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Articles of Interest

April 25, 2018 | The Quest to Solve Additive Manufacturing Challenges

By Rob Meyer

Orthopaedic device companies and their suppliers face a host of critical challenges when implementing and adopting additive manufacturing (AM), or 3D printing.

Companies of all sizes seek to ensure ROI with AM while simultaneously staying abreast of a convoluted, confusing and unclear regulatory path. AM users are constantly managing supply chain expectations, quality control, design considerations, purchasing decisions and much more. Despite these challenges, we believe AM brings transformational potential to the medical device industry.

The exciting future of the technology in the orthopaedic space cannot be understated.

What used to take weeks, or even days, to manufacture now only takes a matter of hours with the technological innovations of AM. Getting products to market sooner can add up to millions of dollars in extra revenue. But with these innovations brings questions. Best practices surrounding the technology are being discussed globally by ORTHOWORLD® customers every day.

These discussions include, but are not limited to, the following topics:

AM Implementation and Advancement for OEMs. Conversations around AM often center on aspects of cost, speed, advanced designs and clinical outcomes. Our highly-regulated, patient-facing industry demands quality — of the process, machine and finished product. Device companies implementing or exploring the use of AM must consider how quality applies to the technology. It’s a question that must be answered whether you’re utilizing additive in-house or exploring outsourcing options.

Enhancing Design through Engineering and Manufacturing Collaboration. Unlike conventional manufacturing, AM requires design and manufacturing teams to work closely together very early in the design phase process. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make AM work for you. We highly recommend developing pre-established best practices when working with both external and internal suppliers.

Powder Considerations. AM is no different from any other manufacturing method in that your part is only as good as the quality and type of materials selected. When choosing materials for orthopaedic AM applications, several factors must be considered. There are various metal powder options to consider when implementing AM. It is imperative companies choose the correct option to meet their manufacturing goals.

Mechanical Test Methods. Medical devices fabricated from additively manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Staying current on the various test methods for characterizing AM devices is critical, as is understanding the differences between testing AM devices and devices fabricated with traditional machining methods.

Developing a Roadmap for Regulatory Guidance and Standards. FDA published its guidance on AM technical considerations late last year, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said the 38-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the AM narrative. With that being said, regulatory concerns are often voiced by ORTHOWORLD® customers. Few topics have dominated our conversations with device companies, suppliers and surgeons like AM has in recent years. In that vein, clearer guidance is desired. We expect the questions we’ll field from industry and our customers alike will evolve as companies experience successes and failures with AM technology.

Supplier Relationships. Amidst the rising popularity of AM, OEMs that want to bring the process in-house must have deep knowledge of and a strong business case for the technology in order to truly adopt it. Many OEMs outsource use of the technology until they’re able to demonstrate the expertise needed and can justify the volume to purchase machines. Still, the need remains for partners who can assist throughout the product development lifecycle. There are many suppliers that will work with OEMs as a trusted partner to guide you down the winding AM path

As orthopaedic companies invest millions in AM, the need has never been greater to identify the tools, expertise and knowledge requited to fully realize the technology’s benefits. Enter OMTEC®, the Orthopaedic Manufacturing & Technology Exposition and Conference, which takes place June 12-14 in Chicago.

OMTEC® 2018 features the GE Additive Tech Center, a one-stop-shop where all of your questions about AM can be answered in a practical, conversational and straightforward manner. Education, discussion and insight will be provided by more than 20 AM experts in a thought-provoking, timely and critical one and a half day seminar.

In short, this is the must-attend AM conversation of the year.

Rob Meyer is ORTHOWORLD's Senior Editor. He can be reached by email.

April 18, 2018 | FDA and Customs Monitoring of International Purchasing: What You Need to Know

By John Gagliardi

Medical device manufacturers own responsibility for every step of their global supply chain when it comes to buying raw materials, finished devices, components and services from overseas suppliers. Therefore, when a manufacturer chooses to utilize overseas or domestic suppliers, it should ensure control over any product or service obtained from such suppliers as defined within their Quality Management Systems. Based upon risk, these controls may extend further if a supplier subcontracts work. 

