Articles from 2018 In September

Is This the Future of Healthcare?

Is This the Future of Healthcare?
Image courtesy of Forward

We’ve all heard the saying, “prevention is the best medicine,” and yet preventable illness continues to impact patients. Could a new approach to primary care employing advanced medical technology such as high-tech sensors make a difference in wellness? And could it be the future of healthcare?

Adrian Aoun hopes so. Dismayed by his brother’s heart attack at the age of 31, Aoun decided to leave his position as director of special projects at Google two years ago to “rebuild the entire healthcare system.” He founded Forward, a member-based healthcare service that offers what the company calls “world-class doctors with advanced medical technology.” The company opened its first location in San Francisco in January 2017, followed by a second in Los Angeles in November 2017. This past September, Forward opened a third location in Newport Beach, CA; another is set to open shortly in Glendale, CA, in late October.

“In tech, we don’t let things happen when we don’t like them,” Aoun told MD+DI, pointing toward companies like Airbnb and others that have emerged to transform their respective spaces.

“The world of healthcare is so reactive,” he said. Forward seeks to counter this by being as “data-driven as possible,” he said.

During a member’s first visit, health data collected by a noninvasive biometric body scan along with results from genetic and blood testing provide doctors and members with information for baseline health evaluation. During consultations, sensor-equipped stethoscopes and other high-tech sensors transmit readings to a touchscreen that collects and displays health history. (Past records can be retrieved from other sources and added to the Forward record, and the program can even develop a pharmacogenetic profile.) Care and treatment plans can then be devised.

“It’s kind of a ‘choose your own adventure’—what do you and your doctor want to work on?” said Aoun. “The system autogenerates a year-long schedule that is always by your side.”

Aoun says Forward has developed the sensors that are used for biometric body scans and the Forward app that provides members with 24-hour access to their medical records and to Forward's care team. Members are provided with other sensor-equipped products, including wearables, that connect to the Forward app to monitor activity and track progress toward their health goals.

Additional sensors can be provided for home use if further data is needed. Sensors that can be sent home include wellness sensors as well as ECG sensors, blood pressure sensors, cataract sensors, glucometers, and more. “If a member is not sleeping well, we can send a sleep sensor home,” Aoun said. All sensors are connected live to the Forward system. 

Forward’s approach “uses technology to reduce the inefficiencies, which allows us to lower the overall cost over time, so we can get this to every single person on the planet that really needs access for better healthcare,” said Aoun in a YouTube video.

At Stanford Medicine Big Data Precision Health 2017, Aoun explained that Forward is creating the notion of a “medical engineer” through monitoring, analytics through algorithms, and tools that allow doctors “to intercede before bad things happen. But the interesting part of this cycle is that it is closed-loop so that anything that our providers and members are experiencing we get to learn from and improve over time and actually start to create that medical AI that gets better and better every day to supercharge our doctors."

“This is the way we’ve always dreamed of practicing,” Dr. Nate Favini, Forward’s medical lead, told MD+DI

Forward currently offers members unlimited access to a full range of women’s and men’s health services, including cancer screening, heart health analysis, wellness counseling, nutrition optimization, sleep management, and vaccines, the company reported in a news release. And the company is launching several specialties: genetic counseling, dermatology, cardiology, and optometry. But Forward won’t stop there—Aoun told MD+DI that Forward plans to move into outpatient and inpatient care.

For now, Forward’s mission is twofold. On the micro level—provide members with “as much info as possible to prevent anything coming down the pike,” Aoun said. And on the macro level—provide scalable healthcare. “Augment doctors with technology—that’s how we are going to get healthcare to everyone,” he said. "We want to supercharge doctors."

When asked whether his brother’s heart attack could have been prevented if his brother had had better information about his health, Aoun told MD+DI that “We'll never know for sure, but Forward exists to answer that question. What happens if you give world-class doctors advanced medical technology that allows them to understand their patient's health comprehensively and build personalized, preventive plans for the future? We believe preventive care leads to greater wellness, and we're delivering that to our members.”

LeMaitre Vascular Expands Clot Management Offerings with New Deal

Pixabay LeMaitre Vascular Expands Clot Management Offerings with New Deal

LeMaitre Vascular said it has acquired the vascular clot management business of Applied Medical Resources Corp. for $14.2 million, of which $11.0 million was paid at closing and $3.2 million will be paid in two post-closing installments.

