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Articles from 2016 In July


What Does Neurology Group's Recommendation on PFO Closure Mean for St. Jude?

The American Academy of Neurology has recommended against percutaneous closure of a congenital heart defect in patients who have had a stroke just as St. Jude Medical anticipates a device to treat the condition will gain FDA approval.

Nancy Crotti

St. Jude Medical doesn't even have FDA approval yet for a device purported to prevent stroke, and a major physicians' group is warning against implanting it in stroke survivors.

Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21, 2016.

St. Jude's Amplatzer PFO Occluder would treat patent foramen ovale (PFO), a congenital defect that causes a hole in the wall between the heart's upper chambers. Study results show that 94% of patients who received the device had effective closure of the holes in their hearts six months after surgery. St. Jude CEO Michael Rousseau recently said he expects FDA approval later this year.

Meanwhile, the American Academy of Neurology updated its guidance to recommend against catheter-based PFO closure for patients who have had a stroke. The practice advisory was published in the July 27, 2016, online issue of Neurology, the academy's medical journal.

Percutaneous PFO closure with the Amplatzer PFO possibly decreases the risk of recurrent stroke while possibly increasing the risk of new-onset atrial fibrillation, "and is highly likely to be associated with a procedural complication risk of 3.4%," the study says.

In other words, one in 60 patients who had the implant might benefit from it, "which is not great," said study coauthor Gary Gronseth, MD, the academy's chief evidence-based-medicine methodologist. "When we meta-analyzed the data, the benefit seems to be small and that estimate is biased, and so great caution must be exercised."

One in four people has a PFO, and most people will have a blood clot in their leg that doesn't cause any symptoms, Gronseth noted. In people who do not have a PFO, these clots are harmlessly filtered by the lungs, but the presence of a PFO might allow clots to pass from the right side of the heart to the left side, which sends blood to the brain, he explained. It also might not. Doctors simply don't know how much of a difference having a PFO makes in terms of having a stroke, he added.

"Clinicians should not routinely offer percutaneous PFO closure to patients with cryptogenic ischemic stroke outside of a research setting," the study concludes. "In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the Amplatzer PFO Occluder if it is available."

The neurology group said its researchers reviewed all available scientific studies on people with PFO--a permanent implant--who had also had an ischemic stroke, which is a stroke caused by a blood clot, or a transient ischemic attack, which is an episode of temporary stroke symptoms.  

The Amplatzer PFO Occluder consists of two disks, a nitinol mesh, and polyester fabric, and can be recaptured and repositioned to ensure proper placement, according to St. Jude.  The product came to St. Jude by way of its 2010 acquisition of AGA Medical Corp.

In May, an FDA panel voted 15-1 that there was reasonable assurance that the device is safe for use, 11-5 that its benefits outweigh the risks, and 9-7 that it is effective for the intended use. St. Jude puts a lot of stock in the panel's recommendation, according to an emailed statement from the company.

"We believe Patent Foramen Ovale (PFO) closure represents an important treatment option for patients with a PFO who have experienced a cryptogenic stroke and is a therapy backed by compelling clinical evidence," the statement reads. "The positive discussion during the FDA meeting and resulting vote is an important step toward approval of the technology in the United States, and we look forward to additional discussions with the FDA in the coming months."

FDA's rules for device approval are not as stringent as those that physicians use to consider device efficacy and safety, according to Gronseth.

"Just because it's approved doesn't mean it's a good idea. Those two things don't equate," he said. "It's still an open question whether it makes any difference, whether it helps."

Nancy Crotti is a contributor to Qmed.

Theranos CEO Courts Controversy at Clinical Chemistry Meeting

Elizabeth Holmes will explain Theranos's testing methodology at the American Association for Clinical Chemistry annual meeting, but some question the decision to give her a podium.

Nancy Crotti

The founder and CEO of secretive and embattled Theranos is scheduled to discuss the science behind the company's proprietary blood-testing technology at a prestigious clinical laboratory conference in Philadelphia on Monday.

Network with your medtech colleagues at MD&M Minneapolis, September 21 & 22, 2016.

