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Articles of Interest

April 04, 2019 | How the European Union's MDR Will Impact Your Company's Supply Chain

Clinical data requirements tend to dominate conversations about the forthcoming EU Medical Device Regulation. To understand the impact the regulation will have on your company as a whole, you must grasp how it affects your supply chain and engage your partners in discussions about the information you need from them—and they need from you—to meet regulatory requirements, your timeline for CE Mark Approval and critical considerations for audits.

To put MDR supply chain changes into perspective, we asked Mike Wolf, Director of Solutions Delivery at Maetrics, to outline points of discussion for you and your suppliers.

How will MDR impact the orthopaedic device supply chain?

Wolf: MDR identifies distributors, importers and EU authorized representatives as Economic Operators, each with specific responsibilities regarding verification of compliance, cooperation in complaint handling and field safety corrective actions, and cooperating with manufacturers and Competent Authorities in device traceability. Manufacturers should review agreements with distributors, importers and authorized representatives to ensure that the interactions with these Economic Operators are clearly defined and agreed upon.

As manufacturers begin the task of achieving the CE Mark for their devices against the MDR, they need to have more data as evidence in support of compliance to the General Safety and Performance Requirements (GSPR). Suppliers can expect to receive requests from their manufacturer partners for additional data as the manufacturer must ensure that each applicable requirement in the General Safety and Performance Requirements (GSPR) is addressed in a comprehensive way.

For example, suppliers of certain types of materials or components that contain CMRs (carcinogenic, mutagenic or toxic to reproduction) may need to cooperate with manufacturers to collect data, perform additional testing if required to demonstrate compliance with the 0.1% by weight limit, and if necessary, discuss with the manufacturer the possibilities for a material change or a rationale for continued use of the material.

As another different example, suppliers of software or components of electrical devices employing software may need to cooperate with manufacturers to demonstrate evidence of adequate IT security measures, including protection against unauthorized access necessary to run the software as intended.

Read more at BONEZONE®.

March 15, 2019 | Here's How Hospitals Want to Collaborate with You

For hospitals, the combination of changes in reimbursement, physician employment and the ever-present drive to improve quality while reducing cost has resulted in an inflection point in the healthcare industry that has prompted device manufacturers and hospital innovation to navigate uncharted waters.

While many manufacturers have endeavored to more effectively and strategically engage with customers, there is still great opportunity and challenge in doing so. For this column, I interviewed three thought-leading colleagues, asking, “What should device companies (vendors) consider when attempting to grow their business with providers?” I’ve also added my experience and insights gained from work in strategic assessment, planning and development in orthopedics and spine.

Opportunity and Challenge

By intimately understanding provider customers and their product use cycle, device manufacturers can forge deeper relations that embed their products and themselves as preferred partners and ideally, expand the traditional supply boundaries and develop strategic partnerships with executive administration leadership.

What Do Hospitals/Health Systems Want Now?

In the constantly changing reimbursement environment, hospitals are scouring their organizations to reduce cost while improving quality. Current terms that describe these processes include value analysis, low-cost/high-value, process standardization, value-based reimbursement, vendor consolidation and physician/hospital partnerships.

Additionally, the Institute for Healthcare Improvement (IHI) has pioneered a model for change, The “Triple Aim” that focuses on 1) improving clinical outcomes for populations, 2) reducing costs and 3) improving patient satisfaction as illustrated in the following graphic.

There is potentially a role for OEMs in this industry-wide initiative, not only delivering cost savings but also incremental service line benefits such as tools and insights to increase market share, redesign care, create differentiation and substantiate demonstrable quality. During the last 10 years, some OEMs have built or acquired “value-add” businesses with the intention of impacting hospital service lines beyond product and price. While providers have been open to such attempts, some value-add business units have devolved or been eliminated, ostensibly due to insufficient return on investment or a fundamental clash of internal cultures; sales versus service line redesign.

Read more at BONEZONE®.

February 25, 2019 | AAOS Preview: First-Time Exhibitors, New Offerings on the Exhibit Floor

The American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting is taking place March 12-16 in Las Vegas. The popular destination is expected to draw ~4,000 more attendees (total of ~30,000) and more exhibitors (~650) than last year’s meeting in New Orleans.

Each year, I invest a few hours studying the exhibitor list because I’m genuinely interested to know who is participating. Without fail, a select few companies always spark my interest because they’re new to me or because I don’t recall having dug into what they do. Have a look at 10 companies that have never exhibited at AAOS…perhaps they are your newest competitor, acquisition target, provider or customer.

By the way, our home base on the exhibit floor is booth #659. If you’ve never visited, please do. We always have a comfortable seat, a cold drink and an ear for your challenges!

February 11, 2019 | Osso VR Gains Funding in Support of Virtual Reality Surgical Training

Osso VR, developer of a virtual reality surgical training and assessment platform, received $222,596 from the National Science Foundation's Small Business Innovation Research Program. Funds will support research and development to advance the product with automation and artificial intelligence technology.

