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Articles from 2018 In October

Another Hold up for NxStage’s Merger with Fresenius

Pixabay Another Hold up for NxStage’s Merger with Fresenius

Fresenius Medical Care’s $2 billion acquisition of Waltham, MA-based NxStage Medical has been delayed yet again. The Bad Homburg, Germany-based company made plans to pick up NxStage in August of 2017 and the deal was supposed to close sometime this year.

However, NxStage said in a regulatory filing that the pending merger could come in February of 2019. The issue around the delay seems to center around Fair Trade Commission concerns.

Earlier this year, to help satisfy FTC’s antitrade concerns surrounding the deal, NxStage sold its Blood Lines business to B.Braun for an undisclosed sum.

“NxStage will close,” Dominik Heger, Head, IR & Corporate Communications for Fresenius, said during an earnings call, according to a release from Seeking Alpha. “We are later in the year than any of us imagined we would be, but we still believe that it will close.

He added, “we've extended the agreement with NxStage to February 5 in order to allow ourselves ample time to get this done with the Federal Trade Commission, and then finally get on in the integration of NxStage into Fresenius Medical Care.”

The acquisition of NxStage is an opportunity to position Fresenius as a global leader in the home dialysis market. NxStage has made a name for itself in the dialysis market with its System One, a portable hemodialysis system designed for patients to use at home, rather than having to go to a dialysis center for treatment.

“Frankly, NxStage has continued to develop very nicely since we announced the transaction last August of '17,” said Michael Brosnan, Fresenius CFO, according to Seeking Alpha transcript. “So, we will refresh our expectations once that deal closes, and that will take us some time as a part of our process to come out with the guidance for these periods.”

This is the second time the merger has been pushed back. In July, Fresenius said it was moving the deadline to acquire NxStage to November.

How Video Games Can Be Used to Improve Diagnosis and Treatment Methods

Courtesy of Level Ex How Video Games Can Be Used to Improve Diagnosis and Treatment Methods

These days when it comes to improving the process of diagnosing and treating patients, medtech companies are always looking for explore the unexplored. Level Ex, an innovative medical technology company based out of Chicago, may be taking the most unique approach with the release of their latest mobile game designed to train, educate, and improve the diagnosis and treatment skills of physicians.

The new mobile game, known as Pulm Ex, was designed for pulmonologists and aims to bring to life the most challenging patient cases for physicians around the country to help improve their diagnosis and treatment skills using highly realistic virtual patients. The game features a library of different pulmonary cases that include obstructive and restrictive diseases, foreign bodies, endobronchial masses, lung cancers, and more.

“Pulm Ex presents physicians with virtual patient case scenarios that can be seen in general and interventional pulmonology,” says Level Ex founder and CEO Sam Glassenberg. “The cases in the game are real cases submitted to Level Ex by leading pulmonologists who have identified these scenarios as some of the most challenging in the field. The game itself is incredibly realistic. Smoke rolls off of freshly-cauterized tissue, blood pools in crevices, foreign objects break and embed in bronchial walls, gooey secretions stick to your scope. These systems are 100% interactive and dynamic, and you will never see the same result twice.”

In order to capture the lifelike elements of these real-life cases, Pulm Ex’s award-winning game developers and designers deployed techniques from popular physics-puzzle games and first-person perspective mobile games. In the game, physicians can be scored based on speed, avoiding tissue damage, decision-making, and other skills — all while competing against their colleagues to achieve the best outcome.

“Pulm Ex is an entirely new paradigm for pulmonologists to stay up to speed in their ever-advancing field, while earning continuous medical education,” Glassenberg says. “The platform enables physicians to try out the latest devices and techniques, while challenging themselves and their colleagues to achieve the best outcome in some of the most difficult patient cases. We believe this will help produce practitioners who are better prepared for the unforeseen circumstances of surgery, diagnosis, and patient management — not to mention provide some much-needed relief from dry, didactic continuing education methods.”

Level Ex has been producing different innovative new mobile games for different fields of medicine for a few years now. The other games currently available are Gastro Ex, a game designed for gastroenterologists; Airway Ex, designed for anesthesiologists and emergency medicine physicians; and soon-to-be-released Cardio Ex, a mobile game designed for cardiologists.

“Our games provide physicians with an entertaining way to practice new techniques and learn about medical device and drug therapies in a risk-free environment,” Glassenberg says. “We try to identify the greatest challenges of medical practice and capture them as video game mechanics.”