As part of the transaction, the parties also signed a transition services agreement under which Applied Medical will continue to manufacture the product line for LeMaitre Vascular for one year.

Applied Medical’s clot management product line, including Syntel embolectomy and thrombectomy catheters, Python over-the-wire embolectomy catheters, Latis graft cleaning catheters and irrigation catheters, is now available through LeMaitre Vascular. Sales of the business during the latest 12-month period were $3.4mm.

In 4Q18, LeMaitre Vascular expects the acquired business to add $0.5 million to $0.6 million in sales, and have no impact on operating income due to short-term business transition related costs.

The company has been successful with its recent acquisitions. In 2016, the company acquired Restore Flow Allografts for about $14 million. During an earnings call this year, the company touted the success of the acquisition.

The highlight of Q1 was the increasing acceptance by the North American sales force of the Restore Flow acquisition,” George LeMaitre, chairman and CEO of LeMaitre said according to a transcript from Seeking Alpha.  “Sales hit a record in Q1, up 48% over the prior year, and we see more growth ahead. These saphenous veins are a close substitute to the in-situ saphenous veins prepared by the LeMaitre Valvulotomes. These two products really are two peas in a pod."

Checkpoint Reels in $9M in Financing Round

Pixabay Checkpoint Reels in $9M in Financing Round

Checkpoint Surgical said it has completed a$9 million financing round. The Cleveland-based company is a specialist in nerve protection and repair. The financing was led by Mutual Capital Partners, existing backers included First Analysis, a growth equity firm based in Chicago, the JumpStart Next Fund and several individual investors.

Checkpoint said the growth capital will be used to expand Checkpoint’s sales and marketing resources, advance new product/market opportunities in nerve regeneration and neuroma pain, as well as bolster Checkpoint’s executive team.

“We spoke with many of Checkpoint’s surgeon-users and distributors and were impressed with the enthusiasm expressed by key opinion leaders at world renowned medical institutions using Checkpoint’s technology,” Wayne Wallace of Capital Partners said in a release. “Checkpoint has the core technology and team needed to build a significant business in a large high-growth market. We look forward to helping the team build on prior success in the nerve protection and repair space.”

SEC Strikes Again: Stryker Coughs Up $7.8M to Settle FCPA Violation Charge

SEC Strikes Again: Stryker Coughs Up $7.8M to Settle FCPA Violation Charge

The SEC has charged Stryker with violating the Foreign Corrupt Practices Act (FCPA), marking the second time the agency has brought an FCPA action against the orthopedic device company.

Stryker agreed to settle the charges and pay a $7.8 million penalty but did not admit or deny the charges. This time around, the agency found that Stryker's internal accounting controls were not sufficient to detect the risk of improper payments in sales of Stryker products in India, China, and Kuwait. SEC also noted that the company's India subsidiary failed to maintain complete and accurate books and records.

In addition to paying $7.8 million, Stryker also must now retain an independent compliance consultant to review and evaluate its internal controls, record-keeping, and anti-corruption policies and procedures relating to its use of dealers, agents, distributors, sub-distributors, and other such third parties that sell on behalf of Stryker.

“Stryker’s failures to implement sufficient internal accounting controls and keep accurate books and records are unacceptable, especially as this is not the first time the company has been charged for these types of violations,” said Marc Berger, director of the SEC’s New York regional office. “The penalty ordered, along with the imposition of a compliance consultant, are appropriate and necessary.”

In October 2013, Stryker settled charges of FCPA violations and was required to pay a $3.5 million penalty plus more than $7.5 million in disgorgement of ill-gotten gains and more than $2.2 million in interest. That time, the company was accused of bribing government officials and doctors to win business in five separate countries.

According to the 2013 charges, Stryker attempted to hide $2.2 million in bribes in Romania, Poland, Mexico, Greece, and Argentina. These bribes were allegedly hidden by booking them as commissions, consulting services, travel costs, and charitable donations. In one bribery example, Stryker is accused of paying for a Polish hospital director's trip to Aruba and New York City. During the trip, the hospital director and his wife received a six-night hotel stay and two live theater tickets compliments of Styrker.

Is Your Design Revolutionary or Evolutionary?

Is Your Design Revolutionary or Evolutionary?
Image source Pixabay

Not all new medtech designs are revolutionary, and that’s ok. Incremental advancements evolving from predicate devices—also known as evolutionary designs—could very well delight users and provide companies with a competitive edge. 

