Part of the Franklyn Health series on innovation in the musculoskeletal space
Written by Rob Bedford
Orthopaedics has never stood still. From the first total hip replacements of the 1960s to today’s robotically-assisted joint reconstruction, the field has continuously evolved in response to clinical need, material science advances and the relentless demands of an ageing global population. But the pace of change is accelerating. A convergence of technologies: artificial intelligence; novel biomaterials; sensor miniaturisation; and additive manufacturing is creating genuine inflection points across multiple sub-disciplines simultaneously.
The pace and scale of this change are remarkable. The companies and clinical teams working at these frontiers are redefining what a medical device can do, what it means to plan a surgery; and how we monitor patients long after they leave the operating theatre.
This article opens our three-part series on innovation across the musculoskeletal space. It sets out the five areas we believe represent the most significant opportunities in orthopaedics over the next decade; and it shines a light on the technologies running through them that appear throughout the pieces that follow. Those articles go deeper into specific territory: first sports medicine and soft tissue repair, then reconstruction of the skeleton across joint replacement, trauma and spine.
1. Next-Generation Biomaterials and Bioresorbable Implants
For decades, the orthopaedic implant has been a permanent fixture: a titanium or stainless-steel structure designed to last a lifetime. That paradigm is changing.
The fundamental problem with permanent implants in fracture fixation is well established. Titanium is significantly stiffer than cortical bone and the resulting mechanical mismatch disrupts natural load transfer, drives stress shielding and in some cases impairs healing. Removing hardware after fracture union requires a second surgical procedure, adding substantial cost, risk and patient burden. The scale is significant: the global prevalence of fracture non-union is estimated at around nine million cases each year, set against a steadily rising worldwide fracture burden.[¹, ¹ᵇ]
Biodegradable magnesium alloys have emerged as promising alternatives to permanent metallic implants due to their unique combination of mechanical compatibility with bone and complete resorption, addressing the persistent issues of stress shielding and secondary removal surgeries.[²] The clinical data is beginning to catch up with the promise: a 2024 clinical study reported that magnesium screws implanted in paediatric fractures fully resorbed within 18 to 24 months, coinciding with complete bony unions and no instances of metallosis.[³]
Beyond magnesium, biodegradable polymers and cements that release drugs directly into the surgical site over a controlled period (including antibiotics, anti-inflammatories and bone growth factors) represent a new generation of implant design.[⁴]
Companies to watch: Syntellix AG has commercialised magnesium-based fixation in Europe under the MAGNEZIX brand, with a growing clinical evidence base in small bone and paediatric applications. Kuros Biosciences has taken a growth-factor-enhanced approach with its MagnetOs bone graft substitute, targeting faster and more predictable bone regeneration in spinal and orthopaedic applications. BellaSeno, working with Evonik’s Resomer biodegradable polymers, is developing 3D-printed scaffolds for complex and large bone defects; an example of additive manufacturing and bioresorbable materials converging in a single platform.[⁵]
Where the field is heading: The next decade will see bioresorbable materials move from niche paediatric and small-bone applications into mainstream long-bone trauma and, ultimately, load-bearing joint replacement components. The regulatory pathway for novel biomaterials remains demanding: ISO 10993 biocompatibility testing, long-term in vivo degradation data and novel clinical endpoints will all be required. But, the commercial and clinical case is increasingly hard to ignore.[²,⁴]
2. Surgical Robotics and Autonomous Assistance
Robotic-assisted surgery has moved from a novelty to a standard of care expectation in joint replacement. The global surgical robots market was valued at USD $12.93 billion in 2025 and is projected to grow at a CAGR of 16.5% through to 2035, reaching USD 59.55 billion.[⁶] Robotics is now an established part of joint replacement and the open question is how far the technology will go.
The current generation of systems: Stryker’s Mako, Smith+Nephew’s CORI and Johnson & Johnson’s VELYS are fundamentally surgeon-directed; the robot constrains the surgical field based on a pre-operative plan but does not act autonomously. Stryker continues to expand the Mako SmartRobotics portfolio, with new additions showcased at AAOS 2026 alongside Smith+Nephew’s handheld robotics for hip, knee and shoulder.[⁷]
The more disruptive opportunity lies in moving beyond constraint-based assistance toward genuine intraoperative intelligence. Johnson & Johnson MedTech has announced development of robotics systems using physical AI and simulated virtual operating room environments to accelerate product innovation and optimise clinical workflows.[⁸] Real-time adaptive robotics: systems that modify the surgical plan based on intraoperative tissue data, remain nascent but represent the logical next step.