Elizabeth Holmes' presentation at the American Association for Clinical Chemistry annual meeting will compare reproducibility and correlation data for various tests comparing Theranos's finger-stick blood collection and storage device with traditional blood-drawing methods, according to the conference program.Holmes will also discuss the methodology that Theranos uses for its diagnostics testing platform, and "share data to demonstrate the precision and accuracy of these chemistry, immunochemistry, hematology, and molecular assays (traditionally performed on separate instruments) using their analytical testing platform, including a novel molecular test for the Zika virus," the program says.

Theranos, which faces sanctions by CMS and is under investigation by the U.S. Department of Justice, has been very secretive about its technology and methodology. The company also faces consumer lawsuits.

Holmes' appearance is provoking controversy, according to a report by STAT, and curiosity as well.

"Would you have Al Capone come and talk about his novel accounting practices?" Geoff Baird, a clinical pathologist at the University of Washington, rhetorically asked STAT.  "Is it acceptable to allow someone to talk about science if they've used that science so horribly inappropriately?"

Others among the 20,000 or so conference attendees will likely be curious to see this latest step in Theranos's attempts to right the ship.

The Palo Alto, CA-based company recently appointed Dave Wurtz, formerly senior director for regulatory affairs, quality, and compliance at Thermo Fisher Scientific, to be vice president of regulatory affairs and quality. Attorney Daniel Guggenheim, former assistant general counsel for regulatory and compliance at healthcare giant McKesson in San Francisco, was named chief compliance officer.

Both will report to Holmes, whom CMS banned from the business for two years. Theranos noted that it has 60 days from the July 7 imposition of sanctions by CMS to appeal the agency's decisions. Those sanctions include fines and cancelling reimbursements for the Newark, CA, lab that was the center of CMS's investigation. Forbes once listed Holmes as being worth $4.5 billion during Theranos's better days. In June, it revised that estimate to zero.

After her presentation, Holmes is scheduled to answer questions submitted in real-time by audience members. 

Nancy Crotti is a contributor to Qmed.

How Can OEMs Respond to the Threat of Medical Device Hacks?

Wireless protocols and standards are urgently needed to protect medical devices from data infringement.

Mike Kanis

Cybersecurity is a critical issue for individuals, businesses, industries, and entire nations these days, and data vulnerability is alarmingly real. Breaches of every scale are reported in the news on a regular basis, usually tied to financial information stored by retailers and banks. The world is going digital in all aspects of modern life, from banking to social networking, fitness tracking, politics, market research, news curation, communication, and just about anything we do or touch in the course of a day. While it offers tremendous convenience, data sharing over the Internet also opens the door to risk.

Learn about cybersecurity, compliance, and patient privacy at the MD&M Minneapolis conference, September 21 & 22, 2016.

In healthcare, digital communications are used to monitor patient statistics. Most medical devices that collect data are going home with patients; many of these are capable of transmitting data over the Internet. Pacemakers, insulin infusion devices, and wearable heart rate monitors are familiar examples. Patients use their tablets, cellphones, or other connected devices to upload the data to the Internet, where it can be stored or transmitted to their health care providers. The benefits include accurate and timely reporting, time savings on both sides, and cost mitigation by reducing the necessity for office visits. However, the Internet connection presents a security risk when information goes out into the ether. The threats can be mitigated using existing encryption and safety technologies, but many experienced hackers know how to break into those systems and extract personal data.

As healthcare becomes increasingly interconnected, it's only natural that medical devices will become targets for attack by unrelenting cybercriminals.

Contending with the Burdens of Change

Stolen data presents an obvious threat to individual privacy, which alone is enough to cause concern. But what if hackers were able to not only view data, but also change it--or worse yet, to manipulate device controls? What was once a foreign notion has become immortalized in pop culture, with a politician's pacemaker being hacked in an episode of a popular drama series on Showtime. Reality check: That particular scenario is currently implausible because pacemakers operate wirelessly in a near field using proprietary software and an interloper would need a code to break in. But it does raise the question of when a Hollywood fantasy becomes a medical device developer's worst nightmare. 