Prior to its launch in the App store, Pulm Ex was played as a prototype by over 1,000 pulmonologists and was named Audience Choice Winner of the 2018 IPF Catalyst Challenge, as the solution to most positively impact the diagnosis of Idiopathic Pulmonary Fibrosis (IPF), an interstitial form of lung disease

Going forward, the company plans to release new cases and levels to its player base every month, and has already begun partnering with top pharmaceutical, biotech, and medical device companies to use the game to educate and train physicians.

“We now have multiple generations of physicians who have grown up on video games,” Glassenberg says. “They’ve seen the breathtaking realism that their Playstation 4 is capable of, or their iPhone for that matter. They won’t tolerate training simulators and tools that look straight out of 1991. They’re looking for more innovative ways to learn that can be accessible to their daily lives. Our mobile games can help fill that gap in medicine by offering incredibly immersive and skill-advancing experiences to physicians right on their phone or tablet.”

Say Hello to Hospital’s New Fully Autonomous Service Robot

Pixabay Say Hello to Hospital’s New Fully Autonomous Service Robot

Swisslog Healthcare, a global supplier of solutions and services for material transport, announced earlier this month the full market launch of their flagship technology, the Relay robot. The new autonomous service robot was designed for deployment in various healthcare settings and is set to debut for pharmacy and laboratory pick-up and delivery to help hospitals improve labor productivity.

The new Relay robot was manufactured by Savioke, a robotic engineering firm based out of California. The two companies decided to partner with one another in 2017 in a move to come together to develop an innovative new technology that could improve hospital workflows and increase laboratory efficiency.

The robot’s basic utility is to transport material between points in dynamic, high-traffic indoor environments. Among the many advantages afforded by an autonomous transport system are the efficient utilization of resources that provide an improvement in both patient and staff experiences.

Standing at just 3 feet tall and weighing 90 pounds, Relay uses WiFi and LTE communications to autonomously call elevators and connect with the RelayNow operating platform to signal the unit location, complete routes, and signal the deployment queue. The new technology also utilizes lidar and 3D vision to sense people and obstacles before adjusting course as needed to move along its programmed route unencumbered.

“Thanks to a small footprint and a sleek human-centered design, Relay is unobtrusive and even invites the curiosity of passersby interested in understanding the robot’s function and purpose,” says Ray Castro, director of solutions management for transport automation at Swisslog Healthcare. “Pharmacists, laboratory technicians, nurses, and other clinicians are accustomed to using technology to execute their duties. Relay has an intuitive interface and simpler operating system to make localized route programming and browser-based batch route programming easy and quick.”

Recent studies have shown that nurses walk an average of four hours out of every 12-hour shift just to conduct manual material transport. That means roughly one-third of their shift could be spent conducting routine, low-value tasks such as transporting blood samples to a central lab location, rather than spending their time on direct patient care. The new Relay robot technology could go a long way toward eliminating a large portion of these tasks in an effort to free up time and resources for direct patient care.

“Delays in patient care and walking long distances are among the top-cited roots of hospital inefficiencies,” Castro says. “Relay robot can help mitigate these inefficiencies, freeing skilled clinicians to do more of the high-value duties in their job scopes.”

When asked whether or not the Relay robot could eventually have an impact on medical device use in hospitals overall, Castro was quick to pump the brakes. She says that the healthcare sector is generally late to adopt technology when compared to other consumer markets. The company designed the Relay robot with this in mind in an effort to help bridge that gap and help encourage a faster rate of technology adoption.

As for the future of the new robot, Castro says that the company could eventually work with Savioke to expand the definition of autonomous services robots beyond delivery tasks to include providing a platform for additional patient care through interaction and communication. For now, the company will focus on educating hospital executives, laboratory managers, heads of nursing, and pharmacy directors about the technology as they look to increase the presence of the new autonomous service robots in hospitals and labs around the country.

How Are Engineers Actually Using VR for Human Factors Review?

How Are Engineers Actually Using VR for Human Factors Review?
Jerry Schafer, a design engineer at Kaleidoscope Innovation, demonstrates how virtual reality technology can be a useful tool for soliciting early human factors feedback on a project.

We've been hearing for some time now that virtual and augmented reality technologies are poised to revolutionize medtech, but can a VR system actually help R&D teams develop a medical device? It absolutely can, according to engineers at Cincinnati, OH-based Kaleidoscope Innovation.