While manufacturers are responsible to comply with the 21 Code of Federal Regulations (CFR) Part 820 and ISO 13485: 2016 for Purchasing Controls and Acceptance Activities, it’s important they understand that FDA and U.S. Customs play instrumental roles in the monitoring of quality systems and products, respectively. Random inspections are done before products cross the border into the U.S., and inspections of medical device QMS are ongoing.

With that knowledge, this article outlines the roles of individual manufacturers selling in the U.S., FDA and U.S. Customs, as they relate to the increasing scrutiny of international purchasing controls.

Read more at BONEZONE®

April 01, 2018 | Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

By Rob Meyer

New stemless (also referred to as stem-free or short stem) shoulder competition could be a significant growth driver for companies’ upper extremities portfolios.

This is the sentiment from industry analysts following the recent announcement of FDA 510(k) clearance for Exactech’s Equinoxe® stemless shoulder. Equinoxe—a bone- and canal-sparing implant for total shoulder arthroplasty—has entered limited launch, with expanded release slated for 2H18.

Equinoxe is seen as direct competition to Zimmer Biomet’s Sidus®—which launched in 1Q18—and Wright Medical’s Simpliciti®. The three represent the only FDA-cleared stemless shoulders on the U.S. market.

Though stemless shoulders are relatively new, several analysts, including Larry Biegelsen of Wells Fargo Securities, noted that the FDA clearance of the Equinoxe “will continue to grow the category.”

Of significance with this Exactech clearance is that, according to analysts, it was done without an Investigational Device Exemption (IDE), which allows a device to be used in a clinical study in order to collect safety and effectiveness data. Both Sidus and Simplicit were cleared by FDA with IDEs. Biegelsen notes that if FDA no longer requires IDEs for stemless shoulders, the agency could allow other manufacturers to enter the market faster than anticipated—in about one year, following Exactech’s timeline for Equinoxe.

For more on the stemless shoulder, read more at BONEZONE®

March 28, 2018 | Globus Medical Making Sizable Push Into Trauma Market

By Rob Meyer

In 2Q17, the leadership of Globus Medical (GMED) expressed a desire to diversify outside of spine, affirming plans for production of trauma products.

Fast-forward to the 2018 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting this month, where GMED displayed its growing portfolio of FDA 510(k)-cleared trauma products in four families, including fracture plates, compression screws, cannulated screws, intramedullary nails and external fixation. Full launch of all systems will commence in 2Q18 (profit contributions of significance are expected in 2019).

Read on at BONEZONE® for more on GMED's new trauma products and for details on the company's strategic initiatives to move away from the pure-play spine label.

March 22, 2018 | Why Labelling Processes Need to Start Early in Design Controls

By John Gagliardi

Mislabeled, misbranded medical devices are one of the top three causes for recalls in the U.S.

I started writing articles about these recalls in the 1980s and, believe it or not, during the 30+ years, this same statistic has barely budged off of this FDA measurement. Here we are in early 2018 and yet again, medical device companies are still making labelling mistakes. One would think that our compulsory relationships with computer software (our friend) would assist this effort. 

Unfortunately, this is not the case.

Today, when companies make labelling errors it results in a “wildfire” because our friend spreads the mistake quickly in the wrong directions—sometimes without the humans even knowing it! Admittedly, many of the labelling issues occur because of errors produced during the manufacturing phases after product development and then into distribution. Mistakes can include, but are not limited to, the following: wrong lot number; wrong label on an immediate container; smudged print; failed adhesive; incorrect product name; typographical errors; wrong product in the rightpackage and vice versa; non-sterile product in a package that indicates “sterile.”

On the flip side, some issues concerned with labels and labelling can also stem from design controls. Where is our friend when we need support?  

