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Articles of Interest

December 12, 2018 | FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

By John Gagliardi

The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities and bureaucratese. FDA has been accused of going overboard when it comes to clearing or approving medical devices for use in the U.S., and because of the invasive concept of “marketing and selling in a global marketplace,” companies are finding that they can do business in other countries without red tape and inconsistent regulations. For example, FDA-related legal terms and their meanings are sometimes non-uniform, even within the U.S. regulatory system.

Yes, the U.S. remains the largest orthopaedic device market. But my observation is that not all companies are interested in running the FDA regulatory gauntlet—a disturbing trend.

The president of a mid-sized medical device company in Europe recently told me that it wasn’t worth the agita to submit a premarket notification for his Class II devices. So, we didn’t. His company has decided to market in Asia and Europe before they entertain a U.S. clearance. Another medical device client in China is only conducting business in China and Southeast Asia to avoid “unnecessary regulations” and the probability of executing a clinical study on a product that has been in use for 20-plus years.

Ex-U.S. markets are spending money on ex-U.S. medical devices because the world economy is not just made up of the U.S. and Europe. Recognizing this environment, FDA continues to choose strategic priorities to streamline the U.S. regulatory process.

Laying the Groundwork

FDA updates its strategic priorities about every four years to ensure that its plan aligns with its annual performance reporting in congressional budget justifications. It sets forth the agency’s intentions to streamline and improve its operations.

Worldwide, FDA has one of the most laborious regulatory standards for protecting public health. Counter to that, the agency has been historically under-funded, which causes inconsistency when it comes to making changes and addressing the challenges of products manufactured overseas. Because of both high regulatory standards and lack of sufficient funding and program-centric challenges, U.S. citizens have waited up to four or more years for access to lifesaving devices.

Of deceptive importance, there must be robust scientific evidence that a device is safe and effective before approving that product for the U.S. market. Maybe it’s too robust. Maybe FDA has gone overboard. The world marketplace is not viewing the so-called allure of selling products in the U.S. as a necessity to be successful.

FDA chose its strategic priorities over the past five years and for the next four to address this problem. The agency has tried to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle, while not compromising the reasonable assurance of a stringent safety and effectiveness standard.

By advancing a Total Product Life Cycle Approach (TPLC), the user fee program has supported and advanced the agency’s efforts. In doing so, the aim is now toward helping innovators choose the U.S. marketplace, rather than be stymied by a complex and cumbersome regulatory process.Personally, based on my perspective of submitting market clearance documentation, the results are off-center. At the same time, FDA has tried to preserve a top-shelf safety and efficacy standard with the need for rigorous science, upon which American patients rely for quality healthcare. Using flexible, patient-centered benefit/risk models, collaborating more with customers, streamlining internal processes and applying a least-burdensome approach, FDA hopes to be more successful in coming years. 

We’ll see. Promises from 35,000 feet are one thing; feet-on-the-ground reality is a different scene when there is confusion at the top echelon level.

Read more at BONEZONE®. 

November 29, 2018 | Professional, Personal Success Linked to Knowing Yourself and Achieving Your Goals

By Rob Meyer

Keys to professional and personal success include leveraging your particular individual strengths, as well as setting and achieving your goals. As demands upon our time continually increase in a world that never slows down, these “life hacks” provided by orthopaedic industry veteran G. Bryan Cornwall, Ph.D., MBA, PEng, were both relevant and relatable to his OMTEC® 2018 audience earlier this year.

Dr. Cornwall is eminently familiar with the orthopaedic device professional perspective. He worked at NuVasive from startup (venture capital-backed with ~10 employees and zero revenue in 1999) to a global spine player, with more than $1 billion in market capitalization.

Dr. Cornwall has called upon subsequent decades of training and managerial experience (including 20 years in the medical device industry), along with his academic credentials (mechanical engineering professor) to back up a position from which he can share insights that helped him successfully hone his professional and personal development skills.

I found Dr. Cornwall’s OMTEC presentation to be informative, enlightening and thought-provoking. The following represents what I felt were his most impactful points. In knowing the challenges that orthopaedic professionals like you often tell us that you face, I believe that you, too, will find these points to be useful in your daily endeavors.

Point #1: To effectively leverage your strengths and perform better, you need to understand YOU.

“The better you understand you, the more productive you can be,” Dr. Cornwall stated in his presentation. What does that mean? Simply put, it is impossible to capitalize upon your strengths if you are unaware of your strengths. Ask yourself these questions:

  • What inspires me?
     
  • What motivates me?
     
  • What am I good at?
     
  • What am I passionate about?


Dr. Cornwall reiterated throughout his presentation that having a solid understanding of you is critical for any kind of success. Think of this level of self-understanding as building a house upon a solid foundation; without it, the rest will crumble.

Read more at BONEZONE®.

November 20, 2018 | Synthetic Bioresorbables: Industry Evolution from PLLA to New Formulas

By Robert A. Poggie, Ph.D.

