ODT https://www.odtmag.com Orthopedic Design & Technology continues to be recognized as an industry-leading publication, widely known for its in-depth, high-quality coverage of the specialized field of orthopedic product development and manufacturing. Tue, 22 Oct 2024 14:54:06 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 https://www.odtmag.com/wp-content/uploads/sites/13/2024/07/odt-favicon.png ODT https://www.odtmag.com 32 32 The Challenging Road Toward a Digital Transformation in Orthopedics https://www.odtmag.com/the-challenging-road-toward-a-digital-transformation-in-orthopedics/ https://www.odtmag.com/the-challenging-road-toward-a-digital-transformation-in-orthopedics/#respond Mon, 23 Sep 2024 15:30:00 +0000 https://www.odtmag.com/the-challenging-road-toward-a-digital-transformation-in-orthopedics/ ODT team, I attended the North American Spine Society annual meeting for the first time. During that event, I observed the state of the spinal industry, which I summed up as the spinal fusion show. However, tucked away between spinal implant companies and fusion technology providers were a variety of vendors showcasing their more natural solutions—biologics. These innovations captivated me and I boldly proclaimed in an Editor’s Letter soon after that the industry would be transformed, possibly in 10 years.

Fast-forward to almost eight years later and the orthopedics industry (not just spinal fusion) is very much in a rapid transformation. Biologics, however, are not driving that change. Rather, digital-based technologies are spearheading a new wave of orthopedic products and procedures. These devices have eliminated any trace of “art” within orthopedic surgeries and replaced it with science based on data. They are providing surgeons with more exact measurements to help ensure accurate surgeries to ultimately lead to more successful procedures.

At least, that’s the idea.

Unfortunately, we’re not quite there, according to research on robotic procedures versus more traditional techniques. A study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) revealed evidence of robotic-assisted procedures not significantly impacting surgical outcomes. Researchers looked at 9,220 cementless total knee arthroplasty procedures, 45% of which were performed with robotic assistance. They found reasons for revisions at two years were similar between both techniques. They also found the rates of revision due to infection were similar. Finally, they found the instance of mechanical loosening is not significantly different between robotic-assisted and conventional surgeries.

This is only one study, but it does resemble anecdotal information I’ve heard in my discussions with industry representatives on both sides of the conversation. Unfortunately, however, it’s not the only challenge faced by the digital revolution in orthopedics.

A September 2023 article published by Cureos features an overview of “The Role of Robotics” in orthopedics. It cites both advantages and disadvantages associated with the use of robotics in orthopedics. Among the benefits mentioned were: enhanced precision, personalized treatment, minimized tissue trauma, improved implant placement, real-time feedback, ability to execute complex maneuvers, and reduced radiation exposure. Curiously, some of those advantages are called into question by studies such as the one presented at the AAOS event.

Unfortunately, the list of disadvantages could be considered more significant than the benefits realized. They included: high initial costs, learning curve, limited flexibility, dependency on technology, time-consuming setup, complexity of integration, and ongoing maintenance and costs. A fair number of these can be resolved with future innovations and ongoing development of future generations. We’re just at the infancy of the robotics’ debut and the systems will undoubtedly improve in multiple ways.

There is, however, one concern brought up that extends well beyond robotics; rather, it’s prevalent for the digital technologies being embraced in the orthopedic space (and the medtech sector at large). Who’s paying for these if they offer no or minimal significant improvements on the current standard of care?

I recently spoke with one of the panelists for the upcoming MPO Summit about this very topic. While he’s worked with several companies on enabling technologies, he maintains one of the most important questions concerns reimbursement. If the product is not being covered by payers, it’s not going to succeed. Before the digital transformation of orthopedics or medtech can take place, the financials need to make sense.

Register for this year’s MPO Summit here!

While this challenge will be considered the most significant by many (and for good reason), it’s not the only one that needs to be resolved. Cybersecurity, data collection, patient privacy, integration of artificial intelligence (AI), and other concerns all still exist and create potential problems as the digital revolution evolves.

I have confidence in digital solutions in orthopedics, though. And perhaps that’s the real way to look at it now. The digital revolution has occurred; now we’re in the digital evolution. The challenges remain the same as they were, but it’s only a matter of time before they are addressed and resolved. Of course, new challenges will emerge and the industry will repeat the process all over again. Hence, evolution is a better way to look at it.

In the meantime, consider the obstacles you face with a new digital innovation. Have you addressed reimbursement, cybersecurity, patient privacy, and others? This evolution is not going to be easy, but we’ll get there and eventually, those researchers will report the benefits. 

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com]]> https://www.odtmag.com/the-challenging-road-toward-a-digital-transformation-in-orthopedics/feed/ 0 Intelligent Testing for Orthopedic Devices & Implants https://www.odtmag.com/intelligent-testing-for-orthopedic-devices-implants/ https://www.odtmag.com/intelligent-testing-for-orthopedic-devices-implants/#respond Mon, 23 Sep 2024 15:20:00 +0000 https://www.odtmag.com/intelligent-testing-for-orthopedic-devices-implants/
“By mid-year, however, there was a noticeable shift as new product development resumed and validation testing increased,” stated Thor Rollins, vice president of the medical device segment for Nelson Laboratories, a Salt Lake City, Utah-based global testing lab specializing in advisory and testing solutions for medical device companies. “This upward trend in testing activity is expected to continue through the remainder of the year.”

Top sectors for testing in 2024 are extremities, trauma, lower back and spine devices, additive-manufactured (AM) devices, and cleaning/sterility testing to support increased regulatory scrutiny across a growing number of medical technologies.

As medical devices become more sophisticated, regulators are demanding more comprehensive data to ensure product safety. For example, a recent update to the ISO 18562 set of standards for breathing gas pathways for medical devices has brought about a series of changes for medical device manufacturers (MDMs) “that will lead to safer medical devices by addressing previously overlooked toxicological concerns,” said Andrew Gottfried, director of North American sales for Eurofins Medical Device Services, a Lancaster, Pa.-based testing laboratory that specializes in biocompatibility testing and regulatory-compliant medical device and combination product testing support. “Clear guidelines and more detailed standards align product development with regulatory expectations, potentially speeding up the approval process. The challenge is balancing the updates and requirements that create more complexity in testing with the potential for additional costs due to these changes.”

Another safety concern over the past few years has been the emergence of new labs to meet the rising demand for preclinical safety testing. Not all these labs, however, possess the necessary equipment or expertise for complete chemical characterization. “Recently,” said Sandi Schaible, executive director of analytical chemistry and toxicology for WuXi AppTec’s St. Paul, Minn.-based analytical chemistry laboratory, which provides regulatory consulting, pre-clinical testing, and post-commercialization product testing support, “U.S. regulators have highlighted an increase in unreliable data from third-party labs, particularly from facilities in China and India. It is crucial for sponsors to partner with credible and capable laboratory testing labs.”

This is especially true for MDMs that do not have much internal experience navigating testing and regulatory pathways and typically need third-party guidance to avoid mistakes.

“We see a steady increase in testing requests from smaller startups and contract manufacturers, which has grown our resource focus on supporting the regulatory pathway for these customers, who have not traditionally had either testing or regulatory expertise within their organizations,” said Jason Langhorn, Ph.D., technical manager for Fairfield, Ohio-based Element Materials Technology, a provider of destructive and non-destructive materials testing and compliance and qualification testing for medical devices. “To make this process easier, we recently launched www.regnav.com, an online regulatory navigation tool that supports the full end-to-end process in device R&D.”

Latest Trends

Compared to last year, there is a significant increase in digital health devices entering the market, reflecting a growing integration of technology in orthopedic care. “The latest trends in testing services and equipment for orthopedic devices are centered around technologies such as artificial intelligence [AI] and the introduction of connected implants—for example, sensors embedded in implants that relay positional data and enable at-home monitoring post-surgery,” Rollins said.

Regulatory expectations continue to evolve and bring more scrutiny to medical devices, especially those with a significant digital component. MDMs need to be fully prepared with supportive data, especially as regulatory reviewers gain their own technical knowledge of complex testing such as extractable/leachable testing. “As a result,” said Schaible, “they continue to ask more questions and seek greater understanding of the testing for a specific product.”

New or improved technologies bring positive change to the overall process of testing and analysis, helping testing labs meet the increasingly complex demands of their MDMs and FDA regulators. “For example, advancements that reduce the reliance on animal testing can also provide more accurate and human-relevant data and improve the overall efficacy and safety of new products and treatments,” said Gottfried. “The combination of advanced chemical characterization, in-vitro alternatives, and toxicological risk assessments will play crucial roles in reducing and eventually eliminating the need for animal testing.”

Evolving manufacturing processes, combined with the increase in smaller and more complex devices as well as the growing number of contract manufacturing organizations, have led regulatory authorities to ask for more worst-case-type testing. AM-made devices have especially attracted the attention of the FDA. “There are more requests for particle and ion testing of test media post-testing, and an increase in worst-case type tests such as third-body wear simulation testing, which exercises the mechanical integrity of an articulating joint device in the presence of particles,” said Langhorn.

Although there is a steady stream of AM implant validation/revalidation work in hip and knee, much of it has been focused on process changes and small changes to implant designs already on the market. The majority of implant innovation in the additive space has occurred in compassionate care/patient-specific devices, spine, and shoulder markets, with new innovative designs incorporating structures to promote bone in-growth, together with dense structural support and/or articulation surfaces.

Regulatory expectations for extractable and leachable materials testing have also increased, with greater attention to the materials that contact devices through the lifecycle process, including packaging and labeling. The EPA has also proposed stricter regulations on emissions from manufacturing facilities that utilize ethylene oxide (EtO) to sterilize devices. This has led some MDMs to look for alternative high-temperature and low-temperature sterilization techniques. “In response, we are seeing a greater number of requests for sterilization validation/re-validation studies,” said Langhorn.

What OEMs Want

Orthopedic OEMs want faster turnaround times for testing services. “With the earlier delays in product development now resolved, there is a strong emphasis on accelerating the testing process,” said Rollins. “We’ve focused heavily on reducing turnaround times through rapid methods and streamlined processes. Speed is the top priority, second only to maintaining high-quality standards.”

Companies are also requesting more biological evaluation plans (BEPs) and biological evaluation reports than in previous years. BEPs are integral to the development phase because they encompass the entire product lifecycle. “With a tailored BEP, cost-efficient plans are aligned to regulatory expectations,” said Gottfried. “Medical device developers should ideally be able to advance seamlessly through testing and achieve regulatory compliance. Further, by incorporating a future-proof mindset, a BEP can outline expected testing needs with anticipated device upgrades and changes.”

With increased regulatory scrutiny on medical technology implants and instrumentation, MDMs are looking for assurance that the testing will be done correctly the first time. They want studies that are carefully designed to ensure regulatory requirements are met and any additional questions from regulatory bodies can be easily answered.

