Medical Design & Outsourcing – MAY 2019 by WTWH Media LLC

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THE 10 LARGEST ORTHOPEDIC DEVICE COMPANIES IN THE WORLD

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CONTRIBUTORS

DYKEMAN

FOWLER

KIM

GAGLIO

LYNCH

DAVID J. DYKEMAN is a registered patent attorney with over 20 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. David's practice focuses on securing worldwide intellectual property protection and related business strategy for medtech clients, with particular experience in medical devices, life sciences, wearables, robotics and healthcare information technology. DAN FOWLER is principal scientist with WuXi AppTec. He has more than 20 years of experience in medical device third-party reprocessing, including a focus on interpretation and application of AAMI TIR30. Dan performs identification and validation of analytical laboratory assays and develops best practices in method development for inoculation/ extractions and efficient cleaning/disinfection strategies. TONY GAGLIO is the product marketing manager, Americas, for ASCO Analytical & Medical at Emerson. He has over 20 years of experience in the in-vitro diagnostic industry and has held positions as a senior chemist and strategic marketing manager for in-vitro diagnostic reagent manufacturers. JONATHAN JURGAITIS is a senior extrusion engineer at Apollo Medical Extrusion by Spectrum Plastics Group. He has been in the custom medical extrusion industry since 2006, manufacturing catheter and medical device components, and has been part of the extrusion industry, in a variety of positions, since 1993. Jonathan’s extrusion focus for the last 10-plus years has been high-heat materials, such as PEEK, and other exotic and difficult-to-extrude materials.

JURGAITIS

THIRUMURUGAN

LOREN KIM is senior human factors engineer at product design and development firm Kaleidoscope Innovation. Loren has previous engineering experience at Baxter and Emergo by UL. She has applied HFE principles to medical device development, including combination products for rare conditions and complex systems. MICHAEL LYNCH is a managing consultant for Intertek with more than 30 years' experience developing a range of medical devices. He has managed the product development process from concept through full-scale manufacture, is co-inventor on five U.S. patents and is recognized within the industry for his technical competence and ability to identify issues during design reviews. PRAGADEESH THIRUMURUGAN is a human factors engineer and specialist in anthropometric and ergonomic evaluations at product design and development firm Kaleidoscope Innovation. He earned his M.S. in industrial engineering, human factors from Penn State University. TOM WILLIAMS is general manager of Millstone Medical. He joined the company in 2008 and has managed Millstone’s packaging facility in Fall River, Mass., and loaner kit and distribution facility in Memphis, Tenn. He works closely with customers to develop new service offerings and to enable speed and efficiency to market.

www.medicaldesign&outsourcing.com

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WILLIAMS

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HERE’S WHAT WE SEE

Are robots the future of orthopedic surgery?

xperts tell me that there used to be a lot of skepticism in the orthopedic device space when it came to using robots to assist in knee, hip, shoulder and spine surgeries. Two events in recent years changed everything: Stryker paying $1.7 billion for Mako Surgical so that it could sell robotic systems to aid knee and hip replacement surgeries, and Medtronic spending $1.7 billion on Mazor Robotics to expand into the robotassisted spine surgery space. Both Stryker and Medtronic made expensive bets that robotic systems would provide unmatched accuracy and precision in ortho surgeries, transforming them from art to science. Now all the other big ortho device companies – including Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew – have either launched or are preparing to launch their own robots.

Even if not necessarily proven to be better medicine, you can't afford not to have an answer to robotics. This year’s American Academy of Orthopaedic Surgeons (AAOS) meeting in Las Vegas, in fact, was reportedly abuzz about robotics. “Even if not necessarily proven to be better medicine, you can’t afford not to have an answer to robotics. There’s a strategy now where having a robot is better than not having a robot,” SVB Leerink analyst Richard Newitter told Medical Design & Outsourcing. Even for a major orthopedic device industry supplier such as Tecomet, the shift to robotics has had an effect, with a need to forge relationships earlier, manufacture at times for tighter instrument tolerances and much more. The curious thing about the trend is that evidence is actually scarce when

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it comes to whether robot-assisted ortho surgery improves outcomes over the long term. Officials at companies such as Stryker and Medtronic point to a host of evidence that robots make a difference over the short-term, improving everything from readmission and reoperation rates to time in the operating room. They suspect the short-term improvements are a good sign that there will be long-term benefits, too. The long-term data, though, simply isn’t there yet. And skepticism still remains. Serial ortho device entrepreneur Doug Kohrs, for example, actually predicts that enthusiasm for robotics in ortho surgery could be short-lived. In two to three years, patient-specific implants produced from surgical planning data – combined with computer-assisted navigation – could provide a more economical alternative, the former Tornier and American Medical Systems CEO told MDO. Stryker’s Robert Cohen countered that the company’s Mako system allows for new ways of positioning implants that older manual instruments can’t achieve. Perhaps more important, he said, are the digital capabilities Stryker can layer on the top of the technology. It seems only time will tell whether the $500,000 to $1 million a health provider pays for a robot-assisted ortho surgery platform is truly worth it. M

Chris Newmarker Managing Editor Medical Design & Outsourcing cnewmarker@wtwhme di a .c o m

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CONTENTS

medicaldesignandoutsourcing.com ∞ May 2019 ∞ Vol5 No3

COLUMNS 5

CONTRIBUTORS

HERE’S WHAT WE SEE

IP ISSUES

COMPONENTS

DESIGN

Are robots the future of orthopedic surgery? Orthopedic device patent strategies you need for success

• • • • • THE ORTHOPEDICS ISSUE

ON THE COVER IS THE ORTHOPEDIC DEVICE SPACE IN THE MIDST OF A ROBOT REVOLUTION? Stryker’s success with its Mako robot-assisted surgery platform has other orthopedic device companies hastening to enter the space. The big question is whether long-term outcomes will justify the expensive technology.

Five benefits of selecting the right valve How to design a sustainable medical device

22 LOGISTICS

Avoiding pitfalls in surgical loaner kit management

26 PRODUCT DEVELOPMENT

FEATURES

Human factors pitfalls to avoid for safer orthopedic surgical devices

42 HERE’S HOW ROBOTICS IS AFFECTING CONTRACT MANUFACTURERS

30 REGULATORY

46 MEDTRONIC HAS BIG PLANS FOR ROBOT-ASSISTED SPINE SURGERY

Reusable devices and Europe’s MDR

34 TUBING TALKS

50 THE 10 LARGEST ORTHOPEDIC DEVICE COMPANIES

What you need to know about PEEK and medical tubing

IN THE WORLD

Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.

64 DEVICETALKS

Why you should get excited about DeviceTalks Boston

56 ORTHOPEDIC PRODUCTS FROM AAOS 2019

68 PRODUCT WORLD 72

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas was abuzz about robotics — and much more.

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IP ISSUES

Orthopedic device patent strategies you need for success Stake claims carefully in the orthopedic device patent gold rush.

P David J. Dykeman | G r e e n b e r g Tr a u r i g |

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atents are the currency of the orthopedic industry. In order to thrive, orthopedic device companies must distinguish themselves from their competitors through their intellectual property portfolios. Strong patent portfolios are the key to success because they embody a well-reasoned business strategy, where each patent is a single strategic building block in a larger portfolio that reflects present and future business objectives. Patent portfolios are often the driving force for major events in the life cycle of an orthopedic company including venture capital investment, mergers and acquisitions, public offerings, strategic collaborations, joint ventures and litigation.

Global Market Insights. One driver of the orthopedic industry boom is an increase in musculoskeletal injuries and conditions in America’s aging population. Given the increase in age-related musculoskeletal problems, the orthopedics industry faces pressure to develop technological advancements and improved medical devices for diagnosis and treatment of bones and joints including hip, knee, ankle, shoulder and spine conditions. Orthopedic devices are typically categorized into diagnostics, implants, prosthetics and surgical devices. The increasing demand for orthopedic devices for minimally invasive and robotic surgery has led to new surgical devices and innovative treatments.

Orthopedics industry booming The orthopedic device industry has flourished in recent years, with worldwide orthopedic devices market size growing to over $42 billion in 2018 for treatment of trauma, bone diseases, sports injuries, degenerative diseases, infections, tumors and congenital disorders, according to

Strong patent portfolios drive growth Developing and maintaining a strategic patent portfolio is critical to an orthopedic device company’s growth and survival. A comprehensive orthopedic patent strategy includes: (1) filing strong patent applications to maximize patent coverage of a company’s current core technology

5 • 2019

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IP ISSUES

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and future improvements; (2) monitoring the patent landscape and exploring ways to patent white space; and (3) considering cross-licensing opportunities with competitors. By using these patent strategies, orthopedic companies can ensure success in today’s competitive and rapidly changing intellectual property environment. For orthopedic companies, the key is to develop a strategic patent portfolio that has comprehensive patent coverage around the company’s innovations. The core technology must have adequate patent protection to provide flexibility and room to operate in the dynamic orthopedic market. To obtain broad patent protection, companies should file an initial patent application covering the core technology, followed by additional patent applications covering key improvements. Orthopedic companies should consider both current and future business objectives and analyze ways that competitors may attempt to design around its patents. Here’s a real-world example of how strong patents help IlluminOss Medical is an FDA approved and venture-backed medical device company pioneering new frontiers in minimally invasive stabilization and treatment of fractured bones. From the company’s formation, IlluminOss Medical has worked with international law firm Greenberg Traurig to study the intellectual property landscape and develop a strong patent portfolio directed to the company’s orthopedic systems. The patent portfolio has helped the company protect its innovative products and raise multiple rounds of venture capital funding. Conducting thorough patent searches early provided the inventor and IlluminOss Medical with information on existing products and ideas of patent white space the company could try to claim. By aggressively staking claims in the patent landscape, IlluminOss Medical has been granted over 45 U.S. patents and created a strong worldwide patent portfolio of over 100 patents in 17 countries that provides a picket fence of patent protection around its innovative 12

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core technology, improvements, potential alternative designs and future innovations. “Building a strong patent portfolio has been of critical importance to protect IlluminOss’ innovative products and as a means to attract investment,” said IlluminOss Medical’s founder Robert A. Rabiner. He added that it helps to have patent attorneys who not only understand complex technologies but can also develop proactive patent strategies to protect the core technology — and find additional areas to patent. IlluminOss Medical patents cover all aspects of its products including the entire system, catheters, balloons, light sources, treatment kits, methods of treatment, improvements, and alternative designs to form a picket fence of patent protection around the innovative fracture fixation technology. The patent portfolio

supports the company’s mission to improve patient outcomes through the treatment of broken bones. Conclusion Orthopedic companies must build and maintain high-value patent portfolios to be successful in today’s competitive and rapidly changing patent environment. By aggressively protecting core technology and optimizing the patenting of white space, orthopedic device companies can build a strong patent portfolio. A strategic patent portfolio will not only secure a company’s competitive advantage in the market by maximizing patent protection, securing funding, enhancing revenue, and increasing marketing value, but it will also enable a company to thrive in the growing orthopedic market. M

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COMPONENTS

Five benefits of selecting the right valve for in-vitro diagnostic instruments From immunoassays to hematology analyzers, medical analytical instruments demand the highest levels of accuracy, reliability and purity.

