MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Medtech Winners of 2018

  • These companies, people, technologies, and concepts had a great year in 2018.

  • Apple

    One of the biggest winners in medtech isn’t a traditional medical device company. Yet Apple managed to do something that few medical device companies have been able to – and that’s make healthcare sexy (interesting). In September, the Cupertino, CA-based company received FDA clearance for the latest version of the Apple Watch to include an ECG. The story dominated medtech headlines and Apple scored a huge coup in the industry making consumers more interested in their health. The company has also teamed up with Zimmer Biomet to study the mymobility app’s impact on patient outcomes and overall costs for joint replacement patients.

  • Artificial Intelligence

    The topic of artificial intelligence may make some nervous that machines could take over, but this year AI seems to be achieving a lot of good.

    Earlier this year MD&M East 2018 speaker Dave Saunders of Galen Robotics noted AI's uses in imaging and diagnostics.

    One example of such use can be seen in the MDEA 2018 finalist iCAD for its use of AI for breast tomosynthesis reading efficiency. A recent study showed that iCAD’s solution increased improvements in both reader sensitivity (8% on average) and specificity (6.9% on average), while cutting radiologists’ reading times by more than half (52.7% on average), MD+DI reported. And the company just reported this month that its latest cancer detection software solution for digital breast tomosynthesis, ProFound AI, has been cleared for commercial sales and clinical use in the United States. Said Stacey Stevens, Executive Vice President and Chief Strategy and Commercial Officer at iCAD, in a news statement: “Clinical reader study results and comprehensive stand-alone testing have shown unprecedented improvements in both clinical performance and reading efficiency. We are proud to introduce revolutionary technology that will fundamentally transform breast cancer detection and patient care.”

    Bay Labs’s EchoMD is being integrated into Edwards CardioCare platform for investigational use to analyze echocardiograms. "Our partnership with Edwards Life Sciences includes multiple initiatives to deploy our artificial intelligence (AI) software with deep learning technology into clinical settings and has the potential to help patients through earlier detection of heart disease," Charles Cadieu, co-founder and CEO of Bay Labs told MD+DI

    MD+DI Medtech Company of the Year 2018 Finalist Beta Bionics was granted an IDE from FDA for the iLet Bionic Pancreas that uses AI to control blood glucose levels. Ed Damiano, founder and CEO of Beta Bionics as well as principal investigator of the trial, told MD+DI: “The device is about the size of a small cellphone and it controls your blood sugar automatically.” 

  •  Diabetes Management

    Strong approvals. Check. Amazing Collaborations. Double check. Growing market opportunity? Triple Check! The diabetes management market continued to see growth and significant change in 2018. From FDA’s approval of Senseonic’s Eversense implantable continuous glucose monitoring (CGM); to Sanofi, Verily, and Sensile forming a collaboration to develop an all-in-one pre-filled insulin pump patch the market has had significant developments.  2018 proved to be a pivotal time for the diabetes management market.

  • Diagnostics

    The Diagnostics market just got a bit more sophisticated. Whether it was from the inception of artificial intelligence-based technologies added to traditional tests (i.e. Gauss using AI to measure blood loss) or mega-mergers such as Roche acquiring Foundation Medicine for $2.4 billion – the diagnostics side of the industry sure was a big winner this year. The liquid biopsy side of the market was hot as Guardant Health raised $238 million in initial public offering.  The Redwood City, CA-based company’s rival Grail also gave a timeline for the launch of SUMMIT, its 50,000-patient trial.

  • Digital Health

    Digital health is booming. This year has seen funding explode—venture fund Rock Health reported that digital health investments hit $3.4 billion mid-year—and these days it seems that digital health advances break pretty regularly.

    Innovators have made significant strides this year. Apple made headlines this year with its ECG App for Apple Watch Series 4, and while others are in the space, the tech giant could drive greater awareness about digital health. Apple could have more planned, as CNBC has reported that Apple has been quietly adding dozens of medical doctors to its payroll.

    Digital health companies have been working to demonstrate effectiveness. For instance, one company that presented at BIOMEDevice San Jose 2018—Leaf Healthcare—has shared data that its wearable for monitoring patient position and movement can make a difference. Leaf Healthcare’s wearable sensor has already been used to track the mobility of more than 20,000 patients for more than 1.8 million hours and has helped healthcare facilities reduce the number of hospital-acquired pressure ulcers by an average of 74%, the company reported in August. "Clinicians quickly recognize the benefits provided by the Leaf System," said Barrett Larson, Leaf CEO and co-founder, in a news statement. "Adoption of Leaf leads to immediate, significant, and sustained reductions in rates of hospital-acquired pressure injuries. Leaf has been shown to be highly effective in both real-world clinical environments and rigorous research settings. Leaf is a safer, smarter solution to pressure injury prevention."

