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Articles from 2017 In November

Check Out the New DES on the Block

Medinol Check Out the New DES on the Block

FDA approved the EluNIR drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. Isreal-based Medinol developed the new DES, and Dublin, Ohio-based Cordis has exclusive distribution rights for the U.S. market.

The EluNIR DES is one way Cordis, now a Cardinal Health company, is trying to make a come back in the stent business. The device, which was recently cleared for sale in Europe, has shown a lot of promise in two randomized trials including more than 2,200 patients in the United States, Canada, Europe, and Israel. FDA approval was supported by data from the BIONICS study, which included 1,919 patients from 76 sites in eight countries. In that study, the device demonstrated a 5.4% target lesion failure (TLF), the lowest reported TLF in a contemporary U.S. pivotal study, and a 0% rate of late stent thrombosis at 12 months.

The stent is designed with a metallic spring tip and the narrowest strut width of any stent on the U.S. market to help clinicians easily deliver the device in highly complex anatomy and disease.

“Medinol has a legacy of developing innovative interventional cardiovascular technologies, which has culminated today with the FDA approval of the EluNIR DES,” said  Yoram Richter, MD, chief scientific officer at Medinol. “For more than 20 years, Medinol has continuously raised the bar for the quality and performance of stenting systems. With our innovative manufacturing process, the EluNIR DES offers clinicians the latest generation DES. Notably, the FDA approval of the EluNIR DES marks the first such approval for a privately held company based outside of the [United States]."

Roche Dismisses J&B from Supplier Lawsuit

Pixabay Roche Dismisses J&B from Supplier Lawsuit

Roche Diagnostics and Roche Diabetes Care have dismissed J&B Medical Supply from a lawsuit filed earlier this year over the retail pricing of diabetes test strips.

The complaint accuses several pharmacies and medical supply companies of exploiting price differences of the strips sold to people covered by durable medical equipment (DME) plans and those covered by pharmacy benefits plans. Roche also dismissed J&B's co-founders, Fawzi B. Shaya and Mary E. Shaya, from the case. No other defendants have been dismissed from the ongoing litigation.

Test strips paid for by pharmacy plans have a much higher list price and a higher insurance reimbursement rate than those paid for by DME plans, but pharmacy plans get significant rebates from Roche that DME plans do not receive.

The complaint accuses the defendants of buying Roche test strips at the lower DME list price and diverting them to sale in channels where they would be reimbursed at the much higher pharmacy plan rate. In doing so, Roche claims the defendants and their "co-conspirators" made millions of dollars in illicit profits, costing Roche as much as $89 million in wrongful rebates and legitimate sales.

According to the lawsuit, some of the defendants, including Centerline, MI-based Binson's Hospital Supplies, and initially Wixom, MI-based J&B Medical Supply, had promised to sell the DME test strips only through DME channels but broke that promise.

John Truscott, a spokesman for J&B Medical Supply, told MD+DI in April that J&B had not purchased any of the test strips in question since 2009 because Roche had some issues with FDA at that time and "numerous insurance companies asked J&B to stop purchasing from them, and they stopped immediately." 

Other defendants named in the lawsuit include Centerline, MI-based Northwood Inc.; East Lansing, MI-based Olympus Global; Flint, MI-based Delta Global; and Cheyenne, WY-based Alpha XE.

According to the lawsuit, Roche uses separate packing and product codes for pharmacy and DME strips so that there is "no legitimate way to engage in a profitable diversion scheme," therefore the defendants and their business associates would have had to have conspired against Roche in order to profit from the scheme.

"Importantly, defendants' profits did not result from offering lower prices to customers, the vast majority of whom pay a fixed out-of-pocket amount set by their insurance plans," Roche said in the lawsuit. "Rather, the profits resulted from causing Roche to pay substantial rebates to pharmacy plans for products that were intended for sale through DME plans."

5 Ways Philips is Moving the Needle for Radiology

Royal Philips 5 Ways Philips is Moving the Needle for Radiology

It’s been quite a busy week for Philips, one of the world’s leaders in health technology. The company announced several new partnerships this week that will look to push a variety of new technologies and digital platforms forward, as the company aims to spread its reach in the areas of oncology, radiology, and diagnostic imaging.

