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Throughout the year, BONEZONE reported on numerous trends, market forces and technologies shaping the orthopedic industry. As 2022 comes to an end, we highlight 10 articles that provided our readers with actionable advice and kept them informed of the competitive landscape. Further, each of these articles could play a role in orthopedic R&D decision-making in 2023. We would love to hear your thoughts on what topics we should cover more of in 2023. Send us an email.
Patient-Specific Implants: Niche Idea or the Future of Orthopedics?
The success of an orthopedic implant hinges on numerous factors, from design to fit to the patient’s overall health. A traditional orthopedic implant system includes a variety of implant sizes to help find the best fit. But patient-specific, or personalized, implants can be designed and manufactured with extreme precision to match a patient’s unique anatomy and perhaps provide a better recovery and outcome.
Three-dimensional modeling through the use of CT scans, MRIs and radiography has been utilized for decades in the orthopedic space. Today, improvements in these technologies and design software mean that anatomical structures can be reconstructed more accurately in the creation of patient-specific implants.
EU MDR Poses Tough Decisions for Orthopedic Companies
So, you want to launch a product in Europe? You might want to reconsider your strategy. The regulatory tables have turned, and it now takes a lot more time, money and energy to launch an orthopedic product in the EU market.
Pursuing a CE Mark will not be the right choice for every orthopedic manufacturer. Only companies with deep pockets, patience and alternative revenue sources will survive the complex and expensive Medical Device Regulation (MDR) certification process.
Hospital and Surgeon Trends That Will Impact Your Work
Designing and selling products, of course, requires that orthopedic device companies consider the surgeon and patient. But successful orthopedic companies think beyond the operating room and respond to the shifting trends and dynamics within the hospital and surgeon landscape.
Patrick Vega, a Consulting Director for Vizient Advisory Solutions, spoke at this year’s OMTEC event on three critical trends: a move of procedures to outpatient settings, such as ambulatory surgical centers (ASCs), scrutiny in hospital purchasing and a desire to form strategic relationships with hospitals. While these trends have been evolving over the last decade-plus, they continue to gain momentum and will impact how device companies think about the products they deliver to the market.
Orthopedic Market Experiences Familiar Challenges in Push Toward Recovery
The orthopedic market made strides in recovery during its second year amid the COVID-19 pandemic, but remains below normal levels. Global orthopedic sales grew by $6.1 billion in 2021 or +12.8% vs. the prior year. Using 2019 as a baseline, the market climbed +0.9%. to $53.6 billion in global sales, just ahead of its 2019 total of $53.1 billion.
After the initial shocks of lockdowns in 2020, challenges to the market evolved in 2021. New variants of the virus caused additional waves of infections. The global supply chain remained under significant pressure and shortages of workers, particularly in healthcare, complicated the market’s recovery. We are experiencing a similar environment in 2022.
How Artificial Intelligence and Machine Learning are Coming of Age in Orthopedics
Despite its technical nature, healthcare moves at a rather stately pace in adopting new care models and technologies. Innovative materials, robotic surgery tools and a fulsome ASC market have long loomed on the orthopedic horizon. In speaking to industry insiders, we believe many of these trends are reaching critical mass and are about to exert real force on the market.
Artificial intelligence (AI) is one of the most rapidly-developing technologies in orthopedics. It is ubiquitous in our daily lives, from autonomous vacuum cleaners to the panoply of “personal assistants” on smart devices. For some of us, however, AI still conjures ideas more suited to science fiction.
How to Switch from Non-Sterile to Sterile Medical Devices
Sterile-packaged orthopedic implants and instruments are not new, but the trend has picked up recently. Though the concept was first commercialized nearly 30 years ago, today, sterile, single-use orthopedic devices can credit their momentum to various market dynamics.
Tyber Medical, an OEM private label company, is well-versed in helping orthopedic device companies bring sterile devices to market. Since product development is a team effort, we spoke with multiple members of the Tyber Medical team to get an idea of how other orthopedic device companies can make the switch from non-sterile to sterile.
Spine and Additive Manufacturing: Why It Makes a Good Match
These days, it’s a rarity to find a spine company that doesn’t market at least one implant manufactured via 3D printing. In fact, a review of FDA’s 510(k) database shows that the vast majority of orthopedic companies that are using additive manufacturing (AM) are doing so for spinal implants.
While plenty of other orthopedic verticals are using AM to some extent, spine seems to be ahead of the curve in terms of widespread adoption. There are several possible reasons for that, including the advantages that AM brings in creating spinal implants with complex geometries and devices that promote osseointegration at a level that isn’t possible through traditional manufacturing.
Magnesium Implants Gain Momentum in the Orthopedic Industry
As the orthopedic market shifts toward a focus on biocompatible and resorbable materials, magnesium is gaining momentum in trauma and sports medicine applications.
The use of magnesium is in response to the need for temporary — yet highly effective — implants. Hardware removal is one of the most common procedures performed worldwide and can be expensive, painful and present additional risks. On the other hand, leaving an orthopedic implant in the body can also pose potential risks for infection or other long-term failure.
A resorbable material removes those risks for indications where short-term fixation is needed, such as in fracture repair. However, current resorbable materials are typically made of polymers, which come with their own set of potential problems.
25 Orthopedic Startups on Our Radar
We discover dozens of orthopedic startups every year via public announcements, industry meetings, LinkedIn, FDA databases…they’re everywhere. We’ve compiled a list of 25 implant and instrument companies that are new to our radar to provide you with a better understanding of the latest technology on the market, perceived gaps in orthopedic care, potential competition and smart individuals with whom to align yourself.
Orthopedic Companies Adopt Industry 4.0 for Efficiency and Accuracy
Orthopedics hasn’t always been known for its speed and agility in adapting to new technology. However, the industry has reached new heights with advancements in manufacturing and expansion into enabling and digital technologies. Those advancements are only expected to continue in the wake of COVID-19 as healthcare and medical device companies strive for greater efficiencies in the way they work.
Enter Industry 4.0. While the Fourth Industrial Revolution isn’t new, today’s market forces will require companies to digitize crucial operations and new products. Experts say a more profound and enduring pivot to Industry 4.0 is vital for companies to compete in the modern orthopedic device industry.
