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Articles of Interest

October 11, 2018 | Healthpoint Capital Closes $100MM for New Fund

HealthpointCapital, a private equity firm focused on musculoskeletal healthcare, announced it closed U.S. $100MM for its fourth fund. The target for Musculoskeletal Fund IV is $500MM.

HealthpointCapital launched the new fund to support eight to ten innovative, growth-stage companies, following the firm’s strategy of investing in differentiated technology and service companies in the orthopaedic, maxillofacial, rehabilitation, digital health and dental sectors.

Orthopaedic companies in Healthpoint’s current portfolio include Alphatec Spine and OrthoSpace. Notable company exits from Healthpoint include Blue Belt Technologies (acquired by Smith & Nephew in 2015) and Nexa Orthopedics (acquired by Tornier in 2007).

"The first closing for Fund IV represents a milestone and a validation of our strategy," said Mike Mogul, Healthpoint President & Managing Director. "Musculoskeletal healthcare offers attractive opportunities that require not only capital, but also operational expertise and strong healthcare professional and commercial relationships."

Mogul, formerly President and CEO of DJO Global and Group President, Orthopaedics for Stryker, is speaking on the state of the funding environment at the Musculoskeletal New Ventures Conference (MNVC), slated for October 23-24 in Memphis, Tennessee.

Source: Healthpoint Capital

October 03, 2018 | 25 Considerations for Companies Seeking Clarity in Design Controls

By John Gagliardi

Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety and effectiveness, is established during the design phase.

FDA believes that unless appropriate design controls are observed during pre-production stages of development, a finished device may be neither safe nor effective for its intended use. This has been true for almost 35 years now. With that being said, some device companies, by their admittance, still struggle with this process and seek clarity.

Forget the convoluted regulatory language for the moment and consider the basic facts.The following is a short list of considerations I have compiled over the years and share with you as key reminders while you’re working through your design controls:

  1. Implementing design controls as a separate entity within the Quality Management System (QMS) is counterproductive and not the way the architecture of 21 CFR, Part 820 was intended.
     
  2. Research is not development. Concept and feasibility is not included in design, per se. Research, though valuable, is not part of a documented design controls process.
     
  3. User needs are not design inputs. Design inputs are measurable.User needs are confirmed during design validation. Design inputs are confirmed during design verification.
     
  4. After design inputs are approved, they are used to verify design outputs, i.e. design verification.
     
  5. Risk analysis is considered a design input, not something that you do later during the process build. The extent of testing conducted should be governed by the risk(s).


Read more design control observations at BONEZONE®. 

September 17, 2018 | Follow These Six Steps to Execute a Strategic Planning Process

As 4Q18 approaches and you're engaging in strategic planning, we felt compelled to share with you this timeless article, originally published in 2013 and authored by consultant Don Urbanowicz.

The advice you will read here can be used as a roadmap to creating and executing an effective strategic planning process for your company. We hope that you find it as helpful, insightful and relevant as we do. 
 

By Don Urbanowicz

A strategic planning process (SPP) provides a systematic way of mapping the handful of key decisions that an organization must get right in order to survive—and thrive—during the next several years.

By definition:

         
           

Strategic = gaining a competitive advantage, long term
Planning = preparation for certainty
Process = systematic approach to a conclusion

The proposed annual six-step strategic planning process may prove essential for those working in most corporations. It provides an opportunity for senior leaders to assist in formulating a company’s strategic plan, implementing the strategic plan and connecting strategy and implementation to a rewards system.

First, before starting the process, secure the commitment of the leadership team up front—or quickly abort. Bring the right people together. Those who carry out strategy should develop it. And remember, if you want to accomplish a strategy, agree to focus on it, and then plan ahead to make it an ongoing process.



The Six Steps of the Strategic Planning Process

Steps 1-3: Strategy Formulation: Looking Within, Looking Around, Looking Ahead

Step #1 in the process consists of conducting an internal strategic audit—or critically looking within your own organization—to answer where are we now?