One of the biggest challenges that Eurofins Medical Device Services sees is clients trying to meet the analytical evaluation threshold (AET). The AET can be daunting for many manufacturers, but especially those testing smaller devices, which include lower and lower AET calculations, along with larger uncertainty factors that go into these calculations. “The lower AET drives the need for high-quality materials that go into the construction of the device that will not degrade under extraction conditions or real-life applications,” said Gottfried.

Regarding types of tests, MDMs are interested in impaction and lifecycle testing of medical instruments, third-body wear simulation testing, and particulate and ion testing. Although an increased emphasis has been placed on these tests by regulatory agencies, there is still limited guidance on what is needed to validate these processes and/or devices, which slows down the submission process.

Advances and Challenges

Over the past several years, key technological advancements include rapid sterility and bacterial indicator testing. These are crucial release tests and, traditionally, the medical device must be held until the results are available. However, with new rapid testing methods, the turnaround time has been dramatically reduced, making the process more efficient and allowing products to reach the market faster. “This advancement is pushing the limits of testing speed while still ensuring safety and quality,” said Rollins. “The traditional method relied on sufficient bacterial growth to be visible with the human eye; now we use signals inside bacterial cells that can be detected much earlier than with the visibility method, utilizing a reduced incubation time in order to get reliable results.”

For materials, MDMs are keeping an eye on the phase-out of certain fluoropolymers (PFAS) used in the manufacturing of polymers such as polytetrafluoroethylene (PTFE). “Even if a suitable alternative can be found, manufacturers are busy assessing the impact of this change on their products,” said Schaible. “And if alternatives cannot be found, it could mean a flurry of products that, without a redesign, are at risk of discontinuation.”

AM has greatly advanced the production of complex and customized parts across the medical device industry, especially implants. However, AM still creates unique challenges and requirements for testing and validation. “When looking at AM-made devices, it is critical to address variability in the material properties for these composites and biocompatible polymers, including areas like tensile strength, hardness, and fatigue resistance,” said Gottfried. “Also, understanding the materials composition is critical to create biologically safe devices when addressing ISO 10993 testing and endpoints. Standards organizations like ASTM and ISO have developed standards specifically for additive manufacturing. These standards provide guidelines for testing methods, material properties, and quality assurance processes.”

Initially, regulatory agencies had concerns regarding the safety and cleanliness of AM-made devices, but now the processes have been greatly refined, allowing any associated risks to be better understood and easier to manage. “The industry has now developed standardized methods for handling and testing these devices, making it easier for them to meet testing standards,” said Rollins. “Overall, AM-manufactured products have improved in quality and reliability, aligning more closely with traditional manufacturing methods in terms of safety and efficacy.”

The Internet of Things (IoT), especially AI, is having a significant impact on testing services and equipment in the orthopedic space. MDMs want to use AI and machine learning (ML) to accelerate product development and speed to market. “The FDA has already approved several AI-driven devices, streamlining their path to market,” said Rollins. “However, validating AI for regulatory purposes presents unique challenges, as traditional validation methods are not well-suited for systems that learn and adapt over time. Our regulatory branch, Regulatory Compliance Services, stays up to date on these evolving requirements to better support our customers.”

MORE INFO: The Future of Artificial Intelligence in Orthopedics

Element Materials Technology relies on AI to operate www.regnav.com, which captures a medical device’s characteristics and uses AI to generate an expert-backed compliance plan. “This plan includes suggested path and class, applicable standards, and testing requirements that are needed for FDA submission,” said Langhorn. “If a customer has a plan, we can also use this tool to verify, or essentially run a gap analysis, to ensure no standards have been overlooked.”

Connected devices and embedded electronics involve additional testing challenges, especially around security. As more orthopedic devices incorporate digital technologies, AI will be essential for improving the design, security, and reliability of these systems. In more of an administrative role, AI can also be used to draft test protocols and post-test reports, giving engineers more time for higher-level tasks.

Regulatory Challenges

Regulatory and FDA challenges for testing services and equipment often revolve around the need for consistency. “The FDA is actively working to enhance consistency, whether through its Accreditation Scheme for Conformity Assessment [ASCA] program, which it aims to extend to extractable and leachable testing, or by participating more in the creation of standards and educating their staff throughout the agency,” said Rollins. “These efforts are focused on ensuring that testing procedures and requirements are applied more uniformly, making it easier for manufacturers to meet regulatory expectations.”

The regulatory environment continues to evolve as a growing number of complex medical devices enter the market. In response, U.S. regulators are scrutinizing data more rigorously than ever before. “Regulatory agencies are employing advanced technologies to analyze submission data and compare it with historical data to identify anomalies or potential fraud,” said Schaible. “Such tools enhance the accuracy and reliability of data verification processes. Eventually, these technologies are expected to be integrated into the design, development, manufacturing, and testing of life science products.”

One of these data applications is the increased use of computer simulation and modeling to support medical device approval through regulatory submissions (examples of ASTM standards that support FEA modeling for stents and orthopedic implants include ASTM F2996-20, ASTM F3161-16, and ASTM F3334-19). The use of simulation and modeling can be an excellent tool in the research and development of new devices, as well as in determining possible failure risk areas in medical device designs. “However, it is imperative that the digital tools fully emulate the physical space—for example, test set-up, friction between design features, and mechanical properties—because differences between the in-silico model and physical counterpart may give misleading information to engineering teams,” said Langhorn. “For this reason, bench testing will likely continue to be the ‘gold standard’ for the foreseeable future, especially as both digital and physical test methodologies merge to create a much more comprehensive testing framework, allowing OEMs to take advantage of the flexibility of digital techniques while retaining the accuracy of bench tests.”

One of the biggest “regulatory” issues with MDMs is their reluctance to adopt new testing technologies or methods. Many are hesitant to move away from testing approaches they have used for decades, which is understandable. “However, testing technology and risk assessment standards are evolving, and embracing these new methods can lead to significant savings in both time and cost,” said Rollins. “Companies need to recognize that adapting to these advancements can enhance efficiency without compromising quality or safety.” A good example is using a risk-based approach to a product’s biocompatibility: many products are made from the same materials and have similar processing, but are tested over and over again because of the reliance on test methods.

An Ever-Changing Landscape

What truly stands out in the field of testing services and equipment is the extent of changes occurring in the standards.

“Nearly all the ISO and ASTM standards we use daily are undergoing significant revisions,” said Rollins. “This is driven by the increasing complexity of medical devices and the adoption of new risk assessment approaches, which are reshaping how we ensure safety and efficacy.”

For example, there are new standards in the areas of AM-made devices and shoulder implants, as well as substantial edits to established standards, on the horizon. The approval and release of these new standards and revisions will greatly impact an MDM’s ability to meet its customers’ testing needs and expectations. “Innovations in shoulder, spine, and extremity devices continue to be areas of growth in medical devices, which also drive considerable efforts in standards committees such as ASTM to modify and develop standard test methodologies,” said Langhorn.

In addition to staying on top of regulatory standards, the next big challenge for testing services is dealing with the increasing complexity and digitalization of orthopedic devices and other products. “As these devices become smaller, smarter, and more functional, the difficulty of testing them grows,” said Rollins. “Ensuring that testing methods keep pace with these advancements is crucial to maintaining accuracy and reliability.”

Testing technologies must continue to advance to solve testing challenges for increasingly complex devices and to meet MDM budgets and timelines. For example, testing absorbable devices requires careful selection of solvents because even the slightest differences in chemistries can greatly impact the accuracy and reliability of the results. “The choice of solvent must consider factors such as polarity, temperature, and the extraction method used,” said Schaible. “We recommend a pre-submission meeting with regulators to ensure testing protocols meet all necessary standards and requirements.”

The European Union’s Medical Device Regulations (MDR) has had a significant impact on the testing of medical devices, requiring that all medical devices marketed in the EU must now be certified—this creates an extra burden on OEMs for both new products and recertification of previously released products. This process has introduced many new quality and safety guidelines for medical device producers, while also providing more transparency to patients regarding the overall risk-to-benefits ratio.

MORE INFO: The Transition to MDR and Important Considerations—An Orthopedic Innovators Q&A

Also, with the second extension of the MDR deadline, many MDMs did not use the extension as an opportunity to hustle and certify their products; instead they paused their push toward MDR compliance to take some pressure off their budgets. “While this may have seemed like a wise decision in the short term, it could pose significant timeline challenges leading up to the deadline,” said Schaible. “Regulatory requirements and changes in other areas [e.g., USP , PFAS phase-out, standard revisions] could very well tax the capacity of testing laboratories and notified bodies, once again leaving manufacturers scrambling to meet critical deadlines to get/stay on the market.”

Testing and analytical services, and all the standards and rulings that regulate them, can be confusing and frustrating to MDMs. For example, they might mistakenly think that failing biocompatibility testing is a “hard stop” for their device. This, however, is where partnering with an experienced laboratory early in device development can help determine if the medical device presents an actual risk for an end user. “If a failure can be explained, and the cause of the failure is not a true hazard for the end user, Eurofins can assist the manufacturer in documenting this result and submitting it to the appropriate regulatory agency, ensuring the testing results will pass regulatory scrutiny,” said Gottfried.

Collaboration and knowledge-sharing are the best ways to advance the field of testing and analytical services on a unified front that involves all key stakeholders. For example, Element Materials Technology is engaged with standards organizations, such as ASTM and ISO. “Ultimately, ASTM/ISO standards are evolving to improve patient outcomes and device efficacy as industrial partners, regulatory bodies, and academic institutions collaborate openly to create meaningful, and clinically relevant, methods and procedures for testing,” said Langhorn. 

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.]]> https://www.odtmag.com/intelligent-testing-for-orthopedic-devices-implants/feed/ 0 Tip Top Shape: A Roundtable on Machining for Orthopedics https://www.odtmag.com/tip-top-shape-a-roundtable-on-machining-for-orthopedics/ https://www.odtmag.com/tip-top-shape-a-roundtable-on-machining-for-orthopedics/#respond Mon, 23 Sep 2024 15:06:00 +0000 https://www.odtmag.com/tip-top-shape-a-roundtable-on-machining-for-orthopedics/
The material retains the metallic properties of high strength, rigidity, and hardness without needing implant removal. The company claims the strength retention of RemeOs implants is tailored to match bone healing, combining the handling and feel of traditional metal implants with absorbable properties.

RemeOs implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating healing of fractures. The company believes the material could make titanium implants redundant and help clinics reach value-based healthcare targets.

The first product made using this material, the RemeOs trauma screw, earned U.S. Food and Drug Administration (FDA) market authorization in 2023 for use on ankle fractures. In achieving this approval, the RemeOs trauma screw won the title of the first and only bioabsorbable metal implant approved by the FDA.

