Medical Additive Manufacturing/ 3D Printing Annual Report 2018 Improving Public Health
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Medical Additive Manufacturing/ 3D Printing Annual Report 2018 Improving Public Health Each year, healthcare needs and costs grow due to an aging population, the rise in chronic diseases, and more. In fact, global healthcare spending is projected to reach nearly $9 trillion by 20201. To address this, practitioners in the healthcare industry continue to look for innovations that can provide quality care to patients at a reasonable cost. But they can’t do it alone. Today, the manufacturing industry is an important partner, with one particularly bright opportunity focused on Medical Additive Manufacturing/3D Printing (AM3DP). From anatomical models to early bioprinting applications, the use of AM3DP is providing benefits for patients and physicians/institutions including: ■ Better patient outcomes ■ Less time in the operating room ■ Reduced costs In 2017, as outlined in this Annual Report, collaboration between hospitals, device manufacturers, U.S. Food and Drug Administration (FDA), and partners such as SME, led to extraordinary strides in identifying industry trends, opportunities, challenges and solutions. These partnerships drive efficiency through best practice sharing as well as accelerate innovation for applications such as bioprinting and tissue fabrication. They also lay the groundwork for 3D printing of organs and scaling up production of tissues which are still decades away. With millions of patients already directly impacted by the technology, this momentum continues into 2018 and beyond where AM3DP will continue to positively impact public health and drive strong business results. This 2017 Annual Report covers: COVER: Justin Ryan holds a pediatric heart model 3D-printed at the ■ Industry Overview Phoenix Children’s Hospital Cardiac 3D Print Lab. Courtesy Phoenix Children’s Hospital ■ SME’s 2017 Medical AM/3DP Survey Results Detailed view of metallic porous surface of acetabular cup for hip replacement. Courtesy SME ■ 017 Highlights 3D-printed vascular structure in hydrogel filled to demonstrate complex geometrical network of vessels. Courtesy IRNAS, ■ Expectations for the Future Symbiolab, Vitaprint 2 Medical Additive Manufacturing/3D Printing By the Numbers FUTURE OF GLOBAL HEALTHCARE $8.7 % TRILLION 11.5 Global healthcare spend Percent of total population projected by 20202 over 65 years of age.3 HOSPITALS IN THE US WITH A OVERALL 3D PRINTING/AM GROWTH4 CENTRALIZED 3D PRINTING FACILITY Compound annual growth Using Materialise Mimics technology % rate (CAGR) of AM industry 21 in 2017 $7.3 2017 AM market size BILLION Approximate revenues 11% from medical/dental pieces AM professionals who expect an increase in 97% Medical AM/3DP applications5 Graph courtesy Materialise 3D PRINTING IN HEALTHCARE 3200% Increase in the number of hospitals in the Number of hospitals16 out of the top 20 as ranked by U.S. with a centralized 3D printing facility U.S. News and World Report that have implemented between 2010 and 2016 a medical 3D printing strategy (using Materialise Mimics technology)5 (using Materialise Mimics technology)6 2018 Annual Report 3 A Look Back Medical 3D Printing Applications⁷ Dramatic news headlines imply that the use of additive According to SME’s 2017 Medical Additive Manufacturing/3D manufacturing/3D printing in medicine is a new way to Printing Survey⁸, 97 percent said they are expecting an increase save and improve lives. The truth is, it’s not so new. Twenty in Medical AM3DP applications like those below. Underway are years ago anatomical models were beginning to be used exciting innovations that are changing patient treatments such as for planning complicated surgeries. In 2000, hearing aid 3D printed microbots made to “swim” through a patient’s body and cases were being 3D-printed and within a few years became deliver drugs to cancer cells and 3D-printed specialized contact industry standard. Medical applications have been a leader lenses developed to help epileptic wearers avoid seizures. in taking 3D printing technology far beyond a product development tool. The combination of using medical imaging data to create patient-matched devices and the ability to manufacture structures difficult to produce with traditional General (non-personalized instruments or prototypes). technologies is compelling to an industry always looking for Examples: Specialized metal instrument for hospital/surgical ways to innovate.