  • Determine your competitive strengths—measurable attributes that make you better than your competition
  • Determine your competitive weaknesses—what prevents you from achieving better results; identify recurring weaknesses
  • Determine people opportunities, challenges and concerns
  • Determine if you can finance the future


Takeaway: Never state a critical weakness unless you make a commitment to fix it.

Read more in BONEZONE

August 22, 2018 | Spinal Cages Continue Trend Toward Metals, Expandable Designs

By Rob Meyer

The trend in newly-launched spinal cages has been a focus on expandables and additively manufactured devices, with a shift away from traditional manufacturing with all-PEEK to those that incorporate titanium, whether in the coating or the body.

Neither manufacturers nor surgeons have reached a consensus on whether or not spinal cages should be 100% PEEK, coated PEEK or titanium. What can’t be disagreed on is the fact the shift away from all-PEEK cages is a direct response by device companies, based on what they’ve been hearing from surgeons, to manufacture implants using materials or coatings with greater strength, porosity and bone-ingrowth capabilities.

With this in mind, and in an effort to get a better understanding of what is happening in this space, we posed questions on spine cage technology to three veteran spine surgeons.

While all three confirmed the shift to incorporate titanium, they also provided insight which we thought you would find interesting—including a forecast for the next five years in cage technology and thoughts on device companies’ priorities.



Michael Steinmetz, M.D., is Chairman of the Department of Neurosurgery at the Cleveland Clinic Neurological Institute.

He also serves as the vice president of the Congress of Neurological Surgeons, secretary of the Council of State Neurological Societies, an executive committee member of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves and is involved with the American Association of Neurological Surgeons, the North American Spine Society and the Society for Neurosciences.

What are your thoughts on cages that are expandable, additively manufactured or those that incorporate titanium?

Dr. Steinmetz: Cage design has been a game changer in spine surgery. Surgical approaches have been somewhat stagnant, but cage design has made surgery easier and potentially safer. Cages require an appropriate “fit” in the interbody space to effectively fuse. If too loose, fusion may not occur; if too large, endplates may fracture or be “plowed” during insertion, resulting in subsidence and construct failure. More importantly, cage placement in the posterior transforaminal route places both the traversing and existing nerve roots at risk of damage during insertion. This may result in the surgeon choosing too small of a cage to lessen the chance of nerve injury, but increase the risk of unsuccessful fusion. 

Expandable cage design permits a smaller cage to be inserted in the disc space, hence easing the chance of nerve and endplate injury, but after expansion an appropriate fit to the endplates. 

Read more on spine cage technology trends in BONEZONE®.

August 01, 2018 | Surgeons Establish Society to Advance Complex Additive Applications

Founded in 2017, the American Orthopaedic Society of 3D Printing (AOS3DP) was formed to provide orthopaedic surgeons with an avenue for collaboration on the use of complex and customized clinical applications of additive manufacturing in reconstruction, revisions and limb salvage. The society also serves as a vehicle for its foundation, whose goal is to provide support for patients.

To our knowledge, this society is the only one of its kind for orthopaedic surgeons. It’s tapped Selene Parekh, M.D., an orthopaedic technology entrepreneur and hand and foot surgeon at North Carolina Orthopaedic Clinic and Duke Orthopaedics, as its chairman.

BONEZONE® asked Dr. Parekh to shed light on AOS3DP’s objectives.

July 15, 2018 | Supply Chain Quality Panel: OEMs and Suppliers Offer Perspectives, Insight

By Rob Meyer

Supply chain quality impacts every device company and supplier partner, involving personnel in R&D, purchasing, quality and sourcing.

OEMs and their suppliers play roles in engaging individuals within their own companies to ensure that product quality, integrity and patient safety remain areas of focus throughout the entire manufacturing process.

At OMTEC® 2018, a panel comprising two OEM and two supplier experts, moderated by an industry consultant, discussed the crucial aspects of supply chain quality. We learned much from the discussion and thought you would, too.  

In Part I of our recap, we present the panelists’ comments on OEM/supplier relationships,and the challenges posed by quality agreements, regulatory oversight and continuous improvement efforts.

In Part II, we present their thoughts on European Union Medical Device Regulation, third-party audits and the need for more consistency in validations across the industry.