When considering preventive measures, robust design controls are a major advantage if handled properly. First, let’s establish some definitions and regulatory positions before we discuss labels and labelling in a more prevention-based mindset. Yes, there are steps you can take to minimize mislabeling and misbranding of medical devices. It comes down to being in control.

Definitions and Regulatory Positions: The Federal Food, Drug and Cosmetic Act (FD&C Act) is the law under which FDA takes action against regulated products. Specifically:

Section 201(k) defines “label” as a:

  • “Display of written, printed or graphic matter upon the immediate container of any article, e.g. a medical device”

Section 201(m) defines “labeling” as “All labels and other written, printed or graphic matter:

  • Upon any article or any of its containers or wrappers, or
  • Accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.”

The term “accompanying” is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, videos, fillers, etc. “Accompanying” also includes labeling that is brought together with the device after shipment or delivery in interstate commerce. The larger concept word “labelling” is defined as basically everything you say and, in some cases, don’t say.

Read more from John Gagliardi at BONEZONE®

March 15, 2018 | Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

By Carolyn LaWell

Kornelis Poelstra, M.D., Ph.D., believes that new materials will bring the next wave of innovation in spine. His belief spurred him to send FDA a letter asking for a list of acceptable materials to study in animals with the intent of future commercialization. It also spurred a partnership when he crossed paths with Jay Yadav, M.D., an entrepreneurial cardiologist working to introduce molybdenum-rhenium (MoRe) to orthopaedics. 

At the North American Spine Society Annual Meeting, Dr. Polestra presented research on the use of MoRe in spinal applications. The data will be used as MiRus, a startup spine company, launches a platform of technologies using MoRe. 

We spoke with Dr. Poelstra, an orthopaedic and neural spine surgeon and founder of The Spine Center of Excellence at Sacred Heart Hospital in Pensacola, Florida, asking him to explain the alloy’s benefits. 

What is molybdenum-rhenium alloy?

Dr. Poelstra: Molybdenum-rhenium is an alloy that’s been used for a long time to make stents in cardiology. The beauty of the material is, compared to what’s commonly used in spine—cobalt-chrome, titanium and stainless steel—it has characteristics that are a lot stronger. MoRe uses a lot less metal to achieve the same strength and durability and is two to three times stronger and four times more durable than cobalt-chrome or titanium.

Read more at BONEZONE

March 07, 2018 | The Contribution of Biomaterials to the Dawning of the Age of the Forgotten Hip

By Robert Poggie

Primary total hip arthroplasty (THA) has undergone 25 years of product development, thanks to contributions from a host of materials technologies. The result? A reliable, fully-functional, pain-free, lifetime hip replacement for most patients. Using today’s lexicon, this now-routine procedure has been succinctly termed the “forgotten hip.” 

As is common in all areas of human progress, the road to the forgotten hip has been paved with certain pitfalls. One example is Sir John Charnley’s discovery of high density polyethylene in the early 1960s as a suitable material for the acetabular bearing, after learning that PTFE (Teflon) was not the solution. The success of THA depends upon many factors including design, surgical technique, post-operative care and materials, with the latter arguably being the most influential in realization of the forgotten hip today and in the future, for most primary THA patients. 

Before we predict advancements, let’s review how we arrived at the current standard for THA. 

Evolution of Fixation

In the early 1990s, cementless primary hip arthroplasty was rapidly supplanting cemented arthroplasty with polymethyl methacrylate, or PMMA, as the majority means of fixation. This shift can be traced back to the 1980s with the introduction of new thermal spray and sintered coating technologies, ranging from “large” beaded coatings most notably promoted by Howmedica, “small” sintered beads marketed by DePuy, fiber metal from Zimmer, hydroxyapatite from Osteonics and plasma sprayed titanium from Biomet.

Subsequently, all companies were offering one or more solutions for cementless fixation by the mid-1990s. (See Exhibit 1.) These surface modifications all had one primary purpose: to provide fixation of femoral and acetabular components to bone. The generally accepted range for porosity of the porous coatings for bone ingrowth was between 250 to 750 micrometers, which still holds true today.