T To n y G a g l i o | Emerson |

he correct fluid-handling technologies are critical to medical sample purity and patient safety. In addition to controlling the flow of blood, chemical reagents and other aggressive media, the right valve prevents media cross-contamination and minimizes external factors that could influence the biological material, thus improving the performance of your analytical device. To reap these benefits, it’s important to partner with a knowledgeable supplier who understands the requirements of today’s medtech market and can design a complete fluidic assembly that addresses these demands up front.

Here are five ways the right valve can improve your analytical process: 1. Precision An estimated 70% of healthcare decisions regarding disease diagnosis or treatment involve a laboratory analytical instrument investigation. Since the fluidic systems involved in these sensitive applications handle and dose samples in very low volumes, small variations have a significant impact. Repeatability and accuracy are key. Although each analytical process is different, many involve volumes between 1 µl and 50 µl. Selecting valves with fast response times will enable actuation without significant delay to ensure precise media control in these low-volume applications.

Clinical laboratories need the correct fluid-handling technologies for sample purity and patient safety. Image courtesy of Emerson

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3. Fast time to market The timeline for new product development in in-vitro diagnostic instruments is highly compressed. Any delay in the design, engineering and procurement of a fluidic system can prevent you from meeting time-to-market goals. A fluidic system supplier must be able to respond to customers’ changing needs while providing fast turnaround on complex, high-performing fluidic systems.

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4. Smaller footprint Smaller, more affordable machines are in demand. As the instruments shrink, the components inside them need to shrink, too. For valves and other fluidhandling components, this relationship isn’t linear, requiring engineers to address new design challenges related to flow, power and heat transfer. As a result, it’s becoming increasingly difficult to design and develop a complete fluidic system that is precise and reliable, reduces system complexity and adds value to your manufacturing process, all while meeting smaller size requirements. Look for a supplier that has extensive experience within in-vitro diagnostic, point-of-care and bioinstrumentation applications. Their technical expertise is critical to delivering appropriately sized, high-performing components and systems, including valves with reduced footprints for smaller instruments.

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2. Reliability A fluidic system typically has a lifespan of seven to 10 years, so fluidic valves must be able to withstand millions of actuations. To avoid premature valve failure, a fluidic system supplier should design the system with the lowest number of fluid connections to minimize the risk of leakage and ensure all valves within the assembly are quality tested. The reliability of an analytical system also depends on sample purity. Look for valves with designs that specifically target and minimize contamination. For example, high-quality pinch or isolation valves will operate upon the tubing that contains the fluid, or hermetically separate the control mechanism from the fluid, respectively. This prevents friction-induced particulate contamination between moving parts.

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5 • 2019

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5. Customization New and next-generation in-vitro diagnostic systems increasingly require custom fluid-handling components for today’s market. But even small changes to a valve can have profound effects on an instrument’s analytical performance. For example, even milliseconds of difference in a valve’s response time or slight alterations to its fluidic path can dramatically affect machine throughput and productivity. To ensure optimal instrument performance and analytical results, a supplier should have technical expertise in the following areas related to fluidic design: • Chemical resistance. While many valves can handle acids, alcohols, bases, solvents and corrosive gases and liquids, modified or special designs may be required, depending on the particular fluid or application.

• Heat dissipation. Managing heat is a balancing act. Valves require the right amount of power to accomplish the task at hand while minimizing heat transfer to thermally sensitive media. • Fluidic path. Optimizing a valve’s fluidic path improves instrument efficiency. Look for designs that reduce the valve’s internal volume as much as possible while eliminating dead volume. • Compliance. As a testament to their quality and safety in critical medical device applications, valves must meet all relevant CE directives and comply with Restriction of Hazardous Substances (RoHS) regulations. They should also be manufactured in a cleanroom environment to reduce any potential for contamination. M

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DESIGN

How to design a sustainable medical device Sustainable design in medical electrical equipment can fulfill regulatory requirements, decrease environmental impact and satisfy demands from patients and healthcare providers alike.

Michael Lynch | Intertek |

nvironmentally conscious product design has taken hold across many industries, including medical devices. Manufacturers who want to design and produce sustainable medical devices and medical electrical equipment must meet certain standards to claim environmentally conscious design. A standard published by the International Electrotechnical Commission, IEC 60601-1-9 provides a formal way to verify sustainability claims, including guidance for the design phase that can be leveraged to develop sustainable medical devices. Standard overview Published in 2007 and amended in 2013, IEC 60601-1-9 is a collateral standard to the widely accepted international standard for the basic safety and essential performance of medical electrical equipment, IEC 60601-1. It seeks to improve environmental impact at all stages of a medical device’s life cycle: initial concept, design, manufacturing, sales, logistics, installation, use and end-of-life management.

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The criteria in IEC 60601-1-9 must be integrated into all stages of the medical electrical equipment lifecycle, from the specification stage to end-of-life management. However, the standard does not provide a simple list of eco-friendly design specifications. Manufacturers instead must demonstrate how they used eco-design principles in the product’s design and development. Compliance assessment checks specified in the standard are based on verifying that procedures are in place and there is documented evidence that those procedures are followed. Requirements IEC 60601-1-9 is related to several other standards, including ISO 14971, ISO 14001 and ISO 14062. Through these links, the following requirements apply to the IEC standard for sustainability: • In compliance with ISO 14971, environmental protection must be included as one element of the overall risk management process. ISO 14971 deals with influences of medical devices on the environment. It considers factors such as emissions of toxic materials, biological threats and chemical hazards. Assessing these factors at each stage of development provides valuable input for the risk management process and for the overall sustainability considerations of the device. • ISO 14001 Edition 2015, which includes guidance on implementing processes for managing environmental concerns throughout a product’s lifespan, integrates lifecycle thinking into IEC 60601-1-9.

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DESIGN

• An emphasis is placed on ISO 14062 to integrate environmental management considerations into product design and development. IEC 60601-1-9 also has its own requirements that are not found in other standards. These include: • Manufacturers must establish, implement and maintain a process to identify and document environmental aspects across all life-cycle stages of a given product. This includes determining aspects that may have significant environmental impacts across the stages and identifying suppliers who contribute to significant environmental aspects. From these suppliers, manufacturers must obtain information necessary to identify and assess these same aspects.

• Manufacturers must also establish and document a process to minimize adverse environmental impacts across all life-cycle stages. Emerging or alternative technologies must be considered and significant aspects of a representative prototype of the final design must be assessed and documented, as should any deviations from the target. • All relevant information on the type and mass of packaging materials must be made available. • Manufacturers must provide instructions in accompanying documents for minimizing the environmental impact of a product during normal use. Additionally, those accountable for the use and maintenance of the product must receive information for proper disposal at end of life.

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Compliance To illustrate a product’s compliance with the standard, manufacturers will need to submit several types of documentation, including: • Design documents and process description relevant to the identification of environmental aspects and information from the supply chain, as well as those that are relevant for the reduction of adverse environmental impacts. • Information on packaging, as well as accompanying documents, and sections relevant for minimizing environmental impact during normal use. • Information related to end-of-life management. Assessments of this documentation can be done independently from the evaluations of the other requirements of the IEC 60601 series. A manufacturer may also use risk analysis to help determine environmental improvement targets, but this is not required. A risk analysis will produce the necessary documentation and build the environmental considerations into the design and production process, providing valuable resources and insights. Manufacturers must balance the acceptability of medical electrical equipment’s environmental impacts against other factors: intended function, performance, safety, cost, marketability, quality and legal and regulatory requirements. That balance can differ depending on the intended use of a device. A solution appropriate for lifesaving or life-supporting equipment might not be appropriate for a device intended to treat a minor ailment. This means a manufacturer must also be prepared to justify that medical benefit outweighs the associated adverse environmental impacts. Regardless of the reasons for verifying a device’s environmental impact, using IEC 60601-1-9 as a guide can support sustainability claims and help bring greener medical devices to the market. M

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LOGISTICS

How to avoid pitfalls in surgical loaner kit management Medical device manufacturers must manage loaner kits effectively and efficiently to drive down inventory costs and better support surgeries. Here are four common pitfalls of loaner kit management and how to overcome them.

A Millstone Medical employee puts device loaner kits into an autoclave for sterilization.

By managing loaner kits effectively and efficiently, device manufacturers can drive down inventory costs and better support surgeries. The process, however, tends to succumb to four common challenges. Here are the four pitfalls and how to overcome them:

Image courtesy of Millstone Medical

To m W i l l i a m s | Millstone Medical |

anaging surgical loaner kits at the highest level can be a huge pain point for medical device manufacturers. Not only is the process of turning loaner kits highly demanding and complex in itself, but it can also easily consume the precious resources of staff hours and free cash. While not a core competency like product development and marketing, loaner kit management is critical to supporting surgeries, meeting demand and growing a medtech manufacturing business. Success in loaner kit management is a combination of these four capabilities: • Knowing exactly where kits and their contents are at all times. • Ensuring that every kit contains all required SKUs and is fully ready for surgery. • Having the ability to respond quickly to demand, especially of an urgent nature. • Maintaining an inventory pool that is neither too small – inhibiting the ability to respond to demand – nor too large, which can trap free cash.

Medical Design & Outsourcing

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1. Lack of visibility and traceability Without accurate visibility, manufacturers cannot be confident that they know what product is ready for surgery and where that product might actually be. Is it in the field? If so, who has it? And where? Traceability can be even more critical for risk mitigation and the assurance it offers, especially when a product has been recalled. Regulatory inspections and requirements for documented evidence of inventory inspections can also spell trouble for manufacturers that can’t trace their loaner kit inventory. An appropriate tracking system can help medtech manufacturers solve visibility issues and comply with traceability requirements. When each part in a loaner kit is traceable via a lot number, and that traceability translates into visibility, suddenly a manufacturer has a transformative birds-eye view of its inventory landscape. That means manufacturers can quickly and accurately identify where every part is in every kit and, if the kit is in the field, pinpoint who has it. 2. Incomplete precision inspection and replenishment Consider the downsides of shipping out a kit with a part that doesn’t meet functional requirements. Delays in surgery cause frustration for surgeons and patients, generating friction that can be difficult for manufacturers to overcome.