July 11, 2018 | Think Different About Management Reviews

By John Gagliardi

If your company’s Management Review sessions are a waste of time, that’s your fault.

Change your approach!
Change the format!
Change the players!
Change something!
Make it real!

Management Review, a regulatory requirement, can be a value-added experience with thoughtful accountability, expected responsibility and successful compliance. Look at them as business tools without the dollars.

Take ownership and make them impactful. Avoid presenting dreary bar and pie charts that send the same message over and over again. This is not complicated, but it can be tortuous if handled in an incorrect or in a highly politicized manner. Keep the politics in the board room and remember that Management Review is actually a good thing. Here’s why.

Accountability is Key

When it comes to the global manufacturing of medical devices, conducting Management Reviews on a consistent and periodic basis is a requirement of 21 CFR, Part 820 and ISO 13485:2016, respectively. Part of total quality management requires companies and individuals to measure performance, compliance and, although not a direct requirement, business acuity.

Yes, you and your company are accountable and this accountability is an edict for doing business in the medical device industry.

I have observed many companies that treat Management Reviews like a necessary evil, or a bitter pill to take. Many companies hold Management Review sessions four times a year, but some only have formal reviews twice (or maybe even once) a year. (See the sidebar on frequency.)

Read more on management reviews at BONEZONE. 

June 21, 2018 | FDA Approves Artificial Intelligence Software for Wrist Fractures

Less than two months ago, FDA commissioner Scott Gottlieb, M.D. announced that the agency would be “implementing a new approach” to the review of artificial intelligence (AI)-based medical devices and tools and digital health as a whole.

Weeks after the announcement, Imagen Technologies, a three-year-old company, received FDA de novo clearance to market its OsteoDetect computer-aided software, designed to detect and diagnose adult wrist fractures. (De novo is a regulatory pathway for low to moderate risk devices of a new type. Moving forward, AI technology will be included in FDA’s Pre-Cert Program.)

This news caught our eye for a couple of reasons, which are explained at BONEZONE. 

May 31, 2018 | Robotics in Orthopaedic Surgery: Answers to Three Questions

By Rob Meyer

Robotics has the potential to be game-changing technology in orthopaedic surgery, as certain companies and surgeons extol benefits that include efficiency, predictability and consumer appeal that could increase procedure volume for adopters. The number of conversations about these technologies increases each year, especially at industry trade shows and conferences.

When analyzing the robotic technologies market, it’s important to realize that many questions need to be answered and that analysis of the technology is anything but simple.

To be clear, we’re referring to the use of a robotic tool during surgery. Nearly 60 companies, by our count, play in the broad computer-assisted surgery market. Ten of those companies have robots.

To better put into context recent announcements that have taken place in the robotic space, we took a look at the players and their technologies, as well as how they fit into the greater industry context of data, outcomes and adoption. Here we share our findings to provide greater knowledge about your competitors and customers.

Who are the players and what are their technologies?

Robotic technologies come in many different sizes, sophistications and price points. The top five players by revenue, DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew and Medtronic (the latter through a partnership with Mazor Robotics), believe robotic technologies are essential to a complete orthopaedic portfolio. It’s expected that their use of robotics will extend to multiple surgical applications and markets.

Read more at BONEZONE® for more about these companies' technologies as well as answers to other questions and further analysis. 

May 24, 2018 | Mid-Journey on the Road to the Forgotten Knee

In the last 45 years, numerous achievements have been made in modern total knee replacement (TKR) in areas of materials, design and computer technology. As it stands today, primary TKR reliably results in a durable joint with low potential for revision, but most patients sense the artificial knee and some studies estimate that about 20% are dissatisfied with their TKR.

TKR traces its origin to the early 1970s at the Hospital for Special Surgery, where John Insall collaborated with surgeons Chitiranjan Ranawat and Allan Inglis, along with engineer Peter Walker, Ph.D., to develop the total condylar knee. In the mid-1970s, cruciate sacrificing (posterior stabilized) total knee and resurfacing designs for the patellofemoral joint were also developed. The biomaterials that made up the implant components at that time remain the same today, with polyethylene for tibial and patellar bearing surfaces, CoCr alloy for the femur and titanium or CoCr alloy for the tibial base plate (or “all-poly”), with PMMA-cement dominating fixation to bone.