Read more in BONEZONE. 

February 27, 2018 | Surgeon Leadership Essential to Influence Implant Purchasing Committees

By John B. Pracyk, M.D., Ph.D.

Editor's Note: How does your work impact the value created by your company’s products? This question should remain top of mind for all orthopaedic professionals, no matter where you fall within the supply chain. Purchasing decisions at the hospital and surgery center level continue to be driven by the clinical and economic value that products create for their systems. This means that product adoption will take teams of teams—suppliers and service providers to device companies included—to meet today’s demands. John B. Pracyk, M.D., Ph.D., Global Franchise Medical Director at DePuy Synthes Spine originally wrote on this topic for ORTHOWORLD in October 2014. At the time of original publication, Dr. Pracyk's titles included neurological surgeon, strategic healthcare consultant and neuroscience program architect. Today we republish his article as an introduction to the conversations he will moderate among surgeons, a value analysis committee member and an integrated delivery network leader at OMTEC® 2018.

Changes in hospital purchasing decisions directly impact the surgeon’s ability to freely select surgical implants. Often, surgeons find they may no longer have access to the implants they have always used, because of the healthcare system’s efforts to streamline purchasing decisions. One strategy is to reduce the hospital’s absolute number of “surgeon preference items,” such as implants handled by the facility. This reduction in implant variation drives efficiencies on a variety of levels.

The Changing Landscape of Hospital Purchasing

Hospitals realize that they clearly spend too much when it comes to purchasing implants. As a result, value analysis teams (VATs) or committees (VACs) have formed to study, review and ultimately decide which implants will be allowed into the hospital, and at what specific price point.

The traditional sales model involved a close relationship between the medical device sales representative and the surgeon. That relationship no longer drives purchasing decisions, as VATs decide the selection of implants from which the surgeon may choose. This formalized process serves as a checkpoint to prevent the surgeon from simply selecting a device based on personal preference, because that decision-making usually costs the hospital in the end. The latest device often commands the highest price, as manufacturers try to increase their production numbers through price increases each and every year.

Surgeons often get a letter from the hospital informing them that the device they have used for years may no longer be available. Naturally, they’re upset and left wondering, “Why is this taking place?” Once they realize that it’s no different than the constantly-changing number of drugs available on the hospital formulary, its starts to make sense. The pharmacy & therapeutics committee’s mission is to maintain the formulary for the hospital. By way of analogy, the VAT’s mission is to maintain a portfolio of surgical implants used at the hospital, and monitor its effectiveness.

Expectations and responsibilities placed upon surgeons are now even greater. If surgeons want to trial a new product, they need to be able to cite the implant’s clinical benefits, along with the economic value that it delivers. Is the product any different than others that are already “on contract” with the hospital? The preference product runs the risk of being commoditized—evaluated on price alone—if it lacks a unique differentiating factor.

Read more from Dr. Pracyk here. 

February 20, 2018 | Price Cap on Hip Implants Expected in India

By Rob Meyer

A price cap on hip implants is likely upcoming in India, according to a recent report in Indian newspaper The Hindu

After implementing price caps on knee implants (following previous caps on cardiac stents) in 3Q17, “the cap on hip implants is also likely in the process,” said orthopaedic surgeon Dr. Ram Prabhoo, president of the Indian Orthopaedic Association. “The price control on all implants has been widely discussed.”

Knee implant prices in India were slashed between 59% and 69% in August 2017. The expectation is that hip implant prices will be cut similarly.

“A price cap on the knee implants has worked extremely well. We feared that high-end implants would be phased out, but because of a clause put by the NPPA (National Pharmaceuticals Pricing Authority), the stocks could not be withdrawn. Over the past few months, more patients have opted for surgeries,” Dr. Pradeep Bhosale, joint replacement surgeon at Nanavati Hospital, told The Hindu. Nanavati Hospital has seen a 40% rise in the number of knee-joint replacements since the price cap was introduced, according to Dr. Bhosale.