In June 2023, Bioretec announced that it acquired a new CNC machining center to increase the production of its RemeOs and Activa products in its Tampere, Finland, facility. The company said the acquired machine is optimized to produce magnesium-based implants, especially for the RemeOs screw.

This reported optimization likely includes the safety features necessary when machining magnesium alloys. Though prized for its lightweight and machinable properties, magnesium holds the inherent risk of its extreme flammability. It can ignite when exposed to air, particularly under high temperatures or when ground into fine particles.

As such, maintaining CNC machine integrity is crucial when machining magnesium. Over time, regular wear and tear can compromise safety, particularly if magnesium residues accumulate in the machine parts. These residues might become ignition sources if they are contacted by sparks or high temperatures.

Machines designed for magnesium may have features that reduce fire risks, like integrated fire suppression systems and designs that minimize the accumulation of magnesium chips. They may also have optimized cutting parameters that lower heat generation.

Of course, the machine is only half the risk—operators must also be properly trained to safely machine magnesium. Training must cover handling magnesium chips, detecting hazards, and taking quick action during fires. Beyond preventing fires, understanding proper machining techniques and learning to avoid tight clearance angles is paramount.

Advanced materials like magnesium, titanium alloys, and cobalt-chromium alloys are just one challenge that machinists face in making orthopedic devices and components. There is a constant drive for precision in orthopedic device manufacturing to create smaller features, tighter tolerances, and more complex geometries. Some devices also demand functional surfaces to promote bone growth.

Machining is a complicated process that needs expensive, high-precision tools and materials, as well as the skilled machinists to operate the equipment. In order to explore this topic further, ODT spoke to several experts in machining technologies and services for orthopedic device manufacturing:
  • David Cabral, president and CEO of Five Star Companies, a New Bedford, Mass.-based provider of surgical instrument maintenance, repair, and manufacturing services to hospital organizations, OEM instrument manufacturers, and surgeons.
  • Tanya DiSalvo, president and CEO of Criterion, a Brook Park, Ohio-based provider of precision machining for the medical device, aerospace, defense, and photonics industries.
  • Matthias Dreher, head of global key account management at Schwäbische Werkzeugmaschinen (SW Machines), a Waldmössingen, Germany-based supplier of single and multi-spindle CNC machining centers.
  • Jobi Ellison, strategic account manager at Rösler Metal Finishing USA, a Battle Creek, Mich.-based provider of machines and integrated systems for mass finishing and shot blasting, as well as development and production of dedicated consumables.
  • Nick Martin, North American business development manager at GF Machining Solutions, a Lincolnshire, Ill.-based provider of milling, electrical discharge machining, laser micromachining, and metal additive manufacturing services for the medical device industry.
  • Karin McQuillian, business development manager, medical industry at Tyrolit Group, a Schwaz, Austria-based manufacturer of grinding and dressing tools, as well as a system provider for the construction industry.
  • Trisha Mowry, CEO of Metal Craft and Riverside Machine & Engineering, an Elk River, Mass. and Eau Claire, Wis.-based full-service machining provider.
  • Eric Ostini, business development manager at GF Machining Solutions.
  • Duncan Thompson, special projects manager at ANCA, a Melbourne, Australia-based manufacturer of CNC grinding machines, motion controls, and manufacturing solutions.

Sam Brusco: What steps does your company take to attract skilled machinists and support their ongoing education?

David Cabral: We attract skilled machinists—and all our associates—through a high-caliber package (health and dental insurance, life insurance, 401k w/match, holidays, vacations) and other generous benefits that make them feel appreciated and valued. We also work with local vocational schools, a community college, and UMASS Dartmouth to provide co-ops, internships, summer, and permanent employment after graduation and apprenticeship programs for those staying in our company.

We have a vast array of job opportunities and offer growth from within based on newly-learned skills, as well as promotional growth as a result of excellent performance. Our associates are truly our most critical asset and we make sure they know it.

Tanya DiSalvo: We cover our bases with what are now basic requirements: Ongoing education, competitive compensation packages, apprenticeship and mentorship programs, tuition reimbursement, investment in technology and equipment, recognition, awards, and company lunches.

I believe what’s most important is having individuals on the team know they have a voice and we value their opinion. We just conducted “stay interviews,” which are the opposite of an exit interview. We take an hour with each employee to find out their morale and mindset and how can we help improve it if needed.

We would rather address small issues before they grow into a big problem that may cause us to lose a team member. I was thankful for everyone’s honesty in this endeavor, and the leadership group has bullet points we are working to address.

Matthias Dreher: We have a comprehensive program that works to attract new entrants through an apprenticeship model, which we run in Germany and across the world, including in the U.S. This way, we generate our own skilled technicians for assembling, applications, or services.

We find it’s important to teach the knowledge from scratch to help apprentices become more confident in the profession later on. Additionally, a very good internal academy and training department is critical to educate on current priorities, technology, and systems, as well as continuing education to improve the depth and breadth of knowledge.

We want to create curiosity among colleagues to understand the “why” behind our company and processes, and empower them to use their skills to make things better, faster, and easier.

Jobi Ellison: Any Rösler technicians that help to install and maintain our equipment across the U.S. must be highly skilled and familiar with the nuances of the machines and processes. Most of the technicians spend a lot of time in our CEC (Customer Experience Center) in Battle Creek, Michigan, and our headquarters in Untermerzbach, Germany.

Trisha Mowry: We are very active with local technical colleges, colleges, and universities. We also partner with smaller trade schools and high school technical programs.
It’s about educating what manufacturing talent is available, then furthering development in the organization. We support further training through tuition reimbursement and training programs on site within our facilities.

Eric Ostini: I hear the statement “I can’t find good people” from our medical customers all the time. We manufacturers also often struggle to find good people that will work in service and application support positions.

Our strategy is when we can’t attract skilled machinists, we create them through internal training and education. Then we provide them ample opportunities to grow within the company.

Duncan Thompson: Being based in Melbourne, Australia, ANCA faces a limited pool of skilled tradespeople and machine operators. This is why we run a four-year apprenticeship program in collaboration with a Melbourne-based professional trade school.

The opportunity to complete formal training while getting paid with hands-on learning is a big draw for new apprentices and provides a stream of new talent to take up roles in machine operating, assembly, commissioning, and more. These same apprentices also get involved in projects working with undergraduate engineers as they compete to build their own race cars as part of their undergraduate degrees. This not only allows them to apply their learnings in a practical and fun project, but also develops comradery in the working teams that we have in ANCA.

Our best and brightest apprentices get nominated for state and national awards for Apprentice of the Year, which is great recognition of their accomplishments. We are very much a vertically integrated company, maintaining skills and capabilities across all aspects of machine design and manufacture. This means graduating apprentices recognize diverse and exciting opportunities in their employment future with us, including opportunities to travel and be posted to our overseas branches.

Brusco: What are the major orthopedic device market forces at present and how are they affecting your business?

Cabral: I see a major force in using 3D technologies for implants and other orthopedic components and assemblies, as well as a continued focus on disposable instrumentation.

This affects my business because we don’t utilize 3D technologies, nor do we derive substantial sales from manufacturing disposable instruments. Although we’re not engaged in these areas, we provide some secondary operations to 3D-printed components and are initiating new opportunities with single/limited-use products.

DiSalvo: Many OEMs and device companies are pushing the envelope, driving more sophisticated devices. The engineers behind the scenes are younger and less experienced in the actual production of complex components. That pushes shops like ours to focus on our investment strategy in order to keep up with cutting-edge technology and continue to satisfy customer demands.

Regulatory standards also require extensive quality management systems. Compliance can be costly and time-consuming for small manufacturers like us.

Dreher: The major market requirements in the orthopedic device space vary widely. One force I see is better understanding and willingness from suppliers in terms of validation and quality, bringing more suppliers to the global field, and driving the cost pressure up. This mostly concerns the cost per part for end customers and has the potential to provide a larger selection.

The quality and machines used in lower-cost regions are also getting better, pushing long-term suppliers to generate savings in their existing production environment.

Most of the time, this means large changes in production and assembly methods after years of success. Therefore, it is necessary to see and understand the current situation, adapt to the challenges, and take a step toward new production technologies.

Ellison: This market is driven by a high incidence of orthopedic disorders, a growing aging population, and increasing degenerative bone disease. When these trends are on the rise, so is demand to increase production of parts like hip stems and femoral implants. High production demand calls for the use of equipment to finish them, rather than manual labor.

Nick Martin: The most dominant orthopedic market force is growth—according to several industry forecasts, the orthopedic market is expected to experience between 6% and 8% growth per fiscal year through to 2027. On top of that, the U.S. market makes up about 70% of the approximately $62 billion worth of worldwide orthopedic sales, with many industry experts expecting that amount to reach $70 billion by 2027.

To keep pace with that growth, the broad range of orthopedic OEMs are undergoing mergers and acquisitions and seeking to further innovate production operations.

McQuillian: An aging and growing population is leading to an increase in age-related degenerative diseases. There’s more access to and investment in healthcare as well, leading to a growing number of surgical volumes. This caused an increase in tools required to manufacture the larger demand for orthopedic implants.

Thanks to our expertise in grinding solutions, we can support continuous and rapid growth of additive manufacturing of hip and knee implants. Customers can achieve their surface requirements, while we supporting the process and help to optimize cost.

Mowry: Building on automation and complete manufacturing have been the largest focuses given our current and rising skilled labor shortage.

Thompson: The growth in orthopedic surgical procedures is driving growth of consumable surgical instruments and implants. This is forcing manufacturers to explore equipment that can help increase their output while still driving down production costs. Reliable, consistent production lines that can run unattended is a key driver for our customers.

Brusco: Which mainstay or newer machining technologies, tools, and/or systems are you finding most useful to support the manufacture of complex orthopedic devices?

Cabral: In recent years, we have been producing similar types of instruments in larger volumes and incorporated use of a pallet pool, a type of machining technology. With this system, our techs can load material blanks while the machine is running and change fixture and program configurations on the fly.

This system minimizes machine downtime and allows us to continue manufacturing in a Lean environment; shortening lead times, while making the product configuration that a customer requires. Because the different finished goods are loaded into the pallet pool, the need for additional setups, tooling, and changeovers are significantly reduced.

DiSalvo: In the realm of manufacturing complex orthopedic devices, we identified three machining technologies, tools, and systems to help us create the factory floor of the future to focus on the team, quality, precision, and efficiency:
  • Computer-aided design (CAD) and computer-aided manufacturing (CAM) software are crucial for producing the intricate orthopedic implants and generating tool paths for machining.
  • Multi-axis machining centers, such as 5-axis and even 7-axis machines, enable simultaneous machining from multiple angles, enhancing efficiency and accuracy when producing complex orthopedic components and allow us to be hands-off as much as possible. This allows for less human error.
  • In-process inspection technologies, such as coordinate measuring machines (CMMs) and optical measurement systems ensure orthopedic devices meet stringent quality standards throughout the manufacturing process.
Dreher: It’s not a specific technology or system that is most useful to support manufacturing—it’s more important to find the right partner to integrate those technologies and systems to specific production needs. A great system or CNC machine will not be helpful if it doesn’t fit the manufacturer’s requirements which are different between companies—even in the same industry.