Speakers at the upcoming MD&M Minneapolis conference will explore the potential of evolutionary design in the October 31 panel discussion, “Employing Evolutionary Design While Satisfying the Requirements for an FDA Compliant Process.”

MD+DI asked panel moderator Tom KraMer, president and CEO of Kablooe, a few questions about evolutionary design and what attendees can expect to learn. (KraMer has been a product innovator for more than 28 years and developed the D3 Process [Design Driven Development].) At the event he’ll be joined by John Cain, lead industrial designer for 3M; Mark Wehde, section head, Technology Development Division of Engineering, Mayo Clinic; Peter Madson, vice president/partner, Worrell; and Mike Bravo, director, preclinical strategy, NAMSA.)

MD+DI: What do you mean by “evolutionary design”?

KraMer: Revolutionary design is often thought of as the breakthrough, game-changing type of design that creates a new paradigm. This can be very difficult in 510k products because of the need for an equivalent device that precedes. Evolutionary design takes that next logical step up in function and meeting user needs, without the risk of creating a new world that users will have trouble adopting.

MD+DI: Why is evolutionary design important for today’s emerging medical devices and today’s healthcare needs?

KraMer: Building on the successes and knowledge base of the past is a great foundation for pushing the envelope to the next logical step. With evolutionary design, you can understand what users, buyers, and other stakeholders will tolerate and set your design goals there. With breakthrough designs, you are really forcing users to adopt or decline using it.

MD+DI: How does the approach help medtech professionals navigate the regulatory process?

KraMer: It can definitely help you stay in the 510k range and avoid costly PMAs. This isn't always the case, but it sure helps. It can also allow for more efficient testing, which can make regulatory submissions a bit easier.

MD+DI: Are there any design or development pitfalls that the process can help avoid?

KraMer: It can. Inherently, a design that evolves from a predicate will have a considerably defined direction. This can help the R&D team focus on a variety of feature and detail options. This can be a great tonic for the problem of focusing too early on a single solution and spending a large amount of time and money developing it before finding the need to pivot.

MD+DI: How does evolutionary design ensure human-centered design?

KraMer: It doesn't really. That is always up to the designers. If the predicate devices are poorly designed from a human-centered standpoint, the evolutionary design could easily be, too. It takes good designers to change this. The inverse is also true.

MD+DI: The panel discussion includes designers and engineers as well as a testing professional and an engineer from a healthcare system. Does evolutionary design ease collaboration among all these types of job functions or assist in any other way?

KraMer: It really can. When the focus is on smaller challenges, the team can go deeper into those areas, and that allows for collaboration and cross functional engagement. Time equals options.

MD+DI: What sort of discussion do you anticipate during the panel?

KraMer: I expect specific regulatory challenges to be surfaced and ideas for how they could have been avoided or turned a different outcome to be discussed. There might be some opposing viewpoints, but I'm sure they will all be valuable ideas from this group.

MD+DI: How will your session cover software and hardware development? Rapid prototyping?

KraMer: Software and hardware have their own verification and validation requirements, and I'm sure some of the differences and similarities will be explored. Rapid prototyping is a great tool to expedite design iterations and can help the evolutionary steps proceed in a tighter direction.

MD+DI: What do you hope that attendees will do differently after hearing the discussion?

KraMer: My hope is that they will take away some methods and tools for their teams back at the ranch to try that will help them more efficiently arrive at their solutions.

Don't miss the October 31 MD&M Minneapolis panel discussion, “Employing Evolutionary Design While Satisfying the Requirements for an FDA Compliant Process.”

What Does the Future Hold for Robotic Surgery?

Intuitive Surgical Inc. What Does the Future Hold for Robotic Surgery?
With 23 years of experience pioneering the robotic-assisted surgery market, Intuitive Surgical currently has 4,400 da Vinci systems in hospitals worldwide, 43,000 trained da Vinci surgeons, and the da Vinci Xi (pictured) represents the fourth-generation of da Vinci systems.

It's hard to believe it's been nearly two decades since Intuitive Surgical launched its first da Vinci system. And yet, in many ways, the field of robotic-assisted surgery is still in its infancy.

"There's no university program on robotic-assisted surgery today," said Sal Brogna, an executive vice president and the chief operating officer at Intuitive. "We're at the early stages of creating a whole new technology sector. I assume someday you'll go to universities and they'll have robotic-assisted surgery courses, but we're creating it now."