    Also, a survey conducted at the 2018 American Nurses Credentialing Center National Magnet Conference found that nearly all respondents (98 percent) agree that "a technology solution that helps guide nurses to turn patients with sufficient adequacy would help improve patient outcomes."

    Also this year, Propeller Health’s sensor helped uncover the link between air pollution and rescue inhaler use, sending usage data and location alerts to patients’ smartphones. Meredith Barrett, vice president of research at Propeller Health, told MD+DI that “by using this medication-use data, we’re able to look at the daily burden of disease.”

    And Adherium's Hailie Bluetooth-enabled sensor is being used to monitor inhaler usage in the SmartAirLA program for asthmatic children. Vik Panda, vice president of marketing for Adherium, told MD+DI that “there is a growing body of evidence that the use of our system reduces the number of missed school days for children and reduces the number of emergency visits to the hospital.”

    The coming new year could bring even more digital developments. During MD+DI’s Webcast, “Top Trends to Watch in Medtech” with Arda Ural Ernst & Young LLP, attendees were asked to identify from this list the healthcare technologies that offer the biggest disruptive potential to their business over the next three years: 3D Bioprinting, Artificial Intelligence, Blockchain, Medical Internet of Things, Genetic Technologies, and Robotics. Medical IoT was the leader by far, having been selected by 33.9% of attendees.

  • Essure Patient Advocates (E-Sisters)

    Bayer's decision in July to stop selling its Essure birth control system in the United States at the end of the year was a long-awaited victory for one very dedicated group of women.

    Known as the E-Sisters, the patient advocacy group that spent years trying to get the birth control device off the market. FDA ordered Bayer to add a boxed warning to the product label in February 2016, complete a post-market study, and require a patient decision checklist be completed to ensure that women considering the device were properly informed of its risks, the E-Sisters often expressed frustration with the agency for not taking their concerns more seriously.

    Bayer insists that its decision to pull the controversial birth control product from the market had nothing to do with safety or efficacy concerns and everything to do with a decline in U.S. sales of the device. But the timing of the announcement seemed awfully suspicious, given that it came just days before the documentary The Bleeding Edge premiered on Netflix featuring horrific patient stories of complications from Essure.

    FDA received 12,000 medical device reports about Essure in 2017.

  • Home Healthcare

    According to Johns Hopkins, home healthcare is needed for about 12 million people in the United States. But even if care isn’t ordered by a doctor, some patients may prefer the privacy and convenience of healthcare products that can be used in the home.

    In 2018, such care got a little easier for patients and caregivers given advances in diagnostics, remote monitoring, and at-home drug delivery. The year saw direct-to-consumer ad campaigns for Neulasta Onpro and Cologuard highlighting at-home use.

    We've seen a few at-home diagnostics emerge, such as a take-home kit for pediatric transplant patients that enables home monitoring of tacrolimus and creatinine. Neoteryx provided its Mitra microsampling devices to the pediatric nephrology team at Nottingham University Hospital for the initiative. Using the company's Volumetric Absorptive Microsampling technology, Mitra allows quantitative, volumetrically accurate capillary blood collection anywhere, anytime, with minimal training, MD+DI reported.

    DxTerity is developing a low-cost autoimmune profile (AIP) test that patients can perform at home to analyze 12 immune-related disease pathways, including type 1 interferon levels. The test involves the patient providing a self-collected blood sample with the company’s DxCollect: fingerstick collection kit, which stabilizes the sample at ambient temperature so it can be mailed to the company’s laboratory for testing, MD+DI reported.

    In terms of medical devices, the 2018 MDEA Best in Show winner AirXpanders offers an alternative to multiple office visits for prepping for reconstructive surgery following a mastectomy. AeroForm is a needle-free, patient-controlled, tissue expander system that can be used at home. The expander is placed underneath the chest muscle after mastectomy to enable the chest wall to be stretched to make room for a permanent breast implant, MD+DI reported. Using a hand-held, wireless dose controller, the patient releases carbon dioxide up to three times a day to gradually inflate the expander. 

    In the coming years we should see even more devices that can be used at home. We’re also likely to see improvements to make existing devices easier for patients to use. For instance, FDA issued a labeling change for home-use pen needles in an effort to reduce user errors.

