving medical AM applications are many, too many to list here, but at the same time, it’s just the beginning. There are so many possibilities and many applications still under development such as the additively manufactured micro-stent produced by researches at ETH Zurich, that could potentially be used in fetuses in the womb (above, the micro-stent, which is just 0.05 mm wide). Another example presented at Formnext was the Marvel Medtech cryotherapy probe additively manufactured with XJet NPJ 3D printing. The probe is designed to freeze and destroy dangerous tiny breast cancer tumors and prevent them from growing before there is a need for biopsies, surgeries, radiation, and chemotherapy treatments. By doing so the procedure and probe developed can potentially save lives as well as improve life quality and treatment in preventing breast cancer. As in any new AM application, there is the trickle-down effect to take into consideration, it might take a while for us to see such applications in person, and hopefully, we won’t need to see or experience it!
It’s always exciting to see new applications for AM, but it’s even more exciting to see them mature into industrialized processes and business models. Tell us about the AM applications you encountered, we’ll try to feature them here and follow us for more #AMapplications. For more insights and information follow us on LinkedIn or subscribe to our newsletter for weekly updates.