Clearly, the medical device and healthcare industries need a proactive plan to combat cyberattacks that could compromise wireless devices' accuracy, safety, and security. While the need has been on the industry's radar for years, regulatory action moves slowly compared with the development of new decryption schemes. It's a tortoise-and-hare scenario with potentially dire consequences.

The fact is, establishing cybersecurity standards for medical devices is remarkably complicated. Besides the usual IT challenges, medical devices are tightly regulated. Their design and operation are approved by FDA for specific uses before they can go to market, and changes can't be made without submitting for time-consuming reapproval. Hackers work quickly to find and exploit vulnerabilities, creating fresh avenues of access to the data they want. The opposite is true of regulatory approvals, which go through a slow and laborious process. Modifications can't be made quickly enough to stay ahead of rapidly evolving intrusion techniques.

Fitting the necessary power inside a device to operate effective security programs presents additional challenges for design engineers. In particular, implantable devices are trending toward smaller sizes while incorporating more and more complex electronics--a feat that becomes more complicated as additional layers of security are introduced.

Adopting New Rules of Engagement

All of the data technology in medical devices was once proprietary, but today the industry is moving toward establishment of standards-based communication systems. As technology advances, wireless protocols and standards are urgently needed to protect medical devices from data infringement. FDA has struggled with defining its role in addressing this issue; development of IT protocols is not within FDA's customary purview, and the agency hasn't yet reached a practical conclusion on its authority or desire to regulate data management aspects of medical devices.

FDA explains its current position this way:

"Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them. There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance."

Medical device manufacturers and healthcare facilities are encouraged to become familiar with the National Institute of Standards and Technology voluntary cybersecurity frameworkand to work together on managing cybersecurity.

Different degrees of processes exist that can potentially alleviate the threat of a security breach into a newly developed medical device. Potential threat modeling, a traceability matrix, is designed to define all potential security issues with a device under development. This allows for selection of clearly defined requirements with regard to design inputs related to security issues.

The next step is to develop software architecture with remediation activities that eliminate separate or even compound security risks. FDA guidance suggests that these activities be considered during development of devices that are subject to Internet security risks.

Finally, developing protocols for penetration testing of devices at all stages of development is essential to demonstrate that the mitigation efforts are working. Tests such as these are designed to probe the software security at different levels.

Right now, a clear path forward is undefined. It is hoped that FDA will eventually issue guidelines, whose scope and specificity remain to be seen. Meanwhile, it is incumbent on medical device designers and manufacturers to stay on top of the issue and build the best safeguards possible into their products.

Mike Kanis is a sales engineer with Proven Process. Reach him at mkanis@provenprocess.com.

[image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]

Brexit, IP, and the Medical Device Industry

Brexit, IP, and the Medical Device Industry

What does Brexit mean for the protection of intellectual property in the medical device industry?

Jay Erstling

Brexit will no doubt have an impact on the US medical device industry, but the question remains as to what sort of impact it will be. 

On June 23rd, the United Kingdom voted to leave the European Union. That surprising and unprecedented vote, known as Brexit, was just the start of the process of withdrawal. The first official step will occur when the UK invokes Article 50 of the Treaty on European Union, which allows a member country to notify the EU of its withdrawal and obliges the EU to begin the complex and cumbersome process of negotiating a withdrawal agreement. The UK will not likely leave the EU until the withdrawal agreement enters into force, which at a minimum will be two years from the date of the notification of withdrawal. The European Council may also vote to extend the two-year period, a result that many commentators think is inevitable.

The UK is a major market for US medical devices--the third largest in Europe--and US medical device manufacturers control the major UK market share. The UK is also a major hub for intellectual property protection for US medical devices. In 2015, US medical device companies received just under 6,000 European patents, almost all of which became binding in the UK, and EU and UK trademark holdings are extensive.   

Although it is impossible to predict with certainty the fallout from Brexit, there are some assumptions that can safely be made about Brexit's impact on the protection of intellectual property.