Companies to watch: THINK Surgical is one of the more interesting challengers in this space. Their TMINI miniature wireless robotic system is implant-agnostic, partnering with multiple manufacturers and positioning itself explicitly against the proprietary implant lock-in that characterises most competitor platforms.[⁹] If the market moves toward implant-agnostic robotics (which health economics may ultimately demand) THINK Surgical’s positioning becomes strategically important.
Where the field is heading: The near-term competitive battle is around expanding robotics into shoulder, extremities and spine, areas where current penetration is lower than in hip and knee. The longer-term prize is closed-loop surgical systems that integrate pre-operative imaging, real-time biomechanical data and outcome databases, moving from constraining the surgical field toward genuinely augmenting clinical decision-making. Clinical evidence requirements for these systems will grow in complexity as their autonomy increases.[¹⁰]
3. Smart Implants and Remote Patient Monitoring
The implant of the future generates data. Embedding sensors into orthopaedic devices to monitor healing, load transfer, gait and implant integrity in real time is one of the most consequential shifts in the field. The global smart orthopaedic implants market was valued at USD 2.6 billion in 2025 and is projected to reach USD 10.7 billion by 2034, representing a CAGR of 17.4%.[¹¹]
Post-operative complication detection currently relies on patient-reported symptoms and periodic clinical review; a system that is reactive and episodic. Smart implants offer continuous, objective data: load through a fracture fixation device, range of motion following arthroplasty, early biochemical markers of periprosthetic joint infection. Zimmer Biomet’s Persona IQ, the world’s first commercially available smart knee implant, can measure range of motion, step count, walking speed and other gait metrics from within the implant itself.[¹²]
The pipeline is broadening. In February 2025, Penderia Technologies received FDA Breakthrough Device Designation for its Sensorized Soft Tissue Anchor System, addressing a critical gap in orthopaedic soft tissue repair through embedded proprietary wireless sensing technology.[¹³] Intelligent Implants has developed SmartFuse, a spinal fusion implant system equipped with embedded sensors and wireless connectivity to monitor fusion progress in real time.[¹⁴]
Where the field is heading: The hardware is largely solved. Sensor miniaturisation, wireless power transfer and biocompatible packaging are all advancing. The real bottleneck lies in clinical workflow integration and the regulatory framework for the software and data components. These devices are combination products: the implant, the sensor system and the data analytics platform each carry regulatory obligations. Clinical validation of the monitoring claims themselves, alongside the implant’s structural performance, will be essential, and this is where many early-stage companies are underprepared. Reimbursement pathways for remote monitoring data in orthopaedics also remain inconsistent across markets.[¹¹,¹²]
4. Artificial Intelligence in Surgical Planning and Implant Design
AI is embedding itself across the entire surgical workflow, from diagnosis and pre-operative planning through to intraoperative guidance and post-operative outcome prediction. In orthopaedics, where image data is rich and procedural variability is high, the opportunity is substantial.
AI models for implant selection have demonstrated femoral and tibial component size prediction accuracy of 82.2% and 85.0% respectively, compared to 68.4% and 73.1% for conventional manufacturer default plans.[¹⁵] That may sound incremental, but in the context of revision surgery, where implant mismatch is a significant contributor to failure, the downstream clinical and economic impact is significant.
Machine learning algorithms can now analyse patient-specific features including bone mineral density, mobility patterns and biomechanical characteristics to inform orthopaedic implant design.[¹⁶] The integration of AI with digital twin technology is the next frontier: virtual replicas of a patient’s anatomy and physiology allow surgeons to test multiple treatment approaches before implementation.[¹⁷]
Beyond planning, AI is beginning to affect intraoperative decision-making. Real-time image processing, integration with robotic systems and adaptive feedback mechanisms are enhancing accuracy, reducing complications and personalising care across joint replacement, spine and trauma surgery.[¹⁵]
Companies to watch: At the large-company level, Johnson & Johnson’s use of NVIDIA Isaac for virtual operating room simulation signals where major players are directing R&D investment.[⁸] Among emerging companies, Oxos Medical has developed AI-powered intraoperative imaging for orthopaedic trauma, reducing radiation exposure while improving implant placement accuracy. This is a strong example of AI applied to a specific, high-value clinical problem with a tightly defined claim.