"When we've got a team that's maybe across the country or across the world, we can get in here and actually be in the same room virtually around the same product," Ben Ko, a biomedical engineer at Kaleidoscope, told MD&M Minneapolis attendees on Wednesday.

Ko's colleague Jerry Schafer, a design engineer at Kaleidoscope, demonstrated just how useful VR can be for soliciting human factors feedback early in the development process. For his demonstration, Schafer used a motorcycle in virtual reality as an example (as shown in the image above).

There are two ways VR technology can have a meaningful impact on the review of a product, Schafer said. One possibility is what he referred to as a black box review, where an engineer sends a virtual rendering of a product to whoever the reviewer is at that stage, whether it is a client, a manager, a marketing team, etc.

"What they can do, which is pretty cool, is they can actually record their review," Schafer said. "They hit record, you don't see a video of them wearing a headset and waving their arms around, you see what they see. You're seeing them walking around [the product] saying 'you know, I don't like the way this seat matches up with the gas tank here, I think we should do something about that' or 'this grip texture looks a little hard' ... you get that video of them live reviewing it."

But perhaps an even more powerful way to apply VR to the review process is through multiplayer review.

"With the multiplayer review, you've got people all around the world in the same virtual space reviewing the same part at the same time," Schafer said. "At Kaleidoscope, one of our human factors experts is based out of California, and we're based out of Ohio. How would we have a human factors review with her normally? We could send her a prototype and then get on a call with her and we're both holding it and we're trying to describe what's going on, or I could try to spin a CAD model around on a GoToMeeting while she's watching."

VR technology takes the distance out of the equation completely.

"We could stand in this room together virtually and she can be right here next to me and we can both be looking at [the product]," Schafer said. "... You can really solicit great feedback from your human factors expert that way."

VR technology can also come in handy during concept down selection meetings.

Five years ago, if you were developing a large piece of capital equipment (like a motorcycle, for example) you would have five early concepts of the product and you would most likely put together a PowerPoint presentation using a graphics rendering of each concept for the client to choose from.

"But often times, that doesn't help you visualize what the concept itself does," Schafer said. "When you're standing in a room virtually with maybe five of these lined up and they're all at 100% scale, you can walk around them and experience the way they really feel in three dimensions. It really changes the feedback that you might get from sales, marketing, or even users in that early conception stage."

As the technology advances and more people become comfortable incorporating virtual reality tools into their process, we could see additional methods for applying VR to product development.

"We think we're really just scratching the surface with virtual reality, but we think that this is going to develop into a really meaningful tool that we can use," Schafer said.

New York State Initiative Hopes to Stop the Spread of Super Bugs

New York State Initiative Hopes to Stop the Spread of Super Bugs
Image source Pixabay

Each year in the United States, at least two million people become infected with antibiotic-resistant infections--so-called super bugs. And at least 23,000 of those people will end up dying from them, according to the Centers for Disease Control and Prevention.

One of the deadliest super bugs, carbapenem-resistant Enterobacteriaceae (CRE) bacteria, has become resistant to all or nearly all the antibiotics available today. Almost half of hospital patients who get bloodstream infections from CRE bacteria die from them. The problem is so serious that CDC has classified CREs as one of three urgent threats to the public health.

To combat this growing crisis, the state of New York is has announced a Life Sciences Initiative. The state’s Wadsworth Center Department of Health, in conjunction with ILUM Health Solutions, a wholly owned subsidiary of Merck & Co., and OpGen are working together to implement a system of diagnosing patients with antibiotic-resistant pathogens and delivering information to providers in real time.

“This is the first step toward developing a digital surveillance network for the state of New York,” Evan Jones, CEO of OpGen, told MD+DI. “It’s really groundbreaking,” he said. “There’s nothing like it in this country.” OpGen’s contribution is the genomic microbiology and Merck’s ILUM’s is providing monitoring software, Jones explained.

The demonstration portion of the program will be in several health systems initially in the first year to show feasibility and improvements over the current standard of care. When a suspected pathogen is identified, a genomic test will be performed by OpGen that will give rapid feedback as to the microbe and its profile and whether it matches other pathogens that have been seen in the facility or other facilities. “That will help guide patient treatment, but it will also give more statewide data than is available today,” said Jones.

