The US Food and Drug Administration (FDA) announced the formation of the Medical Device Innovation Consortium (MDIC) with LifeScience Alley (LSA), a Minnesota-based biomedical trade association. More exactly, the MDIC consists of the FDA’s Center for Devices and Radiological Health (CDRH) and the LSA. For FDA this is unusual–according to the release it is “the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.” LSA includes in its nearly 700 organization membership the Mayo Clinic, Medtronic, St. Jude Medical and University of Minnesota. While this is about biomedical devices, if successful in 1) creating a review model and 2) speeding up the process, it will definitely impact the relations that FDA has with the connected health area, or even expand to include it. (Now if we could also get the FCC into this streamlining….) But the Feds give with one hand and take away with another, with the ACA’s 2.3% excise tax on medical devices (all those implants and stents) starting in January and IRS final regulations now released. FDA release LSA/MDIC release CBS News article
Pre-filled multi-day medication boxes (versus large dispensers meant for an external service area) are becoming increasingly common both in the community and individual home setting, but there is always the risk of an individual’s confusion in taking more than one day’s dose, or the medications all at once versus at the right time. MedMinder’s Jon model, a new seven-day wireless M2M dispenser, can be controlled by the caregiver through their monitoring website to let the individual access only the correct compartment and also at the correct dosage time. It has reminders (beeps, phone calls, emails or text messages) and notes when the compartments have been accessed, similar to its existing Maya model. Their website feature page has a brochure link, but it is for the Maya, not the Jon, model. Editor Donna also finds interesting their payment model of no upfront cost and a monthly fee. (Note to MedMinder’s marketers/general counsel: ‘medminder’ is becoming a generic term for dispensers–the MedMinder team is well advised to register their trade name.) Website release (mind the typos) Also noted is that Bosch is using MedMinder with its HealthBuddy and T400 programs.
This research evaluates how smartphones and tablet PCs at two points–2010 and 2012–have affected healthcare professionals and influenced the way they practice, including the most in-demand information. Compared are providers in the EU Big 5 and the US. Conducted by EPG Health Media (UK). Abstract. Link to full PDF (registration required)
You’ll find the design of this prototype skin sensor out of University of California, San Diego either endearingly goofy or just scary. This paper ‘tattoo’ is actually a solid-contact ion-selective electrode (ISE) made using standard screen printing techniques finished with an electropolymerization process on commercially available transfer tattoo paper. The two ‘eyes’ are actually electrodes which measure perspiration on the skin’s surface to determine stress-related changes in pH and clues to metabolic diseases such as Addison’s, or more simply fatigue or dehydration. The tattoo sticks to even wet skin. It can also measure sodium, potassium and magnesium with different sensing materials. There’s great potential for this not only in sports, but also in assisted living and rehabs where one of the most serious conditions is gradual, invisible dehydration of residents. Tattoo-based medical sensor puts a happy face on detecting metabolic problems (GizMag) Happy face tattoo does serious work (University of Toronto release)
David Shaywitz, co-founder of the Boston-based Center for Assessment Technology and Continuous Health (CATCH) and advocate for humanism in digital health [TA 6 Nov], surprises in his Forbes picks for digital health company, person and book of 2012. First, the company: the EHR that dominates large hospital systems, Epic. Why? It may be awful and the bane of M.D.s, but the hospital system gets basic connectivity that chains together the bits, in a proprietary way, delivered with ‘flawless implementation’–the kind of customer services that holds every hand in MIS and HIT until the boo-boo is better. In other words, they delight the buyer. (Your marketing lesson for today.) Second, for person, none other than The Gimlet Eye’s circular bête noire Vinod Khosla. Shaywitz is this-n-that about the man, believing Khosla underestimates the human factors in medicine while agreeing with him on how behind healthcare is in capturing and using basic