In anticipation of our annual end-of-year feature article by ODT Managing Editor, Michael Barbella, two questions were posed to the brand’s Editorial Advisory Board members. As always, a great response was provided to the following questions.

• What news headline, event, or technology was the most significant in 2019 and why?
• What’s one expectation you have for 2020 that will make an impact on the medtech industry (i.e., what will you be keeping an eye on?)

Following are the responses provided by a number of board members. Take a moment to peruse the responses to see if you agree with the board members or if you have your own perspective on the questions. Further, if you’d like to share your thoughts with me, they may be used in a future feature on the ODT website. Provide those thoughts to me at sfenske@rodmanmedia.com.

Note: These responses were provided throughout October 2019, so that should be taken into account given events that have occurred since that time period, which may alter how a given response is viewed.

Linda Braddon, Ph.D., President, Secure BioMed Evaluations
A Look Back and Gazing at 2020—For SBME clients, the issues surrounding ethylene oxide sterilization and closure of EO locations due to emissions concerns were the most important in 2019. Many medical devices are sterilized via EO and closure of multiple EO facilities is hitting the radar of some of my clients who do not have a Plan B for sterilization. I unfortunately expect more of the same in 2020.

Lee. T. Crowe, Vice President, Sales and Marketing, Tegra Medical
A Look Back—The opioid abuse crisis is a massive problem that continued to be in the headlines in 2019. This year, the National Safety Council found the odds of dying from an opioid overdose were higher than those for dying in a vehicle crash. At least we saw the beginnings of some accountability for this in 2019, with many lawsuits against the drug manufacturers.

Gazing at 2020—Continuing on the theme of the opioid crisis, I expect the medtech industry will focus even more on developing new and safer ways to manage pain. Not all pain relief comes in the form of a pill. There are injectable treatments that can require specific devices and specialized needles to deliver the medicine. One example already on the market uses cryoanalgesia, which is a cold therapy that offers pain relief by preventing nerves from transmitting pain signals. So, you give this to someone who has had a knee replacement and his need for opioids to manage the pain goes way down. Maybe it even lets him decline them completely. I expect we’ll see a lot more products touting their ability to reduce opioid use.

Lisa Ferrara, Ph.D., Owner/President, OrthoKinetic Technologies & OrthoKinetic Testing Technologies
A Look Back—With the advent of 3D printing in metals and expanding into polymeric materials prior to 2019, the ability to print medical devices with open architectures and porous interfaces that engaged tissue incorporation had led to taking the 3D printing process further.

Bioprinting of tissue, such as skin, nerves, bone, and organs, has started to gain momentum, although still in its early stages. The ability to eventually print organized complex tissue structures with the patient’s own tissue to produce a functioning heart, for example, is revolutionary and can change the way medicine is practiced in the future. This has led to significant growth in the field of regenerative medicine.

Gazing at 2020—I expect to see an increase in sophisticated Smart technologies on the market from medical wearables to implantable devices that can sense changing stimuli and automatically respond to that stimuli via wireless transmission. However, with an increase of these medical technologies on the market, there will be a greater need for increased cybersecurity.

David Kelman, Chief Development and Compliance Officer, Sterile Edge Inc.
A Look Back—The wide adoption of robotic surgery in orthopedics, from joint replacement to spinal surgery, was prevalent; it is ushering in a new wave of possibilities. Beginning to see the emergence of additive manufactured products being introduced to the market was also noteworthy.

Gazing at 2020—The CMS move for payment of total knee replacements in ambulatory surgical centers (ASC) will have a significant impact for providers and medical device companies. The number of low co-morbidity patients will begin to be transitioned to the ASCs. Hospitals will have to manage the remaining patients not to impact their budgets or the HCAPs negatively. The ASCs aligned with the minority surgeon ownership unifies the surgeon and administration into basically one. The medical device manufacturers will have to negotiate with a well-informed and unified purchaser.

Dave Neal, President and Founder, STAT Design
A Look Back—Several items immediately come to mind that were newsworthy in 2019.

• Mirus received the 1st FDA approval of a new orthopedic biomaterial—molybdenum rhenium (MoRe)—used in its pedicle screw. The MoRe material is biocompatible, MRI and CT compatible, corrosion resistant, and ductile. It also features high tensile strength.
   
• Antimicrobial silver plasma coating, such as Biogate HyProtect, is addressing the largely ignored infection issue.
   
• FOBA is revolutionizing laser marking with an integrated vision system (fixtureless; randomly place parts in marking field; validated 2D UDI marking).
   