In the span of just a few days, Philips announced a new partnership with 3D Systems and Stratasys to advance 3-D modeling and printing systems, extended its partnership with Banner Health in preparation of a new analytics platform, and unveiled three new imaging technologies that aim to revolutionize body scanning and imaging techniques.

The week began with the announcement of a new partnership with 3D Systems and Stratasys that will bring together two global leaders in the 3-D printing industry to help advance 3-D modeling and printing techniques — a move that aims to provide radiologists with new views that can strengthen anatomical knowledge and improve patient care.

Philips hopes that the new partnership will help their customers virtually connect to a variety of new technologies from both 3D Systems and Stratasys to provide new three dimensional models that can enhance the clinical impact and help deliver more personalized treatment options.

In a related press release, Philips also unveiled its new IntelliSpace Portal 10, the latest edition of its advanced visualization and quantification platform. The new technology comes with a focus on oncology to provide radiologists with an improved set of applications, including access to 3-D modeling and printing applications born from the company’s new partnership with 3D Systems and Stratasys.

The new platform is the first of its kind to feature an embedded 3-D modeling application for creating and exporting 3-D models into clinical workflow. Philips said this new technology will enhance diagnostic capabilities, provide support for cutting-edge imaging techniques, simplify data and insight gathering, and utilize new machine learning applications that can learn from prior usage to help improve patient care.

Philips also said it will extend its partnership with Banner Health, an Arizona-based clinic where Philips has been working to transform clinical practices in radiology through the adoption of its PerformanceBridge practice. PerformanceBridge is a portfolio of software and services the company has been rolling out to assist radiology departments and improve patient care.

With the PerformanceBridge practice, the company hopes to help Banner Health develop simple solutions that can address a range of different areas for improvement. The project is scheduled to get off the ground in radiology departments across 16 different sites in Arizona before expanding to 12 new radiology departments in five other states.

As if these developments weren’t enough, the company also announced the debut of two new imaging technologies as well. As the company prepares to expand its reach in the realm of oncology and diagnostics, Philips unveiled its new I Qon Elite Spectral CT scanner on Monday, a new configuration of the world’s first spectral detector-based CT scanner. The new scanner comes with a range of features that will help physicians deliver more confident patient diagnoses in the first scan, providing a new level of certainty for oncology clinicians and patients.

The company followed that announcement with the unveiling of new MRI solutions at the Radiological Society of North America’s annual meeting in Chicago this week. Its newest MR system, known as the M R Prodiva 1.5T, aims to provide enhanced clinical performance by reducing exam times through a simplified guided patient setup. The new imaging system even hopes to improve patient comfort during the exam through customized visual themes, reducing acoustic noise, and even providing examination instructions.

Moving forward, it’s clear Philips intends to be a major player in the field of radiology, oncology, and diagnostic imaging, and the partnerships announced this week signal its long-term investment in these industries.

Could an Implant Be Developed to Help Restore Sight?

Could an Implant Be Developed to Help Restore Sight?
Image courtesy of Leti

Scientists from a biomedical research consortium could help a U.S. government funded program aiming to restore sensory perception. The U.S. Defense Advanced Research Projects Agency (DARPA) established the Neural Engineering System Design program (NESD) to encourage development of “an implantable neural interface able to provide unprecedented signal resolution and data-transfer bandwidth between the human brain and the digital world,” according to DARPA’s Web site.

DARPA has awarded six NESD contracts, one of which was given to CorticalSight, a program by the Seeing and Hearing Foundation (Fondation Voir et Entendre; FVE) under the leadership of Prof. José-Alain Sahel and Dr. Serge Picaud. CorticalSight is currently working to enable communication between neurons in the visual cortex and a camera-based, high-definition artificial retina worn over the eyes, reports CEA Leti, a partner of FVE. Leti and Clinatec (Leti’s biomedical research center and its Leti partners) will develop an active implantable medical device intended to restore vision through light stimulation of optogenetically modified neurons in the visual cortex interface.