Where the field is heading: The regulatory treatment of AI-driven planning tools as Software as a Medical Device (SaMD) is still evolving. Under EU MDR and the FDA’s evolving framework for AI/ML-based SaMD, post-market performance monitoring of AI models (including handling algorithm updates) creates ongoing regulatory obligations that many device companies have not yet fully scoped. Clinical validation of the AI’s specific claims, in addition to its general performance, will be essential.[¹⁶]
5. Additive Manufacturing and Patient-Specific Implants
Three-dimensional printing has been in orthopaedics for some years, but the technology is now mature enough to move beyond anatomical models and surgical guides into production-grade patient-specific implants at commercial scale. Additive manufacturing allows the creation of patient-specific implants with porous architectures closely resembling natural bone, enhancing osseointegration, while surface engineering techniques including bioactive coatings and antimicrobial layers address persistent issues at the implant-tissue interface.[¹⁰]
The clinical case for patient-specific implants is strongest in complex revision arthroplasty, oncological reconstruction and craniomaxillofacial surgery; cases where off-the-shelf implants are anatomically inadequate. 3D printing enables the creation of custom acetabular cups and spinal cages using titanium, PEEK and specialised polymers that enhance surgical fit and outcome.[¹⁸]
The combination of additive manufacturing with novel biomaterials is particularly compelling. Porous structures that mimic trabecular bone architecture can be printed in titanium, Nitinol or degradable polymers with precise control over porosity gradients; a design space that is simply impossible to access through conventional manufacturing. In December 2025, Medi-Mold partnered with OIC International and AddUp to develop a 3D printed orthopaedic implant manufacturing facility, reflecting the sector’s confidence in additive manufacturing as a production-scale technology.[¹⁹]
Where the field is heading: The near-term growth is in expanding the indications where patient-specific implants are cost-justified and reimbursed. The medium-term opportunity is in combining patient-specific geometry with smart materials and embedded sensors; implants tailored to the patient’s anatomy, stiffness-matched to their bone and capable of reporting on their own performance. Generating the clinical evidence to support these combination claims will require thoughtful study design from the outset.[¹⁰,¹⁸]
A Note on Clinical Evidence
Across all five of these areas, the companies that will succeed are those that treat clinical evidence strategy as a first-principles design question from the very outset. Novel biomaterials need long-term in vivo degradation and biocompatibility data. Smart implants need clinical validation of their monitoring claims, in addition to their structural performance. AI planning tools need prospective evidence that their outputs improve patient outcomes, going beyond mere correlation with surgeon decisions. Combination products (implants paired with software, sensors or drug elution) require integrated clinical strategies that address each component and the interaction between them.
These are solvable problems. But they require deep familiarity with the orthopaedic evidence landscape, regulatory expectations in both the EU and US, and the practical realities of running clinical investigations in this specialty.
At Franklyn Health, orthopaedics sits at the heart of what we do. Our team have worked at the bench and corporate level with some of the world’s largest orthopaedic companies, including Stryker, Smith+Nephew and DePuy Synthes, and we have brought that experience to bear for emerging companies across joint reconstruction, trauma, spine and craniomaxillofacial surgery. If you are building in this space and thinking about your clinical and regulatory pathway, we would be glad to talk.
We are based in Leeds, a city with a legitimate claim to being the birthplace of the modern orthopaedic industry. When Sir John Charnley pioneered total hip replacement at Wrightington Hospital in 1962, a procedure now performed over one million times annually worldwide, it was Chas F. Thackray Ltd, a Leeds-based manufacturer founded in 1903, that made it a clinical reality.[ᴿ¹, ᴿ²] Thackray began manufacturing the Charnley hip system in 1963 and it remains the best-selling cemented hip system in the world. The company was eventually acquired by DePuy, now part of Johnson & Johnson. That lineage, from a Leeds pharmacy on Great George Street to the global orthopaedic market, is a thread that runs directly through the history of the specialty. The University of Leeds continues that tradition today, hosting the NIHR Leeds Biomedical Research Centre, home to the largest international academic facility for preclinical testing of joint replacements, and the Leeds Institute of Rheumatic and Musculoskeletal Medicine, a recognised EULAR Centre of Excellence.[ᴿ³, ᴿ⁴] It is the right place to be doing this work.
This is the opening article in our three-part series on innovation across the musculoskeletal space. The pieces that follow examine sports medicine and soft tissue repair, then reconstruction of the skeleton across joint replacement, trauma and spine.