The most useful way to support the manufacturing of complex devices is a CNC machine and automation supplier that understands the unique issues, has flexibility in their processes, and is willing invest the time to find specific solutions that can help manufacturers build a specialized, sometimes one-of-a-kind, solution.

Ellison: We believe that our drag finishing and surf finishing equipment, along with our media selection and water treatment (on demand as well as fully automated), is necessary for OEMs and contract manufacturers to keep up with the demand and precision required for these parts.

Martin: We are tracking upticks in use of both our wire and sinker electrical discharge machine (EDM), milling machine, laser texturing, and laser micromachining technologies. In particular, we foresee in the next three years that use of our laser technology will increase dramatically in the medical sector, especially for production of implants and endoscopic components.

We also notice more smaller-size suppliers to the medical device industry incorporating automation, ranging from pallet systems to standalone robots to fully automated multiple-machine cells. We expect the demand for automation to continue into for the foreseeable future.

McQuillian: We focus on high-tech tools and customized system solutions for complex orthopedic devices.

With over 100 employees in research and development, we cover the entire spectrum of product development and continuously strive to be at the cutting-edge of innovation. In order to integrate our tools into production processes as efficiently and economically as possible, we rely on our experienced specialists who create application-specific concepts together with customers.

Mowry: Building on automation and complete manufacturing have been the largest focuses given our current and rising skilled labor shortage.  

Ostini: We conduct a lot of research on medical implant surface finishes and how manufacturers experiment with new and unique surface textures to promote osteointegration.

Beyond that, we strive to match the ISO VDI 3400-standard surface finish of an EDM process with our laser texturing technology. When we’ve accomplished this, medical manufacturers can achieve surface finish requirements and be able to impart intricate textures/patterns to those part surfaces.

Thompson: Femoral head implant production is an application where our machine and motor control technology has been key in successful production. Our LinX linear motors driven by our servo drive systems can automatically detect when a grinding wheel touches the part, then applies a programmed force during the grinding operation.
This removed the need for the addition of complex sensing and feedback systems that other companies employ. ]]> https://www.odtmag.com/tip-top-shape-a-roundtable-on-machining-for-orthopedics/feed/ 0 The Way Back: A Report on Spine Technologies https://www.odtmag.com/the-way-back-a-report-on-spine-technologies/ https://www.odtmag.com/the-way-back-a-report-on-spine-technologies/#respond Mon, 23 Sep 2024 14:56:00 +0000 https://www.odtmag.com/the-way-back-a-report-on-spine-technologies/
It’s not for lack of trying—the former bodybuilder-turned-fitness trainer has replayed the moment countless times in his mind, but the injury remains as much a mystery at present as the day it occurred.

“We was playing a little basketball game, some of my athletes, and we was having a little dunk contest,” Sonnier recounted in an online video. “On the last dunk, something happened. I was jumping and twisting, so when I planted and I rotated and accelerated up, I felt it. I felt something crack, it was bad. And then when I hit the ground, I felt it again. Immediately it went to stiffening down the left leg. It wasn’t good at all.”

Not by any means.

Somehow, in performing all those mid-air contortions and hard landings, Sonnier damaged one of his lumbar discs. Commonly referred to as herniated, bulging, or protruding (discs), these injuries are among the most common causes of lower back pain, as well as leg pain or sciatica, afflicting between 60% and 80% of the global population, according to OrthoInfo data.

Lumbar disc injuries (or herniations) typically occur in the lower lumbar spine, at the L4-L5 (fourth and fifth lumbar vertebrae) or L5-S1 (fifth lumbar-first sacral vertebra) disc space. And while they often are a byproduct of the natural aging process, herniated discs also can result from sudden trauma—like a fall, improper lifting, or abrupt jerking movements.

Or, perhaps jumping and twisting to slam dunk a basketball.

“He [Sonnier] had a bad lumbar disc and it was keeping him from doing the things that he really liked to do,” said Jayme Trahan, M.D., a neurological spine surgeon with Lafayette Bone & Joint Clinic (Lafayette, La.). “…he was just really looking to get back to that lifestyle that he enjoys.”

That lifestyle included basketball games (of course), workouts and training sessions at the gym he co-owns (Fame Fit Factory), and activities with his young daughter.

“How long would it take before I got back to work? That was my biggest concern,” Sonnier stated in a distinct southern Louisiana drawl. “The way my business runs is if I’m not at work, I don’t get paid. When do I get back to me?”

Sooner than he anticipated, actually, thanks to a non-traditional surgical technique that accesses the lower spine through the front of the body. Anterior lumbar interbody fusions (ALIF) provide neurosurgeons a direct path to the spine through an abdominal incision, thereby sparing back muscle and tissue. The approach can be performed as an open surgery or a less invasive procedure, depending upon the patient’s condition and medical history.

While entering through the abdomen requires some shifting of blood vessels and organs, it nevertheless provides several benefits over the more conventional posterior (back) approach—namely, faster recovery, less muscle injury, improved lordosis (swayback), and better support through a larger cage size.

In ALIF procedures, a plate and screws, or an integrated plate-spacer and screws may be used to hold the affected vertebrae in place while fusion occurs. Sometimes, the anterior approach is followed with posterior stabilization, where rods and screws are affixed through the back of the body to further secure the vertebrae.

“With how active he is, I think he [Sonnier] was a great candidate for this approach where we can come in from the front—anterior lumber interbody fusion,” Dr. Trahan remarked. “You can stick a very sizable graft, restore height, optimize fusion capabilities, and really kind of restore a lot of that natural alignment and curvature within the spine that you can’t get with a posterior approach.”

Dr. Trahan reinstated the natural alignment of Sonnier’s unhealthy disc with Camber Spine’s ENZA-A Titanium ALIF interbody fusion implant. Cleared by the U.S. Food and Drug Administration (FDA) in June 2018, ENZA’s 3D-printed body has a roughened surface that fosters bone growth onto the device’s cranial and caudal areas. The pores on its upper and lower faces average 500 microns in diameter—the optimal environment for bone growth and full incorporation within the vertebral body. The ENZA-A has multiple openings to accommodate large volumes of autogenous bone graft, and its two anchor plates remain housed within the 3D-printed body until they are deployed into the vertebrae for fixation.

Inserted, deployed, and locked with a single pass, the ENZA-A is available in three footprints and three lordotic profiles to allow for different patient anatomies.

“The 3D printed roughened surface of the ENZA spacer allows direct bony ingrowth onto the actual spacer,” Dr. Trahan said. “…with the [Camber] inserter, it’s very streamlined. Everything can work through a very small corridor whereas before you would need larger surface areas. That makes the incision smaller, that’s less tissue trauma, and that’s less intraoperative bleeding.”

And less healing time. Sonnier missed only a week of work, and returned to his training sessions with the same pre-surgical intensity level (most likely better, since he was now pain-free).

“No rehab, I was back to work in a week, and I’m talking back to work. Back to my old self,” Sonnier recalled, smiling. “So now, I can bathe my little girl. The other day, I got up early and took her to the zoo. She was so excited, ‘Daddy, Daddy, you can hold me now?’ The fact that I can carry her around the zoo with her on my back…that’s what made it all worthwhile.”

Worthiness, of course, is relative, and now more feasible than ever to patients living with chronic low back pain and other spine-related conditions. Sonnier’s treatment path is just one of numerous routes available to patients traversing the spinal sector’s increasingly crowded solutions superhighway.

Advancements in materials, manufacturing, software, and technology (artificial intelligence and otherwise) in recent decades have spawned remedies to suit almost all types of patients, surgeons, and conditions. Diseased/damaged spines are now accessible through the front (anterior), back (posterior), or side (lateral) of the body, procedures can be minimally invasive (or not), and surgeons can leverage robotic assistance (or not) in hospitals (or not).

“There’s a big paradigm shift to ambulatory surgery centers [ASC]. More spine indications have been approved for ASC cases to reduce procedural and lifecycle cost while producing successful outcomes and patient satisfaction,” said James B. Schultz, vice president of customer solutions for Thousand Oaks, Calif.-based ECA Medical, a designer and manufacturer of single-procedure torque-limiting instruments and sterile-packed, surgery ready procedural kits to the medical implant industry. “Many spine surgeons practicing in ASCs are making the case to CMS that complex spine procedures can be performed safely in the outpatient setting. They argue case volume is the top growth opportunity coupled with capturing additional traditionally complex inpatient procedures.”

Robot-friendly surgeons can pre-operatively plan their procedures, better navigate the body’s anatomical support structure, and improve implant placement precision with the help of Medtronic plc’s Mazor X Stealth Edition, Zimmer Biomet’s ROSA system, DePuy Synthes’ VELYS Active Robotic-Assisted System (VELYS SPINE), or Stryker’s Mako Spine, due to debut later this year.

VELYS is the newest of the bunch, having made its debut in early August. DePuy Synthes developed the system with eCential Robotics, which gained FDA clearance two years ago for its own open, unified, modular, and scalable robotics platform. The French firm augmented that offering this past July with FDA-authorized spine capabilities for planning and fusion procedures in the cervical, thoracolumbar, and sacroiliac spine.

VELYS SPINE is designed as a dual-use system offering standalone navigation and a customizable experience with pathology-specific workflows supported by capabilities like the VELYS Adaptive Tracking Technology and VELYS Trajectory Assistance. Its active robotics platform gives surgeons flexibility in their planning and approach, enabling procedural guidance tailored to surgeon preference.

VELYS SPINE’s active robotics feature has figured prominently in the system’s marketing campaign as DePuy Synthes attempts to distinguish its spinal robotic platform from the more established and clinically proven Mazor and ROSA systems. DePuy Synthes is touting active robotics as a revolutionary technology, contending its distinctive features and capabilities could help establish a “new standard” in spine surgical care when VELYS SPINE hits the market in the first half of 2025.

“Surgeons entering practice are looking for enhancements to accuracy, efficiency, and usability through tech-enabled hardware while ensuring that platform components are connected and talking to one another,” stated Keith Evans, vice president/general manager of Enabling Technologies at Stryker’s Spine Division. “We are seeing competitors focus on developing enabling technologies to complement and enhance implants and instrumentation, specifically focusing on pre-operative planning, imaging, smart instrumentation, and robotics. Enabling technologies are helping to standardize and improve care in multiple procedures, allowing clinicians to rally around the best surgical techniques and technologies.”