Intuitive's da Vinci became the first robotic-assisted surgery system to be cleared for general laparoscopic surgery back in 2000. Today, the Sunnyvale, CA-based company is on its fourth-generation da Vinci system that is designed to be a comprehensive surgical device and can serve multiple surgical specialties, from urology and gynecology to general surgery, thoracic surgery, and even ear, nose, and throat surgeries. As of Sept. 30, 2017, Intuitive had 4,271 surgical systems installed worldwide, including 2,770 in the United States.

“It’s been a great journey for us, very rewarding," Brogna told MD+DI. "We obviously started in a very simple place that was a very compelling story, ‘let’s make robotics help cardiac surgeons by doing bypass surgery without cracking open the chest.’ That was a very compelling story. We never fulfilled all the requirements for cardiac surgeons, but as we moved in and other people saw the technology – and that’s been the fun part about the business – as other surgeons saw the technology emerge, they found applications that were relevant, the urologists being the first ones that brought it into prostate [procedures]. Over the years, it’s been a great learning experience because we work closely with surgeons and as more and more specialties came to us, we had to add features and capabilities that the prior generations didn’t have."

The fourth-generation family of da Vinci products, specifically the da Vinci Xi platform, was strongly targeted toward the general surgery market, Brogna said. He described general surgery as a rich marketplace with about a handful of subspecialties within it and the surgeons in those subspecialties had very unique and demanding requirements for a robotic-assisted surgical system. That's why the da Vinci Xi has many capabilities that previous generations of the system just didn't have.

Competition Breeds Innovation

Intuitive Surgical enjoyed a long run as the only company with a robotic-assisted surgical system cleared for general laparoscopic surgery in the United States. Today, the market pioneer is faced with competition from more than a dozen newcomers that are exploring various configurations and approaches to robotic-assisted surgery.

A real turning point in the space came in October 2017 when Morrisville, NC-based TransEnterix received FDA clearance for its Senhance Surgical Robotic System, which is used in gynecologic, colorectal, hernia repair, and cholecystectomy procedures. At the end of the third-quarter, TransEnterix had roughly 14 Senhance systems installed.

With the Senhance, surgeons can sit at a console unit or cockpit that provides a 3-D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. Two key differentiating characteristics of the system are the force feedback, which helps the surgeon "feel" the stiffness of tissue being grasped by the robotic arm, and eye-tracking, which helps control the movement of the surgical tools.

Competitors in the robotic-assisted surgical space would also do well to keep an eye on  Caesarea, Isreal-based XACT Robotics, which received a CE mark in September to sell its robotic navigation steering system in Europe. The XACT robotics system is currently being used for CT-guided percutaneous procedures in the abdomen. Later this year, the company expects to expand into additional clinical centers and with other imaging modalities, such as cone-beam CT and fluoroscopy, and for additional indications, including spinal and lung procedures.

Another company hoping to bring new options to the robotic surgery field is Virtual Incision, which is developing a two-pound robotic device that operates entirely inside the body through a single abdominal incision and is expected to be less expensive and more portable than existing laparoscopic surgery robots. The company is gearing up to seek a 510(k) clearance for its device.

So, how has Intuitive Surgical responded to these competitive pressures? Surprisingly well.

In 2017, Intuitive's leadership began emphasizing the importance of investing in product development to prepare for new entrants to the surgical robot market. In May, the company received FDA clearance for its da Vinci SP surgical system for urologic procedures that are appropriate for a single port approach. Brogna said 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.

Brogna also touched on the company's most recent technological development, which is a flexible catheter program that is still being reviewed 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."

This Isn't Your Father's Spine Surgery

One of the most promising areas of robotic-assisted surgery is in spine procedures. Medtronic made a big splash last week with the news that it has agreed to acquire Caesarea, Isreal-based Mazor Robotics. The two companies first began working together in May 2016 through a multi-phased strategic and equity investment agreement. Last year, Medtronic became the exclusive worldwide distributor of the Mazor X system, leading to the installation of more than 80 Mazor X systems since launch.

Mazor launched its Renaissance Guidance System in 2011 for brain and spine procedures and launched the Mazor X system for spine procedures in October 2016. While the company no longer discloses direct placement numbers, Mazor had a worldwide install base of 188 at the end of 2017, including 129 in the United States.

Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic, took some time during the North American Spine Society meeting this week in Los Angeles to talk to MD+DI about the company's vision for robotic-assisted surgery.

“The vision is pretty bold. I mean, the vision is to transform spine surgery," Martha said. "Right now the outcomes in spine surgery are not consistent enough, there’s too much variation across the board, and that’s led to patients not having a lot of confidence in spine surgery. It’s something that’s necessary if you have a structural problem in your back, but unfortunately, the outcomes have been too variable."

The days of open spine surgery where the surgeon is relying on his or her experience over time, without the help of enabling technologies like intraoperative-imaging and surgical navigation are coming to an end.

"We think it’s definitely shifting to a spot where you’re using that enabling technology, not just for technology’s sake but to actually improve patient outcomes," Martha said. "So we believe we can really mitigate that variation and ultimately transform the surgery to where the patients have a lot of confidence in spine surgery like they do when you get a stent put in or something like that.”

Being the market leader in the spine industry, Martha said Medtronic has an opportunity – and in many ways, an obligation – to improve outcomes and patient confidence in spine procedures. That's where Mazor comes in.

"People talk about robotics, but we believe robotic-assisted surgery is a lot more than just a robotic arm," he said. "It's pre-surgical planning software, a robotic arm, interoperative 3D imaging, navigation, powered instruments … all this needs to work together seamlessly in order to enable these better outcomes."

Medtronic also has experience in integrating these types of technologies seamlessly into the surgeon's workflow to remove some of the barriers of adoption, Martha noted.

"This is the first meaningful and sustainable competitive differentiation in the spine industry that we’ve seen in the last decade," he said. "This is something that we believe will define the industry."

That said, there are other large spine companies that are also helping to shape the market with robotic-assisted surgical systems. Stryker, Zimmer-Biomet, and Globus Medical are also competing in the space. Globus sells the ExcelsiusGPS robotic system, Stryker has the Mako, and Zimmer-Biomet has the Rosa Spine

How Will Machine Learning and Other Emerging Capabilities Impact Robotic Surgery?

Down the road, another disruptive competitor is expected to emerge in robotic-assisted surgery. It's well-known in the industry that Johnson & Johnson has partnered with Google to form a joint venture, dubbed Verb Surgical. Though highly anticipated, not a lot is publicly known yet about what Verb Surgical is calling its digital surgery program. What is generally understood, however, is that the platform is expected to include advancements in robotics, visualization, instrumentation, data analytics, machine learning, and connectivity.

Both Intuitive and Medtronic are already actively working on similar advancements.

"In terms of AI and machine learning, if you think about the planning component of this, you’re presented with some images and the patient presents with whatever the symptoms are, and then you use analytics to determine if the surgery makes sense and if so, what’s the best path," Martha said. "All this data analytics and machine learning should be guiding that."

Brogna said some of the early results he's seen from Intuitive's researchers in those emerging technology areas are quite promising.

"As the robotics were an augmentation to the surgeons and gave them better precision and control, machine learning will give them insights about their cases, will be able to help them understand how they can improve their techniques and get into better training curriculums, but will also be able to give them real-time updates of the case," he said.

For example, Brogna said the integration of machine learning could give surgeons guidance if they get stuck in a particular part of a procedure. Perhaps a short video would automatically pop up to help them through that particular challenge, he said.

Just last week, Santa Barbara, CA-based InTouch Health announced that is working with Intuitive to build an Internet of Medical Things that will enable the surgical robotics company to access its surgical systems within hospitals or surgery centers.

"We've had our systems networked back to our corporate servers for over a decade, and we rely on interconnectivity between taking data from the systems that help inform us for future designs, and help give customers insights on how the product is performing in their hospital," Brogna said. "But with the InTouch engagement, we hope to expand that. We see a growing need for the engagement of more devices in the OR and connecting them more."

One exciting outcome of the InTouch partnership is the possibility of enabling remote proctoring, meaning an expert surgeon would be able to participate in a surgery remotely. They won't be able to control the robot, Brogna said, but from their screen they can have a headset on and offer guidance to the surgeon that is performing the procedure, helping them through their learning curve.

"There are other things we're doing with delivering preoperative images and segmentation of the images to give surgeons a more natural guidance," he said. "So having secure networks that go from either the cloud or from our servers into the ORs is something that we see as an important part of the future."

