With a rising geriatric population and developing minimally invasive surgery sector, orthopedic implant manufacturers continue to make strides to stay competitive. Dean Carson, PhD, the vice president of U.S. operations at Anatomics, a privately owned and neurosurgeon-founded company, discuses the challenges, developments and future of the orthopedic implant industry.
Question: How has imaging evolved to help physicians and engineers develop personalized implants? What does the future look like for CT imaging?
Dr. Dean Carson: High-resolution three-dimensional image data can be acquired within a single breath-hold, making it easier to acquire the necessary data. Improvements in CT resolution provide engineers the foundation for more accurate replication of patient anatomy. The evolution of imaging in regard to
personalized implants has had a two-fold effect: the implants are more anatomically accurate with built-in advanced geometries; and the surgeon-patient relationship is improved through an understanding that treatment is being tuned to the patient. Anatomics believes this is one of the necessary components of
community-based personalized care.
The biggest change we will see in CT imaging will be decreasing the cost of access and precision. Accelerating the image processing speed and automating workflow to help reduce acquisition scan time, for example, will lower the cost of that aspect of the custom implant equation.
Q: What steps do implant manufacturers need to take to remain leaders in the ever-changing orthopedic implant industry?
DC: Use 3-D printing to open the door to advanced geometries for off-the-shelf implants, and create new anatomical solutions that start where current off-the-shelf implants end. In order to remain leaders in the industry, they must continue to push the boundaries of advanced implant design yet focus only on
technology that has a significant impact on patient care, otherwise it can be difficult to stand out among the ever-growing sea of implant companies and take market share from competitors. At the end of the day it’s all about a quantifiable improvement of the status quo. Without that your new tech will not be
compelling enough to gain mass surgeon interest.
Number two, invest in experts and be science heavy over sales and marketing. The price of 3-D printers has come down while the quality of CT scans and 3-D printers have improved. Advances in segmentation algorithms and increased availability of 3-D printers have made it possible to create cost-efficient patient-
specific models and implants in environments outside of traditional implant manufacturers. However, manufacturers can and should remain in the forefront. The physical space and financial investment required as well as experience in designing implants continues to make design expertise important. Anatomics has
been creating 3-D implants from scans since the mid-1990s and in our experience, having the scan and successfully generating printable file formats recognized by 3D printers is where the implant design process begins. Our role can be working with the treatment team to manage these technological and design
aspects so that they can focus on improving surgical planning.
While many focus on the use of 3-D printing to create personalized implants, the cost of 3D printing is becoming more and more competitive for small production runs. Companies with low production volumes or that produce parts or products that are highly complex or require frequent modifications should look to the
advantages that 3-D printing can provide.
Also, the 3-D printed implant model can reduce the amount of inventory sitting on hospital shelves with the added benefit of being able to implement rapid design improvements.
Q: What challenges are orthopedic implant developers currently facing? What challenges will the orthopedic implant market face in the future?
DC: The larger developers are facing challenges mostly related to nimbleness. While some are beginning to experiment with 3-D printing, greater adoption will have to contend with the amount of existing infrastructure and the economies of scale which they currently employ. Larger companies can be late to new
technology, but benefit from their regulatory expertise and power of the dollar. They often have strong user bases that enable them to catch up quickly in order to stay relevant.
For the smaller players working in 3-D printed implants, there are a variety of challenges. A lack of familiarity with the regulatory process (i.e. appropriate studies and preparation of data and filing materials) can delay the approval of new technology allowing other more skilled players to beat them to market. Some
firms come from a software or IT background and, while they have built some impressive technology, they don’t have the relevant medical expertise. Others face resource challenges related to the enormous capital costs associated with R&D and regulatory approval. The advantage that small companies do have is
the ability to stay hyper focused on new, impactful technology that can be ripe for acquisition or rapid market adaptation.
Q: How has the development of personalized implants changed the global orthopedic implant market?
DC: Commercially available standard-sized bone implants meet the needs of most surgical procedures, and will continue to do so. As many surgeons will attest, personalized implants might not be used in all cases. There has been a gap in available solutions when dealing with patients outside the standard implant
size range or have disease-specific special requirements. The development of personalized implants allow manufacturers to fill that gap with their surgeon customers and create improved outcomes for patients. Moreover, the personalized implant process chain requires the collaboration of radiologists, clinicians,
computer scientists and material scientists together, creating more robust customer relationships. As this chain continues to improve in efficiency and quality of end product we hope to see a shift to a community-based personalized approach to each patient.