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December 10, 2019 | Orthopedic Surgeon Advocates for Digital Technology Adoption

Digital technology holds promise in revolutionizing how orthopedic care is delivered, from 3D printing to artificial intelligence to augmented reality (AR) to machine learning, robotics, sensors, virtual reality (VR), etc. While all of these tools are being adopted at varying speeds, they all lie at the forefront of development and deployment by orthopedic companies and implementation by hospitals.

One person pushing for digital technology advancement is Stefano Bini, M.D., a knee and hip replacement surgeon and Chief Technology Officer at the University of California San Francisco Orthopedics. Dr. Bini’s dedication to digital technology drove him to found The Digital Orthopaedics Conference San Francisco (DOCSF) to bring multiple stakeholders together—surgeons, hospitals, industry and investors—to discuss and solve challenges through digital health solutions.

DOCSF will be held on January 11-12, 2020. The conference sponsors (Stryker, Zimmer Biomet and DePuy Synthes) and speaker lineup (experts from Amazon, Google, Microsoft, Kaiser Permanente) indicate the wide range of companies seeking to disrupt orthopedic manufacturing, supply chains and patient care through digital tools.

Dr. Bini will draw on his background and information gleaned from DOCSF in his keynote at OMTEC® 2020 in June.

Before the two conferences, we asked Dr. Bini four questions about digital technologies as they relate to orthopedics. 

How would you describe the state of digital health integration in orthopedic care today?

Dr. Bini: Nascent. The collection and use of data to inform everything from product supply chains to sales cycles are just starting to impact the manufacturing sector in orthopedics. To some extent, the system has been very profitable for a long time and the margins robust. Therefore, the cost-cutting efficiency measures required of sectors with razor-thin margins have not been necessary. Digital health integration, in this context the delivery of care models, has similarly not seen a ton of pressure. All of that is about to change with the rollout of alternative payment models and other measures designed to decrease the overall cost of care without adversely impacting the quality and quantity of care. These two trends will require industry to invest in the digitization of their supply chain first, and provide digitally-enabled systems to their customers second.

What digital technologies do you recommend device companies focus on commercializing in 2020? Why?

Dr. Bini: It depends on the use case for the tech. If you’re trying to modernize your company around your product, the tech may be the same, but how you chose to implement it may differ. 3D printing can be used to make implants or instruments. Artificial intelligence and machine learning can be used to manage patients or support the sales team. VR and AR tools, similarly, can be products for sale or internally facing. Generally, sensors are hot in orthopedics because musculoskeletal medicine is the science of motion, and sensors detect motion well. Predictive analytics are really hot because they can be used to help a group assume risk. Telehealth is also mature and can include remote physical therapy platforms, which can now be paid for under the latest Medicare codes.

Contiue reading for more on DOCSF and digital health technologies.


November 01, 2019 | Startup Blends 3D Printing Open-Ecosystem and Clinical Expertise

In 2012, surgeon brothers Alan BC Dang, M.D., and Alexis BC Dang, M.D., started working with 3D printing. In the short time since then, they’ve gone all-in on additive manufacturing, starting multiple programs at the University of California San Francisco (UCSF) and the university’s VA Medical Center, as well as serving as founding members and co-Chief Medical Officers of the new company, PrinterPrezz. In the course of a day, their 3D printing efforts touch patients, surgeons, students, device companies, contract manufacturers and service providers.

What entices them about 3D printing? “It makes our lives easier and our patients’ lives better,” Dr. Alan Dang said. “Innovative ideas can reach the market more quickly and technologies that enhance safety, performance, ergonomics and efficiency are all welcome.”

We came across Dr. Alan Dang, a spine surgeon, and Dr. Alexis Dang, a sports medicine surgeon, when PrinterPrezz came out of stealth in December 2018. The company was founded by the surgeons along with its Chief Executive Officer, who comes from the semiconductor industry, and Chief Operating Officer, who has a background in big tech, including Apple.

PrinterPrezz has an interesting open-ecosystem business model and collaborates across the supply chain with companies like GE Additive, Materialise, nTopology, Renishaw and SI-BONE out of its facility in Fremont, California.

How does the company’s structure work? What is the future of 3D printing in orthopedics? We asked Dr. Alan Dang for his perspective.

October 09, 2019 | MNVC to Provide Startup and Investment Forecasts

Startups are engines of innovation for the orthopedic industry, and attendees of the Musculoskeletal New Ventures Conference (MNVC) will receive an outlook on these companies from product ideation, investment and acquisition standpoints.