The design of articulating surfaces has ranged from unconstrained to fully constrained with everything in-between, including mobile bearings, rotating platforms, nearly flat on radiused femurs, posterior-stabilized, conforming femorotibial articulation and medial pivot. Throughout most of this history, knees have been mechanically aligned with compensation in component position to better match anatomical rotation and joint line, with ligament balancing and attention to flexion-extension gaps being controlled in planning pre-operatively and via surgery intra-operatively.

Also noteworthy from the past 15+ years are products and procedures focused on localized pathologies of the knee, with unicompartmental knee surgery becoming a mainstay in knee arthroplasty, and cellular, drug and traditional materials solutions to osteochondral defects in various R&D phases in the U.S. today.

Before we predict what TKR will look like in the future, let’s review notable changes to the procedure over its lifetime and ways that materials of choice have changed (or remain unchanged, in many cases).

Read more at BONEZONE®

May 16, 2018 | Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

By Rob Meyer

Japanese researchers found that a use of a patented titanium fiber plate did not yield bone embrittlement after close contact with the bone for prolonged periods, leading developers to believe that the material could eliminate the need for plate extraction and associated surgical risks faced in fracture repair.  

The findings arose from an animal model test conducted at Shinshu University in Nagano Prefecture, Japan.

Unlike conventional implants, the plates are formed by compressing titanium fibers at normal room temperature without changing the fiber shape. 

Read more at BONEZONE®

May 01, 2018 | Eight Steps to Project Triage

By Deborah Munro, Ph.D.

“What should I do next?” is a daunting question as we face multiple-high priority deadlines. No matter that we’ve had management tell us that everything is a priority; the reality is that we must choose which improvements and projects to tackle first. Thus, we all need a strategy to triage our projects. With that in mind, here are eight tips and techniques that have worked well for me.

Develop criteria by which to make priorities for your projects.

Challenge: It’s easy to have a pet project—that one you really enjoy and feel enthused to work on, but it’s unlikely that project is also the most important one for you to work on right now. Borrowing from my regulatory affairs background, you need to avoid bias in your decision-making progress. To avoid bias in choosing subjects for a clinical trial or a literature review, we develop what is called a protocol. This document is written in advance and determines all of the objective criteria by which subjects or journal articles will be included in the study. For design improvements, as an example, your criteria might look like: customer delivery promises, sales goals, lead times and deadlines for others (depending on your deliverable), lead times for delivery of components or manufacturing processes that you need to incorporate, or an upcoming event or tradeshow deadline.

Solution: What is on your list depends wholly upon your projects. The key takeaway is that you need to develop a set of criteria for yourself that dictates what’s truly important or time sensitive. There are likely multiple, competing criteria, so you’ll need input from stakeholders on what should be in your triaging criteria.

Acknowledge the fact that you can’t do it all.

Challenge: Everyone is chronically busy these days. Often, the temptation is to make a special push to get through the massive pile of tasks at hand, and then take a break later. Sorry, but there will never be a later when things are quieter and more manageable. Your plate is always going to be full—no amount of overtime is going to stop your inbox from overflowing the very next day.

Solution: Come to terms with your reality—life rarely slows down. Choices have to made, and understand that all you can do is your best.

Maintain an appropriate work/life balance today, not tomorrow.

Challenge: Contrary to what you may believe, you can’t get rested up on a one- or two-week vacation. Are you constantly working at a high speed throughout the day and continuing to do so each night and weekend? Are you doing so without spending time on a regular basis with friends and family? If you answered yes to both, you’re likely to find that your productivity decreases.

Solution: As many wise people have said, life is a marathon, not a sprint. Thus, focus on being exceptionally productive in eight hours rather than moderately productive in ten or twelve. It’s wise to use that extra time at the end of the day to go home and be with your family, or to enjoy a favorite activity with friends.

Read on at BONEZONE® for the rest of these critical tips and techniques. 

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.