For the last 15 years, ODT has dedicated itself to informing industry leaders of the latest market trends and issues impacting orthopedics. Like the sector it serves, the magazine has evolved and matured, responding to the changes wrought by a volatile world in constant flux.
Throughout time, magazines have acted as communal reflectors, echoing the emotions and ethos of the human spirit. Through their words, illustrations, and photographs, they’ve held up a mirror to the civilized world, becoming silent wardens to history. As American author/journalist John William Tebbel once noted, magazines “have always faithfully reflected the society in which they are produced.”
Orthopedic Design & Technology has never strayed from this mission. Over the past decade and a half, the periodical has become the orthopedic industry’s prime looking glass, exposing its values, mindset, and culture, for better or for worse. The past 15 years have proven interesting, to say the least, as ODT bore witness to the sector’s growing pains. It’s been a memorable journey, filled with unpredictable—and at times, remarkable—twists and turns. To help mark all the milestones along the way (and commemorate the magazine’s birthday), ODT reached out to members of its Editorial Advisory Board for input. Their responses provide for a meaningful and often nostalgic trip down memory lane.
ODT: How has orthopedic technology (overall) changed over the last 15 years?
Lisa Ferrara, Ph.D., Owner/President, OrthoKinetic Technologies and OrthoKinetic Testing Technologies
There has been a significant growth in orthopedic start-up companies over the last 15 years. Many of these companies have developed unique innovations which may provide better solutions for clinical scenarios. Prior history of many orthopedic technologies offers insight for new start-up companies to develop improved versions of similar technologies that may better address the challenges faced by prior versions.
Mitchell Foster, CEO, Mindset Medical
The last 15 years has seen several changes: 1) The adoption of navigation/guidance and minimally invasive procedures. The reduction of radiation exposure to the clinical team, reduced blood loss to the patient, improved accuracy, and reduced time in the hospital post-op. 2) Interbody fusion/decompression devices—from tissue and titanium to PEEK back to titanium to expandable decompression devices (more precision medicine)—there has been significant changes in physician preference and techniques to perfect the decompression and the fusion. 3) the addition of biologics—DBM 20 years ago, to BMP, synthetics, etc. 4) Zero-profile fusion devices/Non-fusion; arthroplasty—zero profile devices in both cervical and lumbar have become more prevalent. In arthroplasty, more specifically for cervical indications, outcomes seem to be very positive even though cervical fusions are seen as a “best outcome” surgery. Tracking patient outcomes will be the key for the future of cervical fusion vs. non-fusion but at the very least, surgeons have options to deploy. 5) Lateral surgery? Clearly with NuVasive’s success and the follow on from basically every market share competitor makes the case that lateral surgery has had a tremendous impact on patient care for the right indication and the right patient. 6) Neuromonitoring? I am no specialist to comment on the technology but the prevalence (cervical, lateral) of companies in the space and the rollups makes me think it does.
David Kelman, P.E., Chief Development and Compliance Officer, Sterile Edge Inc.
- The reduced influence of the surgeon in the selection of implants utilized
- The ability to perform more complex procedures in the outpatient settings, 23-hour total joints as an example
- A change in the reimbursements from fee-for-service to value-based payment models
- The decline of independent surgeon practices to hospital employees
Dawn Lissy, MS, President and Founder, Empirical Testing Corp.
- New materials: PEEK with HA, additive titanium, combo materials of nitinol with Ti and/or CoCr
- Patient-specific implants
- New technologies that are geared toward pain management
- Infection is a large source of implant failures and technologies being utilized to prevent infections
- Down classification of devices (cervical screws, IBFD devices)
- Emergence of ankle, wrist, shoulder implants, rise and fall and slow rise again of artificial disc and NP devices
Ali Madani, Managing Partner and Founder, Avicenne
New technologies have appeared during the last 15 years and have started to enter the mass market.
- Coating: initially used in Europe, coating has started to be massively used in the U.S. and other areas (Asia, etc.)
