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Articles from 2015 In August


Medtech Startups Making Waves in 2015: Airing

Airing

Continuous positive airway pressure (CPAP) machines used to treat obstructive sleep apnea are notoriously bulky and uncomfortable. Burlington, MA-based Airing designed its "maskless, hoseless, cordless micro-CPAP device" to be a less-obtrusive alternative.
          

 [image courtesy of AIRING]

Medtech Startups Making Waves in 2015: Interrad Medical

Interrad Medical

Interrad Medical, based in Plymouth, MN, won our first-ever Medtech Startup Showdown this year with its novel SecurAcath catheter securement device, which can prevent problems such as migration and dislodgement.
          

 [image courtesy of INTERRAD MEDICAL]

Medtech Startups Making Waves in 2015: Progyny

Progyny

New York-based Progyny hopes to improve the high failure rate of in vitro fertilization with its Early Embryo Viability Assessment (EEVA) test, which uses imaging technology to track and evaluate embryo development.
          

 [image courtesy of PROGYNY]

Correction: An earlier version of this slideshow incorrectly identified the company as Auxogyn. Auxogyn merged with Fertility Authority in April 2015 to form Progyny.

Medtech Startups Making Waves in 2015: T2 Biosystems

T2 Biosystems

FDA cleared Lexington, MA-based T2 Biosystems's T2Candida test and T2Dx analyzer in less than four months last year, paving the way for the company to change the way sepsis is diagnosed—and save lives.
          

 [image courtesy of T2 BIOSYSTEMS]

Medtech Startups Making Waves in 2015: Direct Flow Medical

Direct Flow Medical

Transcatheter Aortic Valve Replacement (TAVR) is one of the hottest technologies in medtech at the moment, and Santa Rosa, CA-based startup Direct Flow Medical is hoping to tap into the market—and take on big guys like Medtronic and Edwards Lifesciences—with its TAVR device.
          

 [image courtesy of DIRECT FLOW MEDICAL]

Medtech Startups Making Waves in 2015: AkibaH

AkibaH

AkibaH's solution for diabetes might sound simple, but that's precisely why it just might succeed. The San Jose, CA-based startup is developing a smartphone case that combines a glucometer, lancet, and test strips in one.  
          

 [image courtesy of AKIBAH]

Google Steps Up Its Fight Against Diabetes

Google's focus on diabetes technology is getting clearer as it unveils a growing number of collaborations with companies specializing in treating the disease.

Brian Buntz

Slideshow: 6 Ways Google Could Transform Medtech, and Maybe Cheat Death

Google Glass surgery

First Google announced that it had developed a glucose-sensing contact lens, which was licensed to Alcon. After that, Google announced a partnership with DexCom. And now, the company is announcing a collaboration with Sanofi, the pharma giant also active in the medical device market.  

It's only been about three weeks since Google announced that the birth of its new holding company, Alphabet, which will possibly enable more nimble management of its new life science division. But this year, the company already had been expanding its life science business even before the Alphabet announcement, having hired immunologists, neurologists, and nanoparticle engineers.

Google believes that its own research and its collaboration with Sanofi will eventually further type-1 diabetics' ability to control their blood sugar. Nearly half of diabetics miss their target blood sugar levels, the company states in a press release.

And Google thinks its technology--including sensors, wearables, analytic tools can help.

That concept makes sense to Chris Snider, a type-1 diabetic who serves on the executive board of the Stanford Medicine X conference. "The way I see it, Google is synonymous with 'data.' And proper diabetes management includes a focus on data -- blood glucose values, nutrition, exercise quality, and duration," he says. "And considering they've already announced they are working on a glucose sensing contact lens, this feels like a bigger, more official announcement that they have a stake in the health of the world."

Google's diabetes project also aligns with the company's pre-Alphabet-era moonshot projects that include everything from developing a self-driving car to its goal of combatting aging with its Calico division. "If whatever they work on is successful, data-based results always speak volumes to other groups, whether they be patient advocates, pharma, or whoever is paying attention," Snider says. "I'm sure one of their goals is a headline that reads more or less like: 'Thanks to Google's awesome diabetes thing, the A1c in this population was reduced 10%, and x, y, and z complications were reduced."

In a statement, Google hints its thought process is for treating the chronic condition: "In the labs at Google[x], we've developed sensors and digital tools that we think could accelerate this progress, including our smart contact lens project with Alcon, our cardiac and activity sensor, and continuous glucose monitor partnership with Dexcom. And that's why diabetes is the first disease we're focusing on as we become an independent company."

There have been a wave of recent diabetes technology breakthroughs that are beginning to blur the line between the consumer technology and medical device fields. This could potentially enable Google to better tap its expertise in data management. "All of my diabetes devices charge via USB, and upload to various data aggregation platforms, some of them Web and cloud based," Snider says. "Google's other diabetes partner, Dexcom, just announced their G5 sensor, which transmits from the person with diabetes directly to a compatible mobile phone and then to the cloud for others (with permission and access) to monitor remotely," he adds. "As a technology company at heart, it makes sense for Google to try to improve those services as more and more data is collected and shared through FDA approved (Dexcom) and FDA permissible (Nightscout) means."

