A review of digital health patent slugfests and Unintended Consequences

September 7, 2016 | by

Mobihealthnews provides a recap of the past four years of patent actions pitting company against company in the hushed but deadly rings of the US Patent and Trademark Office (USPTO) and the US International Trade Commission. On the fight card: the never-ending American Well-Teladoc bout (Teladoc winning every decision so far by a knockout [TTA 18 June]–a second American Well patent being invalidated on 25 August); CardioNet vs MedTel, which the former won but has had to chase the latter out of the arena and down the street to collect; Fitbit-Jawbone which has gone both ways [TTA 27 July]; and the long trail of blood, sweat and Unintended Consequences around Bosch Healthcare’s heavyweight IP pursuit against mainly flyweight early-stage companies (not noting, as we did, their apparent ‘draws’ vs Philips and Viterion, then owned by Bayer).

The Reader will note our tracking Bosch’s activities go back to 2012 (here, here and here). Moreover, with Mr Tim Rowan of Home Care Technology, we broke the news of Bosch’s demise in June 2015, drawing the conclusion that their offense versus Cardiocom’s patents (now in Medtronic’s cardiac division) directly led to the invalidation of their key patents, IP–and the very basis of the company’s existence. See the 19 June 2015 article and our recap one year later in reviewing AW-Teladoc. (Any similar phrasing or conclusions within the Mobihealthnews article, we will leave to our Readers to decide!)

Medtronic’s moves in post-acute cardiac care management, monitoring

June 30, 2016 | by

Medical device giant (and inverted to Dublin) Medtronic announced today the launch of their Beacon Heart Failure Management Service in the US. It combines their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices with post-acute patient monitoring from Medtronic Care Management Services (MCMS). The patients are checked both through their recorded cardiac device diagnostics and what they called ‘branching logic’ questions which collect daily qualitative, biometric and symptom information, plus provide patient education. Care managers then review the data along what they term ‘established clinical pathways’ check for growing risk factors and alert providers if needed.

What is interesting is that the in-home delivery and collection platform or hub is not specified. Medtronic happens to own one of the telehealth pioneers, a company which used to be called Cardiocom–which is now part of Medtronic Care Management Services in their Cardiac and Vascular Group (CVG).

No launch clients/partners are mentioned, save a quote from a cardiologist at The Stern Cardiovascular Foundation in the Memphis TN area. Release, FierceMedicalDevices

In other Medtronic news, earlier this week they announced the acquisition of cardiac device company HeartWare for $1.1 billion. HeartWare has developed small implantable (more…)

Can expanding telehealth help VA solve veteran access crisis?

May 18, 2016 | by | 1 Comment

The Department of Veterans Affairs (VA) has been both one of the largest US users of telehealth in various forms–and widely criticized for practices including veteran patient wait lists for care, a lack of accountability, a scheduling system full of problems, an ancient EHR (VistA), and an inability to meet interoperability and modernization goals set over years. Telehealth is, in fact, one of VA’s bright spots with store-and-forward imaging, clinical video telemedicine and home telehealth.

At the American Telemedicine Association ATA 2016 meeting Monday, Under Secretary for Health and VA Chief Executive Dr. David Shulkin noted that the crisis has pushed VA into other options for achieving the goals set for the end of year: every VA medical center provides same day primary care services and same day mental health services. One area of focus is telemental health. Dr Shulkin announced in his plenary speech the opening of five new Mental Health Telehealth Clinical Resource Centers this summer, located in Charleston, Salt Lake City, Pittsburgh, and a consortium of facilities in Boise, Seattle, and Portland, Oregon. West Haven, Connecticut is already open as a specialty hub focused on the most severe and complex mental health issues, such as chronic depression and bipolar disorder. Other VA telemedicine initiatives include kiosks and text messaging to help with medication adherence and chronic condition management. (We’ve reported on their partnering with nhssimple to develop ANNIE, a sister of NHS’ Flo in text messaging to encourage patients in their health monitoring, TTA 2 Dec 15.)