There are two parts to OpGen’s system. “The first is our high-resolution genomic test, Acuitas AMR gene panel, which evaluates 47 resistance genes in the DNA of the pathogen,” said Jones. “And then that is uploaded into our Lighthouse software, which matches and creates tracking profiles for the pathogens.” He said the company’s IVD products also give predictions about antibiotic susceptibility. There is a three-hour turnaround for this testing, as opposed to gram negative testing, which can take five to seven days.

The initiative will only be used for CRE pathogens. But following initial deployment, the infrastructure that is created can be used for other emerging infectious microbes.

“This technology can help, for example, if we face another situation like the Zika outbreak from Africa,” explained Jones. “If you see patients with certain symptoms, this can all be real-time-monitored from hospital data and then patients can be put on a registry that providers know about.”

“We anticipate a real positive impact on patient care and quality of care in the New York state systems,” said Jones, adding that the goal is for the initiative to go live in the first quarter of 2019.

98point6 Uses AI to Help Redefine Primary Care

Pixabay 98point6 Uses AI to Help Redefine Primary Care

98point6 is on a mission to make primary care more efficient with the use of artificial intelligence. The Seattle, WA-based company said it raised $50 million in a series C round, bringing the total amount raised to $86.1 since the company’s inception in 2015.

The Merchant Banking Division of Goldman Sachs was an anchor investor in the Series C round, which was further supported by existing investors.

The funding will enable 98point6 to scale and fulfill strong commercial demand of its text-based primary care service, grow its product and physician teams, expand the capabilities of the platform, and continue to build its channels. Now available in 40 states and Washington, D.C. (reaching 92% of the U.S. adult population), the service is slated to be available in all 50 states by early 2019.

98point6 combines artificial intelligence with board-certified physicians to deliver affordable, high-quality care right to a patient's smartphone. This technology assists doctors by automating and completing tasks that don't require direct physician interaction, allowing them to focus their time on treating more patients. As a result, 98point6 members have experienced a 97% in-app resolution rate with more than one-third of them receiving care in non-traditional locations such as airports, coffee shops, in-transit or at work.

The latest funding will also allow for expansion into new markets, including health plans, health systems and higher education. To date, 98point6 has contracted with 27 companies nationwide across a range of industries (including retail, technology, financial services, healthcare and manufacturing) and is on track to have 100,000 members under contract through employers by the end of the year. Companies that have launched the 98point6 service to their members include Seattle Children's Hospital, Aegis Living and Zones, Inc.

"Primary care is the main entry point for individuals into an increasingly complex healthcare system, making it the ideal setting for providing patient education, encouraging preventive care and controlling downstream costs," said Jo Natauri, Global Head of Healthcare Investing for the Goldman Sachs Merchant Banking Division. "We are excited to partner with 98point6 because they are dedicated to improving the physician and patient experience—empowering board-certified physicians with technology to enhance care delivery and drive patient engagement."

The state of primary care was a topic of discussion at this year’s Cleveland Clinic Medical Innovation Summit. During the summit, panelists said an uneven payment system; millennials seeking out other options; and the rise of wearable devices were shaping how primary care would be delivered in the future.

Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

Sometimes even seemingly good ideas just don't pan out. Read on to see seven medtech products that once held a lot of promise but just didn't make it in the long run. 

Amazon’s Latest Move in Medtech Is a Big Deal

Pixabay Amazon’s Latest Move in Medtech Is a Big Deal

Amazon is continuing its deep dive into the healthcare market. This time the Seattle, WA-based company is teaming up with Arcadia, a consultancy group, to launch an exclusive brand of consumer-use medical devices for diabetes and hypertension management.

Dubbed, the Choice Brand, Amazon’s medical device offerings will start with a range of blood glucose monitors and blood pressure monitors both with supporting mobile apps which offer measurement tracking, data mobility, and reminders.

Amazon’s partner, Arcadia, will help develop the brand. Arcadia has extensive experience in brand development within the diabetes and cardiovascular markets and is widely known as the original architect of Walmart’s ReliOn brand as well as Abbott’s Freestyle line of diabetes devices.

“The Choice brand is all about accessible wellness, Bob Guest, CEO of Arcadia Group said in a release. “Consumers no longer need to drive to a store to stand in-line and purchase their medical devices and supplies. Now, in the privacy of their home, consumers can review, compare and purchase the products of their choice. No insurance is required. Therefore, customers have the freedom of choice. They will no longer be told by their insurance company what brand they can by. Choice is freedom.”