“We’ve seen a lot of peaks and troughs in the 17 years we’ve been hosting MNVC. With that perspective, I would describe the current [startup] environment as healthy,” said Gary Stevenson, Co-Founder and Managing Partner of MB Venture Partners, who hosts MNVC along with Memphis Bioworks Foundation. “During MNVC, we will explore the strong areas (extremities) and the weaker ones (spine), with presenting companies from all segments.”

Held October 29-30 in Memphis, MNVC is expected to attract 200 professionals and connect musculoskeletal startups and entrepreneurs with investors, including capital funds, angels and strategics.

(ORTHOWORLD is an MNVC sponsor, and we’ll be attending the conference.)

The Emerging Companies and Technologies

Twenty-two private companies developing new and emerging technologies, including hardware, biologics, software and diagnostics, are expected to provide pitches at MNVC.

Well-known companies and industry veterans will speak, including Spinal Elements and its President and Chief Executive Officer Jason Blain, as well as Anthony Viscogliosi, John Viscogliosi and Marc Viscogliosi, who will represent Woven Orthopedic, Centinel Spine and Spine BioPharma, respectively. Memphis-based companies Active Implants, CrossRoads Extremity Systems and SweetBio will be returning to provide updates.

In reviewing the lineup of presenters, we found the number of software companies to be of interest. Augmedics, Muvr Labs, OrthoGrid and Statera Spine are on the agenda and offer solutions throughout the continuum of care. It makes sense. Orthopedic strategics have been purchasing and partnering with software startups to gain access to their technology and their people in recent years.

Convergence of the software and hardware spaces remains in a nascent stage, with progress needed to achieve its full potential, Stevenson said.

“For example, we have presenting companies that are developing products that tap the potential of 3D-augmented reality in the operating room. Others have established databases of thousands of electronic images that could be critical in rapid fine-tuning machine learning solutions. Others use software and hardware to improve surgeon and robotic visualization,” Stevenson said. “The potential of combining software and hardware to create new solutions is an investment theme that has dramatic potential for the next 10 years.”

Read the entire preview.

September 05, 2019 | FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

In considering that the NASS 2019 Annual Meeting is weeks away, I thought it an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. 

This round-up shares another entrant into the SI joint arena, a first clearance for an enabling technology for a company that already has implants on the market and additional details about some lesser-known companies to watch.

Biofusion Medical | SI-Restore Sacroiliac Joint Fixation System, K182919

  • First ortho-related 510(k)
  • Filed October 2018, granted January 2019
  • Cannulated titanium screw and washer affixed to screw head for full cortex engagement
  • Uses guide pins for accurate prep and placement of the implant
  • About the company: located in Texas, very limited information available; will be watchful for future activity


Evolution Spine | Whistler Modular Pedicle Screw, K182478

  • Filed September 2018, granted January 2019
  • All components made from titanium alloy, provided non-sterile and sterile forms
  • Manual instrumentation for implantation of the system available for conventional and minimally invasive procedure
  • About the company
  • Founded in 2015; located in Texas
  • Portfolio includes plates and interbody devices for ACDF, ALIF, TLIF and TPLIF approaches
  • Focused on incorporating innovative coatings and packaging to reduce infection potential

Read more at BONEZONE®.

July 25, 2019 | Capitalize on These Opportunities in the Emerging Outpatient Surgery Market

By Patrick Vega, Vizient Advisory Solutions

The purpose of this quarterly column is to introduce and discuss key considerations for device companies from the perspective of their customers: hospitals, health systems and physicians. This article provides a description of ambulatory settings and strategies, and suggests ways that device companies can capitalize on the shift from inpatient surgical settings to hospital outpatient departments, ambulatory surgery centers (ASCs) and outpatient sites of care. The collective contributors to this article hypothesize that device companies that better understand the outpatient setting can more effectively adapt their products, services and support to meet customer needs.


The historical model for orthopedic and spine procedures has been inpatient focused, resulting in high revenue and high margins and requiring extensive infrastructure and resources. The emerging model is both inpatient and outpatient. The principal reasons for this shift include:

  • Patient preference for a least restrictive level of care coupled with the convenience of proximate and community-based care
  • First-time or enhanced reimbursement for outpatient-based procedures, which might include reimbursement models like bundled payments or site-neutral reimbursement
  • Improved technology and patient safety; these include pain management techniques, outpatient patient care pathways, minimally invasive surgical techniques, patient selection and highly defined treatment protocols


Orthopedic outpatient procedures are expected to surge in the coming years. The left-hand column in Exhibit 1 describes overall population increases in the U.S. and increased forecasts for orthopedic outpatient volume growth as captured in the population-based forecast bars. Due to the increased movement of higher acuity orthopedic procedures to outpatient settings, such as spine and joint replacement surgeries, Sg2 predicts a 13% increase in outpatient orthopedic surgeries in the next five years, outpacing the increase of population growth alone. In Exhibit 1 Sg2 projects that outpatient hip and knee replacement surgeries will increase over 200% in the next five years with growth projected to be 580% for hip replacement and 752% for knee replacement over the next ten years. 