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LOGISTICS

Precision inspection is a critical part of successful loaner kit management. Yet it should not stop at gross visual checks of the parts. Precision inspection involves examining each part for damage and to determine that it still meets its functional requirements. The end goal is to ensure that every part in the kit is in its correct location and is 100% ready to perform in surgery exactly as it’s intended to. 3. Inefficient processes The loaner kit process cycle also includes decontamination at the beginning and packout at the end. It’s a demanding and precise process that requires dedicated resources and focus for maximum efficiency. When staff is also juggling other priorities, process efficiency suffers as workers shift attention to loaner kit

management from other needs. When this happens, cycle time can easily balloon and delay response time, which affects the ability to meet demand and support surgeries. Creating process efficiency involves designing and implementing a repeatable process and ensuring the right labor resources are available. Without dedicated labor, it is difficult to flex and scale with demand as needed, but dedicated labor can also drive up fixed costs. Often, outsourcing offers the right resources at a lower cost. 4. Failing to bring it all together Without the ability to quickly and efficiently turn precision-inspected and perfectly replenished kits, medical device manufacturers need a larger loaner kit pool, which can siphon off free cash needed to innovate and grow the

business. Outsourcing with an expert partner can prove the best investment of resources to create visibility and build efficient, repeatable processes to support demand while preserving free cash. Striking the right balance is all about having a loaner kit pool of the optimal size — big enough to support demand, not so big that it’s underused — and turning it quickly and precisely. Manufacturers that can turn kits within 24 hours of receipt, provide same-day service and expedited weekend, holiday, and emergency shipments while knowing exactly where every piece is will succeed in loaner kit management. M

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PRODUCT DEVELOPMENT

9 human factors pitfalls to avoid for safer orthopedic surgical devices A human factors engineering (HFE) process provides important safety benefits during orthopedic device design and development and may help smooth the regulatory process.

O Pragadeesh Thirumurugan | Kaleidoscope Innovation |

Loren Kim | Kaleidoscope Innovation |

RIGHT: Human factors engineers conduct a formative usability test.

Image courtesy of Kaleidoscope Innovation

Medical Design & Outsourcing

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rthopedic surgical device manufacturers are increasingly taking advantage of HFE, but they may not know how to most effectively incorporate it into product development. Not engaging human factors specialists or doing so incorrectly has the potential to lead to setbacks in submissions to the FDA, delays in product launches – and, more importantly, serious harm to patients. While the mortality rate due to medical mistakes in orthopedic surgery is low, preventable human use-related errors could potentially contribute to serious or catastrophic post-operative complications. In fact, 13% of orthopedic surgical errors were classified as errors in technique, according to an article in the International Surgery Journal. These errors have the potential to be reduced by examining and understanding common use errors and “designing them out.” The goal would be a better user/ device interaction, fewer errors and fewer complications and risk to patients. Strong HFE capabilities and support can help manufacturers avoid these nine pitfalls when developing orthopedic surgical devices:

2. No anthropometric and ergonomic considerations While surgeon input is important, it’s also important to consider other user groups such as circulating nurses, scrub nurses and technicians. Issues can arise when all relevant individuals’ hands, fingers, degrees of freedom of movement, gender and other anthropometric considerations are not studied. Device designers should also consider users’ ergonomic preferences. The device should not only be intuitive but comfortable to all who need to use it. This should help mitigate issues that might lead to someone using a device incorrectly or choosing not to use it at all. 3. Insufficient pre-assessment and assessment of usability risk Sometimes problems and complaints with predicate and/or similar devices are repeated in new designs. Use-related risk analyses can help manufacturers to predict potential errors and design to avoid these issues.

1. Minimal or no HFE considerations in early development Waiting to incorporate HFE until the later stages of development, such as during the FDA-required validation study, might turn up use errors that could have been mitigated during the design and development process. The FDA might require changes in design, prolonging the device’s market launch. Usability testing done earlier in the design process opens a new dimension of product use and could reveal use errors with more time to make design improvements. 5 • 2019

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PRODUCT DEVELOPMENT

4. Failure to do formative evaluations Not taking advantage of exploratory formative evaluations could lead to discovering errors or design flaws when it is too late in the process. Performing formative evaluations can reveal ways to improve the design to help ensure the product is safe and effective to use.

thoroughly reviewing product support and instructions for transporting, cleaning and/or discarding the product.

5. Unrealistic training for usability testing During validation testing, training must reflect the real-world scenario, as it may affect the participant’s performance. 6. Ignoring supporting materials and processes Packaging and product labeling are as important to assess as the product itself. Some examples of this include misread or complicated instructions for use, and crowded text that may deter a user from

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8. Disregard for surrounding tissues/ muscles Sometimes overlying structures like soft tissues and muscles on the body around the bones are overlooked while

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7. Designs based on stakeholders rather than end users Instead of designing for the actual users, companies may defer to stakeholders such as the orthopedic sales rep, marketer or orthopedic engineer. Further, while orthopedic surgeons can be involved in a product’s invention, it is important to obtain wider surgeon input rather than default to an orthopedic surgeoninventor’s individual preferences.

testing on plastic models. It is critical to consider the actual complications or serious consequences that could occur in real surgery. Cutting tools similar in appearance but different in performance Understanding the differences between cutting tools is imperative. Designing to differentiate cutting tools that look similar but do not perform alike is a critical HF input. Ultimately, a solid HFE team focused on making orthopedic products more intuitive may contribute to improved patient care. For example, the intended users might be able to perform their tasks with less distraction from device design-related challenges. Implementing HFE principles early may help to inform the design of safer and more effective devices. M

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REGULATORY

What you need to know about reusable devices and Europe's MDR Manufacturers of Class I reusable (Class Ir) medical devices need to identify data gaps and select the appropriate validation study to ensure their devices’ compliance with the European Commission’s Medical Device Regulation (MDR).

he introduction of MDR is putting increased emphasis on the roles that robust data and complete evaluations play in ensuring medical device safety. All devices, including Class I reusable devices (Class Ir), must meet the new guidelines or risk being excluded from the market.

Dan Fowler | W u X i A p p Te c |

Medical Design & Outsourcing

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The changes Class Ir devices are designed to be used more than once and across patients. To obtain a CE Mark under MDR, these devices will require a detailed technical file that proves safety and efficacy of cleaning, disinfection and sterilization methods outlined in the device’s Instructions for Use (IFU). Historically, Class I devices, including reusable

5 • 2019

products, were self-designated, leaving it up to device manufacturers to decide what a validation entailed. But under MDR, every device manufacturer will be responsible for ensuring cleaning, disinfection and sterilization instructions are adequate and validated. A notified body will review the technical files, including these validations, to confirm they comply with MDR and are acceptable according to international standards and industry guidance. As the May 26, 2020 deadline draws near, it is important to note that reusable devices won’t have the luxury of receiving an extension or being grandfathered in. Therefore, prioritize them early, starting by conducting a gap analysis and appropriate validation studies.

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REGULATORY

Conduct a gap analysis Before investing time and money on testing, perform a gap analysis to determine where deficiencies exist in your data and product portfolios. Notified bodies will not rely on historic product performance or reviews alone. Start by reviewing the technical files for your current Class Ir devices to identify missing information or outdated test strategies. This is especially important for MDR compliance, as you will need to confirm that validations exist in the design file that support instructions for use (IFU) claims and meet current ISO standards, including ISO 17664:2017. Begin with legacy devices, as those have been on the market longer and will likely take more time. If a product family consists of multiple catalog numbers and

SKUs, you must document validation evidence across all of the devices. Prepare for testing If the analysis identifies data gaps, run a validation test to rectify them and gather new data or supplemental information. This process can be laborious, but working with a contract research organization (CRO) or laboratory testing partner may help. They can identify and perform appropriate tests to ensure compliance. It is also helpful to identify a partner that can develop experimental design and validation methods that are compliant with the latest guidance and regulatory documents. Conduct testing If validation testing is required, start by

identifying the type of study or studies needed for your product or product family. Then, validation protocols are developed and customized to your product, its IFU and worst-case conditions. Here are some examples of the studies that may be needed: • A cleaning efficacy study validates the efficacy of your recommended cleaning process. It requires that you test devices with clinically relevant artificial soils and other worst-case parameters that confirm the process is reliable and repeatable and ensures that clean endpoints are met. • Sterilization efficacy studies are used to verify that the sterilization methods successfully achieve a targeted sterility assurance level (SAL), even in worst-case scenarios.

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• Dry time validations studies are needed because healthcare facilities must know the effective dry time for devices sterilized using steam. It will be important to have data to back that the drying cycle works according to the given parameters. • Support functionality studies by exposing devices to multiple cleaning, disinfection and/or sterilization cycles beforehand. • Disinfection efficacy studies will produce documentation showing that selected disinfectants can reduce microorganisms to acceptable levels on the medical device. It is important to note that a cleaning validation and its construct is separate from a disinfection validation. Independent protocols and reports for each must be generated to document the effectiveness of each reprocessing step.

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Because these studies can be costly and time-consuming, it is important to perform them properly the first time. Make sure to do the following when conducting your studies: • Select clinically relevant test soil. • Simulate worst-case conditions. • Include proper test controls. • Use two or more cleaning endpoint markers. • Include accumulation cycles. • Perform recovery efficiency. • Perform validations independently. • Demonstrate and document appropriate test soil drying times. After testing is complete, you will need to submit your data to a notified body. However, under MDR, every notified body will have to go through a new designation and notification process before it will be eligible to review your device’s technical file and approve a CE Mark. Communicate with your notified body early and get your device in line, as the industry anticipates capacity constraints. M

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TUBING TALKS

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PEEK and medical tubing: Here's what you need to know

To achieve the highest-performing extrusion, both the component designer and the extruder must understand the many aspects of a medical tubing material such as polyetheretherketone (PEEK).

P Jonathan Jurgaitis | Apollo Medical Extrusion by Spectrum Plastics Group |

Medical Design & Outsourcing

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EEK offers enhanced properties that make it an attractive tubing applications material for medical device designers and engineers. Its high strength, resistance to the most extreme chemicals and high-temperature dimensional stability work well in devices designed for cutting-edge neurovascular and orthopedic procedures as well as for mechanical components of medical and access devices. Device designers, engineers and even processors need to know several things about PEEK to successfully incorporate it into a device or catheter. It can take the heat Experts consider PEEK a high-heat polymer because of its elevated processing temperature of around 700°F. This means that tubing manufacturers cannot process PEEK on standard thermoplastic extruders but must instead outfit the extruders with higher-powered heaters. The metals of construction must be lower-thermal expansion alloys.