- Usage of special plastics and composites instead of metal: Extensively for certain technical plastics like PEEK or Carbon Fiber (plus their compounds) to replace metal cages in the past 15 years. The way is now open for other products: trauma plates, nails, etc.
- Bone substitutes filled with proteins to increase the osteointegration
- Bone cements loaded with one or two antibiotics
- Ceramics to improve bearings in joints
- Single-use instruments: small sets including implants and dedicated instruments
- Additive manufacturing: based originally on Zimmer Biomet’s idea and propriety technology, Trabecular Tantalum (based on the Tantalum Vapor Deposit), metal additive manufacturing started in the early 2000s, mainly in Italy with Lima & Adler Ortho. We estimate that, in Europe, less than 7 percent of all hip, knee, shoulder, and trauma parts are made using additive manufacturing.
- The standard manufacturing technologies like forging, casting, and machining continue to be used massively today. In my view, these services will continue to be massively used in the long-term.
Smart mechanisms, like dual mobility cups took 30 years to penetrate the mass market and solved one or two thorny problems
Orthopedic robotic surgeries: Stryker opened up the mass market; Smith+Nephew, Zimmer Biomet, DePuy, and many others have followed. Robotic-assisted knee surgery today is already on the radar with 10 percent of U.S. knee surgeries. This market is taking off with a double-digit growth rate and should attain one-third of the knee surgeries in the next five years in the U.S. While the industry has no doubt benefited from the growth of robotics in the short- to mid-term, continued growth in other geographies will rely on proven long-term patient benefits and more affordable systems.
Dave Neal, President and Founder, STAT Design LLC
Orthopedic technology has changed to a digital format, be it X-rays, data collection, or more powerful computer-aided drawing (CAD) programs with increased capabilities (i.e., creating trabecular structures directly in the CAD model).
William Pratt, Vice President, Operations and Director of Creative Design, Kinamed Inc.
In total joints we still have plastic articulating against polished chrome cobalt, so I don’t think we’ve seen a sea change in the technology. The underlying manufacturing technology has changed tremendously, but the end-user doesn’t see that. Spinal fusion has obviously seen a big change in the surface technology and ingrowth structures to enhance bony fixation.
Thor S. Rollins, B.S. RM, Director of Toxicology, E&L Consulting, Nelson Laboratories
I have seen a lot of changes, from innovative designs, to dynamic coatings, to additive manufacturing, but the one I find most compelling is the use of new materials. Yes, we still see the common stainless and titanium (why not, they are great and proven) but from the increased use of nitinol, absorbable materials, drug combination, and biologics; the orthopedic industry has really tried to expand the material tool box to fit certain needs to gain improvements. This can be a scary regulatory endeavor, but the patient benefit can make it all worth it.
Chad Ryshkus, Director, Marketing and Business Development, MedTorque Inc.
The influence of outside technologies has changed the driving orthopedic technologies dramatically. Influences like additive manufacturing, material sciences, and robotics have changed the world of orthopedics. Additive manufacturing has led to the rise of numerous interbody spinal cages, patient-matched implants, and a few instruments. Material science advances have impacted implants, specifically. We saw a huge rise in PEEK implants to now titanium-coated PEEK, as well as other coatings on metal implants to aid in fusion to bone. Robotics is now the hottest trend in orthopedics, with nearly every OEM marketing a robotic system to aid in the surgical procedure.
James B. Schultz, Executive Vice President, ECA Medical Instruments
There have been significant advancements over the past 15 years in materials, manufacturing automation, cost reduction, and product reliability. Today, most orthopedic implant products are robust and provide patient value. The gross margins from cost of goods sold is very competitive. The big challenge for medical device companies is the downstream fulfillment cost and huge logistics tail to not only sell and support their products. There’s a big opportunity in the industry to cut those cost and create force multipliers for sales growth.
Christine Scifert, M.S., MEM, Partner, MRC Global
Additive manufacturing, AI, robotics, and mobile apps. Technology has allowed devices to become smaller, faster, lighter, more cost effective to manufacture, and accessible to the patient.