Another factor is that the roster of patients with diabetes is quickly exploding. A 2010 CDC report found that half of the people in the U.S. would be at risk for either diabetes or prediabetes by 2020. "From a pure business perspective, that's a lot of opportunity," Snider says.

Diabetes is important for Sanofi, too. Roughly 20% of its revenue comes from its diabetes treatments.

Google says in its statement that it could work with Sanofi to develop technologies that could, for instance, help doctors understand why a patient's blood sugar is tracking high for several days in a row, or could offer concrete information about how effective a particular therapy is.

For all of the promise, Snider is concerned that only a minority of diabetics will ultimately have access to such next-gen technology. "My biggest concern is that their technological advancements, whatever they may be, will only be available to the 1% of the diabetes community," he says. "By 1%, I mean the plugged in, hardcore advocates, with insurance, that stay on top of these types of developments.

Snider concludes: "What I would like to see down the road is Google make a sincere effort to educate populations of varying socioeconomic backgrounds, reaching the communities that can benefit from prevention initiatives."

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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Medtronic Snaps Up Aneurysm Mesh Tech for $150 Million

The acquisition of Medina Medical is the ninth company purchase or major investment that Medtronic has announced since its $48 billion merger with Covidien.

Medtronic's Post-Covidien Shopping Spree: A Timeline

Chris Newmarker

Medtronic said Monday that it will spend $150 million in cash to purchase Menlo Park, CA-based Medina Medical, which has been commercializing cutting edge treatments for vascular abnormalities of the brain including cerebral aneurysms.  

Medtronic had already bought an ownership stake in the company.

This is Medtronic's ninth company purchase or major investment since the January closing of its massive $48 billion acquisition of Covidien, which has it rivaling Johnson & Johnson as the largest medical device company in the world.

Medtronic has been pretty active, too, when it comes to snapping up new cardiovascular technologies. For example, Medtronic announced in August that it will spend $458 million to acquire privately held Twelve Inc. (Redwood, CA) and its  transcatheter mitral valve replacement technology.

More innovation appears to be making the cardiovascular space a successful area for the medical device industry, Elizabeth Cairns, a medtech reporter at EP Vantage (London), recently told Qmed.

Medina Medical's major technology is the Medina embolization device, a 3-D self-expandable mesh that provides a scaffold across the neck of an aneurysm neck. It is able to conform to the shape of the aneurysm, reducing blood flow in the process.

"Medina Medical's breakthrough technology makes it a natural fit with our neurovascular portfolio, further strengthening our hemorrhagic stroke portfolio," Brett Wall, president of Medtronic's neurovascular division, said in a news release. "The Medina embolization device features advanced technology to treat cerebral aneurysms that we think can one day disrupt the coil market."

Learn more about cutting-edge medical devices at MEDevice San Diego, September 1-2 and MD&M Philadelphia, October 7-8.

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Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

St. Jude Medical Moving Forward on Thoratec Buy

The $3.4 billion deal now has anti-trust clearance in the U.S., with no other suitors found during a "go shop" period.

Chris Newmarker

St. Jude Medical has cleared some important hurdles when it comes to closing its $3.4 billion acquisition of major LVAD maker Thoratec.

The deal's anti-trust waiting period in the U.S. has expired, Thoratec said in a Monday regulatory filing with the SEC. And a go-shop period after the deal was announced in mid-July has also expired, with Thoratec finding no additional suitors for the company.

The merger is expected to close in the final three months of the year, pending approval by Thoratec's shareholders and other customary closing conditions.

The merger is part of Little Canada, MN-based St. Jude Medical's strategy to expand and enhance its established presence in heart failure therapies. The company already has its quadripolar cardiac resynchronization therapy and remote monitoring capabilities. The CardioMEMS device, which St. Jude spent $375 million to acquire amid its FDA approval last year, is about the size of a paper clip and uses MEMS technology originally designed to monitor jet engines to remotely monitor a heart failure patient's pulmonary artery pressure.

Thoratec's HeartMate II is a widely used and extensively studied left ventricular assist device. The Pleasanton, CA-based company company earlier this year received FDA approval to enlarge its pivotal trial for its much-anticipated, next-generation HeartMate III.

Everything hasn't been perfect for Thoratec's technology, however. In early August, an FDA safety communication reported an increased rate of pump thrombosis (blood clots inside the pump) among people using the HeartMate II. FDA also found  a high rate of stroke among people using a competitor's LVAD, the HeartWare HVAD.

FDA officials still think the benefits of LVADs outweigh the risks when it comes to saving the lives of people with advanced left ventricular heart failure, the agency said in the safety communication.

Learn more about cutting-edge medical devices at MEDevice San Diego, September 1-2 and MD&M Philadelphia, October 7-8.