IDx Moves from Angels to VC Investors with $33M Series A

Courtesy of IDx IDx Moves from Angels to VC Investors with $33M Series A

Since 2010, IDx had been funded mostly by angel investors. But now the Coralville, IA-based company, which obtained a nod from FDA in April for its artificial intelligence (AI) solution to detect diabetic retinopathy, has received funding from venture capital firms. IDx said it has raised about $33 million in a series A round.

Previously, the company had raised about $22 million from angel investors.

“After FDA approval we were approached by 55 or so investors and they all wanted to do business with us,” Michael Abramoff, founder and president of IDx, told MD+DI. “We decided that this was a great opportunity. Some of the investors are not only VCs per se, but they also have important strategic relationships.”

Abramoff pointed to Optum Ventures, which is associated with UnitedHealthcare as an example of a strategic relationship -because of its reach and presence. The investment was led by 8VC with participation from Alpha Edison and Heritage Provider Network.

The company's first diagnostic system, IDx-DR, detects diabetic retinopathy without requiring a clinician to interpret the image or results. This enables health care providers who are not normally involved in eye care to use the AI system to test for this leading cause of blindness during routine office visits.

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400, an easy to use and highly accurate robotic fundus camera.

Pivotal trial results assessing the safety and efficacy of IDx-DR were published online in August in the peer-reviewed, open access journal Nature Digital Medicine.

The pivotal trial involved 900 subjects with diabetes at 10 primary care sites across the U.S. The results showed that IDx-DR exceeded all pre-specified superiority endpoints at 87% sensitivity, 90% specificity, and a 96% imageability rate, demonstrating the AI system’s ability to bring specialty-level diagnostics to primary care settings.

The technology has garnered significant attention in recent months as the AI market has exploded. Recently, IDx was named by MD+DI as one of six AI companies set to rock medtech.

IDx executives said the company is definitely moving forward and there might even be an initial public offering (IPO) on the horizon.

“We hope to work toward a public offering maybe next year,” Abramoff said. “That very much depends on factors that are under our control, which are market adoption and getting revenue, but also factors that are not under our control such as market conditions. I don’t know when, we’re certainly working toward [an IPO].”

Supplier Stories for the Week of September 23

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]

Hologic Finds Focal Point in Breast Health with New Acquisition

Pixabay Hologic Finds Focal Point in Breast Health with New Acquisition

Hologic has signed an agreement to acquire Focal Therapeutics for about $125 million in cash to boost its breast health offerings. The deal comes hot on the heels of the Marlborough, MA-based company announcing it would acquire Faxitron Bioptics, another breast health specialist, for $85 million. Hologic said the Focal acquisition is set to close in early October.

With Focal, Hologic will have access to BioZorb, an implantable 3-D marker that helps clinicians overcome challenges in breast conserving surgery, or lumpectomy. The marker, placed by the surgeon, is used to mark the tumor excision site for monitoring and future treatments, and its unique open design allows for tissue in-growth during the healing process.

Aliso Viejo, CA-based Focal Therapeutics generated about $16 million of revenue in the last 12 months. The acquisition, which is expected to close in early October, is estimated to be neutral to Hologic’s non-GAAP earnings per share in fiscal 2019, and accretive thereafter.

“Acquiring Focal Therapeutics strengthens our position in an attractive, adjacent breast health market, and is consistent with our capital deployment goals,” Steve MacMillan, Hologic’s chairman, president and CEO said in a release. “The transaction is accretive to our revenue growth rate and gross margin, broadens our recurring revenue base, and provides attractive return on invested capital.”

Focal and Faxitron are acquisitions that could help significantly bolster Hologic in a way Cynosure initially couldn’t. Hologic admitted it stumbled a bit with Cynosure, earlier this year.

Recently, Hologic updated investors on the anticipated financial impact of its decision to suspend the Vitalia products, which are sold through the Cynosure unit. The company disclosed on an SEC filing that the TempSure Vitalia system suspension could impact fourth-quarter Cynosure revenue by $15 million due to refunds.

Hologic picked up Cynosure, an aesthetics specialist, for about $1.65 billion in 2017.

What Can Medtech Do with Medicare Data via Blue Button 2.0?

What Can Medtech Do with Medicare Data via Blue Button 2.0?

"In the era of artificial intelligence, machine learning, and precision medicine, fax machines continue to be the go-to technology for providers transmitting health information."