Patents 

The good news is that Brexit will have no effect on UK or European patents or patent applications. European patents are granted by the European Patent Office (EPO), which is not an EU institution. EU membership is not a condition of membership in the EPO, and non-EU member countries, such as Switzerland and Norway, have long been EPO members. Applicants will continue to be able to validate granted European patents in the UK, and European patents that have already been validated will continue in force. Similarly, UK patent attorneys will be able to continue acting as representatives before the EPO, which will allow US firms to work collaboratively with UK attorneys in seeking patent protection for US clients.

Erstling

In the longer term, the picture gets a little murky. The EU was moving toward the launch of a unitary patent--a European patent that would have effect throughout the EU--and an EU-wide Unified Patent Court. Neither has come into effect, and without the participation of the UK, the future of both seems questionable. Adding to the doubt, the UK is one of the countries that must ratify the Agreement on the Unified Patent Court to make the court operational, and London was appointed to host one of the court's central divisions.

Trademarks and Designs

Brexit will have a greater impact on trademark and design protection in the UK, but presumably not before the UK will have the opportunity to minimize the effect. Applicants currently register trademarks and designs in the UK either by filing UK national applications or by applying for the registration of an EU trademark or a Community (EU) design. EU trademark or design registration provides unified and unitary protection in all EU member countries. EU registrations will no longer cover the UK when the UK leaves the Union, which raises the question of whether existing registrations will remain effective in the country. Fortunately, it is fully expected that the UK will adopt transitional arrangements either to extend EU registrations automatically or to require a simple re-registration procedure. In the meantime, it may be worthwhile to consider applying for national registration in the UK in addition to EU registration, especially for companies whose business activities are UK-centered. In the end, Brexit is likely to cause inconvenience, but no loss of trademark or design rights.

Trade Agreements 

When the UK leaves the EU, it will cease to be bound by any trade agreement to which the EU is the signatory. If the UK wishes to benefit from an agreement, it will typically need to renegotiate a new one with the trade partner. The EU and the US have been negotiating the Transatlantic Trade and Investment Partnership (TTIP) since 2013. Not only does the draft TTIP contain a proposed chapter on intellectual property protection, it also contains a draft chapter on medical devices that is expected to include provisions on unique device identifiers, device standards, and noncompliant devices. If the TTIP negotiations succeed, the resulting agreement may not extend to the UK.

The UK has so far not been in a hurry to invoke Article 50, despite calls from the EU to get the negotiation process going. While the lingering uncertainty of Brexit may create some economic anxiety, it should also provide reassurance that US business will have ample opportunity to prepare for whatever Brexit brings.

Jay Erstling is an international intellectual property attorney with Patterson Thuente Pedersen, P.A.  He can be reached at erstling@ptslaw.com

[Images courtesy of STUART MILES/FREEDIGITALPHOTOS.NET and PATTERSON THUENTE PEDERSON, P.A.]

Meet the Google Glass Co. Saving Doctors Hours Each Day

Meet the Google Glass Co. Saving Doctors Hours Each Day

Augmedix uses Google Glass to eliminate manual data entry into electronic health records, saving precious time for doctors. We asked Ian Shakil, the company's cofounder and CEO, to tell us more. 

The idea behind Augmedix is surprisingly simple. The business uses Google Glass technology and medical scribes to automate data entry for electronic health records (EHRs). Augmedix cofounder and CEO Ian Shakil has admitted it's a straightforward formula, but it seems to be paying off.  

Shakil explained that just a few years after its inception, the company already has five large healthcare systems and hundreds of physicians using Augmedix. In 2016 alone, Augmedix has been named Fast Company's "Most Innovative Healthcare Company of 2016," closed a $17 million funding round supported by those five major health systems, and also received $16 million in Series A funding.

In a recent Q&A, Shakil told MD+DI about the eureka moment that led to Augmedix, how his background in the medtech industry prepared him to be a digital health entrepreneur, and what's next for the company. 

(Editor's note: This Q&A has been edited slightly for brevity and clarity.)

MD+DI: Tell me about how Augmedix works.