Like what you're reading? Subscribe to our daily e-newsletter.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

6 Questions Medtech Entrepreneurs Should Ask

Got an idea for an innovative medtech-based product, but you're not sure where to start? This is something I get asked about often when mentoring new entrepreneurs, so I put together a list of vital questions to consider before you take the plunge.

Geoff Rogers

Geoff Rogers
Geoff Rogers, PhD, is the director of IntelliMedical, which has developed a robotically steerable guidewire for use in interventional procedures.

Growing up, my uncle had a favorite saying: "KISS!"He was referring to what's become one of my favorite acronyms: "Keep It Simple Stupid!"Why am I telling you this and what does it have to do with medical technology? Above all else, I like to keep things as simple as possible when exploring a new idea for medical technology. So here is the simplest approach to new technology planning that I know of, which is about clearly defining:

  1. Where you are today (the "landscape").
  2. Where you need to get to (the "destination").
  3. How to get there (the "road-map").

Simple, right? Next you just need to ask a few specific questions to guide the process and be familiar with some basic concepts that may come across as jargon if you are new to the space. Examples of such terms include "landscaping," "road-mapping," "minimum viable product (MVP)"/"minimum loveable product (MLP)," "freedom to operate (FTO)," "de-risking," "due diligence," and so on. Don't worry if some of these terms are unfamiliar. You'll be familiar with them all after you finish this article!

Question 1: What Problem Are You Solving?

First, clearly define the problem you are trying to solve. Sounds obvious, but too many people do things completely the wrong way around. They start with a solution or part of a solution, but don't clearly understand the problem they're trying to solve. If they manage to develop their product, they then have to work hard to convince users of the value. This is "market push."What you want is the opposite: "market pull."You want your customers to be desperate for your solution.

Question 2: What Is Your MVP/MLP?

Traditionally, MVP ("viable") is the terminology that's been used, but in recent times MLP ("loveable") has gained traction. I personally prefer to use MLP, because it inspires thoughts of not just developing something that's "good enough,"but something that's worthy of being loved by users. This is key for market penetration and widespread adoption. Regardless of what term you use, the message is the same: define the minimum requirements that your first-generation product must satisfy. This represents the first product that you will sell and provide to users. For example, the first-generation iPhones came without HD cameras and fingerprint sensors. These weren't necessary for users to love them in the beginning, and piling everything into that first-generation would have significantly delayed its release, I suspect.

Question 3: Do You Have Freedom to Operate (FTO)?

Before you invest any further time, it's important to be clear on what competing products are out there, and whether anyone else is currently developing a similar solution. The most critical aspect of this is an FTO search, where you look at the intellectual property (IP) landscape. For products, this comprises a patent search. You can do it yourself to begin with, but you will need to invest a reasonable amount of time into it and think carefully about the search terms you should use. Also, the search needs to be across all jurisdictions, and include provisional and PCT patent applications (patents that are not yet granted). Hopefully this search yields only a few relevant results, with nothing that looks exactly like your MLP.

Question 4: What Technology Do You Need and From Where?

Based on your MLP, what new and/or existing technology do you need? There could be multiple things here, or just one major component. List them all. Next, see whether they exist(if you don't already know). If so, can you lift them off-the-shelf from somewhere, or are they proprietary? If the latter, this would be an example of not having FTO, in which case you would need to consider how to gain access to what you need--either via a license or some other mechanism.

For technologies that don't yet exist, you will need to invent and develop them. Obviously you will need to think about and plan how this will happen, and what will be needed to do it. This is where the technology "road-map"comes in. It creates the clearest possible path from your current location (the landscape) to your destination, seeks to identify potential risks or stumbling blocks and plans for contingencies where possible.

Question 5: Do You Have Clear Rights to Your IP?

If you're bringing existing IP to your new venture, whether it's patents, know-how or any other form, you need to ensure that you clearly own that IP. This is an especially important question for anyone who is or was employed by a similar business or research institute. If you developed the IP within the scope of your employment with that other organization, then it may have a claim to the IP. It's perhaps less obvious that, even if you developed it in your own time after hours, the organization may still have a claim. This could also potentially include people engaged to teach at an institution.

It's best to get advice on this, but if in doubt, at least seek a letter from the organization's legal department declaring that they make no claim to the IP. Whatever you do, do not skip or avoid this step. It can bite hard and your future investors will ask the question.

Question 6: What's Next?

Now that you've answered questions one to five, you should have a much clearer picture of what needs to be done next. This could include negotiating access to key proprietary technologies, starting to work on de-risking your major technical challenges, addressing skills shortages within your team, or seeking funding. Either way, now that you have a road map, in a sense all you have to do is follow it!

If you found this checklist useful, keep an eye out for my upcoming posts on exactly how to answer some of these questions.

Geoff Rogers, PhD is a medical engineer and entrepreneur, who specializes in the development and commercialization of next-generation medical devices. He has successfully cofounded and led a number of medtech companies. He is most widely known as the founder of IntelliMedical.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

Like what you're reading? Subscribe to our daily e-newsletter.