Amazon has been making significant moves in the healthcare industry this year. Back in January, Amazon along with Berkshire Hathaway and JP Morgan Chase caused quite the stir with news of a new venture aimed at providing their U.S. employees with "simplified, high-quality, and transparent healthcare at a reasonable cost." And in March, Amazon hired Taha Kass-Hout, MD, a former FDA chief health informatics officer, to serve in a business development role focusing on healthcare projects.

There has been speculation on how Amazon can shake up or impact the healthcare industry. In 2015 analysts said that Amazon had the potential to disrupt healthcare.

Amazon’s move into medtech and healthcare is similar to Google’s move into the industry in 2014. The Mountain View, CA-based company eventually restructured and its life sciences division, now called Verily, continued to penetrate the healthcare market at a rapid rate through a series of collaborations.

Also, both Amazon and Google’s Verily have been targeting diabetes market – which is considered an easy entry point into the healthcare market.

Supplier Stories for the Week of October 28

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 [email protected] with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

What Will Be Your Next Move in the In Vitro Diagnostic Space?

What Will Be Your Next Move in the In Vitro Diagnostic Space?

When it comes to in vitro diagnostic (IVD) technologies, medical device and diagnostic companies have been chomping at the bit to produce the next big innovation. The last few years have seen a surge in IVD technologies in the market, as device makers expand their knowledge and resources surrounding IVD technologies.

With new products in the marketplace for direct-to-consumer tests (DTC), point-of-care diagnostics, and next-generation sequencing, we may be on the threshold of a new wave of diagnostic technologies that could have an impact on other diagnostic areas as well, such as gene sequencing and editing. These new IVD technologies could potentially be the key that unlocks the door for a whole new generation of diagnostic possibilities.

In an effort to explore some of the latest IVD technologies, as well as the trends that paved the way for them, MD+DI spoke with Bill Harries, chief scientist at Aromyx, a medical technology company that focuses on capturing human olfactory and taste receptors on a disposable biochip for different therapeutic applications.

Harries earned his PhD in human anatomy and cell biology from Wayne State University School of Medicine and has spent the last 30 years researching integral membrane proteins in an effort to help design, express, and incorporate the human olfactory and taste receptors into a scalable sensor platform. He’ll also be part of a panel discussion at the BIOMEDevice San Jose Conference in December on the topic, "Your Next Move in the IVD Space: Is Merging, Mixing, and Matching in IVD Still the Rule?"

MD+DI: For starters, can you talk a little about some of the latest IVD technologies that have caught your attention that may be worth keeping an eye on?

Harries: IVD technologies that sense or detect changes in the body from outside the body could have quite an impact. For instance, sensors that can detect high intraocular pressure without having to touch the eye or measure blood chemistry without piercing the skin are certainly worth keeping an eye on in the coming months ahead.

MD+DI: How do you think gene sequencing and editing technologies like CRISPR will have an impact on IVD products and technologies?

Harries: I think that CRISPR technology will play a significant role in IVD product development in the near future. The capabilities that CRISPR can provide will give molecular biologists fast, efficient tools to modify genes of interest, as well as modify biochemical pathways with much more speed and efficiency.

MD+DI: What are some tips that you could share when it comes to evaluating new IVD technologies? Are there certain attributes that you prioritize?

Harries: Certainly, having a non-invasive sample acquisition that does not require the patient to significantly alter their behavior can be a very high attribute. Also, having IVD technologies that provide coverage of diseases and health conditions that have not had adequate diagnostic tools developed to date could also be of very high value.

MD+DI: Finally, in your personal opinion, what do you think are some of the biggest challenges facing IVD innovation? How do you think that these challenges can be overcome to help produce exciting next-gen technologies?

Harries: I think the regulatory environment must become an ally to innovators, rather than being a hindrance. Getting investors to commit to significant funding is hard when they know that much of their investment will be consumed in multi-year hoops that have to be jumped through. Refinement of the testing/validation process will take a concerted effort by all involved to achieve significant reductions in the time-to-market, but here doesn’t seem to be the will to make it happen on the regulatory side. One reason for this is that the regulators don’t have much skin in the game. Significant increases in small business innovation research funding would go a long way to help small, agile innovators take academic and private research innovation to the development and validation stage.