5 • 2019

The high-heat aspect of PEEK comes into play in manufacturing devices that use multiple components, especially in fabrication processes that require thermal processing, such as over-molding, reflow processes and thermal welding. PEEK remains dimensionally stable at temperatures of 465°F to 500°F and has a melting point of 644°F. These “normal” PEEK temperatures are 200°F to 300°F are higher than typical, “low-heat” medical thermoplastics. This means that thermal processes to bond PEEK to other thermoplastics, such as thermal welding and reflow, will at best only have a mechanical bond to a PEEK part. Additional design features may be necessary to ensure strong bonds between these thermally dissimilar materials. Machines to do this secondary thermal processing must also be capable of reaching the elevated processing temps for PEEK. Less friction PEEK has a low coefficient of friction, a beneficial property for many catheter

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TUBING TALKS

applications, such as neurovascular or other procedures that use microbore tubing. PEEK’s coefficient can be in the .35 range, compared with fluoropolymers, which land in the .1 to .2 range. For microbore applications, PEEK allows smooth movement through the vasculature and access for devices without coatings or lubricious liners. These procedures can also benefit from the stiffness, push-ability and torque response of PEEK at diameters much lower than 2 French. To achieve similar performance, other materials would need to be not only braided but also have thicker walls, and end up costing much more. Many other applications, such as bushings, wear components for spinning, or sliding tools and tool access devices, can benefit from the lubricity of PEEK.

Medical Design & Outsourcing

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Why it works PEEK is a semi-crystalline polymer, which means a portion of its molecules align and form crystalline structures. The bonds between the molecules in the crystalline regions are quite strong and require a lot of energy or force to loosen or break them. These strong bonds also give PEEK its extreme chemical resistance, its high-temperature thermal stability and its stiffness. Some semi-crystalline materials, such as acetal, HDPE and polypropylene, will fully crystallize regardless of processing method, but it’s possible to freeze PEEK in an amorphous state before it can achieve its semi-crystalline state. In an amorphous state, all of PEEK’s properties decrease. This can harm medical components in situations

like sterilization, exposure to extreme chemicals and repeated flex cycling, causing PEEK components to change shape and size, stress crack and underperform. Material manufacturers typically do not state this, but the provided test values for PEEK on technical data sheets are based on fully crystallized test samples, so tubing that is not fully crystallized will not perform to the level that the device engineer may have expected for his or her application. The standard state for PEEK products should be considered fully crystallized and only in some unique situations will a customer specify amorphous PEEK. The performance of PEEK in its amorphous state is less well known because there can be varying degrees of crystallinity that complicate how to characterize

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amorphous PEEK products. Achieving fully crystallized parts can be very challenging and may require a secondary annealing process, but this has its own challenges as PEEK parts can go through dramatic changes while being annealed, so inline crystallization of extruded tubing is the ideal method.

achieve performance that no other lowheat material can approach. Working with an extruder that is experienced with PEEK and its extrusion nuances and special requirements will help designers use PEEK extrusions to their fullest in their medical applications. M

Versatility gives PEEK an edge A tubing manufacturer can extrude PEEK into just about any configuration that can be achieved with low-heat materials, including microbore tubing, multi-lumens, thin-wall tubes, filament and profile shapes. Some aspects of making these shapes in PEEK will be different than their low-heat counterparts, but it can be done. PEEK can also offer design options that are not possible with metal and

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Stryker’s success with its Mako robot-assisted surgery

ore than five years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way bringing robotplatform has other orthopedic device companies hastening assisted surgery to the orthopedic space. The Kalamazoo, Mich.–based orthopedic device giant has already placed more than 650 Mako to enter the space. The big question is whether long-term robots around the world, with more than 76,900 knee and hip replacement procedures performed in 2018 and outcomes will justify the expensive technology. double-digit growth in installations expected in 2019. In the process, Stryker has also grabbed share in a knee surgery devices and implants market that was previously static, according to SVB Leerink analyst Richard Newitter. “We’ve never seen any one company engender CHRI S N EWMARKER market share swings in the order of magnitude Stryker MAN AGI N G EDI TOR has in the last three years, and a good chunk of it is about robotics,” Newitter told Medical Design & Outsourcing recently. “If you use a Stryker robot, you have to use the Stryker knee. … It’s a Trojan horse.” Stryker’s big competitors — Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew — are taking notice: They’ve either launched or are preparing to launch their own robots. There’s little long-term data, though, on whether a $1 million robot such as Stryker’s Mako improves outcomes and reduces overall healthcare costs. Stryker officials suspect the short-term benefits they’re seeing, such as improved readmission and reoperation rates, are a good sign. “If you see patient satisfaction and less pain, that’s a good indicator. So all the right indicators that we look for as an industry are in our camp,” Robert Cohen, VP of global R&D and CTO at Stryker Joint Replacement, told MDO. Newitter, for one, is optimistic, and he thinks Stryker’s Mako so far is farthest along with best-in-class technology. “My sense is we’re on to something here as an industry,” Newitter said.

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Mako total knee surgery system images courtesy of Stryker

ORTHOPEDIC ROBOTICS

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The Mako difference There are levels when it comes to computer-assisted surgery. There’s the preoperative data modeling and planning. Software and displays can assist the surgeon with navigation during the surgery. “Looking at information preoperatively and intraoperatively would rely on a lot of different inputs. This is where robotics comes into play,” Cohen said. After acquiring Mako in 2013, Stryker launched a total hip replacement tool in 2015 and a total knee arthroplasty application in 2017. Cohen went through the steps of how the Mako system improves total knee replacement for someone with arthritis pain: 1. The system takes a CT scan of the patient’s knee and converts it into

a three-dimensional model of the knee joint, the femur, the tibia, and even the surfaces that the arthritis has damaged. 2. The surgeon with his or her own preferences can then preoperatively plan the best location of a femoral component and tibial component over the model bone, based on factors including patient size, angle of legs, location of articulating services, and how the femur moves on top of the tibia. 3. The health provider team then loads the plan onto the robot. The surgeon in the operating room compares the plan to the individual patient’s motion — bending the knee, flexing, straightening it out,

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ORTHOPEDIC ROBOTICS

R O B O T- A S S I S T E D S U R G E R Y I S A B I G D E A L I N O R T H O : H E R E ’ S H O W I T ’ S A F F E C T I N G C O N T R A C T M A N U FA C T U R E R S ROBOT-ASSISTED SURGERY IS A GAME CHANGER, NOT ONLY FOR ORTHOPEDIC DEVICE COMPANIES BUT THE CONTRACT MANUFACTURERS SERVING THEM. FOR MAJOR SUPPLIER TECOMET, IT MEANS FORGING RELATIONSHIPS EARLIER, SOMETIMES TIGHTER INSTRUMENT TOLERANCES — AND MUCH MORE.

Chris Newmarker | Managing Editor |

Barry Parker | Te c o m e t |

It makes sense that Tecomet officials would see the rise of robot-assisted surgery in the ortho space as a big deal. The Wilmington, Mass.–based company touts itself as the largest supplier to the OEM orthopedic marketplace in the world, with about 17 locations and more than 3,000 employees globally. Tecomet counts all of the major companies in the space as its customers, including Stryker, DePuy Synthes, Zimmer Biomet and Smith & Nephew. Tecomet makes surgical implants, instruments, delivery systems, cases and trays, and much more. The company’s work has shifted in recent years toward supporting new robot-assisted surgery systems, including Stryker’s best-selling Mako robots. Barry Parker, Tecomet’s SVP of design and development/innovation, recently discussed the changing landscape with Medical Design & Outsourcing: MDO: We’re seeing robot-assisted surgery becoming more common in knee, hip and spine surgery. How does that affect a contract manufacturer in the ortho space such as Tecomet? Parker: We haven’t seen this as a particularly disruptive technology compared with what we provide in traditional manual instrumentation, but it’s more of a manufacturing adjacency, because we provide both services to the OEM customers. This is still a capability that is in our wheelhouse. Some of the specific process capabilities that are required are a little different than we use to support the traditional orthopedic instrumentation, and because of that, we’ve structured and invested a little bit around that difference as we set up for this. MDO: Tell me more. What is the difference? Parker: We followed the robotic surgery market for a number of years prior to it making its way into ortho. We’ve been supplying companies in the surgical robotics space for probably seven or eight years. The biggest difference really comes in terms of dimensional schemes and tolerancing. Anytime

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you have a multilevel assembly, you have to design to eliminate tolerance overlaps to make it work. Since this is a very precise type of a surgical procedure, all of your tolerance goes away. These are a lot more demanding tolerance schemes. That’s predominantly what we see. Also, some of the end effectors, the jaws, if you will, and so forth, are a lot smaller scale in terms of manufacturing, so it’s more precision machining than just machining. For instance, if we’re talking a standard orthopedic instrument, what would be considered a tight tolerance is plus or minus two-thousandths [of an inch], for instance. On a robotic instrument, that might be two ten-thousandths [of an inch], so it’s sometimes a scale of magnitude different from what traditional instruments are. What that causes you to do from a manufacturing process standpoint is rather than milling a feature, you would probably grind that feature. You’re still creating the same geometry, but you’re using a different manufacturing process to create that geometry. Not all components have extremely tight tolerances. It really just depends on the role the component plays within the robot. We also are involved in producing a fair amount of product located further upstream within the robot, beyond just the functioning instrument end. We produce things like housings and pivots that the robot arms work from. MDO: When did you notice robotics moving into the orthopedic space? Parker: We noticed that entry around four to five years ago, probably first with the Mako launch [by Stryker]. I think as technology has evolved through the orthopedic market, our challenge has been gaining early-stage project involvement to better leverage how we can add the most value. A lot of the technology has come to our OEMs through acquisition and, as a result, there was not a lot of opportunity to collaborate on design, which we always like to have the chance to do, so that the components can be produced most cost-effectively. But it’s understandable why it’s gone the way it went.

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ORTHOPEDIC ROBOTICS

(CONTINUED) MDO: Have you had to bring on new expertise and capabilities to better serve the shift toward robotics? Parker: We have been fortunate as Tecomet had made some key acquisitions over the last five to six years which helped to support this robotic market opportunity. A few of our facilities were already supplying into the computer-assisted, endoscopic and arthroscopic instrument markets, which do translate well into a robotic surgical instrumentation manufacturing capability, and we have since invested further in advanced manufacturing technology such as precision grinding to better serve our customers in this market space. We also actually created a new structure and strategy, commercially segmenting out what we term as “Advanced Surgical,” which includes robotics.