According to the NPPA, estimates indicate that India is likely to witness 15% to 20% growth in arthroplasty by 2030, due to increasing incidences of diabetes, osteoporosis, osteoarthritis, obesity and increased awareness of the benefits of arthroplasty. At present, according to the NPPA, an estimated 15-20 million Indian citizens require orthopaedic surgical intervention, but they either remain undiagnosed or are diagnosed but can’t afford the cost of implants.

When announcing the knee implant price caps, the NPPA said that orthopaedic implants in India had unjustified, unreasonable and irrationally high trade margins, leading to exorbitant pricing.

Arguments against these price controls include possible curbs on innovation and the removal of certain proven products and solutions from the Indian market.

“While the [Indian] government’s intent is to cap prices in the patient’s interest and make healthcare affordable for all, this pricing has the potential to block innovations and limit access to world class medical care and options to patients,” AdvaMed said in a statement last year.

“The price ceiling will also negatively impact the future environment for investment and FDI inflow in the country. It is critical to evaluate the long-term negative impact of such decisions on patient outcomes, consequent increase in adverse events and subsequent rise in long term healthcare costs, which defeats the entire purpose and spirit in which this price control exercise has been undertaken in the first place.”

How are medical device companies being impacted by the price caps? Examples include:

  • Part of DePuy Synthes’ 2017 growth offsets arose from the impact of knee implant price caps in India, to the tune of $10MM in 3Q17 and $2MM to $3MM in 4Q17.
  • Zimmer Biomet reported a loss of $5MM in 3Q17 directly attributed to the knee implant price cap.


Going forward, we expect some companies to incur further losses due to the hip price caps, much as they did after the knee implant price caps were implemented. The economics of Indian healthcare could also be impacted adversely, as supply and demand issues may begin to occur.

Finally, we note that device companies can expect to continue to face cuts on implants as countries seek to rein in spending. In addition to India, China and Japan are slated to target pricing on total joint implants. While much of the Asian market is expected to experience double-digit growth, device companies and their supplier partners must consider how price caps impact their investments in the region. 

February 15, 2018 | Augmedics Bringing X-Ray Vision to Surgery with X-VISION Visualization System

By Rob Meyer

Last year, we shared with you news about a small Israeli start-up and its “see through skin” technology. Augmedics X-VISION is an Augmented Reality head-mounted display that is designed to let surgeons "see through" skin and tissue by projecting a 3D image of the patient's spine onto the surgeon's retina in real time.

We found this so interesting that we sought some time with inventor and Augmedics CEO and Co-Founder Mr. Nissan Elimelech, who has ten years of experience in various medical device markets, including spine (Medtronic).

“What we add to the basic surgical navigation system is, we take data from the patient and create a 3D model of the anatomy and project it onto the surgeon’s retina, in real time,” Elimelech said. “So, the surgeon is not only looking on a screen, but also gets the information sent directly to his or her eyes; the surgeon basically has x-ray vision, where he can see the patient’s anatomy through skin and tissue.”

Visit BONEZONE, where we share more of Elimelech's thoughts, vision and future plans for X-VISION. 

February 07, 2018 | UDI: Is Your System Ready for Scale?

By Carolyn LaWell

Call it a forever project, program, capability—unique device identification (UDI) is gaining adoption globally and cementing its role as a normal business practice for orthopaedic companies. In theory, the ability to track a device throughout its lifecycle seems smart and necessary.

In execution, the requirement of UDI has led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval.

The U.S. is the largest orthopaedic device market and, therefore, the rollout of UDI systems worldwide will be on a smaller scale in other geographic regions. But once you decipher, understand and execute on different countries’ regulations, you’ll realize that it is a mammoth undertaking. With the EU and other Middle Eastern and Asian countries preparing to require UDI, experts say that now is the time to take a step back and examine your compliance process—specifically, your data.  

Read more about UDI compliance in BONEZONE.