VA delivered 2.1 million episodes of telehealth care last year (FY 2015), in 45 specialty areas of care, including 400,000 telemental health visits. They also reduced bed days by 56 percent, reduced readmissions by 32 percent, and decreased total psychiatric admissions by 35 percent, maintaining high user satisfaction scores at 89 percent.

Dr Shulkin also noted that four generations of veterans are served by VA–WWII, Korea, Vietnam and Desert Shield through current Iraq/Afghanistan–and all four have different delivery requirements. He closed with what is, for VA which has been very proud of their ‘home grown’ solutions from the time of Dr Adam Darkins in the early 2000s on, something unusual: “We’re looking to learn, we’re looking to work with all of you who are innovating to help take better care of veterans.” (Next on tap: the award of the next five-year round of home telehealth providers, which is presently down to two Grizzled Pioneers, Medtronic (Cardiocom) and Viterion.) Mobihealthnews, VA press release

Artificial pancreas for Type 1 diabetics may be closer

April 3, 2016 | by

A victory in this perpetual Battle of Stalingrad? Three universities, plus Dublin-based Medtronic, are developing devices that may bring a commercial artificial pancreas for Type 1 diabetics to market within the next few years. Medtronic is estimating that their system could be in market by 2017. The University of Virginia‘s Center for Diabetes Technology has a final clinical trial this summer on the inControl system which is being commercialized by start-up company TypeZero Technologies. Other research programs are underway at Cambridge University and Boston University, on a product that will measure both insulin and glucagon. Type 1 diabetics produce no insulin, making their lives literally dependent on close glucose monitoring and correct insulin delivery. These are “closed-loop” systems, consisting of a pump worn outside the body, a continuous glucose monitor, which measures glucose from fluid under the skin, and a device that runs continuous algorithms to determine insulin delivery. Much of this research has been funded by the Juvenile Diabetes Research Foundation (JDRF). Perhaps there will be a better and safer way soon to fight this perpetual Battle of Stalingrad for those with Type 1 diabetes. CNBC

Medtronic favoring early-stage acquisitions, diabetes; American Well and Teva

June 4, 2015 | by

Medtronic plc, now firmly planted in the Auld Sod of Ireland, reported a tidy $7.304 bn in its 4th quarter global revenue closing 24 April versus a prior year of $7.257 bn, with a net loss of $1 million. Their report yesterday (2 June) was primarily centered around the integration of Covidien and the foreign currency loss. Results were especially strong in the US with an 8 percent gain in fourth quarter. Earlier speculation that the major Covidien acquisition in addition to Corventis, Zephyr Technologies (through Covidien) and telehealth provider Cardiocom would slow future investments seems to be the direction CEO Omar Ishrak is taking, based on his comments during the analyst call. The Covidien strategy of making early-stage company acquisitions is to his liking and with new revenues from Covidien (and a more favorable tax domicile) certainly there is not a lack of funds despite a small loss in fourth quarter revenues. Another change from being a cardiac-centric device company is apparent in the growth area of global diabetes, shifting from pumps to diabetes management. They have a minority investment in diabetes manager Glooko, a partnership with IBM Watson Health for diabetes management, and acquired a Dutch clinic and research center, Diabeter. Jonah Comstock at Mobihealthnews has more on that call.

In a surprising move, Israel’s Teva Pharmaceuticals is putting a reported ‘tens of millions of dollars’ into American Well and their telemedicine (virtual consult) platform. The pharma interest at once may be narrow in utilizing these consults in clinical trials, but as we have seen with Merck’s telemedicine clinics in Kenya, there’s also a focus on monitoring critical medication at long distances. Late last year American Well completed an $81 million Series C, but it is not clear whether Teva is a part of this and the news is just now catching up. MedCityNews, Globes (Israeli business website)

Do startups truly threaten the ‘healthcare establishment’?