Mako total knee surgery system images courtesy of Stryker

MDO: Overall, how do Tecomet officials view the rise of robotics in orthopedic surgery? What’s real and what’s hype from your standpoint? Parker: We view the rise of robotics in orthopedics as a very real event. It’s hard to dispute that the robotic approach delivers

all while looking at how the motion is replicated on the robot’s screen. Based on whether ligaments are lax or tense, the surgeon might tweak component positioning by fractions of millimeters before locking in the final plan.

a higher level of precision versus a manual approach when doing arthroplasties. But you do have to take into consideration the expertise of the surgeon performing the manual approach as to whether it really provides a significant advantage. There is obviously a lot of industry discussion going on around the actual degree of improved clinical outcomes, because I’m sure, as you talk to people, it’s too new to really see whether it’s going to improve outcomes over time, and it’s a pretty high cost of capital equipment for the hospital or surgical center. But there’s definitely an advantage and we certainly see it as real. It also seems to be fully supported by financial markets. They’re behind it. Our customers are responding. From a Tecomet perspective, we’ve both structured and invested in being well-positioned to grow in the business around this whole robotic orthopedic surgery approach and try to be in the best position to support all of our OEM customers participating in the market. We don’t think it’s hype, and we definitely see that it’s got legs. It definitely provides some salient advantages, so we’re structured to capitalize on it. M

4. The Mako robot arm will lock the plane of its saw blade into a place relative to the position of the final three-dimensional plan — and assists the surgeon with performing the cuts. The surgeon actually pushes the saw, but the robot limits where the saw can go in space. “The surgeon still performs surgery, but now with an accuracy and precision specific to a plan, specific to a patient that we could not do before with conventional, manual instruments,” Cohen said. The robot’s haptic boundary prevents soft-tissue www.medicaldesignandoutsourcing.com

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trauma, according to Cohen. He said Stryker has about 100 peer-reviewed publications on the Mako’s shortterm benefits, including reduction in post-operative pain, increased patient satisfaction, increased flexion, less opioid drug use, reduction in length of stay, and fewer readmissions due to complications from the procedure. Even as more knee replacement surgeries move from hospitals to outpatient surgery centers, Cohen thinks the Mako robot’s benefits will justify its price tag — which company officials in the past have said was about $1 million. The majority of Mako robots are in hospitals, but they are going into outpatient centers, too, he said. “Because the outcomes are going to get measured on Medicare databases, on joint registries, outpatient surgery centers have to perform equal or better than the hospital environment. They can’t take a step back,” Cohen said. 5 • 2019

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Zimmer Biomet’s Rosa robot-assisted total knee surgery platform won 510(k) clearance for knees in January and for spine in March. It includes 2D X-ray and 3D pre-operative planning tools, allowing surgeons to conduct virtual procedures ahead of the actual surgeries. The Rosa system also provides real-time intraoperative data on soft tissue and bone anatomy, the company says. Zimmer Biomet acquired the initial Rosa technology through its roughly $132 million purchase of French robot-assisted surgery firm Medtech in 2016. Smith & Nephew spent $275 million in 2016 to acquire Minnesota-based Blue Belt Technologies and its handheld Navio system, adding a

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total knee arthroplasty application to Navio in 2017. In March, it announced the purchase of Brainlab‘s orthopedic joint reconstruction business, with plans to install Brainlab’s hip software onto its currently-in-development Navio 7.0 software.

The surgeon still performs surgery, but now with an accuracy and precision specific to a plan, specific to a patient that we could not do before with conventional, manual instruments. •

•

Globus Medical announced in December 2018 that it had installed its ExcelsiusGPS robotic guidance and navigation system in several European countries. The company said health providers had performed numerous open and minimally invasive spine procedures with the system. Medtronic in December 2018 closed on its $1.7 billion purchase of Mazor Robotics and its robotassisted surgery platform for the spine, launching its Mazor X Stealth platform in the U.S. a month later. (see sidebar, pg. 46) NuVasive put its Pulse integrated navigation platform on display at the North American Spine Society’s annual meeting last year. SVB Leerink’s Newitter said at the time that Pulse was a “step in the right direction,” but added that “it still feels like the company is behind on the robotics front.” FDA cleared Pulse as a spinal surgical automation platform in 2018.

Orthopedic surgeons are paying attention to robotics, and all the companies are starting to realize that, Newitter told us. “Even if not necessarily proven to be better medicine, you can’t afford not to have an answer to robotics,” he said. “There’s a strategy now where having a robot is better than not having a robot.” Helping hospitals introduce robotics for the first time is about more than

Mako total knee surgery system images courtesy of Stryker

Competition heats up Stryker’s competitors, however, appear to see an opening with the shift toward outpatient. Perhaps there will be demand for more affordable robots. Last year, for example, J&J’s DePuy Synthes bought Paris-based Orthotaxy, which is expected to launch an orthosurgery robot in 2020. A prototype displayed at the American Academy of Orthopedic Surgeons conference in March was the size of a shoebox, attaching to an operating table. “There are no blocks required. There’s no pinning required. We saw this as what the world actually needs. This is bed-mounted. It’s not a huge device that sits on the floor,” Liam Rowley, VP of R&D for knees at DePuy, told MDO. The Orthotaxy robot will be much smaller and less expensive than surgical robots currently on the market. Because the Orthotaxy robot will not require surgeons to use disposable instruments, it can save from $1,500 to $2,500 per procedure, according to Rowley. “It’s smaller. It’s actually quicker,” Rowley said. “There’s no CT required. In terms of world healthcare costs, this is not upping the cost that somebody has to bear to get standard of care. There’s a per-procedure reduction in costs.” Other major orthopedic device companies are also making moves into the space:

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ORTHOPEDIC ROBOTICS

M E D T R O N I C H A S B I G P L A N S F O R R O B O T- A S S I S T E D SPINE SURGERY OFFICIALS AT THE WORLD’S LARGEST MEDICAL DEVICE COMPANY THINK THEIR MAZOR X STEALTH ROBOTASSISTED SPINAL SURGICAL PLATFORM COULD MOVE COMPLEX PROCEDURES FROM AN ART TO A SCIENCE.

Chris Newmarker | Managing Editor |

Dave Anderson | Medtronic |

Medtronic is betting that robot-assisted surgery could be a game changer when it comes to spine surgeries. The company late last year closed on its $1.7 billion purchase of Mazor Robotics and its robotassisted surgery platform for the spine. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S. The Mazor X Stealth combines robotic guidance system technology from the Mazor acquisition with Medtronic’s StealthStation surgical navigation technology. Dave Anderson, VP and general manager of enabling technologies at Medtronic, recently spoke with Medical Design & Outsourcing about how the Mazor X Stealth could greatly improve spine surgery outcomes. MDO: Why is it important for Medtronic to compete in the robot-assisted orthopedic surgery space? Anderson: It’s really about improving outcomes. If you take spine in particular, for example, you can see over the past decades that it hasn’t been as predictable as we want. It’s complex. So how do we move complex procedures to be really predictable, moving them from art to science? How do we simplify them? All those things are what robotics can bring us. … In many procedure types, and spine being a classic example, there’s been a lot of innovation, but outcomes aren’t where we need them to be.

[StealthStation] navigation brings is the ability to confirm along the way that you are doing exactly what you intended to do and to visualize that. … That combination is what improves outcomes. MDO: What is the surgeon doing in the procedure versus the robot? Anderson: Today, what the robotic portion is doing is setting up the trajectory so you have an end effector on the robot that moves to the preplanned position and creates a trajectory that the physician can then place a pedicle screw through to ensure that it’s going in the right location, the right angle, and by combining with navigation, you’re able to visualize the pedicle screw on the screen to show it’s going to exactly the right location and depth. Then the robot will automatically move to the next position, and you’ll be able to move from position to position and execute all the pedicle screw placement that was planned. Down the road we’ll incorporate more pieces of the procedure such as interbody placement, bone cutting, etc. to also be robot-assisted. MDO: How does this guarantee consistency of the procedures? How is that able to happen? Anderson: So let’s start with a deformity case, one of our complex procedures. You have the correction that you’re looking to achieve, and you need to know, “Where do I precisely place these screws and rods so that it straightens the spine to achieve the

MDO: Medtronic’s Mazor X Stealth system — how is it able to, as you said, move complex procedures from an art to a science? Anderson: Prior to even going into the procedure, you can look at the construct, look at what your goal is, plan precisely where you want to place your screws, how your rod is going to be oriented to achieve the biomechanics that you’re looking for. And then in your procedure, you execute that plan with robotics. So now you have the precision to know you’re exactly performing the plan as intended to get the outcomes you were striving for. That’s the robotics side. What

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ORTHOPEDIC ROBOTICS

(CONTINUED)

outcome I want?” And you’re actually able to look at the forces that would cause the actual correction that would be achieved, and so from a computerplanning perspective you’re pre-deciding what’s going to happen and the outcome that will occur. Then you execute that plan robotically. In an open procedure, imagine that you’re doing that same thing, but you don’t have a plan. You’re just in a sense visually looking at the patient and making decisions on a level by level basis that your experience and history would leave you to believe would come to a certain outcome, but there’s much less certainty and predictability as when you create that plan in advance and then execute it. MDO: What kind of evidence have you been able to gather so far to demonstrate that this is an improvement postoperatively over what was done before? Anderson: We’re still early in our evidence. … We just launched the Stealth Edition. What I can say is from prior generation products, including the [Mazor X guidance system and the Renaissance robotassisted spine surgery device] before that, we do have publications, peer-reviewed, that talk about pedicle screw accuracy and show the significant improvement in the accuracy of placement versus in freehand. One of the publications also shows a six times risk reduction in the need for revision surgery. So the risk of revision surgery has been reduced sixfold. … With the Stealth edition, because we just launched it, we have prospective studies planned. Over time we’ll be able to publish even stronger outcomes. If I were to look at our roadmap for the future, for example, we have a goal of reducing OR time by 40%, and that’s something that we plan to study and publish. … Our goal is to have a range of study types.

required. Disc removal is another example, again depending on the procedure. So as we think about the future, it’s really about how do we look at all the steps for all the procedures, where can we add the most value, where can we move from unpredictable to predictable and really save time and improve outcomes for our physicians? MDO: A robotic system can be pretty expensive. How do the economics work for health providers? Anderson: It’s a high-cost capital item. That being said, if we look at the goal of reducing OR time by 40% or we believe we can reduce total procedural costs across all the steps by 10%, you can start to pretty quickly look at the reimbursement levels of spine, the cost of those procedures, the quantity of procedures performed. You can see how it can drive economics pretty quickly with that once you’re able to utilize at the levels we’re looking to utilize. MDO: How much interest are you getting in the Mazor system? Anderson: Interest is really high. Because we’re early in adoption, there’s still a minority of total centers that have this equipment. There’s very high interest, but … many that are evaluating right now when they’ll move with a robotic system. So very high interest, still early in the adoption curve in terms of how many centers currently have a robot. M Images courtesy of Medtronic

MDO: So where do you want to take this next? Anderson: Our next big step is how do we make each of these steps work seamlessly together, work better together when you use the whole ecosystem. That’s the whole strategic focus for us. We have a broad swath of procedures that we support even today. But how do we improve specific steps of the procedure using robotics? And that’s where we can talk about more of our future features. I mentioned bone-cutting as an example, so that’s a procedural step and depending on the procedure you may have more or less bone-cutting

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ORTHOPEDIC ROBOTICS

just selling a robot, according to Stryker’s Cohen. It’s about setting up a training program, medical education, increasing satisfaction rates and more. “If you accept what I say on soft tissue protection and the saw blade not going into tendons and ligaments, there’s no other robot coming on the market that has that capability,” he said of Mako.