⁶ use (e.g., plate bending); prototypes for iterative design process EOS FACTORS CONTRIBUTING TO MEDICAL 3D PRINTING INCREASES Photo courtesyPhoto 3D printing applications in medicine are Prototype clamp produced with the EOS increasing due to many factors: StainlessSteel 17-4 PH IndustryLine parameter set. Only the internal springs were not Precision medicine: Better patient outcomes 3D printed. and lower costs from developing treatment plans and devices specifically for the patient Anatomical Modeling (patient-matched anatomical 3D printing processes: More accessible models from medical imaging studies like CT/MRI). technology becomes mainstream Examples: Cranial conjoined twins model for training and simulation; scoliosis model; simulation/demo model (e.g., Materials: Workable materials from polymers to stent deployment, implant sizing) metals allow for varied applications Software: Improved software allows for faster Printed with resin, and more accurate segmentation of medical this anatomical imaging files hand features clear sections of skin, Resources: Industry rallying behind potential revealing veins, and sharing body of knowledge muscles, and bones, Stratasys thus making it Studies: Growing evidence of patient outcomes useful for training and cost-effectiveness medical students and educating patients. Photo courtesyPhoto 4 Medical Additive Manufacturing/3D Printing Surgical Planning (templates, guides and models after Active & Wearable Devices (devices that include electronics or preparing a patient-specific surgical plan in a software other active elements). Examples: Wearable sensors; lab on a environment/3D printed items brought into operating room). chip; microfluidics. Examples: Surgical marking guide; implant placement guide; radiation shield; surgical saw guide. Photo courtesy Alex Valentine, Valentine, courtesyPhoto Alex Lewis/ K. and Jennifer Lori Sanders, Harvard University Photo courtesy Photo 3D Systems Healthcare Anatomical model of conjoined McDonald twins Potential application of 3D printing flexible sensors with guides developed via virtual planning for include custom strain and pressure sensors to track separation and the 3D-printed. post-surgery rehab progress with direct measurement of joint angles, body position, and extremity deflection. Precision Prosthetics (patient-matched implants, prosthetics, or orthotics). Examples: Small quantity cases (e.g., oncology case); knee replacement; nasal stent; hearing aid cases Bioprinting/Tissue Fabrication (materials that incorporate living cells). Example: Tissues or scaffolds used for regenerative engineering, drug delivery, drug discovery, etc.; organ on a chip. Photo courtesyPhoto Arkema Inc. An orthopedic shoe insert designed to provide comfort, pain relief, and orthopedic correction. SME Permanent Implants (“off-the-shelf” implants). Examples: Bioprinted gelatin Metallic implants (e.g., titanium, cobalt chrome alloy); tracheal for tissue repair splint; cranial implants. courtesyPhoto and regeneration including bioprosthetic ovary developed at Northwestern University. Cobalt Chromium Orthopedic Knee implant Photo courtesyPhoto GE Additive/Arcam 2018 Annual Report 5 The Players Traditional manufacturers such as device manufacturers make up the bulk of the industry, often partnering with contract manufacturers. Smaller hospitals may also work with contract manufacturers for segmentation and to prepare files for 3D printing. Larger research hospitals may have their own in-house 3D printing laboratories (see POC Manufacturing Sidebar). Another important group are the bioengineers doing “Forward-looking hospitals research as industry looks at continuing innovation for applications such as bioprinting and tissue fabrication. are implementing on-demand While 3D printing of organs and scaling up production 3D printing service lines and, in of tissues are decades away, research can be accelerated with additional focus. turn, are reaping benefits of an improved patient experience, better training of physicians and growth TRADITIONAL MANUFACTURERS in innovation which can drive non- traditional revenue streams in Device Contract addition to the inherent cost saving Manufacturers Manufacturers that can be realized.” —Todd Pietila, Global Business Development, 3D Printing for Hospitals, Materialise POINT-OF-CARE MANUFACTURERS Hospitals Hospitals connected - Government to university - Non-profit engineering - For-profit departments Contract Manufacturers 6 Medical Additive Manufacturing/3D Printing Point-of-Care Manufacturing Benefits of POC Point-of-Care (POC) is a non-traditional form of manufacturing While POC may not be for every hospital due to referring to the just-in-time creation of anatomical models, the investment in equipment and staff, for those surgical instruments, prosthetics, scaffolds, and other 3D printed that are considering this business avenue, there applications at the place of patient care, based on their personal are a number of benefits: medical imaging data (MRI, CT, or surface scans). Larger research hospitals may have their own in-house 3D printing laboratories ■ Quicker Turnaround: Traditionally, models,