May 19, 2015 | by

Or are successful startups fitting into their game? Chris Seper in MedCityNews paints the picture of one side of a quandary. The ‘healthcare establishment’ fundamentally and to its detriment does not understand and is threatened by the startup and innovation process. A startup may begin with an idea which is, in his words, ‘almost always flawed, sometimes deeply’. If the founders are smart, they will test their ideas, validate them and change them appropriately. If not, they will fail. But it is easier for the Establishment to point at the most egregious of the bad ideas and use them to rationalize the status quo.

But being congenital contrarians, we paint the house on the other side of the street. Has the Establishment caught up with–or in some cases, co-opted startups, making them and their funders ‘do their diligence’ and be more cautious before emerging? This Editor would argue yes, and largely for the better.

**The ‘Wild West’ days are over. A few years ago, a truly bad or deeply flawed health tech idea or could easily find funding, because it was all blank slate, new and ‘transformative’.The sexiest hooks were Quantified Self, sleep, employer health incentives, interactive coaching, genomics, app prescribing and (last) wearables. A lot of founders imagined themselves as the Steve Jobs of Healthcare, down to the black turtleneck. Now there is a history of success and failure. The railroads reached the dusty frontier towns.

**There’s now a ‘Startup Establishment’. National accelerators (more…)

Ford disconnects research on heart attack-sensing car seat

May 4, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”150″ /]The Gimlet Eye returns and hopes that Ford has a better idea, because this wasn’t it. The automaker announced over the weekend that it is abandoning research on car seats that would detect cardiac anomalies such as a heart attack and then (presumably safely) bring the car to a halt (and also presumably, call for medical assistance). A corporate statement to the FT stated that Ford was ‘transitioning’ to other projects, based on advances in consumer wearables. No indication of spend out of a $5.5 billion budget. Undoubtedly, the potential for sensor problems in seats and the danger of shutting down a car while driving were insurmountable. No tears though…. (more…)

IBM Watson Health adds 2 companies, three partners, moves to Boston and into the cloud

April 13, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/04/IBM-Watson-Announcement.jpg” thumb_width=”200″ /]A Day with a Big Exclamation Point for Healthcare Data and Analytics. In a series of press releases late NY time on Monday and a spectacular announcement at HIMSS (photo hat tip to Sandeep Pulim via Twitter), the recently quiet-on-the-healthcare-front IBM Watson has announced multiple major moves that re-position it squarely into the healthcare arena as the 90,000 lb. Elephant.

  • IBM Watson Health is now a separate business unit headquartered in Boston. The Watson New York headquarters will be expanded, but that may be for their other businesses: travel, retail, veterinary care, cognitive computing, and IT security and support. IBM claims that Watson Health will be hiring up to 2,000 healthcare consultants, clinicians and researchers, folding in existing units such as Smarter Care and Social Programs.
  • The IBM Watson Health Cloud is now their secure, open and HIPAA compliant platform for health-related data: physicians, researchers, insurers and health and wellness companies.
  • Three new partnerships were announced, designed to bolster IBM in different aspects of what is to be done with All That Data being generated from health and fitness devices. IBM Watson Health Cloud will be the secure platform, storage and analytics for Apple’s HealthKit and ResearchKit. Johnson & Johnson will be working with Watson on pre/post-operative coaching and education and Medtronic on diabetes management using data from Medtronic devices. (more…)

Reforms, restructuring at Veterans Affairs announced (US)

November 13, 2014 | by

A new Secretary, but the same old process? New Secretary of Veterans Affairs (VA) Robert McDonald is quickly finding out that cleaning house at a government agency is not quite as straightforward as at Procter & Gamble, where he had been CEO. Since being confirmed by the Senate in late July, he has had to fight the fires of multiple scandals, beginning with the Phoenix VA ‘secret’ veterans care wait list leading to uncovering disastrous delays in care at VA regions across the nation. As of this week, and convincingly timed around Veterans Day, McDonald announced a reorganization of the VA to the Washington Post–a restructuring of the VA around the creation of:

  • A new customer service organization across the entire VA, headed by a “chief customer service officer” reporting to McDonald
  • A standardized regional framework meant to streamline partnering and coordination
  • Realignment of internal business processes into a shared services models to improve efficiency, reduce cost and increase productivity
  • Collaboration with partners to create a national network of Community Veteran Advisory Councils

Heads are rolling, but slowly. There are pending disciplinary actions affecting at least 35 employees and perhaps as many as 1,000 employees upcoming. (more…)

Brain neuroprosthetics, stimulation for TBI, PTSD

August 11, 2014 | by

A signature injury of the Iraq and Afghanistan wars has been traumatic brain injury (TBI), as well as an outcome of all wars–post-traumatic stress disorder (PTSD). Over 270,000 veterans since 2000 have been diagnosed with TBI–along with 1.7 million civilians per year. The US Department of Defense (DOD) has been funding research in several areas to help veterans–and eventually civilians–with these traumas.

  • DARPA’s RAM: Restoring Active Memory program is seeking to compensate for brain injury by developing a neuroprosthetic to aid memory function. (more…)

Medtronic, Covidien and what it might mean for digital health

June 17, 2014 | by

“This acquisition will allow Medtronic to reach more patients, in more ways and in more places,” Medtronic Chairman and CEO Omar Ishrak

Cover the Earth? While the healthy Medtronic offer ($42.9 billion in cash and stock) for Ireland-headquartered Covidien plc is not a ‘digital health deal’, it does point to Medtronic’s strategy which includes digital health. There is of course the obvious: growth by acquisition and integration. Acquisitions require cash, and the highly controversial change of domicile to Ireland via ‘tax inversion’ will fatten the exchequer in two ways. First is through the lower overall Irish corporate tax versus the 35 percent US tax, one of the highest in the world. Second is much more flexibility in repatriating plentiful foreign earnings at lower Irish corporate rates rather than the high US rates which Medtronic has avoided. Third is increasing dividends, which can drive up stock price and investor interest. Of interest to the latter is also that Covidien adds horizontal (and global) competitive strength to Medtronic in the clinical area–surgical, vascular, respiratory and wound care.

More Ways-More Places. Not just staples and sutures, Covidien has developed its own advanced in-hospital mobile patient monitoring in Vital Sync as well as several hospital monitoring devices in their Nellcor line. In addition to technology collaboration, the next point of integration could then be with Medtronic’s post-acute telehealth devices from Cardiocom, purchased less than one year ago. We noted at the time that it gave Medtronic entreé into the “chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems.”

Approval will take time. Both the US and UK, through various regulatory agencies, scuppered the Pfizer-AstraZeneca deal on similar tax domiciling and competitive grounds. If it does go through, there will be a lot of reorganization. But while it digests, this Editor will be watching Medtronic for its usual pattern of making smaller ‘more ways/more places’ deals in the interim with an eye to diversifying past US-taxable medical devices. One pointer is their just-announced partnering with Sanofi to develop drug delivery-medical device combinations and care management services for diabetes patients (MedCityNews).

Related reading: Medtronic hints at more acquisitions following $43 billion Covidien deal (MedCityNews); The Medtronic, Covidien Inversion Deal Is More About Dividends Than Tax (Forbes); Medtronic agrees to buy Covidien for $42.9b in cash, stock (Boston Globe); Medtronic’s $43B Covidien deal—and Irish tax move (CNBC)

 

More on DARPA’s ‘brain chips’ for PTSD, TBI

May 30, 2014 | by

DARPA’s continued research on deep brain stimulation (DBS) implants to treat PTSD and TBI, as well as other neuropsychological conditions, is given the once-over in this Defense One article. New information from the time this Editor last wrote about it in December is that the SUBNETS program (Systems-Based Neurotechnology for Emerging Therapies), funded with $12 to 26 million, will work with the University of California at San Francisco, Lawrence Livermore National Lab and Medtronic to create an implant with electrodes reaching into the brain and which does not require staying still under a machine in a lab. The prototype development is expected to take five years. The article also points out the US Air Force initiative studying the effects of low amounts of electricity on the brain to boost alertness delivered by an external cap.