The Osso VR offering provides realistic, haptic-enhanced interactions in an immersive, repeatable training environment–an alternative to cadaver lab education. Individuals or teams wearing off-the-shelf gaming hardware, like Oculus, insert themselves into a virtual O.R. with all that they need to perform a procedure. Users are scored after each training module based on mastery of steps, precision and efficiency. Assessing technical skill in virtual reality has the potential to significantly improve patient outcomes by highlighting a surgeon’s procedural mastery or shortcomings after completing each of Osso VR’s training modules.

Read more at BONEZONE®.

January 22, 2019 | FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

By John Gagliardi

I began my career in the medical device and pharmaceutical industries in 1970 and have had the opportunity to see FDA’s 510(k) process evolve first-hand. From a standpoint of effectiveness and efficiency, the Premarket Notification process has certainly had its ups and downs since its origins in 1976.

Why the history lesson?

Because after 42 years, FDA announced several changes to keep up with new technologies and more sophisticated approaches to healthcare.

For medical device companies, the most important of these changes came in 4Q18 when as part of its new Medical Device Safety Action Plan, FDA announced a strengthened and more modern 510(k) pathway, used for clearance of low- to moderate-risk devices. This new pathway has a focus on predicate medical devices 10 years old or less. This framework is aimed at efficiently advancing beneficial technology to patients, while congealing FDA’s high standards for safety and efficacy. FDA is reaffirming its commitment to protecting patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.

The Need for Modernization

In 4Q18, FDA broadcasted changes to modernize the 510(k) clearance pathway, which accounts for the majority of devices that FDA reviews every year. In 2017, the Center for Devices and Radiological Health (CDRH) cleared 3,173 devices through the 510(k) pathway, representing 82% of the total devices cleared or approved.

The Safety and Performance Based Pathway (finalized by FDA on January 22), focuses on progressively improving safety and performance of new products. The submitting company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by FDA and reflect current technological principles in the industry. New devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. At the same time, the agency is reportedly going to pursue additional actions that will allow it to sunset outdated predicates, especially in cases where the industry has seen safer or more effective technology emerge. 

The 510(k) process allows FDA to recognize that medical devices exist across a continuum of complexity and risk, and that the scope of premarket review should reflect this risk-based approach. This is a contemporary slant to the regulation. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes, wouldn’t be efficient in advancing beneficial new technologies to patients and wouldn’t allow FDA to effectively prioritize its scientific resources.

Read more at BONEZONE®.

January 07, 2019 | NuVasive Announces New Organizational Structure, Streamlined Leadership Team

By Rob Meyer

NuVasive announced a new organizational structure and associated executive team selected by Chief Executive Officer J. Christopher Barry.

Mr. Barry succeeded Gregory T. Lucier as NuVasive’s CEO, effective November 5, 2018.

“Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability,” Mr. Barry said in a press release.

Mr. Barry, who most recently served as a senior vice president at Medtronic, has kept most NuVasive executives in place and expanded  certain of their roles. The following people will report directly to Mr. Barry. These personnel changes went into effect January 3:

  • Matt Link, promoted to President in November, will continue to serve in that role, but in an expanded capacity to include direct management of NuVasive Clinical Services and Global Logistics.
     
  • Jim Garrett, Chief Compliance Officer and leader of the company’s Global Risk and Integrity (GRI) function, will assume an expanded role overseeing Business and Quality Systems functions, including GRI, Regulatory Affairs/Quality Affairs, Information Technology and Environmental Health & Safety.
     
  • Lucas Vitale is named Chief Human Resources Officer. Mr. Vitale most recently served as Vice President, Human Resources and Sales Training.
     
  • Dale Wolf will continue to oversee the company’s manufacturing efforts, including the facility in West Carrollton, Ohio. Mr. Wolf was hired in 2H18 and is a former GE executive with 20 years of medical device manufacturing experience. As noted in its 3Q18 earnings call, by the end of 2018, NuVasive anticipates producing about 70% of the SKUs planned for self-manufacture.
     
  • Raj Asarpota will continue to serve as Executive Vice President and Chief Financial Officer.
     
  • Nate Sisitsky will continue to serve as General Counsel and Corporate Secretary and lead the company’s legal department as well as the NuVasive Spine Foundation. Mr. Sisitsky will also oversee the company’s Real Estate and Facilities function.
     
  • Suzanne Hatcher will continue to lead the company’s Internal and External Affairs functions, including Investor Relations, Public Relations and Internal Communications.
     
  • The positions of Executive Vice President, People and Culture and Executive Vice President, Global Process Transformation, previously held by Pete Leddy and Stephen Rozow, respectively, have been eliminated.


NuVasive’s Global Commercial regional leaders include Paul McClintock (U.S.), Erin McEachren (Europe), Takaaki Tanaka (Japan/China) and Jim Abraham (Australia/New Zealand).

NuVasive has continued to perform above market growth as its undergone multiple transitions at the CEO and executive leadership levels since 2015. The company announced preliminary 4Q18 revenue of $288MM, +6% vs 4Q17, and full year 2018 revenue of $1,102MM, +7.2% vs. 2017. 

NuVasive will announce full FY2018 revenue results in late February.

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.