Paul Vasta, Ph.D., Chief Technology Officer, Gramercy Extremity Orthopedics
The degree and impact of technology change in orthopedics over the last 15 years is a dichotomy in many ways. There have been some marvelous advancements in and around the periphery of the devices themselves, examples include robots elevating precision device placement and minimizing the extent of tissue damage, surface coatings and implant designs that promote bone adhesion, and additive manufacturing allowing custom (i.e., patient-specific) and complex designs to be rapidly produced. In contrast, some of the more fundamental, infrastructural areas of orthopedics have seen very little technological advances. The system of delivering implants and instruments in an autoclave steri-tray, for example, has basically been unchanged for over half a century. The impact on a surgical procedure in terms of efficiency and patient safety—given the legacy process where sales representatives shuttle steri-trays around town and hospital and ASC staff are charged with cleaning, sterilizing, and organizing them in preparation for surgery—has been disregarded but improvements there can have very meaningful effects.
Elise Wolf, General Manager, Computer-Assisted Surgery and Vice President of Quality Control, BioMedGPS
In terms of the orthopedics CAS space, a shift has occurred with regard to the adoption of assistive technologies. Although the overall penetration of navigation into spine surgery and to an even larger degree in joint replacement surgery remains fairly low, enabling technologies have started to gain some real traction. While the orthopedic and spine markets have seen headwinds over the years due to pricing pressure, reduced procedure volumes and reimbursement non-coverage, robotic and other enabling technologies have offered companies means for differentiation and growth. As surgeons continue to recognize the value of integrating imaging, preoperative planning, navigation, and robotics for improved workflow, orthopedic implant companies with robots and other enabling technologies are gaining a competitive advantage and increasing their market share through implant pull-through.
ODT: What has been the most impactful change in orthopedic technology since 2005?
Mitchell Foster: Minimally invasive surgery (reduced blood loss, shorter hospital stays); expandable interbody for precision decompression and CT intra-op imaging, navigation/guidance/robotic applications (and, robotic application with integrated guidance/navigation) which have driven reduced radiation exposure, improved the adoption curve for minimally invasive surgery (i.e, eliminating k-wires can eliminate additional imaging, etc).
David Kelman: There has been a significant shift in surgical techniques. This has, at times, led to different implant designs, and new and unique instrumentation.
- The desires of quicker rehab, less muscle and tissue damage
- The move to “greater precision” of surgery first with navigation, patient matched cutting blocks and now the push with robotics
- Additive manufacturing is just starting to come into its own, has the potential to impact implant designs that are impossible to design/produce with conventional techniques. The ability to shorten time to market
- Data is becoming more important from clinical and registry data to having actionable data to improve business operations
Dawn Lissy: Patient-specific implants—using additive manufacturing technologies to meet patients where they are at in their anatomy.
- FDA’s relationship with medical device companies—RTA program, EIR programs, ELP programs, organization of first Ortho Town Hall (postponed due to COVID-19), guidance documents, virtual workshops, customer service feedback surveys, publication of acceptance data. Basically, FDA has spent a significant amount of time and effort to change the dynamic and working relationship with the orthopedic industry.
Dave Neal: Without a doubt, the advent of additive manufacturing has changed the way orthopedics design is approached. AM gives design freedom in ways that was once difficult, not possible, or not cost effective. Additionally, smaller orthopedic companies can benefit from ordering lower quantity lot sizes to achieve a similar economy of scale that was only possible with large runs when machining a product.
Design cycle time has been reduced with 3D printing. Now, a plastic mock-up can be placed in a surgeon’s hands in a matter of hours, instead of the typical one- to six-week lead time for a machine shop to fabricate a part.
Thor Rollins: For me I think it has to be the start of additive manufacturing. We are still at the beginning so who knows what this could be in the future, but the potential of personalized medicine and more intricate designs make it potentially industry-changing.