Indeed, there are plenty of rally sites from which to choose. Quite a large gathering has formed around extreme lateral interbody fusion (XLIF), a minimally invasive spinal procedure performed through the side of the body. Formed more than 20 years ago, this group is comprised of approximately 300,000 XLIF procedures, 200-plus educational courses, over 500 peer-reviewed publications, and more than 60 products, the latest of which premiered in August.

The ADIRA XLIF Plate System refines lateral plating by providing simplified insertion workflows and a rigid coupling mechanism. The solution is designed to align plates confidently over interbody spacers to enhance construct stability.

Launched by Globus Medical Inc., the system is compatible with bone screws and lateral minimally invasive surgical anchors, providing procedural versatility for bone fixation options as well as interbody spacer types. The ADIRA XLIF Plate System is compatible with the company’s lateral portfolio, as the plates are designed to rigidly thread into RISE-L, Modulus XLIF, Hedron L, Cohere XLIF, TransContinental, and CoRoent XLIF interbody spacers to help reduce the risk of spacer migration and accommodate various patient anatomies and surgeon preferences.

Using an alignment screw, the ADIRA XLIF Plates can be assembled to various lateral lumbar interbody fusion devices to create a plate spacer assembly that provides structural stability in skeletally mature patients after a discectomy. The plate-spacer assembly is used with bone screws and/or lateral anchors, and are filled with autograft and/or allogenic bone graft consisting of cancellous or corticocancellous bone.

“Many of today’s spine implants have moved from a single piece static component to multi-piece assemblies requiring moving parts meant for adjustments during their implantation procedure,” noted John Ruggieri, Senior VP of Business Development for Bloomfield Hills, Mich.-based ARCH Medical Solutions Corp., a precision machining, contract manufacturing, and supply chain integration resource for medical OEMs. “Small and intricate components fitting together in an extremely tight envelope require more than just the ability to make the individual pieces. Strong and scalable skill sets for assembly are required to effectively support an OEM for these types of implants. Capabilities for both additive and subtractive manufacturing provide customers with the options they need to address their product innovations.”

Additive manufacturing capabilities have been outpacing those of its counterpart in the last two decades amid the healthcare industry’s penchant for minimally invasive approaches, customized solutions, and creative product design. In orthopedics, additive manufacturing—a.k.a., 3D printing—has emerged as a transformative force, providing a precise means to implant development and fabrication.

3D printing technology specifically has spawned a profusion of spinal innovations since its birth nearly 30 years ago. Not only is it regularly used to create accurate surgical training models, it also is tapped to develop customized jigs used to design and produce patient-specific implants like interbody fusion cages and intervertebral discs.

Carlsmed’s aprevo implants, for example, are created using a patient’s medical imaging (X-rays, computed tomography) as well as proprietary algorithms that combine predictive analytics and prior outcomes data. The Carlsbad, Calif.-based company’s aprevo line of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches received its second FDA breakthrough device designation last fall—three years after receiving its first breakthrough designation and FDA 510(k) clearance. aprevo is reportedly the first implant to receive both authorizations simultaneously.

The aprevo implants won Medicare coverage for spinal fusions this past summer and will be eligible for reimbursement starting Oct. 1. The devices earned the New Technology Add-On Payment by CMS and transitional pass-through payment in 2021.

Carlsmed’s customized aprevo devices are among the more recent innovations available to spine surgeons. However, the company itself is a relative newcomer to the orthopedic 3D printing arena compared to other implant makers.

Stryker has perhaps the most extensive 3D printing history, having worked with the technology since 2001. Its additive manufacturing process—dubbed AMagine—has enabled the orthopedic device behemoth to develop implants with geometries that were once “difficult or impossible” to manufacture.

Stryker conducts the research, development, and commercial launch of additive manufacturing technologies at its AMagine Institute in Anngrove (Cork County), Ireland. The 100,000-square-foot facility opened in 2016 and is complemented by a second 156,000-square-foot plant that came online in 2022.

“Stryker is a global leader in additive manufacturing, also known as 3D printing, technology development, and use,” Evans boasted. “We scaled the application of additive manufacturing…through our global AMagine Institute in Cork, Ireland, which explores and industrializes platform technologies to innovations in healthcare products in line with our mission. There is significant opportunity for continued innovation, specifically with patient-focused implants.”

Significant opportunities abound in implant design and surface treatments as well. Case in point: Stryker’s Tritanium In-Growth Technology is designed to mimic cancellous bone’s porous structure. The material features a random interconnected architecture with rugged, irregular pore shapes and sizes that can wick or retain fluid. According to Stryker data, Tritanium has a 55% to 65% mean porosity range and a 100μm to 700-μm pore range size.

Spineart SA’s 3D-printed bone-like matrix, Ti-LIFE, has a similar porosity—overall between 70% and 75%—and a 0.9-mm average pore diameter. Natural bone, by comparison, has a porosity that ranges from 70% to 95%, and a pore diameter spanning 0.3 mm to 1.5 mm, the Swiss company claims.

Spineart’s Ti-LIFE porous titanium technology is incorporated into both posterior and anterior spinal cage options. The JULIET line of posterior cages feature a smooth bullet-shaped self distracting nose and polished chamfer, which makes them easier to insert and distracts the intervertebral space while mitigating the risk of endplate, nerve root, and soft tissue damage. JULIET cages are manufactured in a wide range of options to address various patient anatomies and surgical approaches.

Ti-LIFE also is the main ingredient in the SCARLET AC-Ti secured anterior cervical cage, which won FDA 510(k) clearance in May. Building on a decade of experience with the SCARLET systsem, the SCARLET AC-Ti introduces new features such as the MIMETIX morphometric profile, developed with digital vertebral models to optimize the contact surface between the implant and endplates. The system’s three screws have a very sharp endtip with flutes and quadri threads for easy the insertion into the vertebra. The zero-profile, one-step locking mechanism with pre-assembled cam locks prevent screw migration.

“Creating implants like intramedullary nails, plates, and screws involves precise designs to meet specific requirements accurately,” stated Abraham Sayger, sales manager from the Hernando, Miss., location of Tegra Medical, a Franklin, Mass.-based contract manufacturer of finished medical devices and complex components including surgical instruments, needles, and implants. “3D manufacturing makes it possible to craft individualized implants tailored to each patients’ unique needs and intricate shapes that were once unachievable, through traditional methods.”

Camber Spine’s SPIRA Technology is not so much intricate as it is unique, at least compared to other implant manufacturers. Its proprietary SPIRA architecture uses an arch design to distribute load and create strength while minimizing titanium volume and allowing maximum space for through-bone growth.

Interbody cages with SPIRA Technology contain up to approximately 80% porosity and are structurally similar to trabecular bone. As the new bone forms through the cage, it grows onto and attaches to the implant surface, giving it better fixation than traditional cages that usually only have bony ingrowth at the endplates.

Camber’s latest SPIRA innovation, the SPIRA-A Integrated Fixation system, passed muster with the FDA in July. The anterior lumber interbody fusion device features an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion, as well as additional fixation options to secure the implant in the disc space.

SPIRA-A Integrated offers a complete solution to the ALIF procedure, with integrated fixation deployed in a traditional ALIF cage and approach, as well as a windswept cage geometry for accessing L5-S1 with difficult vascular anatomy, and each implant offers up to 40 points of endplate contact.

The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. SPIRA-A’s screws and anchors have been designed to complement the cage’s performance, increase cortical endplate fixation, and provide 3D-printed anchors with a SPIRA Surface, designed to increase osseointegration potential and resist pull-out.

“3D printing allows manufacturers to create more innovative structures while controlling surface design. The ability to create biomimetic implants through different manufacturing techniques has given the surgeon community a better selection of implants for their patients.The future of spinal implants will be interest as manufacturers focus on better ways to address both the biomechanical and biological needs in spinal fusion,” Camber Spine CEO Brooks McAdam told ODT. “There is a lot of exciting innovation in the market focused on combining structure and surface in both the interbody and fixation space. I believe industry is in the early stages of innovation in this arena…”

One of the trailblazers in this arena is Precision Coatings Company, a Woonsocket, R.I.-based provider of proprietary coatings for medical applications, including single-use devices and reusable instruments and tools. The firm’s Ti360 surface technology deposits less than a 1 micron titanium layer on the surface of PEEK (polyether ether ketone)-based devices to improve osseointegration.

Ti360, is deposited with Precision Coatings’ ion beam assisted deposition technique, which combines concurrent ion beam bombardment with a low temperature PVD process in a high vacuum environment. In contrast to plasma spray techniques, this process reportedly obtains a much more robust bond and favorable surface geometry. Since PEEK’s hydrophobic nature leads to poor bone tissue attachment compared to titanium-based devices, Ti360 is ideal for orthopedic and spinal devices, particularly interbody cages.

“Many requests we receive require surface technology solutions to improve osseointegration on complex geometries that require limited impact to critical features,” noted Michael Gianfrancesco, the company’s vice president of engineering and technology. “At Precision Coating we are able to utilize our Ti360 to…improve osteointegration with little to no impact on critical features. Precision Coating also utilizes our NanoLaze technology to create custom surface textures to improve osseointegration. NanoLaze is a high-speed laser technology that can be programmed to create custom geometries on flat and contoured surfaces.”

“Customers are always looking for a surface technology to assist directly with osseointegration,” agreed Eric Manojlović, orthopedic sales manager, “which is why our ion beam-assisted deposition solution Ti360 is so critical in the orthopedic space.” ]]> https://www.odtmag.com/the-way-back-a-report-on-spine-technologies/feed/ 0 Will Orthopedic Robotics Contribute to Ambulatory Surgery Centers’ Success? https://www.odtmag.com/will-orthopedic-robotics-contribute-to-ambulatory-surgery-centers-success/ https://www.odtmag.com/will-orthopedic-robotics-contribute-to-ambulatory-surgery-centers-success/#respond Mon, 23 Sep 2024 14:46:00 +0000 https://www.odtmag.com/will-orthopedic-robotics-contribute-to-ambulatory-surgery-centers-success/
These concurrent market shifts have induced natural curiosity about ASCs’ impact on orthopedics—specifically, the ongoing dynamics of companies in the industry, their technologies, and their ability to contend and expand within the ASC market now and in the future. It may be assumed that any orthopedic company that cannot successfully compete in the ASC market may disappear from the U.S. market (in the same form) in 10 years. We believe the growth of orthopedic robotic procedures in ASCs is helping these centers boost the growth of minimally invasive outpatient procedures.

It would be nearly impossible to measure ASCs’ potential impact on the industry, however, without first exploring the factors contributing to its >10% compound annual growth rate.

Key ASC Growth Factors: Cost, Convenience, and Technology

An ASC’s out-of-hospital setting offers a cost-effective alternative to traditional operating rooms, as procedures are often 35% to 50% less expensive than those that take place in hospitals. Payers and patients tend to gravitate toward ASC procedures if it ultimately saves them money.