“Clinatec’s integrated approach to high-tech, medical-device R&D, extending from Leti’s technological development to in-house clinical expertise and testing capabilities, allows our teams to address cutting-edge medtech development challenges,” stated Prof. Alim-Louis Benabid, Clinatec’s chairman of the board, and co-investigator of the CorticalSight project, in a news release. “This contribution to the CorticalSight consortium will pave the way to new therapeutic devices for vision restoration thanks to the NESD program.”

CEA Leti will develop the external control module and the implantable parts, including the optical microsources, explained Fabien Sauter-Starace, project manager, active implantable medical devices, at Clinatec, to MD+DI.

One of the external parts is a set of goggles to be worn over the eyes, also called a “smart neuromorphic camera on glasses,” Sauter-Starace said. (Please see the  above image.)

These glasses “will capture the image and communicate with the external control module developed by CEA Leti. The latter will provide power and data to the implantable modules,” he said.

Leti will also develop hermetic packaging and radiofrequency links for the implantable system and will conduct technical test benches.

Leti was created in 1967 as the Laboratoire d’Electronique et de Technologie l’Informatique. In 1976, it created and installed the first whole body X-ray scanner at the Grenoble General Hospital. Over the years it has developed various electronics for multiple industries.

Supplier Stories for the Week of November 26

This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Is Digital Health Making an Impact on Healthcare?

StockSnap/ Is Digital Health Making an Impact on Healthcare?

Mobile health (mHealth) apps and telemedicine have the potential to lower costs and improve patient care by allowing closer collaboration between patients and healthcare providers. The increasing adoption of health apps and other tools means not only healthier, more informed patients, but a more robust market: mHealth technology is expected to grow to $60 billion in 2020—an increase of 33%.

Is digital health the panacea it's made out to be, or are we just generating data for data's sake? Deneen Vojta, executive vice president of research and development for UnitedHealth Group, said it's too soon to say.

"Digital health is worth investigating," she said. "We've seen a lot of healthy people leveraging devices to understand fitness. And we do see growing evidence in healthcare of organizations leveraging similar technology to improve care. We have to better understand how patients engage and study the outcomes. There are the early adopters, and there's the rest of us."

Johnson & Johnson hopes patients of all technical persuasions will embrace Health Partner, a new connected digital platform that guides patients through all steps of surgery, from consideration to rehab. A website provides articles and tools for patients debating surgery (Health Partner currently focuses on weight loss, hip, and knee). A mobile app walks patients through surgery preparation and recovery. A care portal allows real-time interaction between physician and patient.

"All three digital tools put the patient at the center," said Amy Foley, vice president of product innovation and delivery for Johnson & Johnson. "Our behavior scientists and digital product experts put together what we think and know, based on research, will work with a particular population."

Through Health Partner, Johnson & Johnson collects, analyzes, and draws insights from patient data to further refine its capabilities and deliver a more tailored experience. "We might assume a certain set of behavior change techniques works well for a population based on experience and literature," Foley said. "But as users work with our tools, we might see a subset of those tools that are most effective."

Princeton HealthCare System's joint replacement program has grown from 800 procedures a few years ago to 1500 in 2017. Evaluating the program, Princeton Health System leaders found a gap in patient engagement. It brought in Health Partner to help boost engagement.

"Health Partner allowed us to close the gap from when patients commit to surgery, through preparation, a hospital stay and post op," said James Demetriades, Princeton HealthCare System's vice president of operations. "We have a goal to improve time from discharge to home, which we feel is an important indicator of prompt recovery."

Since implementing Health Partner, Princeton HealthCare System's joint replacement program has remained at or above the 90th percentile in patient satisfaction. Over the past 24 months, 80% of its patients either went home after surgery or went home with home care. Five years ago, it sent 80% of patients to skilled nursing or rehab facilities.

FDA Pre-Cert

mHealth apps and other devices won't engage anyone if they don't get to market. FDA, which recently launched its Software Pre-Cert Pilot Program, wants to make that happen more efficiently. Johnson & Johnson joins Roche Holding AG, Verily Life Sciences, and six others, including startups Pear Therapeutics, Phosphorus, and Tidepool, as the first nine companies to participate in the program.