That's Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, at the HIMSS18 Conference, speaking on interoperability issues providers still face when using electronic health records (EHRs).

In an effort to solve some of these issues, or at least make progress, in August, CMS went live with Blue Button 2.0, an API that gives developers access to four years of Medicare Part A, B, and D data for 53 million beneficiaries. Patient data includes the type of Medicare coverage, drug prescriptions, primary care treatment, and cost.

Although it's not as detailed as a medical device manufacturer would like, it's worth experimenting with. Access to prescription history and other healthcare information could potentially drive decision support, provide tighter integration with other devices and systems, and/or enhance patient care.

"If a medical device has a contraindication for a disease or medication, Blue Button 2.0 could provide a first pass screening for the contraindication," said Andrew Boyd, MD, associate professor of biomedical and health information sciences in University of Illinois at Chicago's College of Applied Health Sciences.

For example, say a diabetic patient visited a nutritionist that's not affiliated with his doctor's health system. If his blood glucose monitor "knew," using Blue Button 2.0 data, that he saw that nutritionist and modified his diet, it could incorporate this information into blood sugar history reports. His primary care doctor would then have a more detailed insight into why the patient's blood sugar levels changed over time.

Medical device companies thinking "beyond the device" to enhance products with connectivity and patient engagement features could aggregate Blue Button 2.0 data to provide patients with more customized information. The knee replacement that comes with its own app could prepopulate profiles with medical and prescription information.

Other potential uses include post-market surveillance and pre-market research. "The value depends on the device and the data needed," says Boyd. "There are 80,000 ICD-10 [disease] codes, plus procedure codes, and between 30 and 40,000 FDA-approved drugs in Medicare Part D in the API."

Elements also included in Blue Button 2.0 profiles include gender, date of birth, race and claim details. CMS mapped more than 1,300 fields from the CMS claims data warehouse into the HL7 FHIR standard (Fast Healthcare Interoperability Resources) specification, a standard for exchanging healthcare information electronically.

Blue Button at Work

Some SaMD companies have already taken advantage of Blue Button 2.0 data. Humetrix launched iBlueButton, the mobile embodiment of the initiative, earlier this year. The app allows users to pull, receive, aggregate, store and share payer claims, provider EMR, and Blue Button 2.0 data. The app serves Medicare beneficiaries, veterans, and individuals using Tricare, the health program for the military.

EHR companies Epic, Allscripts, and Cerner have agreed to work with third-party apps so patients can access their health records on their phones. A few of these apps include Medisafe, a medication management app; RxREVU, a prescription intelligence platform; and CareEvolution, which provides interoperability, population health, and analytics technologies.

Removing Interoperability Barriers

CMS launched Blue Button 2.0 to add value for beneficiaries, providers, healthcare organizations, researchers and others in the healthcare and life science spaces. says research organizations can prepopulate medication lists for clinical trials patients. Doctors can access information on patient care provided outside of his or her health system for a more comprehensive patient view.

More than 700 developers have signed up to experiment with Blue Button 2.0. Tech heavyweights Amazon, Google, IBM, Microsoft, Oracle, and Salesforce signed a pledge showing their support and committing "to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI."

What we have right now, Verma said, in a speech at the Interoperability Forum in Washington DC, in August 2018, is data in silos, systems that speak different languages and patients and providers that don't have the information they need to take charge of their health.

"One of the challenges Medicare recipients have comes from seeing multiple doctors," says Boyd. "Sometimes it's confusing to tell who is treating what disease. If a software is able to help visualize this information, and help patients and doctors understand who is treating what, and who is billing what, it would go a long way in helping reduce Medicare fraud and improving patient engagement."

Verma points out in her speech the oddity that patients don't yet have this level of access. "If my phone knows what podcast I might want to listen to next based on my purchase history, shouldn't our medical decisions be fully informed by our medical history?"

Blue Button 2.0 data isn’t the ideal solution for enhancing medical device features or interoperability, but Boyd sees it as a step in the right direction. "Blue Button billing data is one step removed from clinical decisionmaking, which would provide a more complete picture," he says. "However, the data from this model can be used for future, more detailed sharing. As devices become more sophisticated they're going to need a bigger clinical integration for the device to perform at the optimal level."

To get started with Blue Button 2.0, read the developer docs. Once you start building, Blue Button 2.0 also has an active Developer Group where you can ask questions.