Similarly, with shorter wait times and the likelihood of returning home within hours of the procedure, ASCs provide a more convenient and efficient surgical experience. It has been often noted that “…hospitals are a great place to go to die…” due to their infection rates. Not surprisingly, ASC infection rates are significantly lower than hospitals because patients leave the medical center quickly (usually same day).

Cost effectiveness and efficiencies aside, ASCs foster technological innovation that benefits both orthopedic implant developers and the centers themselves. The solutions being developed address the precision necessary in minimally invasive techniques and provide them in a footprint that is viable and affordable for the ASC.

MORE INFO: The Growth of ASCs for Orthopedic Procedures

Driven by technological advancements, an aging world population, and the increasing demand for minimally invasive surgical procedures, the orthopedic robotics market is experiencing unprecedented traction. Consequently, adoption of these new technologies is reshaping surgical practices in orthopedics, with a boost from private equity.

Orthopedic Robotics’ Impact on the ASC Market

Robotics is playing a crucial role in ASCs’ expansion and success, especially in orthopedic surgery. The integration of robotic systems in ASCs is transforming these facilities into centers of excellence for outpatient surgery.

Robotic systems enable ASCs to offer a broader range of procedures, including complex orthopedic surgeries that were previously limited to hospitals. This expansion is not only increasing the volume of surgeries performed in ASCs but also elevating their reputation as high-quality surgical centers.

Additionally, the precision and consistency offered by robotic systems lead to better surgical outcomes, including fewer complications, shorter recovery times, and higher patient satisfaction. These improvements are crucial in the ASC setting, where patients are usually discharged the same day as their surgery.

Because they are more precise and consistent than traditional procedures, robotic-assisted surgeries typically are more efficient, with reduced operative times and quicker patient turnover. This efficiency enables ASCs to perform more surgeries within the same timeframe, increasing their revenue potential and making them more attractive to surgeons and patients alike.

Robotic technology is truly becoming a transformative force in orthopedic surgery by offering improved precision, enhanced patient outcomes, and greater efficiencies. These systems have become increasingly sophisticated and are now integral to various orthopedic procedures, including spinal surgeries, joint replacements, and arthroscopic interventions.

Driving the growth of robotic-assisted orthopedic surgery are technological advancements, patient demand, and surgeon adoption.

MORE INFO: Partnering for Precision—Contract Manufacturing for Robotics & Surgical Navigation

Evaluating the Major Players and Their Technologies

A handful of key players currently dominate the orthopedic robotics market, and each of them contribute to the ongoing evolution of surgical practices through their respective technologies (and some occasional “price bundling”). A brief overview of the companies and their robotic systems follow.

Stryker Corporation/Mako System: It’s not surprising the top orthopedic device company has the leading platform in robotic-assisted orthopedic surgery, specifically in total knee, partial knee, and hip replacements. Helping to improve Stryker’s marketshare (as if it needed any help), Mako has been widely adopted in ASCs and is driving growth in the outpatient orthopedic procedure market.

Zimmer Biomet/ROSA Robotic System: ROSA is designed for both knee and spine surgeries, offering a high degree of flexibility and adaptability. Its user-friendly interface and versatility have made the system a popular choice in ASCs.

Johnson & Johnson’s DePuy Synthes/VELYS Robotic-Assisted Solution: Specifically designed for knee replacement surgeries, VELYS’ compact design sets it apart from its competitors, making the system well-suited for ASCs’ space constraints.

Smith+Nephew/NAVIO Surgical System: Smith+Nephew’s NAVIO system is a handheld robotic solution that offers real-time intraoperative feedback without the need for pre-operative computed tomography scans. Moreover, NAVIO’s portability and ease of use make it a valuable tool for a wide range of orthopedic procedures.

Medtronic/Mazor X Stealth Edition: Although initially focused on spine surgeries, Medtronic’s Mazor X is increasingly being used in joint orthopedic procedures. The system combines robotic precision with advanced navigation and 3D imaging, enabling surgeons to perform complex surgeries with greater accuracy.

Orthopedic Robotics and ASCs—Ideal Partners

The ASC market for orthopedic robotics is expected to steadily grow and be shaped by various key trends in the coming years, including increased adoption of robotic-assisted solutions, robotic systems’ overall market growth, expanded indications, integration with artificial intelligence and machine learning, regulatory decisions, and reimbursement developments.

Stryker, Zimmer Biomet, and Smith+Nephew currently hold significant market share in the orthopedic robotics space but the trio could relinquish their supremacy to other players as the competitive landscape evolves. In a macro shift for the ASC sector, major orthopedic robotics companies could hold a combined market share of more than 70% in the coming years, industry estimates predict.

Conclusion

The orthopedic robotics market is rapidly evolving, with far-reaching implications for the U.S. ASCs. The integration of advanced robotic systems into orthopedic surgery is not only enhancing surgical precision and improving patient outcomes but also driving ASCs’ expansion. As the technology advances and becomes more accessible, the ASC market is expected to experience steady growth, with robotics playing a central role in shaping the future of outpatient orthopedic surgery.

The future is bright for ASCs and orthopedic robotics, as the potential exists for significant market expansion, improved patient care, and a broader range of surgical offerings. As more ASCs adopt robotic-assisted surgical systems, the orthopedic robotics market is set to become an even more integral part of the healthcare landscape, heralding a new era in outpatient surgery.

MORE FROM THESE AUTHORS: Insights Into Top Orthopedic Company Dynamics

Florence Joffroy-Black, CM&AA, is a longtime marketing and M&A expert with significant experience in the medical technology industry, including working for multi-national corporations based in the United States, Germany, and Israel. She currently is CEO at MedWorld Advisors and can be reached at florencejblack@medworldadvisors.com.

Dave Sheppard, CM&AA, is a former medical technology Fortune 500 executive and is now focused on M&A as a managing director at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com.]]> https://www.odtmag.com/will-orthopedic-robotics-contribute-to-ambulatory-surgery-centers-success/feed/ 0 How CDMO+ Drives Orthopedic Product Quality and Speed to Market https://www.odtmag.com/how-cdmo-drives-orthopedic-product-quality-and-speed-to-market/ https://www.odtmag.com/how-cdmo-drives-orthopedic-product-quality-and-speed-to-market/#respond Mon, 23 Sep 2024 14:38:00 +0000 https://www.odtmag.com/how-cdmo-drives-orthopedic-product-quality-and-speed-to-market/
In a professional kitchen, everything is ready in the right place since each second counts as the team works in concert to deliver a premium service. Similarly, to drive speed to market, an engineering team must have the right mix of technical resources: implant designers; finite element engineers; surgical experts; and manufacturing, prototyping, and testing engineers—all in the same place, working together seamlessly with the necessary resources. This accelerates the iterative sequential design process essential for orthopedic implant and instrument development, enabling rapid design, ideation cycling, analysis, surgical review, and performance evaluation.

This solution also eliminates a problem faced by many OEMs—a manufacturing supply partner offers design for manufacturing support, but they receive a product that’s been submitted for 510(k) and the design is essentially already locked. This results in launch stresses between the supplier and the OEM over the feasibility of manufacturing a 510(k)-cleared device that has little to no flexibility for adjustments.

Enter CDMO+—the smarter engineering solution. Imagine having everything you need in one place: a team comprised of surgical technique leaders; product, design, and manufacturing experts; and testing specialists housed alongside end-to-end manufacturing. In addition, this is all supported by a leading, top-tier regulatory group.

The Three Unique Elements of CDMO+

1. A Proven Process: Streamlined product development with end-to-end manufacturing and post-market surveillance, reducing iterative design cycles.

The CDMO+ model addresses the OEM’s need for a proven, reliable process. A specialist company with device experience, rapid prototyping, full-scale manufacturing, and regulatory support can ideate and develop implants and instruments, leveraging its deep expertise.

The best designs need refinement for performance optimization. While design engineers rapidly build out concepts, typically, the development cycle starts to stretch out at the point of prototyping and testing. Even with the most responsive prototype suppliers, the production cycle can be weeks—not days—and as a result, the development team is backing up against cadaver lab schedules and the expediting of parts.

At every stage of this cycle, a proven product development process accelerates the sequencing. Co-located rapid prototyping cells create samples ranging from 3D-printed plastic and metal samples to fully machined implants, assemblies, and instruments. As a true end-to-end process provider, the CDMO+ team has every necessary element for the finishing process. This allows for new product development (NPD) engineers to fine-tune surface processing, obtain the best results, and get products into the hands of surgeons and technical experts, thus creating truly usable samples and cutting time to the evaluation labs.

Since the design process is iterative and test results highlight areas for optimization, feedback can be rapidly incorporated and retested within the current setups. This translates into not just quicker development, but also enhanced product performance and quality as design optimization is no longer traded off against long testing widows. Faster development and superior products, where innovation and quality are never compromised, is the ultimate goal and able to be achieved under one roof.

2. Cross-Functionally Trained and Aware Engineers: “You can’t really understand another person’s experience until you’ve walked a mile in their shoes.” —Mary T. Lathrap

To build cross-collaboration and a shared common understanding, a company’s leadership team might consider developing an engineering rotation program. The objective of such a program is simple: broaden the range of experiences of engineers so they understand the development process from the point of view of their colleagues in other departments. Over a fixed time-period (for example, a two-year period in six-month increments), engineers are exposed to a range of end-to-end disciplines from conceptual development to production including: design, NPD quality, regulatory/clinical, process/manufacturing engineering, operations quality, continuous improvement, etc.

The growth plans are tailored to each engineer considering their desired endpoint and the areas of greatest impact. This builds versatility and exposes the team to the broad range of efforts required to design, develop, manufacture, and maintain medical devices. Engineers who cycle through the rotation understand the capabilities and constraints of the other teams participating in the design process, enabling them to work more effectively and collaboratively. Ultimately, this will drive improved outcomes in terms of design performance and development times based on a better appreciation for how the team works to meet the OEM needs.

3. Expertise and Muscle Memory: Better designs and better outcomes delivered faster through learning and repetition.
Specialization matters—as the CDMO+ teams evolve, they accumulate a wealth of experience and shared knowledge. Where an OEM might release a specific new product line type every few years, the CDMO+ teams are repeating new product launches frequently across a portfolio of diverse customers. This repetition builds invaluable muscle memory. It is then honed through development and exposure to an extensive array of proprietary knowledge and intellectual property related to medical device development, surgical techniques, and historic performance, as well as the closed-loop feedback from post-market maintenance.

Rather than starting from scratch with each design, the product development process leverages past experiences, minimizing trial and error. This not only shortens development time, but also accelerates speed to market and revenue generation compared to a large OEM. By continuously refining expertise, the CDMO+ model drives efficiency and innovation.

The Benefits of the CDMO+ Approach

Adopting a holistic approach to product development, the CDMO+ model leverages co-located, end-to-end processes and a team of seasoned engineers from diverse disciplines.