See the exhibit and read the full article in ORTHOKNOW®.

June 18, 2019 | 3 OMTEC Takeaways: Personalized Medicine, Data and ASCs

During the opening keynote panel at OMTEC® 2019, a group of executives spoke about the future of the orthopedic industry, answering the questions: How will technology personalize the patient’s experience? What role will data play in surgeon and device company decision making? Will companies’ strategies for implant design and the supply chain change to meet the needs of the growing ASC market?

The keynote was moderated by Mike Mogul of HealthpointCapital, who is most known for his leadership roles at Stryker and DJO Global. The device company executives on the panel—Rob Ball, Genesis Innovation Group; Vernon Hartdegen, CrossRoads Extremity Systems and Andy McLeod, Corin USA—often turned the questions to the surgeon panelist, Padraic Obma, M.D., of Strive Orthopedics and owner of an ASC.

We offer three takeaways from their discussion.

Better Personal Care through Advanced Technology

Dr. Obma said that he will delay patient’s surgery if they haven’t met their exercise goals in the six weeks leading up to the procedure. He knows if they’ve met their goals because his company, Strive Orthopedics, uses mobile software and wearable technology to measure their actions.

“We take it seriously enough to where we’ll cancel or reschedule surgery if they’re not engaged,” said Dr. Obma. “A bigger cost to us is not the case we didn’t do, it’s the case we did and had a complication afterward.” 

Patient-facing technology works because it makes patients feel connected; it increases engagement and improves outcomes, Dr. Obma said. Personalized care through remote access will be a “shift in dynamics.”

Mr. McLeod suggested that this shift in dynamics will also create more personalized implant technology, giving patients better long-term results. Even with off-the-shelf implants, Mr. McLeod said that surgeons will be better able to plan for sizing before the operation. And as robotics advance, surgeons can better plan for customized implants that are more highly personalized to the patient. The evolution of this technology will force the orthopedic industry to look differently at implant design, he said. 

For example, within the next two years, Mr. McLeod believes that there will be a greater understanding of each patient’s soft tissue structure. “If you’re able to preoperatively predict ligament tension or soft tissue involvement within the joint, you’re going to see much different implants,” he said. “Every patient is different; every patient has different soft tissue.”

Corin recently purchased OMNI Orthopedics and its robotic system, which features tools to measure ligament function. Hospitals and patients have shown that they’re willing to pay more for technology, Mr. McLeod said, and the number of people willing to pay will increase as costs come down. With total hip and knee replacement expected to surge by 2030, better care will be essential. Mr. McLeod said that better care means software and technology that produces results based in evidence, not simply bragged about in marketing.

Enhanced Data Leads to Improved Results

While Dr. Obma said that the data Strive receives through its patient-facing app has helped improve care, his company and most others are still in the data collection stage.

Soon, that will change when companies with technology like apps, navigation and robotics are able to aggregate and disseminate the data to help create better procedure and implant insights and results.

When optimally leveraged, data will work for the orthopedic industry just as game film works for football coaches, Dr. Obma said. Football coaches can identify successful strategies when watching game film, whereas surgeons will be able to look at surgery data to confirm why a knee replacement turned out well. This will allow surgeons to refine their processes, ridding themselves of poor techniques and focusing on what works best.

“That certainly benefits the provider and the patient,” he said. “If we can extend the longevity of the implant five to 10 years, that’s a massive impact in terms of cost savings for the country and the world.”

Mr. Hartdegen said that better data has led to better preoperative planning and intraoperative adjustments.

“It’s predictability,” he said. “It needs to be patient specific and procedure specific.”

Right-size Implant and Instrument Sets for ASCs

Orthopedic procedures continue to move away from the hospital because outpatient settings have demonstrated the ability to increase patient satisfaction and lower the cost of surgery. Device companies have been forced to execute on new product and supply chain strategies, including a smaller number of implants and instrument trays.