Foley said Johnson & Johnson is still discussing which product or platform it will focus on for the pilot program. "We will have a number of in-person opportunities with FDA over the next six weeks to help illuminate the approach," Foley said.

During these meetings, FDA will work closely with participating companies to "understand how we can apply systems related to security, privacy and patient safety in a rigorous and consistent manner, one which they could anticipate we would deliver time and time again," Foley said. "Our opportunity to improve speed-to-market and access because of the PreCert program is huge."

Patient Knows Best

Of all the new apps on the horizon, the tools consumers stick with will address their needs, varied as they may be. "Take glucose monitors," Vojta said. "Some have alarms, some don't. Which one's best? Whichever one the patient thinks is best."

In a study published this year in the American Journal of Managed Care, investigators found that among new adult insulin pump initiators, 8.5% had resumed regular refills of basal insulin and had no further evidence of pump-related supplies by the end of year one. By the end of year two, that number climbed to 13.9%.

Higher costs may contribute to patients' decision to return to basal insulin. It's also possible, Vojta said, that maintaining the catheter and having a device permanently attached to your abdomen made the pen seem not so bad.

"There is no one size fits all," Vojta said. "We need to figure out the best way to connect people when they really need it, automating what can be automated, and leverage patient data so people get the right care at the right time at the right place."

Challenging the Status Quo of Project Management

Marlisa Kopenski Challenging the Status Quo of Project Management
The combined Orion core team after another multi-day milestone meeting.

The constellation Orion contains two of the universe’s brightest stars. It is located on the celestial equator and can be seen from anywhere in the world. As such, Orion has served as a guide for generations of navigators. It’s fitting that Abbott Point of Care gave the name Orion to a global pricing and messaging initiative with the intention of the project being as recognizable and important to the organization as the constellation is to the night sky.

Abbott Point of Care is the market leader in “with-patient” point-of-care lab testing devices. Its i-STAT system is a small, handheld device that can deliver a range of laboratory results in minutes with just a few drops of blood. In 2014, the company recognized that the accelerating pace of change in the healthcare industry meant it needed to re-examine its U.S.-centric pricing, messaging, and value proposition. This required new thinking and a different problem-solving approach. Abbott Diagnostics made a bold decision to hire not one, but three, consulting partners, each in a different city, to define the problem, approach and responsibilities. This is the story of how three consultants worked hand-in-hand and shoulder-to-shoulder over 16 months to challenge the status quo, deliver a long-term growth strategy for a shared client, and not only not kill each other, but become close allies and friends.

Hear Marlisa Kopenski's case study on using project frameworks to create order out of chaos at the BIOMEDevice San Jose conference on December 6, 2017. Use promo code "MDDI" for free expo access and 20% off conference registration—or win a free pass here.

What does it take to drive innovation in a corporate environment, particularly when the project team itself is 100+ people? And the core leadership team is six people? How does a team not get bogged down by the corporation or by each other?

The answer can be boiled down to three things:

  1. Rigor and flexibility (which are not mutually exclusive)
  2. Co-learning and co-creating
  3. Unconventional collaboration

Rigor and flexibility sound like two mutually exclusive attributes, but they are not. When wrangling a large team, rigor means knowing who is responsible for what and when. Abbott Point of Care designated a program manager, responsible for the ultimate deliverable of the project. I was assigned the role of project manager, which meant I was responsible for making sure all the consultants were doing what needed to be done. We had a standing weekly meeting with a standard agenda, an agreed-upon reporting template, and a robust SharePoint site where all deliverables were posted. We divided the project into three phases and scheduled all major milestone meetings for the first phase at the project launch meeting. In many ways, these processes are just best practices for large projects.

A secret to success was also flexibility. When the budgeting cycle required that the majority of our research travel be completed before the end of the calendar year, teams were in Asia within three weeks. When planning glitches delayed travel to four other continents, teams did not go pencils-down on the effort. One team asked for permission to further examine an observation from the early field research through the production of a Pecha Kucha—a presentation style that forces creators to consider only the essence of an idea. By reframing a disappointing delay into an opportunity to think deeply and differently, two foundational insights were created. The team observed that the i-STAT system was a “complex, easy-to-use device” and challenged the idea of “handheld” by positing that “portable” might be the more accurate description. The ultimate Orion strategy would have been very different if the team hadn’t been flexible enough to take a different tact when original plans stalled.