Capitalizing on a proven, scalable model—honed through extensive experience and repetition in implant development—yields substantial advantages. Development cycles can be slashed by as much as 30% to 60%, thanks to specialization, which enhances implant quality and drives significant advancements in instrumentation. Synchronous development and rapid iterations lead to superior product refinement and performance, setting a new standard in the industry. 

Rich Warren is the chief commercial officer (CCO) at Resolve Surgical Technologies, an Orthopedic CDMO+. In this role, he is responsible for the commercial strategy, new product engineering, and regulatory group. Before joining Resolve Surgical Technologies, Warren served as the CCO for Medical Manufacturing Technologies Inc. (MMT). There, he led strategic sales and marketing activities and oversaw the TotalCare forward stocking program, which set the benchmark for aftermarket service and support. Previously, Warren spent 15 years at the LISI Group of companies in commercial and general management roles, where he delivered strong, meaningful growth in its medical and aerospace business units. In addition to his time at LISI, Warren also held various roles at GKN and has a master’s degree in mechanical engineering. ]]> https://www.odtmag.com/how-cdmo-drives-orthopedic-product-quality-and-speed-to-market/feed/ 0 Powering Volume Implant Production with CoCr and Laser Powder Bed Fusion Printing https://www.odtmag.com/powering-volume-implant-production-with-cocr-and-laser-powder-bed-fusion-printing/ https://www.odtmag.com/powering-volume-implant-production-with-cocr-and-laser-powder-bed-fusion-printing/#respond Mon, 23 Sep 2024 14:30:00 +0000 https://www.odtmag.com/powering-volume-implant-production-with-cocr-and-laser-powder-bed-fusion-printing/
Yet, its resistance to wear makes CoCr an ideal material for orthopedic implants, especially in large joint and total ankle applications. Unfortunately, until recently, use of CoCr in healthcare manufacturing has generally been for large implants and, therefore, cost prohibitive for AM. However, multi-laser 3D printing technologies made metal AM faster and more cost-effective. Now, manufacturers can leverage AM’s design flexibility to integrate lattice structures and 3D print personalized implants in CoCr.

The Unique Strengths of CoCr

With recent advances in 3D printing technologies, CoCr is securing its place as an important material for additive manufacturing, allowing medical device companies to:
  • Increase efficiency: The combination of CoCr and AM can yield highly durable monolithic implants in a single step. Additionally, using AM to produce implants with CoCr eliminates the need for time-consuming surface treatments like porous plasma spray.
  • Reduce costs: In addition to the cost savings gained through more efficient production, additively manufacturing implants using CoCr empowers medical device manufacturers to produce parts on demand, eliminating the need to stockpile large quantities of inventory that may become obsolete. Producing only what is required when it is required allows manufacturers to expand their device portfolios without investing in and holding inventory costs.
  • Positively impact outcomes: 3D printing with CoCr offers unparalleled design flexibility, allowing for customized implants that optimize joint alignment. Additionally, the capability to integrate lattice structures, similar to those found in titanium devices, has the potential to enhance bone in-growth.
To better understand how to achieve these advantages, let’s explore the mechanical properties of CoCr, the optimal combination of 3D printing technology and post-processing, and the importance of validating and dedicating 3D printer platforms to CoCr production.

Advantages of a CoCr Additive Manufacturing Workflow

With AM, it’s not just about the material, the 3D printing technology, or how you finish the part. All the components must be assembled into a comprehensive solution, designed to address the application need. We believe the material is at the heart of each solution.

As a biocompatible alloy, CoCr is ideally suited for medical implants and instruments because of its natural material properties. Among these properties is CoCr’s strength and durability, which enables the implant to withstand the rigors of the human body. Its excellent wear resistance is crucial for implants that experience friction, such as joint replacements. This material is also compatible with various additive manufacturing techniques, allowing for complex and customized implant designs that are able to achieve a completely polished mirror finish in the final part with minimal post-processing steps.

MORE INFO: Developing Orthopedic Implants with Direct Metal Printing—An Orthopedic Innovators Q&A

While compatible with a wide range of 3D printing technologies, one of the more common technologies used is laser powder bed fusion (LPBF). Of course, when the part is removed from the printer, it requires post-processing to bring it to its final state, which is ready to be placed in the human body. One of the most common is hot isostatic pressing, more commonly referred to as HIP—a post-processing technique that employs high temperature and uniform pressure to eliminate porosity and enhance the structural integrity of materials. In the course of working with a variety of medical device OEMs, vacuum stress relief (VSR) with furnace cool proved to be a more optimal heat treatment method for CoCr.

Not only is VSR a highly available option with a lower price point, it is often able to reduce lead times while maintaining the mechanical performance achieved by HIP. This becomes particularly critical for patient-specific applications where turnaround times are extremely tight. Additionally, VSR does not develop a green oxide layer, which is a risk with HIP. In applications that benefit from lattice structures, this layer becomes nearly impossible to remove. Finally, using CoCr in many advanced LPBF printers enables manufacturers to achieve printed part densities greater than 99.9% when using CoCr with VSR.

As with any medical device, production must be done in facilities that have received ISO certification (i.e., ISO 13485, ISO 52920), but each 3D printer and material must be validated. Dedicating a 3D printer to CoCr applications is essential for minimizing part-to-part variability to produce high-quality medical implants. The combination of consistent material handling and rigorous process control mitigates contamination risks, enhances production efficiency, and improves the reproducibility of implants. Ultimately, this also helps ensure compliance with regulatory standards and can lead to better patient outcomes.

Reshaping the Healthcare Landscape

While the orthopedic industry was at the forefront of adopting AM, particularly in spine surgery with titanium implants, the advent of additively manufactured CoCr is opening a host of large joint applications. Some that are gaining momentum are glenospheres, femoral components, and patellae, as well as partial and total taluses. These implants for shoulders, knees, and ankles, respectively, are used in areas of the body that withstand not only repeated movement but also significant force.

AM offers unprecedented design freedom and production efficiency that is rapidly advancing orthopedic care. Specifically, the use of CoCr alloys in LPBF manufacturing workflows is enabling the creation of intricate, patient-specific implants for joint replacement surgeries. This revolutionary approach holds the potential to significantly enhance surgical outcomes, reduce costs, and improve the overall quality of life for countless patients. With the continued acceleration of innovation—both in AM and orthopedics—the future of device manufacturing and patient care holds immense promise. 

MORE FROM 3D SYSTEMS: PEEK-ing into the Future: How 3D Printing Is Redefining Cranial Implants

Aaron Schmitz is additive process engineering manager with 3D Systems’ Application Innovation Group, specializing in metal laser powder bed fusion process development as well as validation and qualification. He is a seasoned mechanical engineer with prior experience as both a design engineer and additive manufacturing engineer at GE Aviation and GE Additive. Schmitz received a bachelor’s degree in mechanical engineering from the University of Wisconsin Madison and a master’s degree in mechanical engineering from The Ohio State University.

Colton Steiner is a senior validation engineer with 3D Systems focused on improving additive manufacturing processes, particularly in laser powder bed fusion and material extrusion. In this role, he helps healthcare customers build confidence in these technologies through the development, qualification, and validation of these additive processes using advanced materials. Prior to joining 3D Systems, Steiner leveraged his additive manufacturing expertise at Johnson & Johnson where he held roles as a materials and process engineer evaluating the technology’s applicability to applications in orthopedics and robotic surgery. He received bachelor’s degrees in mechanical engineering and mathematics from the University at Buffalo, and a doctorate in materials engineering from Purdue University.]]> https://www.odtmag.com/powering-volume-implant-production-with-cocr-and-laser-powder-bed-fusion-printing/feed/ 0 The Growth of ASCs for Orthopedic Procedures https://www.odtmag.com/the-growth-of-ascs-for-orthopedic-procedures/ https://www.odtmag.com/the-growth-of-ascs-for-orthopedic-procedures/#respond Mon, 23 Sep 2024 14:20:00 +0000 https://www.odtmag.com/the-growth-of-ascs-for-orthopedic-procedures/ 1

The change in procedure location has impacted many specialties, and this is definitely true in orthopedics. In 2023, the U.S. orthopedic ASC market was valued at approximately $10.6 billion and is expected to grow to over $15 billion in the next 10 years (Table 1).2 This nearly 4.5% CAGR provides opportunities for manufacturers to continue innovating and providing ways to improve the effectiveness and efficiency of procedures performed in ASCs; however, this growth presents both opportunities and challenges for medical device manufacturers. To succeed in this evolving market, orthopedic device manufacturers must understand the unique needs of ASCs and develop innovative products to meet the needs of the clinicians and administrators working at the centers.


Table 1: The U.S. orthopedic ASC market size2

ASCs consider their priorities and constraints differently than hospitals. Cost pressures are more acute, as reimbursement rates are typically lower. ASCs also place a premium on efficiency, requiring devices that enable quick procedures and fast patient recovery. Additionally, storage space is often limited, necessitating compact equipment and streamlined inventory management. This all means the “full-system” options that were typically offered to hospital purchasing managers are often not right-sized for the ASC.

MORE INFO: Designing Specifically for the Ambulatory Surgical Center Environment

Several manufacturers have embraced these differences and offered ASC-oriented websites and product families to address their specific needs. These companies have tuned their offerings to address the current and growing procedures at ASCs (Table 2).


Table 2: Market share by procedure at U.S. orthopedic ASCs (2022)3

DePuy Synthes, for example, offers multiple resources on “The Building Blocks of Your ASC” website, which includes sections on Clinical Excellence, Economic Value, Operational Support, and Building Your ASC Vision, as well as opportunities for professional development.4 Offering support as well as customized products should help develop, maintain, and grow relationships with the ASCs outside the traditional hospital settings and is a key approach to addressing ASC needs. The new and revised product areas will be key to the future of these relationships.

While hardware and implants are a main focus of device development, there is an abundance of new and emerging software tools for the ASC. These have been designed to automate workflows, eliminate redundant tasks, or improve quality in an effort to leverage new technologies in these time-centric centers.

In 2019, research was published on the ability to implement quality improvements in ASCs as a result of the first major national effort aimed at improving quality through reducing infections and other surgical complications in the ASC setting.5 The team recruited 665 ASCs in 47 U.S. states and found that while there were resources available to implement quality improvement processes at ASCs, these tools and approaches to implementation needed to be directly tailored to the ASC environment. Using current tools took too much time to retrofit or reorganize to meet ASC needs compared to the hospital setting. That being said, a quick search using a typical search engine finds pages and pages of software companies looking to address needs and improvements for the ASC.

The growth of orthopedic procedures in ASCs represents a significant opportunity for medical device companies. However, success in this market requires a deep understanding of ASC needs, innovative product development, and a strategic approach to demonstrating clinical and economic value. By focusing on these areas, orthopedic device manufacturers can position themselves as key partners in the ongoing shift toward outpatient care.