January 31, 2018 | AAOS 2018 First-Time Exhibitors Emphasize Navigation, Orthobiologics, Outcomes

By Julie A. Vetalice

In examining the list of AAOS 2018 exhibitors, I see that a number of first-time exhibiting OEMs offer either orthobiologics or navigation…I’m not surprised, as it’s rare for a “new” hip or knee replacement device company to appear, any more. Rather, first-timer or not, I see numerous exhibitors addressing needs “beyond the device.”

Some are notable for their systems to manage patient care before, during and after a procedure; to deliver the implant to its destination or get it into the body in a more efficient manner; or make it work better once it’s in there.

You always ask us to keep you apprised of who is doing what, in the industry. I’m expanding on the following exhibitors to help you—and us—get to know them better.

We’d love to spend some time with you, too, in New Orleans, and invite you to stop in at ORTHOWORLD's Booth #3820.

(First-time exhibiting companies are differentiated below with their names in green.)

OEMs

Anika Therapeutics | Booth #6933 | Bedford, Massachusetts, U.S.
anikatherapeutics.com
Orthobiologics

  • First-time exhibitor…really? Yes, really! Aside from clinical trial progress on viscosupplements and mesenchymal stem cells, we expect that Anika folks will want to talk about their recent FDA 510(k)-cleared resorbable, injectable hyaluronic acid-based bone void filler. It reportedly represents one of just a few bone graft substitutes that can be administered in a minimally invasive manner.
  • The timeline from submission to clearance? Submitted in 3Q17…cleared in 4Q17.

 

Read on for more details on first-time exhibitors at AAOS 2018. 

January 10, 2018 | Survey: In 2018 and Beyond, Where do Opportunities Lie for You and Your Company?

Each year, ORTHOWORLD publishes THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.

This year, we endeavor to collect your voice beforehand.

ORTHOWORLD is conducting an Orthopaedic Industry Survey, an 8-question survey that we estimate takes just 3 minutes to complete.

We will use survey answers and data in the 2018 ORTHOPAEDIC INDUSTRY ANNUAL REPORT, where helpful. This will be done anonymously, of course. (We will not include or publish names without express written permission.)

Not only does this survey give us a clearer picture of the state of the orthopaedic industry, based on the answers you provide, but is also gives us a better understanding of the challenges you are working to overcome and the opportunities you are working to seize.

Thank you in advance for your candor, cooperation and participation in our research.

Please click here to begin the survey.

January 01, 2018 | FDA CDRH Proposed 2018 Draft Guidance to Include Alternative 510(k) Pathway

By Robert Meyer

As 2017 came to a close, FDA released its annual priority list for the new year, as well as previously-issued final guidance documents for which the Center for Devices and Radiological Health (CDRH) is accepting feedback as part of its retrospective review.

Prioritized medical device guidance documents that FDA intends to publish in FY18 include an alternative pathway for manufacturers seeking 510(k) clearance.

Read more at BONEZONE.

December 14, 2017 | FDA Finalizes Additive Manufacturing Guidance

By Carolyn LaWell

FDA recently published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.

Like you, we’ve eagerly awaited the finalization of this guidance. Few topics have dominated our conversations with device companies, suppliers and surgeons like additive has in recent years. FDA points out that the 31-page document is considered “leapfrog” guidance, a term reserved for FDA’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers will continue to arise as the technology is adopted.

What we do know is that FDA outlines its thoughts on the phases of design development, production process, process validation, semi-finished and final finished device testing.

While the full guidance, “Technical Considerations for Additive Manufactured Medical Devices,” can be read online, we’ve chosen to highlight three points related to questions with which readers have often approached us: device design, materials and cleaning/testing.

Read more at BONEZONE.

December 07, 2017 | CMS Finalizes Joint Bundled Payment, Outpatient Changes

The Centers for Medicare & Medicaid Services (CMS) finalized cancellation of the mandatory hip fracture and cardiac bundled payment models that were to be operated by the CMS Innovation Center and implemented changes to the Comprehensive Care for Joint Replacement (CJR) bundled payment model.