There's no CT required. In terms of world healthcare costs, this is not upping the cost that somebody has to bear to get standard of care. There's a perprocedure reduction in costs. An expensive fad? Still, there’s skepticism in the orthopedic device industry about robot-assisted surgery. Stryker and other big ortho players turned to robotics because it gave them a competitive edge based on their size, since the systems are expensive to develop, explained Doug Kohrs, the former Tornier and American Medical Systems CEO and a serial entrepreneur in the ortho space. Kohrs suspects that the enthusiasm for robotics in ortho surgery could be short-lived, due to be supplanted by an emerging technology. In two to three years, he said, patientspecific implants produced from surgical planning data – combined with computer-assisted navigation – could provide a more economical alternative. “When you start putting that implant down the femur [if it’s a hip] or the humerus if it’s a shoulder, once you start it, since it matches the patient, you’re not going to get it out of alignment,” Kohrs said. “You do not need a robot to control the alignment of the implant because it can’t go anyplace other than the right place.” And even at the relatively low price of $500,000, robots are still big-ticket items for increasingly cost-conscious healthcare providers. “It’s not a criticism of robotics. It’s just acknowledging that there’s a better way to do it than robotics that’s more costeffective,” Kohrs said. Cohen counters that Stryker’s Mako allows for new ways of positioning implants that older manual instruments can’t achieve. Perhaps more important, he said, are the digital capabilities Stryker can layer on the top of the technology. “It’s all about writing new software. It’s all about different user information. It’s about new applications,” he said. “We will get into the world of predictive analytics and the things that we never could’ve conceived of before without a robot.” M Senior editor Nancy Crotti contributed to this report.

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The

co 10. ConMed – Orthopedic Surgery 2018 revenue: $446.7 million ConMed saw its domestic orthopedics revenue grow 4.5% in 2018, with international orthopedics revenue up 3.5% year-over-year. Orthopedic products generating excitement at the Utica, N.Y.–based company include its MicroFree cordless small-bone power system, CEO Todd Garner said during a January earnings call transcribed by Seeking Alpha. The MicroFree cordless, battery-powered, pencilgrip instruments for small bone are meant to provide the freedom of cordless for ortho surgeons while still delivering the necessary power. 50

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CHRI S N EW MAR K ER MAN AG I N G ED I TO R

largest orthopedic device companies in the world

Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies. Here’s what is new among the 10 largest companies in the medical device industry’s ortho sector.

9. Orthofix Medical 2018 revenue: $453.0 million

8. Wright Medical 2018 revenue: $836.2 million

Orthofix Medical stock fell by nearly a fifth in value in late February and early March after the Lewisville, Texas– based company failed to meet Wall Street analysts’ expectations for its fourth-quarter and 2018 sales. The company had some good news in recent weeks, however. People implanted with Orthofix’s M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality-of-life scores, according to an investigational device exemption (IDE) study.

Wright Medical used the American Academy of Orthopaedic Surgeons show in Las Vegas in March to tout its Revive revision shoulder system. The Revive system includes specialized extraction instruments for implant removal and a unique humeral prosthesis for joint reconstruction. Memphis-run Wright plans a U.S. launch of Revive in the first half of this year.

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ORTHOPEDIC COMPANIES

S U M M I T

E X P O 7. NuVasive 2018 revenue: $1.102 billion

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NuVasive’s stock jumped about 17% in value, to around $58 per share, in early February after media reports that Smith & Nephew was in talks to acquire the minimally invasive spine product maker. NuVasive’s stock price settled down a bit in March, though, after Smith & Nephew agreed to spend $660 million to acquire Osiris Therapeutics. “NuVasive delivered strong year-overyear revenue growth of more than 7% in 2018, demonstrating the company’s ability to take share in a stable but relatively flat U.S. spine market,” CEO Chris Barry said in a February earnings release. “Additionally, we made significant progress at our West Carrollton manufacturing facility, exiting the year at 70% SKU rationalization,” Barry said. “Collectively, these achievements serve to advance our mission to bring disruptive technology to surgeon partners to enable better, more predictable patient outcomes.” NuVasive recently announced the U.S. launch of its X360 system, intended for lateral single-position spine surgery.

6. Colfax Corp. – DJO Global 2017 revenue: $1.186 billion Colfax Corp. in February closed on its $3.15 billion acquisition of DJO Global – the Dallas-based maker of knee, shoulder and hip implants, joint and spine bracing, and much more. “They are a clear leader with a strong history and an attractive potential for future growth and margin improvement,” CEO Matt Trerotola said in a news release. DJO used the AAOS show in Las Vegas in March to introduce its Adaptable surgical arm, which it touted as the first fully sterile, surgeon-controlled leg and retractor holder designed for direct anteriorapproach total hip arthroplasty.

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ORTHOPEDIC COMPANIES

5. Medtronic Spine 2018 revenue: $2.7 billion Medtronic in December 2018 closed on the $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine. A month later, it launched its Mazor X Stealth robot-assisted spinal surgical platform in the U.S. Medtronic officials expect Mazor X Stealth to help grow the company’s neurosurgery business and create demand for spine implants, CEO Omar Ishrak said during a February earnings call. “We’ve received early enthusiastic feedback for this combination of best-in-class robotics and navigation capability.” Ishrak mentioned strong capital equipment sales supporting Medtronic brain therapies growth. “As we execute more of these contracts, we would expect our core spine implant sales to grow over the coming quarters,” he said. Fridley, Minn.–based Medtronic runs its spine division out of Memphis.

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4. Smith & Nephew – Sports, Trauma & Reconstruction 2018 revenue: $3.629 billion Smith & Nephew’s knee implants business grew 3%, to more than $1 billion in 2018, and its hip implants business was up 2% to $613 million. Officials at Smith & Nephew are excited about the company’s dual-mobility technology for hip implants, which they say protects against dislocation without compromising the device's range of motion, CEO Namal Nawana said during a February earnings call. London-based Smith & Nephew used the AAOS meeting in Las Vegas in March to introduce Navio 7.0, the latest software for its hand-held robotic surgical system. Expected to launch during the second half of 2019, the Navio 7.0 will include a new intuitive interface, expanded surgical preferences and streamlined workflow that may reduce surgery time. It’ll include hip software acquired through Smith & Nephew’s purchase of Brainlab’s orthopedic joint reconstruction business. “We are a very relevant part of the overall robotic placements and units in the world today,” Nawana said of Navio. Smith & Nephew in recent years has bolted on new technologies through acquisitions, including Rotation Medical and its regenerative shoulder repair treatment, and Ceterix Orthopaedics and its NovoStitch Pro knee repair device.

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ORTHOPEDIC COMPANIES

3. Zimmer Biomet 2018 revenue: $7.9 billion

2. J&J – Orthopedics 2018 revenue: $8.9 billion

Zimmer Biomet is in its second year of a two-year restructuring effort to boost competitiveness under CEO Bryan Hanson, the Medtronic EVP who took the reins at the Warsaw, Ind.–based ortho device giant in late 2017. About 70% of Zimmer Biomet’s leadership team is new to the job, Hanson said during a February earnings call. Backorders are down, and the company is executing a remediation plan at its Warsaw North Campus in communication with the FDA, Hanson said. Zimmer Biomet also achieved some important clearances from the government watchdog. In October 2018, the agency granted 510(k) clearance for the Persona customized revision knee implant. Early this year, Zimmer Biomet won clearance for the Rosa robot-assisted total knee replacement surgery platform, followed by clearance for the Rosa One robotic spine system. There is also Mymobility, Zimmer Biomet’s new patient care management app for the Apple Watch and iPhone. Zimmer Biomet lost $379.2 million off $7.93 billion in sales in 2018. The company also suffered a legal loss in late 2018 when a federal appeals court affirmed Stryker’s enhanced $248 million win against Zimmer Biomet in a surgical tool patent case. “Overall, our financial results for the full year were in-line with our expectations for the progress of the turnaround of the business, and increase our confidence in achieving our 2019 objectives,” Hanson said in a news release at the time.

Johnson & Johnson’s orthopedic device sales were down 1.9% to $8.9 billion in 2018, according to the company’s annual report. The shrinking business was partly due to J&J selling its Codman Neurosurgery business — maker of spinal cord and cranial repair products — for more than $1 billion to Integra LifeSciences in 2017. J&J also saw a decline in sales of products for knee procedures, due to competitive pressures in the U.S. At the same time, New Brunswick, N.J.–based Johnson & Johnson has been introducing new products related to the hips and spine. New spine products include the Concorde Lift expandable cage and the Viper Prime system for minimally invasive surgery. During a January earnings call, investor relations VP Chris DelOrefice also touted continued strong demand in the hip products sector for the primary stem Actis. Surgeons can implant the Actis total hip system through tissue-sparing approaches, such as the anterior approach, as well as traditional approaches, according to J&J and its DePuy Synthes Cos. Johnson & Johnson is also developing robot-assisted orthopedic surgery platforms after acquiring French robotassisted surgery company Orthotaxy in 2018. The Orthotaxy robot will be smaller and more affordable than surgical robots currently out there, Liam Rowley, VP of R&D for knees at DePuy, told Medical Design & Outsourcing recently.

