Prior to Michael Barbella, managing editor, writing his 2018 Year in Review feature, the team reached out to the magazine’s Editorial Advisory Board to ask two questions:
 
1. What news headline, event, or technology was the most significant in 2018 and why?
2. What’s one expectation you have for 2019 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on?)
 
As always, we received great feedback from a number of board members who shared their thoughts on the questions. Unfortunately, only a handful of quotes were able to be featured in Barbella’s article, so all of the responses are provided here.
 
Note: These responses were provided throughout the second half of October 2018, 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.
 
Lee Crowe, Vice President, Sales and Marketing, Tegra Medical
2018 Reflections—The FDA’s May announcement of its intention to replace certain aspects of its Quality System Regulation (QSR) with specifications of the international consensus standard ISO 13485:2016 was big. When this happens, it’s supposed to make compliance more efficient for companies selling their products outside of the U.S. by harmonizing domestic and international requirements. Manufacturers will appreciate the reduced record-keeping and compliance burdens.
 
Looking Ahead—Data is hot and getting hotter. It’s being generated in larger quantities than ever before in all facets of the healthcare industry. But it’s totally useless if it’s not being used to gain insights, operate more efficiently, and improve patient outcomes. I expect we’ll hear a lot more about how manufacturers, payers, and providers all need to get a handle on what data they have and how to make it work for them.
 
Dawn Lissy, President and Founder, Empirical Testing Corp.
2018 Reflections—A major item this year was additive manufacturing in orthopedic devices, along with all the impact to related and connected areas—regulatory, testing and quality considerations, limitations, and benefits. Mergers and acquisitions was another substantial area for the industry.
 
Looking Ahead—More and more funding for innovative technologies is occurring, although the ROI isn’t the astronomical number it once was. The call for better solutions is reaching VC and new technology research is slowly being supported and gaining traction again.
 
Ali Madani, Managing Partner and Founder, Avicenne
2018 Reflections—In orthopedics, robotic-assisted surgeries and the success of Stryker in this field (to be continued) and reactions of other players was noteworthy. For contract manufacturing, new comers like Medplast with the Integer acquisition, NN Inc. with the Paragon acquisition, etc., were interesting to watch (and likely will continue to be).
 
Looking Ahead—In 2019, robotics will certainly be a segment to keep an eye on. Also, watch for the implementation of additive manufacturing for other implant applications beyond cups and cages.
 
Andrew J. Miclot, Vice Chairman and President, WishBone Medical
2018 Reflections—A strong U.S. economy was the most significant event in 2018 because it is good for medical devices globally. The U.S. is the largest medical device manufacturing country with new innovations consistently helping patients globally.
 
Looking Ahead—My one expectation for 2019 is the medical device industry will remain strong and there will be no speed bumps with tariffs or a major economic slowdown. Geopolitical issues can positively or negatively impact the medical device industry.
 
Dave Neal, President and Founder, STAT Design
2018 Reflections—One of the most significant technologies to come about in spinal orthopedics has to be anterior scoliosis correction (ASC) and vertebral body tethering (VBT). My growing teenage son was recently diagnosed with scoliosis and it progressed to the point where spinal fusion was indicated. Having done some research and knowing that fusion is forever, I came across these vertebral disc preserving procedures for scoliosis correction. We selected minimally invasive ASC and his hospital stay was short, he quickly resumed normal activities, and the follow-up results are amazing! While his early results appear promising, these procedures are still in their infancy with long-term follow-up unknown.
 
Looking Ahead—Metal additive manufacturing and 3D printing are having a huge impact on the medtech industry. Companies like Markforged and LAR Technologies are working on breaking the barrier to produce manufacturing equipment that make metal parts for under $100k.
 
Universities and public schools are investing heavily in 3D printers to get the students ready for this manufacturing revolution. My son’s school, Sacred Heart University, recently bought the old GE headquarters in Connecticut and is building an 11,000 sq. ft. makerspace in the space—even larger than the one at Yale.
 
My high school daughter’s public school system in Jefferson Township, NJ just got approval through a town referendum to invest in a makerspace as well as modern science and technology labs.
 
One thing I recently found out though—not all school teachers have the proper training on how to run and troubleshoot these 3D printers. Once word got out that I have knowledge on using the equipment, I graciously accepted their request to help out. I encourage those who also have an understanding of this equipment to assist their local schools too. The students of today will be tomorrow’s workforce, ready to embrace this 21st century technology!
 
William Pratt, VP Operations, Director of Creative Design, Kinamed
2018 Reflections—I thought a recent headline about K2M shareholders suing to block the Stryker acquisition stands out because they voted to approve based on allegedly incomplete information. It sort of falls into the “lies, damn lies, and statistics” category of complaints and seller’s remorse. Not very sexy, but financially intriguing.
 
Looking Ahead—AI and remote diagnosis are coming, and healthcare companies (not physicians) are going to make money off of it. Also, among today’s headlines is the announcement of a new AI college at MIT—very heady stuff. I know going to the Mayo Clinic website and trying to self-diagnose something is pretty fruitless, but this is going to be different. If Amazon can do a better job than Cardinal in the medical device distribution game, then this industry is going to change. Now, if we get to point of having robot reps run the laser pointer in the O.R., then the guy with the most robots will win.
 
James B. Schultz, Executive Vice President, ECA Medical Instruments
2018 Reflections—Market consolidation overall and the drive to the outpatient market are the common themes. Medical device firms are positioning for the future and doing it faster than ever to protect market share, hold or improve margins, and gain new customers in new markets. The regulatory and free market forces at play in reimbursement and value-based medical care; the need for larger, turnkey, and globally based supply chain partners; and the move to ambulatory surgical center (ASCs) are all driving change that is exciting to watch and be a part of.
 
In the CMO segment alone, dozens of acquisitions have taken place over the past 12 months, signaling a response to medical device firms’ desires for end-to-end design, development, manufacturing, packaging, and fulfillment solutions that provide measurable value.
 
Looking Ahead—More applications and good outcomes for robotics, escalation and adoption of robust and cost effective sterile packed and single-use instruments and products, and the movement of surgical procedures to the outpatient setting. ASCs will represent 60 percent of all surgeries by 2020, up from 53 percent today, and will include increasing numbers of hip and knee arthroplasty as well as traditional extremity and trauma procedures in the orthopedic segment.