These changes will offer greater flexibility and choice for hospitals in providing care to Medicare patients, according to CMS.

“While CMS continues to believe that bundled payment models offer opportunities to improve quality and care coordination while lowering spending, we believe that focusing on developing different bundled payment models and engaging more providers is the best way to drive health system change while minimizing burden and maintaining access to care,” CMS Administrator Seema Verma said, in a release.

Ms. Verma expects to announce new voluntary bundles at a later, unspecified date. In the final rule, CMS reduced the number of mandatory geographic areas participating in CJR from 67 areas to 34. CMS is also making participation voluntary for all low-volume and rural hospitals in all 67 areas.

Read on for more details abut these CMS changes, cancellations and finalizations. 

November 29, 2017 | The Joint Surgeon's Wish List

By Julie Vetalice

Matthew Dietz, M.D. is an Assistant Professor for the orthopaedics department at West Virginia University School of Medicine. In his surgical practice he performs primary hip and knee arthroplasties, including complex revisions—fueling his research focus on biophysical disruption of biofilms in total joint arthroplasty and the care of patients affected by prosthetic joint infection.

As is well-known, the Baby Boomer joint surgery candidate is a different kind of patient from her grandparents. She is a healthy patient with functional limitations, and as Dr. Dietz described, surgeons “want to provide efficient, safe, surgical care; we want to improve patient outcomes and limit complications. When we do have to deal with complications, we want to address them in a safe, effective manner.”

In the Knowledge Pod at OMTEC 2017, Dr. Dietz shared his take on challenges with patient care using present systems and devices, and offered thoughts on what he’d like to see in the future. Here are three points from Dr. Dietz’s Wish List:

Prevent Burnout
We need to collect data that lets us know how we’re doing. However, with studies showing that 28% of our time is spent on patient care, while 43% of time is spent on data entry to feed electronic medical records, increasing numbers of surgeons are opting to leave the practice altogether. Data entry and data analysis need to be made easier. We need implants and technology that can help to collect information and report it to our healthcare providers.

Read on for more items on Dr. Dietz's Wish List.

November 21, 2017 | Quebec: A Growing Orthopaedic Innovation Hub

By Robert Poggie

North of the U.S. border, about a six-hour drive from New York City, lies the Canadian province of Quebec. Known for the French language, the iconic hotel Chateau Frontenac, maple syrup, hockey, snow, vast woodlands and countless lakes, it’s also home to a robust orthopaedic industry characterized by innovation, research, a history of achievement, manufacturing prowess and investment. Since the 1960s, private companies, government, education and healthcare institutions and pre-clinical research organizations have coalesced into an engine for commercializing innovative products. This article spotlights the people, companies and products — many of whom I’ve worked with — that have placed Quebec firmly on the world map as an orthopaedic center of excellence.

Leaders in Education and Orthopaedic Research

Significant contributions to orthopaedic innovation can in part be traced back to 1967 and the founding of the Jo Miller Laboratory at the Montreal General Hospital/McGill University. Originally planned for biological and surgical research, the lab, led by Jo Miller, M.D., quickly evolved into a center for biomechanical and materials testing.

From the 1970s to mid-1980s, original pioneering research was performed on porous coated implants, bone ingrowth, fixation and stress-related peri-implant bone remodeling, development of improved bone cements and cementing techniques and commercial implant designs such as the MultiRadius and Miller-Galante knee systems.

Read more about how Quebec is becoming home to a a robust orthopaedic industry characterized by innovation, research, a history of achievement, manufacturing prowess and investment.

November 15, 2017 | Examining Critical Trends in Trauma Surgery

By April C. Bright

Two of the greater challenges that trauma surgeons face today are an increased number of complex fractures and complications from fractures. The Orthopaedic Trauma Association (OTA) convened for its annual meeting in October, and many of the themes that resonated in surgeon voices and research—areas ripe for device company product development—fell in line with those two issues.

