The Growing Business Cases for Additive Manufacturing of Orthopedic Implants

Additive Manufacturing of Orthopedic Implants

This new blog that examines additive manufacturing of orthopedic implants is drawn from new report, Additive Manufacturing In Orthopedics: Markets for 3D Printed Medical Implants 2019

Looking at market opportunities for additive manufacturing and 3D printing technology, it’s common in today’s world to focus on what’s just on the horizon –those areas where AM/3DP is just beginning to have an impact and shaking up product design, supply chains, business models, and manufacturing implementations. However, it’s also necessary to look at those areas where AM is already a more mature technology (relatively speaking). The areas that often ‘pay the bills’ for stakeholders in the broader AM ecosystem.

One such area is in the additive manufacturing of orthopedic implants. For the sake of exploration, let’s use a more specific definition –in the additive manufacturing of implants for orthopedic applications, defined as those medical devices which are otherwise permanently implanted into the body to correct deformities of bone or muscle. At SmarTech, we like to call this particular segment ‘additive orthopedics.’

In the additive orthopedic market today, AM/3DP technologies have advanced into a new evolution of use, where the focus and industry conversations and related conferences have shifted from those of ‘what is theoretically possible in the future’ to ‘what is economically feasible today with the current solutions and supply chain.’ This shift is the hallmark of a technology moving into a new stage of mainstream relevance, and if one examines headlines and articles in popular trade press outlets for orthopedic business, it’s clear that AM/3DP is, indeed, a mainstream concept.

A necessary step in becoming a mainstream force in any industry that AM might disrupt is developing key business cases for application of printed components or parts –in essence, not just talking about AM’s possibilities, nor just producing pre-production parts that are not yet subject to economic constraints. Real rubber-meets-the-road business cases for real parts that will be fielded and used in the real world. Along these lines, the business cases in additive orthopedics continue to expand, and now cover the entirety of the traditional orthopedics industry structure ranging from major joint replacement to trauma solutions. The graphic below provides a visualization of business cases across the industry today.

Source: SmarTech Analysis

Over the last two years, there has been some very compelling movement forward in the orthopedic industry in two important ways. First, within established business cases, such as the printing of lumbar spinal fusion cages using titanium alloys, there has been significant market uptake from a huge number of device OEMs in both internal production and outsourced contract manufacturing. Secondly, and equally important, has been efforts to demonstrate the viability of new business cases for the use of AM to produce devices. In some cases, these cases have been ‘validated’ previously, but now with much wider competitive support and global presence, they have become a more universally recognized business case across the industry.

We would call particular attention to a couple of potentially very interesting market examples in the expansion of the business cases for additive orthopedic implants which could significantly push the overall industry forward.

The first is in the emerging sector of additively produced off-the-shelf shoulder arthroplasty systems with components produced via metal additive technologies. At least two leading innovators in the world of AM implants have are preparing full market availability of such devices this year, to include Lima Corporate’s SMR TT Hybrid Glenoid, and ExacTech’s Equinoxe Stemless Shoulder systems. These devices address the fastest growing segment of the shoulder arthroplasty market, which in itself is expected to under exceptionally rapid growth as an underserved joint replacement opportunity in the future. These systems feature titanium printed cage glenoid structures with known porous printed features for biologic fixation, drawing on existing market acceptance of similar structures applied across spine, hip, and knee segments over the last several years.

Second, is the continued establishment of patient-matched knee solutions with directly printed implant components. Although there are existing solutions from BodyCAD and ConforMIS that have utilized 3D printed surgical guides and casting molds, at least one company in Italy known as Rejoint is now preparing for full availability of a directly printed implant system drawn from patient imaging data.

Finally, although first announced almost two years prior from today, American company SI-Bone has demonstrated how additive manufacturing can also be successfully clinically applied to specialty areas of orthopedics with its iFude3D sacroiliac joint stabilization implant. The device somewhat mimics printed spinal cages in appearance and design but is tailored to addressing sacroiliac dysfunction in the pelvic region.

Overall, the building of new business cases is critical for the expansion of AM in the world of orthopedics, as is the continued acceptance of otherwise proven business cases among a wider swath of device companies over time. For more insights on the current state of additive manufacturing technologies in the orthopedic industry,

SmarTech Analysis has just released its latest study on additive orthopedics, available for order.

BIOLIFE4D demonstrates ability to bioprint human cardiac tissue patch

Chicago-based biotech company BIOLIFE4D announced this week that it has successfully 3D bioprinted a human cardiac tissue patch, bringing the company a small step closer to its ultimate goal of 3D bioprinting a viable and transplantable human heart.

In the world of bioprinting, many tend not to look past a headline, leading some to believe that 3D printed transplantable organs are close on the horizon. And while we know this isn’t quite the case—it is still interesting to track what bioprinting companies whose goal it is to print organs are up to.

BIOLIFE4D is one such company and it is undoubtedly excited to have achieved an important milestone in its bioprinting research. According to the biotech firm, it successfully demonstrated its ability to bioprint a cardiac patch just days after the opening of its new JLABS research facility in Houston in May.

The bioprinted tissue reportedly contains multiple cell types (as opposed to just cardiomyocytes), similar to a real human heart and integrates “preliminary vascularization.” Spearheaded by Dr. Ravi Birla, Chief Science Officer of BIOLIFE4D, the innovative bioprinted cardiac patches could be used to restore myocardial contractility in patients with acute heart failure.

“We are extremely excited to have achieved this milestone and to successfully demonstrate our ability to 3D print human cardiac tissue,” said Dr. Birla. “When we began this process, we knew this would be a key step in validating our technology and scientific approach, so we are pleased to be able to have accomplished this so quickly.”

biolife4d

“We have always believed that our scientific approach, as well as the tremendous team we have assembled, positioned us for rapid scientific accomplishment. The speed at which we bioprinted 3D human cardiac patches, within days, is unheard of within the scientific community. These efforts clearly demonstrate our ability to bioprint human tissue and provide a clear and rapid pathway towards bioprinting human hearts.”

The speed at which BIOLIFE4D succeeded in bioprinting the cardiac patches seems to have come as a surprise to the company itself, as most research indicates that bioprinted human cardiac patches require six to eight months to develop. With the promising early start, the company says it will now begin to focus on other constructs including valves, blood vessels and a mini heart.

BIOLIFE4D says its bioprinting process enables scientists to “reprogram” a patient’s white blood cells to iPS cells (a type of stem cell) and then into different types of cardiac cells. These are then bioprinted into tissue patches and perhaps one day into viable human hearts. Obviously, the implications of being able to 3D bioprint a transplantable human heart are massive, especially as heart disease is the leading cause of death in the United States. But again, it will likely be a long time before we hear of the world’s first bioprinted heart transplant.

“This is a tremendous time for BIOLIFE4D and we could not be prouder to have accomplished this scientific landmark in such a short period of time,” commented Steven Morris, CEO of BIOLIFE4D. “From the beginning, our mission has been to utilize our technology to save lives. Today, we believe we are one step closer to ultimately achieving that goal.”

UCSF to advance AM applications for orthopaedic surgery with INTAMSYS’ high-performance 3D printing & materials

As per a new partnership agreement, Shanghai-based 3D printing company INTAMSYS will be collaborating with the Department of Orthopaedic Surgery at the University of California, San Francisco (UCSF) to further advance additive manufacturing applications for orthopaedic surgery and, specifically, applications for PEEK and other high-performance materials. INTAMSYS, which specializes in 3D printing solutions for high-performance …

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