The MedTech Strategies Perspective

Given the number of software offerings and the need for data and improvements in ASCs, only companies that provide the best collection of tools to streamline adoption and integration into the ASC setting will rise above the rest. 

References
  1. tinyurl.com/odt240901
  2. tinyurl.com/odt240902
  3. tinyurl.com/odt240903
  4. tinyurl.com/odt240904
  5. tinyurl.com/odt240905

MORE FROM THIS AUTHOR: Wearables for Improving Outcomes: Don’t Forget Your Smartphone!

Ilsa Webeck has over 25 years of work experience assessing commercial and market viability in the medtech space. Founding MedTech Strategies in 2014 and joining Simbex in 2024, she has worked with a wide range of organizations focused on assessing commercial fit and identifying product and service value propositions, as well as uncovering customer/user needs to understand a path to commercial success. Her past experiences include group product director at J&J’s DePuy Spine, leading the strategic marketing and upstream marketing team, and associate director for global commercial strategy in the MS Franchise at Biogen Idec. For more information, visit www.medtechstrategiesllc.com.]]> https://www.odtmag.com/the-growth-of-ascs-for-orthopedic-procedures/feed/ 0 Who’s Responsible for an Orthopedic Device Product’s Quality? https://www.odtmag.com/whos-responsible-for-a-orthopedic-device-products-quality/ https://www.odtmag.com/whos-responsible-for-a-orthopedic-device-products-quality/#respond Mon, 23 Sep 2024 14:12:00 +0000 https://www.odtmag.com/whos-responsible-for-a-orthopedic-device-products-quality/
Weekly, I receive questions about specification, inspection, and validation responsibilities from contract manufacturers (suppliers) and device manufacturers:
  • “What if I’m going to package an off-the-shelf (fill-in-the-blank) with my device for surgeon convenience?”
  • “The contract manufacturer is ISO 13485 certified; why worry about inspection or validation?”
  • “Our (fill-in-the-blank) is just like the competitor’s product that gets sterilized at the same location, so do we really need to validate the sterilization process?”
Answering these and similar questions is not easy; start from the beginning with the regulation’s verbiage and the definition of the terms.

21 CFR § 820.50 Purchasing controls: Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
  • (1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
  • (2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
  • (3) Establish and maintain records of acceptable suppliers, contractors, and consultants.

(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 820.40.


Table: Examples of potential risks associated with supplier materials and processes.

Purchasing controls apply to supplied products, components, services, and consultants. “Product” means components, manufacturing materials, in-process devices, finished devices, and returned devices. “Component” means any raw material, substance, piece, part, software, firmware, labeling, or assembly intended as part of the finished, packaged, and labeled device.

21 CFR § 820.3: “Service” (contractor) means parts of the manufacturing or quality system that are contracted to others, for example, plating of metals, testing, and sterilizing, among others. (Preamble, Comment #102)

Purchasing controls apply to all or nearly all suppliers for any raw material, components, manufacturing material (chemicals used in any manufacturing process), outside processes, etc. that are part of, come in contact with, or impact the finished device’s quality. The manufacturer is responsible for finished device’s quality. This depends on the quality of the raw materials, components, processes, and services. It’s not possible to outsource that responsibility to contract manufacturers or suppliers through quality agreements or assignments.

Section 820.50(a)(1) makes it sound simple: “evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluations shall be documented.”

The first item is evaluation shall be documented, which means the manufacturer needs a documented process that lays out a repeatable method to complete evaluations and document results. Evaluating potential suppliers often involves quantifying the risk associated with the product or service and a list of qualification activities that increase in depth as the potential risk to quality increases.

According to Section 820.50(a)(2), a manufacturer shall “define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.” The first step involves a risk assessment that varies slightly from process and design risk assessments but uses information gleaned from those two types.

For products or processes listed in the table, those where a supplier failure is difficult to identify in incoming inspection should be considered high risk and a higher “extent of control” is required. If the manufacturer can’t confirm a raw material is exactly as specified in a certificate of analysis, there must be overwhelming confidence in the material supplier and their documentation. The same applies to most other products and processes in the table because most companies can’t inspect unseen product or process characteristics.

Two types of risks to be evaluated are risks inherent to the product, component, or process, and risks based on the supplier’s internal quality controls. If a supplier meets all initial requirements but incoming inspection identifies a high number of failures, that supplier should be considered high risk. There should be cooperation with the supplier to improve performance and increased inspection until the issues are resolved.

Supplier qualification activities should be based on risks identified for that product or process. These include collecting proof of ISO 13485 certification, supplier surveys, facility audits, increased incoming inspections, review of validation activities, and a quality agreement. A supplier shouldn’t be considered qualified until all required activities are completed. For consultants, it’s the manufacturer’s responsibility to have documentation related to education, experience, and certifications.

According to Section 820.50(a)(3), the manufacturers shall “establish and maintain records of acceptable suppliers, contractors, and consultants.” The general practice involves having an “approved supplier list” (ASL) controlled by the quality department and a method of preventing products or services from being ordered from any company that isn’t on the ASL for that specific product or process.

There are generally re-approval timelines, like annual review of the supplier survey or a facility re-audit every three years. The quality system should have ways of triggering supplier review if there are problems with quality identified through nonconformances found in incoming inspections, or through failures in the field. A quality agreement (contract) should be in place with each supplier that includes a clause requiring the supplier to notify the manufacturer of any changes that may affect the finished device’s quality. If a manufacturer receives a notification, documented activities should include a thorough assessment of any modified or new risks associated with the change.

FDA warning letters, product recalls, and patient harm are why purchasing and supplier controls are so important. In September 2022, Med Pen Concepts received a warning letter partly because their purchasing control processes were not followed: “Activities surrounding acceptance of devices were not documented showing that your firm is inspecting, testing, or otherwise verifying that devices received from contract manufacturers conform to specified requirements.”

In June 2023, Vitang Technology received a warning letter partly for “not defining the type and extent of control to be exercised over supplier services” and when asked for a documented evaluation of the contract manufacturer, the company only provided “a Manufacturing and Supply Agreement.”

A manufacturer cannot contract away the responsibility for product quality.

MORE FROM THIS AUTHOR: How to Hit the Moving Target of Medical Device Cybersecurity

Meredith Vanderbilt, director of consulting at Empirical, is an internationally known medical device regulatory affairs consultant unafraid to communicate directly and honestly with regulatory bodies and clients about strategies and submissions to provide compliant and high-quality devices to the market.]]> https://www.odtmag.com/whos-responsible-for-a-orthopedic-device-products-quality/feed/ 0 Details of Note: What Piqued My Interest in the Top 10 Company Reports https://www.odtmag.com/details-of-note-what-piqued-my-interest-in-the-company-reports/ https://www.odtmag.com/details-of-note-what-piqued-my-interest-in-the-company-reports/#respond Thu, 08 Aug 2024 12:03:00 +0000 https://www.odtmag.com/details-of-note-what-piqued-my-interest-in-the-company-reports/ top 10 revenue-producing orthopedic device manufacturing firms. While this undertaking still seems somewhat overwhelming when it “sneaks up” on me and my colleagues in late May, it undoubtedly affects our view of the industry. In writing our assigned reports then proofreading the remaining entries, we gain interesting perspectives on both the individual organizations and the industry at large. Insights on trends, technologies, innovation drivers, and more are all revealed throughout the reports. With that said, I wanted to take a company-by-company approach to share what I found most interesting from each company’s summary.

Stryker—The company’s willingness to “practice what they preach” in terms of its commitment to ESG stood out. Specifically, the news stating the organization would be leveraging the power generated by a wind farm for their North American (NA) facilities was pretty remarkable to hear. The Sunflower Wind project will create a 200-megawatt wind farm in Kansas and is part of the company’s pledge to be powered by 100% renewable energy sources by 2027. The electricity generated at this location is anticipated to account for 70% of Stryker’s total NA need over a 12-year period.
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DePuy Synthes—This observation is more about J&J as a whole. The company has been going through a substantial transformation, separating from its consumer health portion (spun out as Kenvue). If you dig back a few years, you’ll find reports stating that many investors were calling for this move to take place. The result leaves J&J as two halves—pharmaceuticals and medtech. Might these remaining pieces split at some point? Are there synergies enjoyed across them or are they run like two separate companies operating under a single banner?
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Zimmer Biomet—This company has impressed me in continuing to appear to be one of the most digitally savvy orthopedic device firms in the top 10. Funny enough, some of these capabilities are relegated to its “Other” segment in its annual report. Undoubtedly some of the coolest offerings of the firm, and it doesn’t even get a proper name. Zimmer Biomet, keep doing what you’re doing in being a leader for digital innovation, but give these technologies a proper division name!
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Smith+Nephew—Remember when everyone speculated on who was going to buy this firm? They’re still flying solo and that purchase price (if you were going to determine one) keeps growing. Anyone looking to get them for a song missed the boat. Look forward to continuing to follow their growth and innovations.
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Medtronic—Speaking of sales, is the orthopedic unit of Big Blue its red-headed stepchild (or is that the Patient Monitoring and Respiratory Interventions division that was to be sold)? On more than one occasion, members of industry have speculated its ortho unit would be sold off or spun out. Anything’s possible, but couldn’t the same be said of any other seemingly disjointed division of the company? Cardio, diabetes, and spine all under one roof? Will we see anything moved or its core competencies reassessed?
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Arthrex—Candidly, as a Jets fan, the Aaron Rodgers Achilles tendon technology was most of interest to me. But I was also thrilled to finally get this major industry player into the list as it always seemed like an odd anomaly not to include them (we’ve only previously ever reported on public companies that produce an annual report). Including them feels like we’ve developed a more complete list.
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Enovis—After its split from Colfax, Enovis wasted no time rolling up its sleeves, making a couple of acquisitions, and announcing a few products. The firm seems laser-focused on emerging as a major player, able to stand alongside its larger peers. The purchase of LimaCorporate should prove interesting; I will be interested to see what innovations are spawned.
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Globus Medical—Before reading this report, I was curious to see what was said of the NuVasive buy. The jump in revenue was the most notable aspect. A little too much ballyhoo, however, from the company’s president/CEO about how integrated the two entities already are. I hope it’s all true, but as someone who was part of an acquired company, I know those memories run deep. How many folks still say they are with Covidien, Bard, or St. Jude?
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Össur—A company providing prosthetics for those missing limbs. Quite the mission and I wish them all the best.
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Orthofix—Welcome back! Another company jumping substantially in revenue due to an acquisition. The integration of SeaSpine had a dramatic impact on this company’s 2023 fiscal. Now let’s see if they can keep the momentum going and what the next steps are.
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Which company were you most curious about or what detail did you find most interesting? As always, I welcome your thoughts and comments. 

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com]]> https://www.odtmag.com/details-of-note-what-piqued-my-interest-in-the-company-reports/feed/ 0