Chad Ryshkus: If I had to pick just one, I would go with additive manufacturing (AM). This is mainly due to the multifaceted benefits it can have on both the implant and instruments used in orthopedic surgery. On the implant side, it becomes possible to combine manufacturing operations with the ability to print almost any geometry. The ability to print a porous surface eliminates post-machining processes that would normally apply such a surface. AM utilized in patient-matched implants provides a speedy option for personalized implants. For instruments, the same benefit exists for combining machined operations or creating geometries that are difficult to machine. There are still a few hurdles to overcome with additive manufacturing, but the path has been cut and the future is optimistic.
James Schultz: Robots in the OR and automation on the factory floor offer potential for efficiency gains, cost reduction, and price elasticity.
Christine Scifert: Digital platforms, software, and interfaces have expanded the capabilities of most products and especially the interaction with hospitals and physicians. This has led to new requirements and guidance around electronic signatures/records and cybersecurity.
Paul Vasta: I don’t think we’ve yet seen the true impact of additive manufacturing on orthopedics, but I believe it will continue to progress and drive many areas of device design. If we generalize orthopedic “technology” to include the incorporation of more common capabilities applied in new and innovative ways, then I would say that total joints have demonstrated a significant impact to orthopedic healthcare. Over the past 15 years, the technology around total joints has been so impactful that these procedures have become commoditized where a once difficult surgery with not insignificant risk of outcome is now considered low-risk and commonplace. Patients are walking within hours after surgery! This isn’t just an achievement of the implant itself, but of the instruments and clinical/surgical components evolving in concert.
Elise Wolf: The entrance of robotics into the orthopedics and spine space has had a positive impact on the of adoption of other enabling technologies, and has helped companies with robotic platforms to achieve above-market growth quarter over quarter. A few years ago, the question was: Are robotics here to stay in orthopedics, or are they going to become very expensive pieces of equipment gathering dust in the corner similar to what happened with many navigation systems since 2005?
ODT: How will orthopedic technology change over the next 15 years? What kinds of innovations can be expected to emerge by 2035?
Lisa Ferrara: Significant advancement in robotics combined with medical imaging systems have been present in orthopedics for many years, with continued advancements in image quality, navigation, and haptic feedback. However, robotics has currently opened the door to the next phase of advancement: Virtual and augmented reality and artificial intelligence in medicine. It has already started in healthcare, but it is still in its infancy. Combination of these emerging technologies may provide rapid and accurate diagnoses at early stages that are not detectable with conventional systems. This can lead to patient-specific treatments during very early stages of a disease and offers a higher probability of success for the patient, thus changing the face of healthcare.
Mitchell Foster: Will stem cell treatments “cure” degenerative disc disease? Can the laminectomy/bony resection become safely automated? What new instrument will radically, and more importantly, safely, change the workflow of the procedures in spine that captures the mind of the surgeon? Can automation/robotics improve outcomes?
I believe we will see leapfrog technology in simulation, accuracy for navigation and robotics (think improvements in line of sight), augmented reality, speech recognition inside the OR, and imaging integration with robotics (might be sniffing glue here). By 2035, I believe we will know so much more about outcome measures, and precision medicine for patients (as well as patient selection) that spine surgery will become exceptionally safe and effective.
David Kelman: Additive manufacturing will play a significant role in the future. The ability of smaller companies to enter the market with innovative ideas has the potential to upend the largely risk-averse medical device companies. The ASCs will be where a large percentage of cases will be performed. The surgeon will now also be the administrator—how will they balance this where in the past, the medical device companies could play one against the other? Will biologics finally start having a role and displace metal and plastic?
Dawn Lissy: Stem cell technologies, combo devices, feedback mechanisms for loading (ACL replacements, artificial disc motions, etc.) of implants, and lower infections (fingers crossed here).
Ali Madani: More smart mechanisms, more reinforced plastics (even for hip and knee), growth in additive manufacturing, and common usage for the spine cages, hip cups, shoulder cups, and tibial knees.
Implants with integrated electronic sensors (e.g., Orthosensor’s VERASENSE), remote-controlled smart implants (e.g., NuVasive’s Precice internal lengthening nail), wireless communicative implants, active implants (containing medicines), etc.