1. Stryker 2018 revenue: $13.6 billion The world’s largest orthopedic device company is enjoying momentum at the start of the year. Stryker’s bottom line more than tripled to $3.6 billion in 2018, and sales were up 9.3% to $13.6 billion. Stryker officials see the company bolstering its position in the spine market as it integrates K2M, which the company acquired for about $1.4 billion in November 2018. Kalamazoo, Mich.–based Stryker also expects double-digit percentage growth in the number of Mako systems for robot-assisted knee and hip surgery implanted this year, said Katherine Owen, Stryker’s VP of strategy and investor relations, speaking during a January earnings call.

SVB Leerink analysts wrote during the AAOS annual meeting in March that Mako remains best-in-class in an expanding category: “We continue to hear from docs that if one wants a true robotics platform, Mako is the way to go.” Stryker also used AAOS to introduce a redesigned ReUnion S humeral stem for shoulder arthroplasty, and Stryker’s trauma and extremities division launched Adapt for Gamma3 augmented reality software. The company also continues to snap up new technologies, announcing in March that it was offering $220 million for OrthoSpace and its InSpace rotator cuff repair device.

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Orthopedic products from

2019 you need to know

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas was abuzz about robotics — and much more.

NA NC Y C R OTTI SENIO R ED ITO R

Medical Design & Outsourcing

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tryker’s Mako platform may be “best-in-class,” but robotassisted surgery proved to be an expanding category at this year’s AAOS meeting, according to SVB Leerink analysts. Other major orthopedics companies used the March meeting to introduce new robot-based offerings or tout updates to existing ones. Another hot topic at this year's AAOS gathering was the trend toward performing orthopedic procedures in outpatient/ambulatory surgery centers. Ortho device companies, in fact, are positioning themselves to better serve these lower cost-of-care settings. In contrast to hospitals, outpatient/ambulatory surgery centers require greater OR efficiency, more sensitivity to equipment costs and the requirement for quicker patient discharge. Here are some examples of what ortho device companies touted at the meeting:

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AAOS 2019

Early this year, Zimmer Biomet won clearance for the Rosa robotassisted total knee replacement surgery platform.

Zimmer Biomet: Robotically assisted knee replacement Zimmer Biomet showed off its Rosa robot-assisted total knee replacement surgery platform, cleared in January by FDA. The newly cleared Rosa system includes 2D X-ray and 3D preoperative planning tools and real-time intraoperative data on soft tissue and bone anatomy, allowing surgeons to conduct a “virtual knee replacement” with predictive outcomes of balance and implant placement before performing any cuts. In addition to helping surgeons improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.– based company said that the Rosa system includes the ability to analyze data for better post-operative long-term outcomes.

Zimmer Biomet's Mymobility app connects joint surgery patients with their care team before and after surgery.

More from Zimmer Biomet: An Apple Watch app Zimmer Biomet recently launched a clinical study of Mymobility, its new patient care management app for the Apple Watch and iPhone. The platform is designed to help patients prepare for hip or knee replacement surgery, allowing them to connect with their surgeon and care team before and after the procedure, receive reminders for tasks to complete and encouragement throughout the process. Patients may also share photos with their care team, such as a snapshot of the surgical incision site for a healing assessment. The app collects and monitors objective data about patients' surgical preparation and recovery to help surgeons deliver better support and guidance, according to the company.

Image courtesy of Zimmer Biomet

Smith & Nephew: New robot-assisted surgery software London-based Smith & Nephew offered a preview of Navio 7.0, the latest software for its hand-held robotic surgical system. Smith & Nephew designed Navio 7.0 to improve the surgeon experience through a new intuitive interface, expanded surgical preferences, and streamlined workflow that may reduce surgery time over the previous version. The new software could be available in the second half of 2019. The company also said it plans to introduce a nextgeneration Navio system and handpiece in 2020. It will be smaller than the current device and CT-free, which will enable its incorporation into the company's sports medicine tower and make it more usable in ambulatory surgery centers. Smith & Nephew added that its research & development program is looking to add augmented reality, as well as stand-alone robotic arms and machine learning, to its platform. The company plans to open a new R&D and education center focused on robotics in Pittsburgh. Stryker: A better humeral stem? Stryker introduced a redesigned ReUnion S humeral stem to improve bone preservation, alignment and stability in shoulder arthroplasty. Certain humeral short stems have been associated with unacceptably high rates of malalignment, loosening, shortening, increased proximal bulk and other adverse bone reactions, according to a statement from the Kalamazoo, Mich.–based company. Stryker says the new humeral stem is "more anatomically relevant." The company did some internal studies and determined that the ReUnion S:

Stryker's ReUnion S humeral stem

Image courtesy of Stryker

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AAOS 2019

• Preserves more bone mass proximally and distally compared to competitive stems. Keeping the wedge shape proximal body may give the user better soft-tissue management rather than limiting it by the stem design. • Improves alignment to avoid varus/valgus placement of the stem. • Boosts stability because the enhanced medial sweep of the stem avoids distal engagement while the alignment focuses length. Incremental distal sizing options prevent canal migration. The S stem is designed to retain the alignment and stability benefits of a longer humeral stem prosthesis. More from Stryker: Augmented reality software, new nailing system Stryker's trauma and extremities division launched Adapt for Gamma3 software and the T2 Alpha nailing system. Adapt for Gamma3 uses augmented reality to project 3D-based measurements on patient X-rays. The software may eliminate the need for certain hardware instrumentation while enabling surgeons to guide implant alignment, lag screw length determination, lag screw positioning and distal targeting, a company statement said. T2 Alpha implants are designed to adapt to diverse intraoperative needs, addressing varying patient anatomy. T2 Alpha also has an advanced locking screw option for added axial and angular stability. It limits relative motion between the nail and screw, allowing surgeons to provide additional nail stability when needed, according to the company.

Stryker's Adapt for Gamma3 software uses augmented reality to project 3D-based measurements on patient X-rays. Image courtesy of Stryker

Wright Medical: Giving surgeons more tools for shoulder revisions Wright Medical showcased its new Revive revision shoulder system, which provides surgeons with specialized extraction instruments for implant removal and a unique humeral prosthesis for achieving successful joint reconstruction. The Revive prosthesis was designed to simplify humeral reconstruction and optimize stability and function by giving the surgeon independent control over implant fixation, height and rotation. Amsterdambased Wright expects to launch Revive in the U.S. in the first half of this year. Image courtesy of Wright Medical

“Shoulder surgery volumes have doubled in the last 10 years, and we believe we are approaching an inflection point for revision surgeries," Wright Medical president and CEO Robert Palmisano said in a prepared statement. "The upcoming launch of our Revive revision shoulder system is a significant new product launch for our shoulder business and highlights our ability to help physicians address this segment of the shoulder market, which is growing at approximately twice the primary shoulder replacement market.” www.medicaldesignandoutsourcing.com

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AAOS 2019

DJO Global: An adaptable surgical arm for total hip arthroplasty. DJO Global (Vista, Calif.) introduced its Adaptable surgical arm at AAOS. Billed as the first fully sterile, surgeon-controlled leg and retractor holder designed for a safe direct anterior approach (DAA) total hip arthroplasty (THA), the fullymechanical, carbon fiber surgical arm is designed to work seamlessly with any standard operating table and has the potential to reduce the number of assistants needed in the operating room, according to the company. DAA is the fastest growing THA approach, representing approximately 40% of all hips being done in the U.S., according to a 2018 poll of the American Academy of Hip and Knee Surgeons. DJO designed the Adaptable surgical arm as an alternative to large, heavy, costly and difficult-to-store specialty surgical tables introduced in the early 2000s to assist with patient positioning and exposure during the DAA procedure. The tables also require specially trained personnel to operate them and may not be an option for many hospitals and surgery centers, the company said. The Adaptable surgical arm weighs about 10 lbs., is less expensive than a specialty table and may be easily transported between hospitals, DJO added. It may be used for retractor placement or leg positioning for femoral exposure, range of movement and leg length assessment.

DJO Global’s Adaptable surgical arm for direct anterior approach total hip arthroplasty. Image courtesy of DJO Global

Kyocera Medical Technologies expects FDA clearance for its Aquala acetabular liner this year. The Aquala liner is partially visible in this photo of the Initia total hip system.

Kyocera Medical Technologies: Acetabular joint liner tech with 'ceramic-like' wettability Kyoto, Japan-based Kyocera Medical Technologies touted its Aquala acetabular joint liner technology as having “ceramiclike” wettability in highly crosslinked ultra-high-molecularweight polyethylene (UHMWPE) for improved wear. Kyocera said it designed Aquala to create an exceptionally low-friction bearing surface on the acetabular side of the hip joint, which couples with diamond-polished ceramic on the femoral side. The company developed the technology with the University of Tokyo to reduce wear debris and extend the life of artificial hip implants. Hip joints using Aquala technology have been used in approximately 45,000 total hip replacements worldwide. FDA has them under review, with 510(k) clearance expected this year.

OrthoSensor’s Verasense enables surgeons to quantify ligament balance and customize implant position.

OrthoSensor: Two new sensors are in the pipeline OrthoSensor said it's working on MotionSense, a wearable sensor for patient data collection, and Shoulder Sensor, an intraoperative sensor for reverse shoulder arthroplasty. Neither is commercially available, and Shoulder Sensor hasn't received FDA clearance. But the Dania Beach, Fla.–based company had news about the performance of its Verasense sensor-assisted device cleared in June 2018 for use with Zimmer Biomet‘s Persona knee system during total knee replacement procedures. The Verasense device uses advanced sensors and wireless connectivity to analyze knee balance and improve outcomes, OrthoSensor said. "Our growing body of clinical evidence is proving that Verasense helps surgeons address soft tissue balance during TKA and improves patient-reported outcomes," said OrthoSensor president & CEO Ivan Delevic in a prepared statement. "Our results also demonstrate Verasense can save as much as $725 per patient by lowering variable of post-operative and post-acute care."