For greater context, we spoke with Michael D. McKee, M.D., Chairman of the Department of Orthopaedic Surgery at the University of Arizona College of Medicine and Program Chair of the Annual Meeting. Dr. McKee outlined four areas of opportunity identified at the meeting: periprosthetic fractures, infection prevention, early weight-bearing recommendations and percutaneous pelvic fractures.

Periprosthetic Fractures

Dr. McKee: A number of papers and talks centered on the use of various implants to treat periprosthetic fractures, especially in the lower but also the upper extremities, because these fractures are becoming much more common. The number of patients who have multiple periprosthetic fractures is increasing, so now we’re seeing interprosthetic fractures—meaning a fracture not only below the total hip, for example, but below a total hip and above a total knee in the same leg.

One of the teaching points made by several authors was that if you have a total hip or bipolar hip and you break below it, rather than simply fixing the fracture, perhaps it’s time for orthopaedic surgeons to consider protection of the entire femur. Even if you have success with a fracture union, there is a much-increased rate of another fracture below your implant.

BONEZONE: What is your recommendation for femur protection?

Dr. McKee: In the previous example, you would need an implant that would go all the way down to the condyles, with screws across it, to help protect the entire femur at risk. Companies are designing and manufacturing such implants, or a surgeon may choose to maneuver a regular implant to do the job in that fashion.

Similarly, implants that are amendable to fix a fracture between a total knee and total hip will become more popular as time moves on, and I think a number of other authors thought the same thing.

For periprosthetic fractures, which often occur in older women, making them non-touch or weight-bearing afterward is counterproductive and impractical. We need to make our construct strong enough so that we can allow full weight-bearing after [surgery].

Read Dr. McKee's insight on infection prevention, weight-bearing loads and pelvic devices.  

November 08, 2017 | 5 Steps to a Highly Collaborative Supplier Agreement

By Kate Vitasek

If your recent experiences with contract negotiations are something like visiting the dentist for a root canal, there is a much better—and pain-free!—way to go about wrangling that strategic agreement.

It’s called Getting to We—a five-step process for crafting business relationships with the intent to drive collaborative partnerships. (The process is described in the book, Getting to We: Negotiating Agreements for Highly Collaborative Relationships.)

There are plenty of negotiation ”how-to” books out there. So, what is different about the Getting to We methodology? Simply put, Getting to We puts the focus on negotiating the foundation of the relationship, not just on getting to a deal. You still get to a contract, but how you get there is vastly different.

Getting to We starts by changing the way you approach your negotiation to embrace a “what’s-in-it-for-we” (WIIFWe) philosophical mantra, forming the structure of a collaborative and trusting relationship.

Negotiating the true nature of the relationship under a WIIFWe mindset means that the negotiating parties move away from the usual tit-for-tat cycle of tradeoffs and concessions; instead, they create a negotiation atmosphere that encourages cooperation.

So, how do you do it?

Five Simple Steps

  1. Getting ready for WIIFWe

The first step is to candidly discuss three foundational elements for a successful collaborative relationship: trust, transparency and compatibility. Completing this step helps the parties to understand to what extent they can build the foundation for their relationship. The more trust, transparency and cultural fit between a buyer and supplier, the more the parties will be comfortable making investments in the relationship, innovations and continuous improvement opportunities that can benefit both parties. 

For example, let’s say that you traditionally negotiate an annual contract renewal with an incumbent that has been a trusted “strategic” supplier for the last five years. You have a good cultural fit and work well together, but have operated under a conventional transaction-based business model with limited transparency. This year, you decide to host a two-day offsite meeting to discuss the art of the possible with the relationship; the agenda starts with a discussion about ways to improve trust, transparency and compatibility. The conclusion? You can make a good relationship great by being more transparent, which will enable the parties to work collaboratively to reduce total ownership cost and not just the “price.”

Read the next four steps.