This change has been noticed by doctors and nurses alike, making surgery easier for both groups. Mr. Ball noted that he’s seen nurses fist-bumping at how easy it is to have a single tray of instruments, and has had surgeons ask him, “Where’s all the stuff?”

“It feels good to get that kind of feedback,” Ball said. 

This smaller footprint has changed the way that surgeons and nurses operate, and it’s also changed the way that device manufacturers produce. Hartdegen said that he now gets questions like, “How much shelf space will these instruments take up?”

“I can tell you early in my career as an engineer, I did not think about shelf space,” he said.

The panelists agreed that personalized medicine, data and ASCs are the future of orthopedics and device companies of all sizes must embrace strategies to leverage these shifts.

Hal Conick is an ORTHOWORLD® Contributing Editor. 

June 06, 2019 | Orthopedic Robot Recap: Today's Players and Strategies

It's been an active year for robotic and digital surgery developments. New entrants into the orthopedic robot market like Zimmer Biomet’s ROSA Knee may lead to longer buying cycles as hospital administrators thoroughly evaluate each option. As the adoption of digital surgery tools increasing, leadership from joint replacement and spine companies are indicating that they have seen a direct sales benefit from upselling and product pull through.

For more on this trend, read our year-to-date recap with comments from Medtronic, Stryker and Zimmer Biomet (Member only) or view our Robots in Orthopedics infogaphic.

May 17, 2019 | Meet Future-Minded Orthopedic and Spine Surgeons at OMTEC 2019, June 11-13

A select group of orthopedic surgeons will share their insights and ideas with industry professionals at OMTEC®, the 15th Annual Orthopaedic Manufacturing & Technology Exposition and Conference, June 11-13 in Chicago. Surgeon speakers Include a world leader in robotic surgery, a past president of the American Academy of Orthopaedic Surgeons (AAOS) and a co-founder of Global Spine Outreach.

In the Keynote Panel, Innovation in Orthopedics, three surgeon panelists will share perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for hospitals and ASCs.

The Surgeon Pod, sponsored by Elos Medtech, is exclusively staffed by surgeons with deep engineering, entrepreneurial and “get it done” backgrounds. The Surgeon Pod experience is ideal for executives, engineers and regulatory staff seeking opportunities to speak one-on-one with surgeons.

Over the course of two days, surgeons will speak on the future of:

  • Artificial Intelligence and Augmented Reality
  • Digital Health and Wearables
  • Hospital and ASC Inventory Logistics
  • Orthobiologics in Trauma Procedures
  • Advanced Materials in Spine Surgery
  • Personalized Implants in Joint Replacement

Conference education is steered by OMTEC’s Advisory Board, boasting representation from market leaders and key players DePuy Synthes, Zimmer Biomet, Stryker, Arthrex, Smith & Nephew and Medtronic. OMTEC 2019 speakers include experts from Aesculap, Camber Spine, Corin USA and Orchid Orthopedic Solutions.

Registration is open and interested parties are encouraged to visit the conference website, www.OMTECexpo.com, where they can learn more and confirm their participation. All told, nearly 1,200 participants are expected.


May 02, 2019 | Surgeon Says, Orthopedic Coatings Expected to Rapidly Evolve

Dr. Stuart B. Goodman is the Robert L. and Mary Ellenburg Professor of Surgery, and Professor in the Department of Orthopaedic Surgery and (by courtesy) Bioengineering at Stanford University. His clinical research interests center on the outcome of surgery to treat arthritis, including primary and revision total joint replacement, juvenile arthritis and osteonecrosis of the hip and knee. His basic science interests center on biocompatibility of orthopedic implants, inflammation and musculoskeletal tissue regeneration and repair. Search the internet for biologic coatings, and his research is one of the first results.

What important roles do biologic coatings play in orthopedic implants?

Dr. Goodman: The first thing to know about biologic coatings is that work needs to be done to truly understand the effectiveness and possible risks of regularly incorporating them in orthopedic implants. However, we know that the potential is there to diminish some of the existing risks of implants.

For example, we’re hopeful that biologic coatings may reduce the risk of infections associated with orthopedic implants. There is also potential for coatings to treat infections internally. When it comes to revision joint replacement, specifically when the host bone or biological environment is suboptimal, it may be possible to change the surface with coatings or other treatments that could help with osseointegration. But before the scientific and medical communities can definitively make these claims, we need more comprehensive studies using the right technology with optimal controls in order for coatings to be proven as both safe and effective, as well as cost effective.

Read more at BONEZONE®.

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.


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