    Sowmya Rajagopalan, industry principal of Frost & Sullivan, believes monitoring solutions and diagnosis and screening tools will play a role as home healthcare increases. Hospitals will no longer be the focus—“care will take place at home, 24/7, through screening and monitoring,” she said, speaking at The MedTech Conference in “Top 4 Predictions for Global Medical Devices Industry in 2019.” And “AI has to be a tool that clinicians use to predict disease.”

  • Personalized Medicine

    Are we moving toward the day when devices and drugs are tailored to specific patients? It might be too much to customize every healthcare product, but we are definitely seeing an increase in medical treatments that match patient anatomies or genetics.

    MD+DI's Medtech Company of the Year 2018 Finalist Conformis uses CT scans to capture a patient’s precise bone measurements and then its iFit Image-to-Implant technology to produce customized implants. Single-use instruments tailored to those patient-specific implants are then 3D printed. A study shared earlier this year on the Conformis iTotal CR Knee Replacement System showing a low risk of revision surgery for patients treated with Conformis iTotal implants.

    Experts discussed the potential of 3D printing during a panel discussion at Advanced Design & Manufacturing Expo in Cleveland, but they did suggest that it is more suited toward developing custom implants than mass producing products.

    There are also recent strides in using diagnostics to better identify drug regimens. Medtech Company of the Year 2018 Finalist Roche is spending two-thirds of its R&D time on projects with companion diagnostics. The drug-and-diagnostics maker also just bought Foundation Medicine, whose liquid biopsy test FoundationOneLiquid and FoundationOne CDxgenomic profiling (CGP) assay can be used for all solid tumors.

    Myriad Genetics shared word that its GeneSight test could help identify treatment for Major Depressive Disorder. Study results presented at the American Psychiatric Association annual meeting showed that patients who were evaluated by the GeneSight test were 50% more likely to achieve remission and 30% more likely to respond to therapies. Bryan Dechairo, Ph.D., executive vice president of clinical development, Myriad Genetics, told MD+DI that “our goal was to prove that when doctors and physicians see which medications are inappropriate for a patient and avoid using them, then that will actually improve the chances of the patient getting on a medication that will work for them.”

  • Robotic Surgery

    The year 2018 is sure to be remembered as a milestone year for the field of robotic surgery thanks to so many new entrants that have emerged to challenge pioneer Intuitive Surgical.

    TransEnterix, XACT Robotics, Virtual Incision, Medrobotics, CMR Surgical, Medtronic, Verb Surgical, Stryker, and Zimmer are just a few of the companies developing (if not already selling) surgical robots.

    But one of the most interesting things about the market is how well Intuitive has responded to the increasing competitive pressure. Competition does breed innovation after all, and we've seen the surgical robot king really step up in the past year to improve its own offerings. Most recently, the company received FDA clearance for the da Vinci SP surgical system for urologic procedures that are appropriate for a single port approach. But that was no easy feat, even for the market leader.

    Sal Brogna, an executive vice president and the chief operating officer at Intuitive Surgical, told MD+DI in September that designing a system that brings four robotic arms through one singular 25mm port was a "really compelling and hard challenge."

    "We didn't have to do it, we chose to do it," he said. "We said if we could do that there will be derivative technologies that flow across the product line, and that's what has happened. There is technology from our da Vinci SP that we're just releasing that is already in our Xi product that was released four years ago. It took us 12 years to get to da Vinci SP and it was a tremendous learning challenge."

    Intuitive is also responding to the market demand for a flexible catheter program and has such a system currently under review by FDA. If cleared, that device will allow surgeons to navigate through the body through natural orifices without the need for a surgical incision.

    Raynham, MA-based Medrobotics received FDA clearance to market its Flex Robotic System for colorectal procedures, making it the first such system to reach the U.S. market for that indication. The technology, which has been described as slithering like a snake, is expected to give colorectal surgeons new treatment options that may not be possible with traditional instruments.

    "Many of the ideas that we see coming from competitors are ideas that we have attempted and, in some instances, have rejected, whether it is for workflow improvements, or safety requirements, or cost-effectiveness," Brogna said. "Each of them are nice and novel, and we salute their inventiveness and we welcome the challenge that they bring to the marketplace."

    Competition is good for the sector, he added, in part because it encourages Intuitive to rise to the occasion and strengthen its own product lines.

    "We follow the competition, we hope that they can get to the market, because it validates a market that we took 23 years to really get established, and it's encouraging to see," Brogna said. "In the end, I think all patients will get better outcomes and less variability, and I think robotic-assisted surgery is clearly going to be the future of all surgery. It's just a matter of how long it takes for us to evolve and give surgeons everything that they need."

  • Surgical Training Technologies

    This year we continued to see large strides made in the advancement of virtual reality (VR) and augmented reality (AR) technologies, and medtech is beginning to realize the potential of VR and AR as a training tool.