Dave Neal: Over the next 15 years, orthopedics will see more and more additive manufacturing being employed (both implants and instrumentation), along with shortened product development lead times through rapid prototyping with inexpensive 3D printers. Digital surgery and utilizing disposable smart surgical tools are beginning to take hold in the orthopedic market and will potentially offer improved clinical outcomes while keeping down costs, compared to expensive robotic systems.
William Pratt: Pretty soon we’ll have too many patients chasing too few surgeons, so operative efficiency and productivity improvements will be rewarded by market acceptance. Directed cell growth and antimicrobial properties at the surface of implants will be common and more effective. As we understand autoimmune processes better and can halt the onset of arthritis, then the need for joint replacements may be reduced—but there’s always a need for trauma products. AI may make patient-matched implants more affordable by reducing the design overhead, but the low-hanging fruit there may be in the massive deployment of disposable customized cutting jigs to make surgery more time efficient and accurate. We already have physicians examining patients remotely with the help of clinical robots, perhaps the same model could be applied to sales representatives in the OR.
The golden rule is “do no harm,” but that’s hard for a specialty where most procedures start with a scalpel (and saws, hammers, and chisels!), so we have the challenge of improving instruments and implants so they actively assist in the healing and recovery process.
Thor Rollins: This is a great question and if I knew for sure then I probably could retire early, but what I am seeing is due to the high regulations and scrutiny, it’s harder for small start-up companies to get a thought to approval. This historically is where most of the innovation originated, so if this trend continues, then we will need to see larger medical device manufacturers invest more into innovation.
Chad Ryshkus: I think leaps in innovation will be most evident in the surgical suite with ancillary technologies assisting surgeons throughout the procedure. We are experiencing the early stages of this now with robotic-assisted surgery becoming more pervasive in orthopedic and spine surgery. It will only progress further and will integrate more technologies that have yet to be developed.
James Schultz: The advancement of polymers that mimic stainless steel offer significant potential to reduce instrumentation cost and also accelerate adoption of single procedure kits that are sterile-packed and surgery-ready. This presents a paradigm shift that allows forward thinking firms to capture market share at lower cost of sales and scale at a profit. The COVID-19 period showed the industry you must have your sterile implants and sterile instrument sets ready on the shelf in a rep-less or rep-light model.
Christine Scifert: More personalized and mobile healthcare. Care will be more customized and patient-focused. The primary point of care will continue to move away from the typical hospital setting. More and continued use of data to design devices and customize care.
Paul Vasta: Unfortunately, I’m inclined to believe that the most of the major orthopedic device manufacturers will do their best to continue along the same path we’ve seen in the last 15 years. It’s a model that is familiar and profitable. It is a calculus of maintaining the status of incremental device improvements that incorporate advances in manufacturing technology which, in turn, support market differentiation while minimizing risk to shareholders. That is not a knock on our current industry, but rather a perspective on the symbiosis of the orthopedic healthcare environment. It has been a community that does not readily embrace rapid or substantial departures from the status quo. That said, the utilization of today’s most impactful and wide-reaching technology—i.e., network connectivity and information availability (both data collection and accessibility)—should be the basis of the changes emerging in the coming years. We have already seen inklings of it within orthopedics and medical devices in general. Because implementing this technology tends to be extensive and systemic, major advances will take the cooperation and coordination of both the device manufacturer and the healthcare provider to realize meaningful impact that stretches beyond the devices themselves. This isn’t an easy road and it can be risky, but we are surrounded by examples of why it is one worth taking.
Elise Wolf: Digital technologies in orthopedics will continue to rapidly advance over the next 15 years, potentially transforming how orthopedic surgery is performed. Integration of different types of enabling technologies such as surgical planning, navigation, robotics, augmented reality, and, of course, artificial intelligence, into multifunctional systems will continue to push the envelope of technological capabilities, address limitations to adoption, and most importantly, assist in improving patient outcomes.