The easy steps of operating an i-STAT are made more complex by external factors such as environment, situations and personal preferences (actions).

For a large team to stay aligned over the course of a long, complicated project, the members must learn from and with each other. In the case of Orion, it was important that everyone level-set on what the i-STAT device was and how it worked. We asked an Abbott Point of Care field training specialist to host an in-service to train our team, just like a nurse or doctor would be trained in a hospital or clinic. It was eye-opening. Even the Abbott Point of Care team members understood first-hand the precision and skill involved in filling a cartridge with only a few drops of blood. 

This exercise was an empathy-building warm-up for the user-centered research approach Orion undertook in the course of interviewing more than 150 people in six different countries. Without a budget to send everyone everywhere, we decided on two different methodologies that would overlap. One team spent time in the field observing and interviewing i-STAT users. Another team gathered information from executives and decision-makers. The efforts overlapped in their interaction with influencers, who had both a business and patient care perspective. It was very important to the team to balance what we heard from the three groups. We hosted “co-analysis” sessions at the end of research where everyone came together to essentially “unpack their bags”—show raw video, flip through their notes, and share stories and photos. Making time for authentic sharing—not curated stories or formed opinions—allowed the team to share, probe, and challenge. Our common thinking evolved as new data came in. Everyone on the team learning together and collaborating on a shared point of view was amazing for two reasons. First, the trust on the team was incredible. Second, the foundation for each team’s recommendations was rooted in a shared understanding of the problem, resulting in final deliverables that were integrated at their very core.

One of the strains on big projects are bloated meetings that happen either too frequently or not frequently enough. The Orion team made a conscious decision to “play by the rules” with large share-out meetings for stakeholders and leadership every six weeks. These were typically two-day meetings with 17 consultants and up to 50 Abbott stakeholders. There is no getting around the fact that best practice in huge corporations is sharing in this way. We looked at these meetings almost as theatre—a little wooing, some gauging of the audience, and, ideally, loud applause, which translated to permission to proceed. The real work, like in real theatre, took place behind the scenes. Besides our “co-analysis sessions” we also held “co-synthesis” sessions, where we previewed and pressure tested our deliverables with each other. This is definitely not a best practice in large corporations or, especially, among consultants, who are often better at guarding their territory than letting their guards down.

A very unconventional approach was our ad hoc “Beer Summits.” While there was actually no beer served (until we adjourned, of course), a Beer Summit was called when it seemed appropriate for the four main team leaders to get us in a room together. Wearing our most casual clothes and showing up as our most honest and passionate selves, we would set the next course, right the course, or deviate drastically from the course we thought we would be traveling. At the start of the project, we were wise enough to know that we couldn’t plan every single meeting. However, we were naïve to think the finding calendar dates was going to be one of our bigger problems. Big, bold projects always wobble at some point. That is part of the learning. Beer Summits—because they were ad hoc, face-to-face and both strategic and tactical—allowed us to have the difficult conversations with each other, to flounder and be lost together. We also celebrated as a group when we made a breakthrough. Beer Summits were critical to the success of Project Orion.

In sum, so much of what made Project Orion successful was intentional human interaction. We did not let geography, time-zones, or corporate norms hinder us from getting together face-to-face to have essential discussions, and not necessarily the ones the project Gantt told us to have.

Project Orion ended in December of 2016 with the delivery of a new strategy for global pricing and messaging. But beyond that, the organization built empathy for the users of its “complex, easy-to-use-device” and cultivated a deeper understanding—even pride—in the value of the i-STAT system to patients and customers around the world. Seeing for ourselves how the device accelerates decision-making for patients and improves patient care in all types of care settings was very rewarding. In the end, Orion was a spot-on name for this project. It did serve as a guide for Abbott Point of Care. It continues to shine brightly within the organization, beyond just the i-STAT team. And for those of us who contributed, the project was a career highlight and a source of great personal satisfaction.

Can Boston Scientific Bounce Back from Lotus Setback?