    “You can make a major impact in patient outcomes in how surgeons are trained,” Justin Barad, founder and CEO of Osso VR, told BIOMEDevice Boston attendees in April.

    A pediatric orthopedic surgeon himself, Barad developed Osso VR, a virtual reality system for training surgeons. Osso VR is a “hands-on, reliable, interactive” system that allows “you to see at a granular level the technical ability of product users,” he said.

    Improving patient outcomes is central to Osso’s mission, as are increasing adoption of higher-value medical technologies and democratizing access to education. Barad said hospitals and surgeons may continue to use existing technologies because surgeons don’t have the time and opportunity to train on the newer products.

    There’s also a skills gap, “as residency programs are aware that residents go out into the world not ready,” Barad said. And there’s a fixed number of surgeons to serve an aging population. “It’s projected to be short by 50,000 surgeons by 2050,” he said.

    The company creates virtual training scenarios utilizing CAD files from medical device customers. “We create virtual ecosystems using their content,” he said. “It's more efficient for surgeons to be able to practice on the actual device they’ll be using.” The system utilizes the Oculus Rift headset and Oculus Touch handheld device.

    The platform creates a virtual operating room that allows for collaborative training for the whole team, including surgical techs and nurses. Up to 10 staff can train in one module, regardless of where they are in the world. “A lot of people are involved for a successful surgical outcome,” he said, later telling MD+DI that “when your team doesn’t know how to use equipment, you’re not focused on the patient.” The system also allows for remote mentoring and coaching.

    Staff can even train before procedures, he said, pointing to a pilot study of just-in-time training that showed a trend toward double the performance.

    Currently focused on the orthopedic space, Osso offers five virtual procedures and is expected to be up to 8 to 10 by the end of the year. Barad also plans to expand into robotics and cardiology, particularly procedures involving the structural heart.

  • Zimmer Biomet CEO Bryan Hanson

    Bryan Hanson knew when he accepted the job of CEO of Zimmer Biomet in December 2017 that he had a tall order to fill. The company has struggled with quality control and supply chain problems since December 2016, which created investor frustration that ultimately led to former CEO David Dvorak's resignation.

    But during Hanson's first year at Zimmer, MD+DI identified several positive qualities in his approach to leadership and while the company is far from making a comeback, we think Hanson deserves some recognition for what he's achieved so far.

    First, Hanson quickly set out to gain something that was previously lacking between the company's sales team and upper management: trust.

    "There's just a lack of trust right now from the sales organization for corporate," Hanson said in January, just six weeks into the job. "We have given them timelines that we have failed on and they've gone out, through the information they have received from us, approached the customer, only to have to pull back again."

    Early on, Hanson spent a considerable amount of time in the field working one-on-one with sales staff, visiting customers, observing cases, and essentially trying to spend a day walking in their shoes.

    Throughout his first year at Zimmer, Hanson has been clear with investors about the company's remediation progress, and his expectations. Most recently, during the company's third-quarter earnings call, Hanson said the company must start reducing the size of its portfolio in order to simplify the supply chain and improve service levels to customers.

    Another important change we observed this year is Hanson's dedication to closing a huge culture gap that existed in the organization since the merger of Zimmer and Biomet in 2015. The new CEO was quick to correct analysts during earnings calls when they referred to the company as "Zimmer" rather than "Zimmer Biomet."

    "There are still camps of Zimmer and Biomet and we need to create Zimmer Biomet, forget the legacy companies," Hanson said in late January.

    A more subtle distinction was made in the way Hanson referred to the manufacturing facility where the quality control issues occurred. During earnings calls last year the management team often referred to it as "the legacy Biomet facility." During 2018, that facility became known as "the North Campus."

    Finally, smart leaders understand that you have to spend money to make money, and Hanson also addressed investment early on.

    "We've got to have investment," Hanson said in January. "As an organization, we've been chasing the bottom line because we've had top line misses."

    He said the company would concentrate on investing for growth as a primary vehicle for growth. That means earmarking money for R&D as well as investing in the commercial structure to support the existing portfolio.

    "We've got to spend more on research and development and bring on innovations that don't just help us in the near term, but also help us in the longer term," Hanson said.

    On the commercial side, he said he sees room for broader investments to "be able to have more feet on the street," to drive the portfolio that Zimmer Biomet already has and take advantage of the new products already in the pipeline.

    Zimmer Biomet's quality control and supply chain problems won't disappear overnight, but it seems as though the company, under Hanson's leadership, is at least headed in the right direction.

Filed Under
500 characters remaining