Bioresorbable synthetic polymers were first introduced as medical devices in the late 1960s for sutures made of glycolic and lactic acid-based polymers. They continue to have broad applications in orthopaedic devices and as a component in bioresorbable biocomposites, drug delivery, cardiovascular applications and regenerative medicine. Further, current research and investments indicate a future where new bioresorbables will replace the current materials in orthopaedics.

The basis for developing bioresorbable devices was to eliminate the need for re-operation (e.g. sutures, bone screws and plates), eliminate stress shielding and enable normal regeneration of tissue, improve imaging capability and improve ease of revision.1,2 The early research of bioresorbable polymers led to the definitions of bioresorption in the context of degradation of polymers in vivo, and importantly, the degradation of products being safely metabolized and resorbed within the body while not eliciting an adverse reaction, and causing minimum consequences to the patient.

David F. Williams, Ph.D., Professor at the Institute for Regenerative Medicine at Wake Forest University, is considered one of the world’s leading authorities on biomaterials. Professor Williams has defined bioresorption as “the process of removal by cellular activity and/or dissolution of a material in a biological system.” The foremost performance requirement is biocompatibility, defined as “the ability of a biomaterial to perform its desired function with respect to a medical therapy, without eliciting any undesirable local or systemic effects in the recipient or beneficiary of that therapy, but generating the most appropriate beneficial cellular or tissue response in that specific situation, and optimizing the clinically relevant performance of that therapy.” The criteria for the ideal bioresorbable polymer is defined as: “does not evoke an inflammatory/toxic response, disproportionate to its beneficial effect; is metabolized in the body after fulfilling its purpose leaving no trace; is easily processed into the final product form; has acceptable shelf life; and is easily sterilized.”2

Read more at BONEZONE about the industry's transition away from Poly-L-lactic acid (PLLA)-type resorbable polymers to updated and novel resorbable biomaterials that are designed to perform better clinically.

November 07, 2018 | Orthopaedic Product Development: Forecasting Changes to Come

By Deborah Munro, D.Eng.

The orthopaedic industry has been in a steady state of incremental to slow product advancements. I anticipate that will change in the near future. There are a host of factors playing into what I believe will be a decade of rapid and radical change, and savvy device companies will be ready to respond to new market needs.

So, what forthcoming changes can we anticipate in surgical techniques, indications, technologies and regulations? Here are seven shifts that device companies should consider when choosing new product development initiatives.

Smart Implants

In almost every healthcare market outside of orthopaedics, medical devices incorporate electronics and sensor technologies; even the Internet of Things inundates the market with health monitoring devices. An opportunity exists in orthopaedics to incorporate smart implants that are capable of providing diagnostics, health status and other alerts to the patient and their physician.

To prepare to sell in this market, it’s imperative to learn what is possible with electronics. Consumer electronics shows and niche conferences on medical sensors and implantable devices are great places to learn about the latest innovations. Once companies are aware of electronic advancements, they can determine which products are suitable candidates to convert into smart devices that may provide additional, useful information, thus changing the industry paradigm.

Customization

With the increase of additive manufacturing technologies for implants occurring in parallel with enhanced imaging capabilities and robotic-assisted surgery, I believe there will be a portion of the market that will move away from standardized implant sizes.

Patient-specific implants are becoming a cost-effective solution. This shift will improve outcomes and reduce inventory and fabrication costs. OEMs should consider investing in these new technologies, particularly additive manufacturing using titanium. Spinal implant companies use this technique, and the potential exists to make hip stems, tibial trays and reconstructive plates quickly enough to be used in these larger markets.

Used in parallel with advanced imaging techniques and precision robotic-assisted surgery, the advantages will become obvious, increasing demand by both surgeons and their patients.

Read more at BONEZONE®.

October 24, 2018 | New Healthcare Investment Firm Mend Medical Debuts

Mend Medical, a new Fort Wayne, Indiana-based healthcare investment firm, has launched.

Mend Medical will focus on healthcare companies “dedicated to improving accessible, affordable, quality patient care and eliminating incentives that put profits ahead of patients,” according to a press release.

“Our strategy is to identify and invest in companies that are changing healthcare right now,” said Ben Joseph, President of Mend Medical. “We're looking for unique, innovative technologies and leaders that are frustrated with the status quo and are passionate about making change happen. We're partnering with operating and early stage companies to create a collaborative network of bold leaders that are building a better healthcare economy.”

Joseph spoke at the 2018 Musculoskeletal New Ventures Conference (MNVC) to introduce the company's investment strategy and interest in exploring partnerships that advance musculoskeletal treatments. 

Mend Medical currently manages a group of legacy medical technology investments on behalf of parent company Ambassador Enterprises, a philanthropic equity firm, also based in Fort Wayne.

Source: Mend Medical

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 Simpliciti 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®