Image courtesy of Kyocera

Image courtesy of OrthoSensor

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AAOS 2019

Conformis: New customized hip system tops 200 procedures since July Conformis showed off its 3D-designed, customized total hip replacement system after announcing the first two procedures in July. Since then, more than 200 cases have been completed at some 20 U.S. sites, the Billerica, Mass.– based company said. Similar to the design process for the Conformis knee technologies, the company's hip system uses proprietary software to design, manufacture and deliver the implants and iJigs instruments. After each patient’s CT scan is converted into a 3-dimensional computer model, the unique measurements of that patient’s anatomy are transformed into a comprehensive, individualized, pre-operative surgical plan that is delivered to the surgeon in advance of the operation. Patient conforming, single-use, 3D-printed cutting guides are included in the patient-labeled kit, limiting the need for the many reusable instruments required for a standard, off-theshelf total hip replacement, the company said. “We have been very pleased with the feedback we have received over the past seven months from the participating medical advisory board surgeons and are excited to speak widely to the conference attendees about our new technology,” said Conformis president & CEO Mark Augusti. M

Conformis now offers custom hip systems with 3D printed cutting guides. Image courtesy of Conformis

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DEVICETALKS

DeviceTalks Boston: Here's why you should get excited There’s a lot to look forward to at DeviceTalks Boston, June 5–6 at the Seaport World Trade Center. Sarah Faulkner | Program Manager – D e v i c e Ta l k s |

ight years ago, DeviceTalks kicked off its inaugural event in Boston with a keynote interview featuring soon-to-be Covidien CEO Joe Almeida. A panel of nextgeneration executives included Abiomed chief Michael Minogue, Zoll’s Rick Packer and David Lucchino, then of Semprus Biosciences. And the recently installed director of the CDRH, Dr. Jeffrey Shuren, made a last-minute appearance. It’s safe to say that things have changed since then. We’ve grown

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DeviceTalks into a two-day educational forum designed to bring together engineers, commercialization professionals and medtech leaders to share the challenges and best practices of getting medical devices to the market. The program now runs three times a year in Boston, Minnesota and California. Here are some of the highlights that should make this year’s DeviceTalks Boston both exciting and useful for medical device industry insiders:

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DEVICETALKS

• A look inside the big companies’ device development process. Gearing up for our eighth year in Boston, we’ve turned to some of New England’s most interesting companies to bring attendees behind the scenes of the device development and commercialization process. Kevin Bourque, Abbott’s VP of R&D, will lead a session exploring the technologies within the global medtech firm’s heart failure portfolio. Boston Scientific’s VP of corporate research, David Knapp, will share how he has worked to address unmet clinical needs across divisions at his company. • New medtech companies worth following. Attendees will also hear from up-and-coming medtech companies, like Akili Interactive. This exciting group has developed a digital

therapy for ADHD that is delivered through a video game experience. Akili’s head of R&D, Jason Trees, plans to discuss how the company built this unique medical treatment. • Tackling emerging trends. My team has always focused on building content that aligns with emerging trends and technologies. That’s why at this year’s DeviceTalks Boston, we have panel discussions that will dive into topics such as building devices designed to tackle global healthcare challenges. We also have an all-star lineup of speakers that will share how they’re navigating medtech’s digital transformation. • Tapping into the local ecosystem. To ensure that we’re connecting DeviceTalks Boston attendees with

the best Massachusetts-based minds in medtech, we partnered again with the Massachusetts Medical Device Industry Council (MassMEDIC). The group will once again host its Investor’s Showcase featuring 25 local startup companies at DeviceTalks Boston. MassMEDIC has also put together a panel discussion highlighting healthcare robotics companies from Massachusetts — a perfect complement to our 66

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co-located sister event, Robotics Summit & Expo. • A leader in diabetes treatments. In keeping with the event’s signature component, we invited the leader of one of Massachusetts’ most exciting companies to come and share their work at DeviceTalks Boston in a live keynote interview. Shacey Petrovic, president and CEO of Insulet, started as the company’s chief commercial officer in 2015 and worked her way up to the corner office. We are thrilled that she will join us at DeviceTalks Boston to share her story and insights into Insulet’s tubeless Omnipod Insulin Management System. • Medtech’s leading voice in D.C. Attendees will also hear from AdvaMed president and CEO Scott Whitaker in a live keynote interview at DeviceTalks Boston. A leading voice in the medical device industry, Scott helps to shape government policies that affect every device company. At DeviceTalks Boston, he will give attendees an inside look at AdvaMed’s priorities for the coming year. • The whistleblower who helped expose Theranos. And to close out the event, DeviceTalks Boston is hosting a live interview with Theranos whistleblower and entrepreneur, Tyler Shultz. Tyler will bring attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Once the darling of Silicon Valley, Theranos collapsed after Shultz went public with his concerns about the company. The lessons learned from Theranos are of value to anybody working in the medical technology industry. We can’t wait to hear directly from the person at the center of this story. This is just a snapshot of what attendees can expect at DeviceTalks Boston. I can’t wait to share with you all of the great work we’ve been busy with behind the scenes for the last six months. I hope you’ll join me at DeviceTalks Boston on June 5–6! M

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Don't miss these speakers at DeviceTalks Boston 2019

DAVID KNAPP

VP Corporate Research; BOSTON SCIENTIFIC

SHACEY PETROVIC President & CEO; INSULET

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PRODUCT WORLD

RayVio touts new ultraviolet LEDs Health and hygiene company RayVio has started shipping its new XR 308nm Series UV LEDs, meant to support the development of phototherapy treatments for skin diseases. Available directly from Digi-Key as an emitter or pre-mounted on a star board to aid in development and product integration, RayVio’s new LEDs deliver 13 mW at 100 mA and are rated for up to 10,000 hours of continuous use. UV Treatment of psoriasis and vitiligo has been limited because of the size and cost of the equipment, as well as risk to surrounding tissue, according to Yitao Liao, chief innovation officer and co-founder at RayVio. “Excimer laser systems address the targeting of treatment to avoid damaging healthy skin, but the systems are bulky and very expensive. Our 308 nm UV LEDs are being put into compact, handheld devices that are portable,” Liao said in an April 11 news release. –CN RayVio Hayward, Calif. rayvio.com

KNF unveils FP 400 low pulsation diaphragm pump KNF Neuberger is touting its next-generation FP 400 low pulsation diaphragm pump, designed for recirculation applications in the medical device space and a host of other markets. The FP 400 incorporates the traditional advantages of diaphragm pump technology such as self-priming, the ability to run dry, and a long, maintenancefree lifetime under continuous-operation conditions. The FP 400, though, also has a pulsation level comparable to gear pumps, according to KNF Neuberger. Pulsation for the new FP 400 is less than 150 mbar, and the company said levels much lower are achievable, depending on system tubing hardness, tubing inside diameter and flow path length/configuration. –CN KNF Neuberger Trenton, N.J. www.knfusa.com

S.S. White Technologies touts its custom flexible shafts for medtech Officials at S.S. White Technologies say their bespoke flexible shafts can be useful in a variety of medical applications. Much like a solid shaft, flexible shafts transmit rotary motion. But it’s possible to curve a flexible shaft over, under and around areas in ways a solid shaft cannot. Flexible shafts have found uses in handheld flexible screwdrivers and flexible drills used in surgery, laparoscopic and endoscopic surgical equipment, robot-assisted surgery technology, and breast biopsy probes. In breast biopsy probes, for example, the flexible shaft drives a biopsy needle actuator that performs the collection of tissue. –CN S.S. White Technologies St. Petersburg, Fla. www.sswhite.net/medical 68

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PRODUCT WORLD

Richmar launches antimicrobial electrodes Richmar has introduced an anti-microbial electrode intended to prevent infection in users of electrotherapy devices. The MicroBlock electrode was designed to inhibit and kill the growth of common disease-causing bacteria as well as superbugs such as methicillin-resistant Staphylococcus aureus (MRSA) in people who use a transcutaneous electrical nerve stimulation (TENS) device in a hospital, rehabilitation or other healthcare setting. MicroBlock electrodes are effective against common bacteria on and around the “zone of inhibition” — the area directly surrounding and including the electrode, according to the company. –NC Richmar Chattanooga, Tenn. richmarweb.com

Getinge launches new surgical table in U.S. Getinge recently announced the U.S. launch of its Maquet Yuno II surgical table, which the company touts as a versatile option to support advanced orthopedic techniques. Officials at the Swedish medical device company think the table — with its multiple configurations supporting a variety of procedures — could also reduce the complexity of setup for trauma surgeries and neurosurgery. The table, according to Getinge, could save hospitals systems money because they no longer need to rely on specialty surgical tables. The Maquet Yuno II has interchangeable table tops that support multiple advanced configurations. –CN Getinge Gothenburg, Sweden and Wayne, N.J. www.getinge.com

Qosina touts multi-purpose, single-use hand instruments for procedure kits Qosina is touting its wide selection of single-use hand instruments that are designed to be used in procedure kits. The hand instruments are designed in a number of lengths, colors and distinctive style tips to be used in kit-packing. They are made from high-quality plastics and stainless steel to perform under tough conditions. Qosina says the single-use hand instruments require no maintenance, repair, sterilization or reprocessing fees. Since they are single-use, the company also says that crosscontamination is reduced with the added assurance of functionality. –DK Qosina Ronkonkoma, N.Y. www.qosina.com

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AD INDEX

Accumold................................................... 29 Altech Corporation.................................. 2, 3 Bay Associates Wire Technologies........... 17 Bird Precision............................................. 54 Cadence Inc............................................... 25 Carlisle Interconnect Technologies.......... 24 CGI.............................................................. 21 Clippard...................................................... 41 CPC - Colder Products Company............ 13 Eagle Stainless Tube.................................. 33 Evonik Performance Materials.................... 7 Fabco-Air, Inc............................................. 53 Green Hills Software.................................. 65 IKO International....................................... 32 Interpower.................................................. 61 Keystone Electronics Corp.......................... 9 Master Bond............................................... 49 MasterControl............................................ 45 Medbio, Inc................................................ 40 Memory Protection Devices..................... 11 MICRO Medical......................................... 16

Microlumen.......................................... 36, 37 MICROMO................................................. 28 MW Medical Solutions ............................. 48 New England Wire Technologies & New England Tubing Technologies.... 35 Nitto Kohki USA......................................... 49 Orchid Orthopedic Solutions................... 23 Renishaw..................................................... 57 Resonetics............................................ IFC, 4 Rotor Clip Company, Inc.......................... BC Schneeberger ........................................... 27 Smart Products USA.............cover/corner, 1 Solar Atmospheres.................................... 12 Sorbothane................................................ 20 Spectrum Plastics Group........................... 15 STEUTE Meditech, Inc............................... 19 TechBriefs Media....................................... 69 Tegra Medical.......................................... IBC The Lee Company..................................... 31 Ximedica..................................................... 63

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Jami Brownlee 224.760.1055 jbrownlee@wtwhmedia.com

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Bill Crowley 610.420.2433 bcrowley@wtwhmedia.com

Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029

LEADERSHIP TEAM Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

Medical Design & Outsourcing

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VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

5 â&#x20AC;¢ 2019

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CMY

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Rotor Clip 5-18.indd 56

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