References
[1] Stewart SK. Fracture Non-Union: A Review of Clinical Challenges and Future Research Needs. MOJ Orthopedics & Rheumatology. 2019;11(4). Global prevalence of fracture non-union estimated at nine million annually. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6702984/
[1b] GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990–2019. The Lancet Healthy Longevity. 2021;2(9):e580–e592. https://www.thelancet.com/journals/lanhl/article/PIIS2666-7568(21)00172-0/fulltext
[2] Tsakiris V, et al. Biodegradable Mg alloys for orthopedic implants — A review. Recent Advances in Biodegradable Magnesium Alloys for Medical Implants. MDPI Crystals. 2025;15(8):671. https://www.mdpi.com/2073-4352/15/8/671
[3] Frontiers in Bioengineering and Biotechnology. Surface engineering of nano magnesium alloys for orthopedic implants: a systematic review. 2025. https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2025.1617585/full
[4] Global Healthcare. Orthopaedic Biomaterials Market Analysis & Forecast – 2035. 2025. https://globalhealthcaree.wordpress.com/2025/12/10/orthopaedic-biomaterials-market/
[5] Global Market Insights. Bioresorbable Scaffolds Market Analysis. 2024. https://www.gminsights.com/industry-analysis/bioresorbable-scaffolds-market
[6] Expert Market Research. Surgical Robots Market to Reach USD 59.55B by 2035. 2025. https://www.openpr.com/news/4318834/surgical-robots-market-to-reach-usd-59-55b-by-2035
[7] Stryker. Stryker Showcases Continued Innovation Across Orthopaedics at AAOS 2026. Surgical Robotics Technology. March 2026. https://www.surgicalroboticstechnology.com/news/stryker-showcases-continued-innovation-across-orthopaedics-at-aaos-2026/
[8] Johnson & Johnson MedTech. Johnson & Johnson to Advance Robotics Development with NVIDIA Isaac for Healthcare. Press release. October 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-to-advance-robotics-development-with-nvidia-isaac-for-healthcare
[9] THINK Surgical. TMINI Miniature Robotic System — First Cases Completed. Press release. February 2026. https://thinksurgical.com/
[10] Misar Abdulhamit M, et al. Current developments in orthopaedic implant technology. Journal of Orthopaedic Surgery and Research. 2025;20(1):927. https://link.springer.com/article/10.1186/s13018-025-06279-w
[11] Global Market Insights. Smart Orthopedic Implants Market Size & Share 2025–2034. March 2025. https://www.gminsights.com/industry-analysis/smart-orthopedic-implants-market
[12] MedTech Dive. Companies see a future for smart implants. Doctors are waiting for proof. June 2022. https://www.medtechdive.com/news/zimmer-biomet-canary-smart-knee-implants/626133/
[13] Towards Healthcare. Implantable Sensor Orthopedic Market Growth Forecast 2025 to 2034. November 2025. https://www.towardshealthcare.com/insights/implantable-sensor-orthopedic-market-sizing
[14] Straits Research. Smart Implants Market Size & Forecast 2025–2034. https://straitsresearch.com/report/smart-implants-market
[15] Cureus. AI-Enhanced Surgical Decision-Making in Orthopedics: From Preoperative Planning to Intraoperative Guidance and Real-Time Adaptation. September 2025. https://www.cureus.com/articles/407907-ai-enhanced-surgical-decision-making-in-orthopedics-from-preoperative-planning-to-intraoperative-guidance-and-real-time-adaptation
[16] Han et al. Artificial Intelligence in Orthopedic Surgery: Current Applications, Challenges, and Future Directions. MedComm. 2025;6(7):e70260. https://onlinelibrary.wiley.com/doi/full/10.1002/mco2.70260
[17] PMC. Artificial intelligence in orthopaedic surgery: exploring its applications, limitations, and future direction. 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC10329876/
[18] Orthopaedic Biomaterials Market. Customization via Additive Manufacturing. December 2025. https://globalhealthcaree.wordpress.com/2025/12/10/orthopaedic-biomaterials-market/
[19] Ortho Spine News. Orthopedic Implants Market Outlook 2025–2034. January 2026. https://orthospinenews.com/2026/01/30/orthopedic-implants-market-outlook-2025-2034/
[R1] John Charnley Trust. Transforming Hip Surgery. Total Hip Replacement pioneered at Wrightington Hospital by Sir John Charnley, 1962. johncharnleytrust.org. https://johncharnleytrust.org/transforming-hip-surgery/
[R2] Gomez PF, Morcuende JA. A historical and economic perspective on Sir John Charnley, Chas F. Thackray Limited, and the early arthroplasty industry. Iowa Orthopaedic Journal. 2005;25:30–37. https://pmc.ncbi.nlm.nih.gov/articles/PMC1888784
[R3] NIHR Leeds Biomedical Research Centre. Musculoskeletal Disease Research. Host to the largest international academic facility for preclinical testing of joint replacements. leedsbrc.nihr.ac.uk. https://leedsbrc.nihr.ac.uk/musculoskeletal-disease/
[R4] University of Leeds. Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM). Recognised EULAR Centre of Excellence. medicinehealth.leeds.ac.uk. https://medicinehealth.leeds.ac.uk/leeds-institute-rheumatic-musculoskeletal-medicine
Franklyn Health is an employee-owned medical device and diagnostics CRO based in Leeds, UK. We work exclusively in medical devices and in vitro diagnostics, with a particular focus on orthopaedics, sports medicine and musculoskeletal medicine. For enquiries, contact us at hello@franklynhealth.com.