Ian Shakil: The pain point that we're addressing is this tragic fact that doctors spend two, three hours a day on the computer, typing and clicking, typically right in front of the patient with their back turned. Everybody dislikes this. The patients don't like it. Doctors hate it. It's not what they went to med school for. Doctor management doesn't like this either.

What we do is say--Doctors, hey, stop doing it this way. Simply wear Google Glass and go into the clinic. Go have a normal conversation with your patient, a human dialogue, like you always wish you could have had. In the background, from Google Glass, from the audiovisual stream, we will fill in the forms and fields and dropdowns and structured data of whatever EHR system you use, better and faster than you could, thereby saving you that time. Giving you a third of your day back.

We will also serve you information on demand . . . if you're a doctor you can say, "Show me the labs. Who is the next patient? What's the cholesterol?" You name it and it pops up. You don't have to go fetch this information or distract yourself and the patient.

The audiovisual is streamed to a human being elsewhere in the world. We call them an expert, a remote scribe. They see and hear what the doctor sees and hears, are sitting in a secure cockpit, and have all the tools to do all the documentation and serve the doctor right then and there. They have the electronic health record up--the Epic, the Cerner, the Practice Fusion, whatever the doctor uses--and they have all the tools to create cards, manipulate Google Glass from afar, see the schedule, etcetera.

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MD+DI: Where did the idea for Augmedix come from?

IS: I've worked in various healthcare settings, mostly in the medical device industry, and I became very familiar with the trials and tribulations of being a doctor by working with doctors. I went to grad school at Stanford to get my MBA. My cofounder (Pelu Tran) went to med school at Stanford to get his MD. The two of us met in grad school and knew we wanted to do something big together, but just didn't know what, exactly.

We had a rare opportunity in 2012, right after I graduated, to try on a very early version of Google Glass. That was a eureka moment, really. We knew then and there that this device was ready for prime time and we could just see, "Oh my gosh, it belongs on doctors. And we know just what to do with it." We became obsessed quickly. I quit my job and Pelu, my cofounder, dropped out of medical school. Together, we formed the first Glass company, more or less to do then what we now do today without hardly any pivots or deviations.

We now have around 500 people around the world working for us, up from the two of us in 2012.

Shakil

MD+DI: That's incredible. Tell me how you two got the company and product off the ground so rapidly?

IS: I wish I could say it was easy or something. One, hiring expert people. We brought in some of the foremost experts in scaling these technology-enabled body-heavy services and brought them into our company quickly. The folks who founded the world's first medical transcription companies in the 1990s, which are foundational in this space, and grew them to over 20,000 employees--early on, they came and started working for us. That was one of the ways we got into rapid-scale mode.

Two, it's just about keeping it simple. There are a lot of really exciting things you could do with Google Glass when they're sitting on the eyes and ears of doctors all day, everyday. We want to do those things too and it's an amazing platform opportunity, but right now, we're really just focused on knocking it out of the park with our core service.

Those are the two secrets to going quickly. Maybe number three is, just finding the right customer partners and figuring out the ones who will let you scale quickly and losing the people who are merely dabblers and piloteers . . .

MD+DI: How did you get your first physician users to adopt the product? Did it take much convincing?

IS: The service itself is pretty compelling. I meet very few doctors that, when they hear about it, don't say, "Hey, I want that." Demand is extraordinary and even to this day, demand is off the charts. We struggle to fulfill demand, which is a good problem to have.

In the early days, we engaged independent doctors. Doctors that are unaffiliated and told them about the service . . . "If you try it, you like it, you keep it." We got enough of those people, dozens, engaged and loving it and showing good data, that we had enough juice to go out and engage big, mega health systems. The first of those was Dignity Health. We now have five major health systems that are commercial and expanding with us.

It was just a slow progression: independents, then one health system, then everyone starts to pile in. Interestingly, today our five health systems have so many doctors that we really don't need to add any more health systems. We would be a billion-dollar company multiple times over just servicing the doctors in the health systems that we have. That's pretty astonishing. We are adding more health systems but it's not what we're all about as a company.

Also, our health systems have recently become our venture investors. A couple months ago they . . . joined a coalition to back us, partner with us, help us scale deep into their organizations and across the country.  