Medtronic and Aetna: the good and bad implications

March 12, 2014 | by

A break in the ‘Perpetual Battle of Stalingrad’ that is also a Pointer to the Big2Big Future

Last week US insurance giant Aetna announced a partnership with medical device Gargantua Medtronic to pilot a program for uncontrolled Type 2 diabetes. Aetna will use claims data to identify 300 members who meet candidate standards for insulin pump therapy, Medtronic will reach out to them through their physicians to enroll them in the Getting2Goal program–as long as the insulin pump is Medtronic’s. The two-year program’s metrics will evaluate overall health outcomes and medical costs such as reduced ER and hospital stays. This is a fairly solid, albeit small N program for both. Other Aetna/Medtronic partnerships are a program for congestive heart failure (CHF) detection announced at HIMSS14, where Aetna plans to monitor device data to track the extra water retention that is usually an indicator of progressing heart failure; and an implanted glucometer program to monitor insulin levels for diabetics to avoid hypoglycemia.

Is this a Pointer to a Limited Future for Small, Innovative Independent Companies? Is this now signalling the US’s Big Payers only want to deal with Big Medical Device? “Value-based arrangements with companies like Medtronic” (release) make it ‘one-stop shopping’ for payers when it comes to physician relationships, IT implementation, data sharing and analysis. Will the end result be that payers stifle the revenue opportunity for small to midsize innovators by saying ‘don’t bother to knock”? Are these financially and technologically the best solution for the patient and for outcomes? (It’s like specifying only one hip or knee implant for all, and may sound familiar to our UK readers who have been following our recent articles on a certain telecare provider.) Aetna release, MassDevice, MedCityNews

Now three medical device maker networks hacked

February 14, 2014 | by

St. Jude Medical, Medtronic and Boston Scientific targeted. The San Francisco Chronicle reported earlier this week, from what they termed a source close to the companies, that all three companies had data intrusions that lasted for several months during 2013, and were not aware of them until alerted by Federal authorities. None of the companies, nor the FBI, confirmed or commented on this for the Chronicle. The attacks were “very thorough” and the source stated that they showed signs of being committed by hackers in China. The attraction of all three companies–Medtronic being the world’s largest– is their intellectual property and of course patient data, with the article mentioning confidential patient data collection from clinical trials. Also iHealthBeat.

Previously in TTA: US health data breaches hit record; Healthcare.gov backdoored?

Medtronic’s telehealth strategy begins to emerge (UK & US)

September 3, 2013 | by

Hot on the heels of our two recent posts (12 August and 27 August) on Medtronic’s takeover of Cardiocom, maker of telehealth devices, came the news in the FT yesterday that Medtronic had won cardiology management contracts with NHS hospitals (University Hospital of South Manchester NHS Trust and Imperial College  Healthcare NHS Trust).  They will also develop local cardiac services.

Now in an article today, Fierce Medical Devices explains how the two fit together (more…)

Medtronic confirms forecast direction change, the market reacts, and brains are stimulated

August 27, 2013 | by

The ‘reasons why’ we (and others like David Shaywitz in Forbes) proposed back on 12 August for Medtronic’s purchase of Cardiocom were fully confirmed by their CEO Omar Ishrak in Bloomberg (21 August) and an analysis in Forbes (24 August). However, the Forbes article continues on to dump a bucket of cold water on Mr. Ishrak’s  ‘solutions provider’ strategem (so reminiscent of 2008-9 with different companies), positing that telehealth belongs with wireless/mobile companies (Qualcomm), companies further downstream (Allscripts, a major US pharmacy benefits manager) or other technology/monitoring companies. Mr. Market held the roses though (Deutsche Bank’s reiterated hold rating in Benzinga reflecting the consensus in Yahoo Finance).

What is interesting are their advances in brain stimulation to relieve pain in two areas. (more…)