• Surface Dynamics’ XClean process to remove trapped 3D printed powder from medical devices.
   
• Vertebral body tethering as a fusion alternative for treating pediatric scoliosis, such as that from Zimmer Biomet.

Gazing at 2020—I’ll be keeping my eye on smart instruments/implants. The embedded sensors and electronics to obtain data and improve surgical accuracy offer numerous benefits.

Thor Rollins, Director of Toxicology and E&L Consulting, Nelson Laboratories
A Look Back—For me, it’s been the implementation of MDR and the change its had on the European regulatory arena. Companies are spending millions and scrambling to update device files to be ready for either an up classification or when they have to submit for renewal of their CE mark. The problem isn’t just the fact that many of these devices have been on the market for decades and have huge gaps per current standards but also that the Notified Bodies are struggling to be ready. Previously, there were as many as 75 different notified bodies to choose from; now we are looking to have under 40 that will apply for designation under MDR. As of right now, we only have 5 that are designated to approve devices under MDR and the deadline is May 2020. We have heard from companies that their notified bodies are telling them that it could take up to 6 months to even hear back from them, so unless we get an injection of designated notified bodies, I am not sure how we will be ready by May.

Gazing at 2020—Besides the circus of MDR designation and up classed devices, I am interested in the movement away from animal testing. We are working with the FDA to get approval of in vitro tests for irritation and thrombosis that will hopefully reduce the dependence on antiquated animal tests.

Chad Ryshkus, Director, Marketing and Product Development, MedTorque Inc.
A Look Back—Robotics has now become pervasive in the orthopedic space with nearly every major orthopedic and spine OEM investing in the development or acquisition of a robotic platform. The potential advantages of robots in the OR are still being debated and demonstrated. Ideally, they present an opportunity for increasing efficiency in preoperative planning, reducing OR time and complications, and improving overall outcomes.

Gazing at 2020—The increasing number and types of orthopedic and spine procedures moving to ambulatory surgical centers (ASC) will challenge OEMs on how they service these institutions. ASCs lack the extensive infrastructure found in most hospitals; therefore, a trend toward simplified procedure kits and disposable instrumentation will become more prevalent in order to gain traction.

Christine Scifert, Executive VP, MRC-X LLC
A Look Back—More and more, companies are researching and developing artificial intelligence (AI) based technologies. FDA has approved technologies through the de novo pathway and introduced a guidance document regarding regulatory framework for AI/Machine Learning-Based Software in 2019. FDA continues to work with industry related to new and novel technologies.

Gazing at 2020—Just three words: Medical Device Regulation. May of 2020 is a milestone for the new regulations in Europe and everyone is waiting to see how it all unfolds.

Scott Shankle, VP Operations, MicroPort Orthopedics
A Look Back—The evolving implementation of the European Medical Device Regulation (MDR) is certainly one of the most significant developments in orthopedics this year. It seems to be clearly the most disruptive event going on in orthopedics, with imminent implications on product portfolios and the costs to maintain products on the market. It is also clearly further complicated by Brexit, where one of the largest orthopedic notified bodies is headquartered.

While the MDR is the first to come to mind, a case for “most significant” could certainly be made for additive manufacturing or the trends toward outpatient models and reimbursement.

Gazing at 2020—From a manufacturing and operations perspective, the largest expectation for 2020 will clearly be the increasing focus on the overall cost to serve our customers. In the U.S., the trend in reimbursement and outpatient facilities will continue to generate cost pressure. Other factors that will continue to increase the focus on costs include increased global and regional competition, country of origin based contracts and tenders, and corporate efforts to maintain profitability and sustainability.

Paul Vasta, Ph.D., Chief Technology Officer, Gramercy Extremity Orthopedics
A Look Back—Digital technology has continued to push the boundaries of healthcare delivery within and outside the operating room. This year saw increased focus and expanded offerings around technologies like robot-assisted surgeries, diagnostic and training software, pre- and post-intervention patient monitoring, IoT, and inventory management—all examples of a continued industry shift beyond the device itself. These efforts continue to lay the foundation for future disruptive products that will change the way healthcare is delivered in the years to come.

Gazing at 2020—I think we will continue to see OEMs focus on the value-add position beyond the device itself. One area that should continue to impact the industry is terminally sterile packaging for a wider range of devices, specifically in orthopedics. There are a number of disadvantages associated with traditional autoclave steri-trays that are eliminated by sterile packaging. This is slowly attracting attention as a means to add value for the healthcare provider and patient as well.