MD+DI: How many physicians are using Augmedix now?

IS: We're not yet in the thousands. We will be next year. We're still in the hundreds . . . That may not sound like a lot of doctors, but we charge each doctor user in the low-single-digit thousands of dollars per month. So even at that level it's a significant amount of revenue.

MD+DI: I know you worked at Edwards Lifesciences earlier in your career. How did your experience at a traditional medtech company inform your work at Augmedix?

IS: When I first joined Edwards, I joined their leadership rotational program, which is the best in the industry. It was awesome. I should have paid them for the experience, because they sort of force you to bounce all around the company and take on different roles. I was an R&D engineer. I was a manufacturing supervisor of 70 people in a cleanroom. I was in the IT Quality group and then I was in marketing and then I was in business development. So they literally just force you to see a company from every angle. It's really good training for being an entrepreneur in the healthcare space. I couldn't have asked for more, really.

It also exposed me to how doctors and health systems think and make decisions, as well as how to operate in a regulated environment. In that case it was FDA. In this case, we have other regulations involving HIPAA and CMS. We also have to be mindful of privacy regulations regarding camera usage as well as HITRUST and SOC 2. There were a lot of parallels between the two worlds.

MD+DI: What are future plans for the technology?

IS: What's amazing is we offer an incredible service that saves doctors a third of their day, improves the doctor-patient interaction, doctors are delighted, and documentation is better . . . But eventually we want to take advantage of the fact that we're sitting there on the eyes and ears of doctors all day, every day, and we have a pipe to the EHR. That allows us to, over time, do so much more. 

For example, we can start serving carefully timed and curated guidance and reminders to doctors to help them with chronic care condition-related matters. We can help doctors communicate with other doctors and provide team communication services. We can actually save the audio-visual and send it to the patient on the patient portal so that they can relive the moment with their family. We can ultimately service all types of different content to the doctor, even content outside of the EHR. Ultimately, we'd like to be able to get into the world of small data and big data and be able to perform helpful analytics to assist doctors and help them know how they fare relative to benchmarks or help Dignity Health know the variances and practice patterns with respect to this drug prescription or this productivity-related matter.

We will be in a position that will be perfect to provide these sorts of services. In many cases they will be human-powered, over time they will be powered by speech recognition and natural language processing. Ultimately we'll be able to say--"What are the three words uttered before the missed diagnosis of the flu in women over 40 on Tuesdays in northern Colorado?" . . . Nobody else has that platform to do that today.

MD+DI: What obstacles to expansion remain? Will the approach of remote scribes eventually become a bottleneck?

IS: We are a supply-constrained company, not a demand-constrained company. I know that sounds strange, but demand obviously outstrips our ability to supply, and it probably will for years to come. The constraint is not Google Glass units. The constraint is human beings, scribes, as well as their project managers, QA-ers, trainers, and implementers. In other words, the entire operations team, particularly the scribes.

As a capital-constrained startup, we can only take on so much risk at a time. Hiring in waves, implementing in waves, and doing so while obsessing over quality and staying within a defined cost envelope. So that will be the limiter for us for a while. We want to be in the 6000-10,000 doctor range by 2019-2020. We'll need a similar number of scribes. On any given day, there's a one-to-one relationship between a scribe and a doctor. So we're going to have to scale to a population, a workforce, that is that big.

There are companies that do coding and transcription that have employee bases that are that big or significantly bigger. It's achievable and we have many people working for us that have expertise in doing that. Nonetheless, that is the rate-limiting step for the company.

MD+DI: Augmedix strikes me as a connected health device company that has gotten a lot of things right. Do you have any advice or lessons learned to share?

IS: The first rule is, there's no rule. The second rule is, don't listen to me or any expert too much. I'm not a serial entrepreneur. I have an n-of-1 experience.

Keep it simple. We're using human beings in a business model that a kindergartner can understand . . . It's just simple. I think a lot of people would say, "Let's start doing these four things at a time and see if we can use speech recognition today." Then, I think you end up disappointed and trying to do more than is possible. I think you can only innovate on so many dimensions at a time. You can't innovate on every dimension all at once. I see a lot of inspired entrepreneurs that just lose sight of that.