Boston Scientific Corp. Can Boston Scientific Bounce Back from Lotus Setback?

Boston Scientific shares took a beating Tuesday after the company abruptly backed out of a scheduled appearance at the annual Piper Jaffray healthcare conference in New York. As investors seemed to fear, the sudden change of plans foreshadowed another Lotus setback.

The company's stock (NYSE: BSX) dropped 7.5% by market close on Tuesday, slashing Boston Scientific's market cap by about $2.9 billion. About three hours after the close, the company said it had pushed back its previously-reported timelines for re-introducing the Lotus Edge aortic valve system in Europe, and the filing of a final pre-market approval (PMA) module with FDA.

The Lotus Edge for transcatheter aortic valve replacement (TAVR) may be one of the most watched products in Boston Scientific's pipeline. The device has drawn interest from the medical and analyst community because the current generation of the valve, Lotus, is known for having low rates of paravalvular leak (PVL). The Lotus Edge has been described as being designed to maintain those low PVL rates while also reducing permanent pacemaker implant rates with its Depth Guard technology.

The company halted commercial implants of the Lotus Edge last year after a locking issue with one pin of the valve's commisure was observed in seven of roughly 200 commercial implants (4%).  Then, the company recalled all of its Lotus valves from the market in February after getting reports of a similar mechanical problem with a pin that connects the valve to the delivery system. The Lotus Edge received a CE mark in September 2016, about a month after the company previously recalled the device.

After the recall in February, the company said it implemented manufacturing process and design specification changes to the Lotus Edge delivery system with the intent of re-introducing the product in Europe by the first quarter of 2018 and filing the PMA module with FDA by January.

"We continue to see value in the unique benefits of the Lotus valve platform in treating patients with aortic stenosis," said CEO Mike Mahoney. "While we are disappointed in this delay to our timelines, we are working to carefully analyze and implement necessary modifications to pass our rigorous internal quality standards."

The company is expected to provide an update on the status of the Lotus Edge valve during its fourth quarter 2017 earnings call, scheduled for Feb. 1. In the meantime, Boston Scientific said it will continue to work with U.S. and European regulatory bodies to share pertinent updates about these delays and impact to submission timing. The company also said the delay is not expected to have a material financial impact to its fourth quarter or full year 2017 guidance.

While the setback is likely to have a near- to medium-term, transient impact on the business, Canaccord Genuity's Jason Mills said in a research note that he expects Boston Scientific will bounce back from the latest Lotus delay by the middle of 2019. More importantly, Mills said he still sees the company as a formidable long-term player not only in the TAVR space, but in the broader structural heart field.

Based on the delay, however, Canaccord Genuity lowered its worldwide TAVR estimates for Boston Scientific in 2018, 2019, 2020, and 2021 by $70 million, $114 million, $67 million, and $9 million, respectively.

Similarly, Needham & Company removed Lotus from its model for Boston Scientific and lowered 2018 and 2019 revenue and EPS estimates for the company. Still, Needham's Mike Matson said in a research note that he believes shares of the company are undervalued considering its current growth profile excluding Lotus and even more undervalued considering the potential growth impact of Lotus. The analyst said he views the sell-off as a buying opportunity for the stock.

Medtech Supplier Innovation on Tour at BIOMEDevice San Jose

Our Medtech Innovation Tour of these five innovative companies will take place at BIOMEDevice San Jose on December 7 from 11 am to 12 pm. To join the tour, please meet Editor Daphne Allen at the Information Booth, where you'll be given a headset and tour map. Please arrive at least 5 minutes before the tour starts.[Image source Aysezgicmeli/Shutterstock]

8 New Developments That Could Revolutionize Pacemakers

For years, pacemaker devices have been an essential technology for patients who struggle with cardiac arrhythmias, but they often come with their own set of problems. Despite their ability to help patients maintain a steady heartbeat, pacemakers require maintenance such as battery replacement and software upgrades to protecting the devices from hackers.The good news is, many researchers and device developers have already begun to address some of these issues with the latest in technological developments that aim to usher in a new era of advanced pacemaker devices. In the following slideshow, we take a look at some of the technology advances that are pushing the envelope when it comes to pacemakers.