The other things is, solve a really big pain point. We're saving doctors a third of their day and we charge a lot for it too. It's worth it. But I see a lot of people out there with healthcare innovations where you need a microscope to see the ROI (return on investment). It might show up after three years, through the noise. Those aren't the innovations that America needs right now. Those aren't the innovations that venture capitalists are excited to invest in right now, especially if you're a first-time entrepreneur.

I guess it's easy for me to say, "Go solve a big problem." I guess that sounds like an old, tired truism. But if you're not doing something disruptive, you're going to have a hard time in this market if you're a first-time entrepreneur.

MD+DI: What role do you think the emerging area of digital health, mobile health, and wearables will play in the mainstream medtech industry?

IS: I think they're on a collision course for each other. I constantly talk to medical device people who are asking, "What's our digital strategy? How are we engaging patients? How are we getting into the services area?" It makes sense. The lines are blurry. These medical device companies already have channels into these health systems and into doctors. They sell suites of services. Why limit that expertise and that channel to just devices? Why not offer expertise that provides a 360-degree experience for surgeons and doctors to offer things to their patients? I think it's just a natural extension. I think doctors want that too. I think patients want that too. Patients are increasingly engaged as well and they want to know about their devices and want to engage with their devices. Their devices are going to increasingly offer not just therapeutic benefits, but even lifestyle and health benefits. There are just so many areas where the two worlds are seeping into each other.

I think the smart medical device companies as well as the smart biopharma companies are just trying to figure out what their digital health strategy is.

MD+DI: Anything else you'd like to say?

IS: A lot of people have this perception that Google Glass and the smartglass space is dying or dead. That couldn't be further from the truth. It's just all about enterprise and the world of work these days . . . It's not just Google Glass. It's also other smartglass platforms from folks like Vuzix and Sony and other Asian manufacturers. The more the merrier, from my perspective. They're being adopted in all kinds of enterprise use cases, even outside of healthcare. For example, oil and gas, frontline manufacturing fields. There are a lot of similarities for how smartglass can make a dent in those sectors versus healthcare.

[Images courtesy of AUGMEDIX]

Earlens Corp.

    Arrow  backSan Diego Tricorder

Earlens Corp.'s novel hearing aid uses a processor and light tip to convert sound to light, which is transmitted to a lens inside the ear that stimulates the users own hearing system. The result eliminates the annoying whistling sound that plagues traditional hearing aids. The Menlo Park, CA-based company brought in $53.6 million in venture capital last quarter.

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[image courtesy of the company]

TransMedics Inc.

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Transmedics is seeking to improve the process of transferring organs from donors to transplant patients, which typically involves a simple cooler and lots of room for error. The Andover, MA-based company's Organ Care System provides a better way to maintain organs such as hearts, lungs, and livers outside the body through proprietary perfusion technology. Venture capitalists pumped in $51.2 million last quarter.

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[image courtesy of the company]

CVRx Inc.

    Arrow  backSan Diego Tricorder

CVRx says its implantable Barostim System "triggers the body's own natural blood flow regulation system" to treat high blood pressure and heart failure. The device has the CE Mark and may be sold in Europe but is limited to investigational use in the United States, although it has received Expedited Access Pathway from FDA. The Minneapolis-based company attracted $46.5 million in venture funding this past quarter.

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[image courtesy of the company]

Mitralign Inc.

    Arrow  backSan Diego Tricorder

Mitralign plays in the hot markets of transcatheter mitral and tricuspid valve repair. Its Mitralign Percutaneous Annuloplasty System (MPAS) received the CE Mark this past February for treatment of functional mitral regurgitation, and its Trialign system for treatment of functional tricuspid regurgitation is now enrolling patients in an early feasibility IDE study in the United States. The $39.8 million the Tewksbury, MA-based company brought in in venture capital last quarter will be used to support clinical studies of Trialign and launch the MPAS system in Europe, according to the company. 

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[image courtesy of the company]