data, much less integrating more advanced data produced by monitoring. Editor Donna and the Eye take a dimmer view, believing that much of Khosla’s ‘disruption’ is to gain notice for (OK, hype) his investments such as AliveCor’s iPhone case heart monitor (just receiving FDA Class II clearance), cellphone microscope Cellscope and data collection/platforming Ginger.io (leading $6.5 MM in series A funding). Finally, Shaywitz’s pick for book of the year is”Why Nobody Believes The Numbers,” by Al Lewis. Disease management takes longer, saves less, has difficulty in achieving any ROI but can work out best for the patient in the long run, if we ever get there. But didn’t we know that already? Forbes article
Related: Khosla vs. Kvedar at the mHealth Summit. From Khosla, the usual ‘80% of healthcare can be delivered without doctors’, ‘50% of doctors are below average’ and most Americans today understand health information at a fifth grade level (so much for everyone being Quantified Selfers!). Kvedar argues the same points from ‘60% of healthcare costs are labor’ and that computers are better than humans at algorithmic tasks. Not much of a debate here as Khosla gets 80% of the article lineage. mHIMSS
Are you a clinician who feels overwhelmed by the jillions of one-trick-pony medical apps on your iPad? Is your day characterized by wild mood swings due to frustration (left) in not being able to customize your apps? According to this website, you could be a victim of Medical Apps Disorder*. This clever website and funny video is but a teaser for a new app in phase 3 clinical trials that promises to alleviate said symptoms. Let’s hope the cure lives up to the promise made by app developer Skyscape and info/decision support division Physicians Interactive. * Not in the American Psychiatric Association’s soon-to-arrive DSM-V, but perhaps it should be.
Based on reports coming in, the mHealth Summit this week in Washington D.C. had a greater focus on the US and patient engagement than the past two years, which emphasized governmental programs and non-profit NGOs, but with a twist–insurers are moving upfront in the picture. From Aetna‘s CEO Mark Bertolini keynoting and promoting their iTriage management app to the announcement of the open CarePass mobile platform that organizes 20 smartphone apps that help consumers manage their health and fitness, UnitedHealthcare Group‘s similar OptumizeMe and even AT&T insisting it’s a payer (self-insured), the rationale is better health for consumers, better care quality–but most of all reduction of that ‘$750 billion in waste’ that exists in the current system. Here’s select early coverage to get you started. Consumers will engage if mHealth is easy, Bertolini says (mHIMSS); Mobile tools help public, private payers be more proactive, Healthcare cathedrals and the consumer health bazaar (Mobihealthnews)
Update 7 Dec: David Lee Scher, M.D., well-known US consultant and former cardiologist, outlines five reasons why payers will be playing a major role in mHealth adoption (Ed. Donna comments): they hold the purse strings (very true), they can change physician behavior (ditto), they realize importance of patient engagement (uneven), they are the largest users of patient portals (of a limited type) and can perform clinical studies (they can, but not credible without academic involvement). Why payers are critical to mHealth adoption (mHIMSS)
Neil Versel argues that Editor Donna’s question may very well be an understatement. To those of us in the technology community, the ‘button’ is a relic of an earlier time (and in the US, a reminder of an inadvertently funny ‘schlock shock’ commercial of the late ’70s). Starting in 2005, behavioral telecare elevated standards of safety (QuietCare then HealthSense, GrandCare, WellAWARE, etc.), and then fall detectors, telehealth-based care management and countless mHealth apps further raised the bar. The technology parade has passed PERS by. But to the implementers, the carers and community executives, the plain-jane PERS alert button remains a mainstay of senior housing on both sides of the Atlantic at least. Not that there are not abundant real-world alternatives. Yet more advanced ‘passive PERS’ with a fall detecting accelerometer built in (Philips Auto-Alert, Aerotel GeoSkeeper, AFrame Digital) and behavioral telecare, despite proving greater safety and proactive care metrics, are still in a low stage of adoption. But as Versel points out, PERS can no longer be considered the standard of adequate care, whether at home or in a facility–and moreover, provides little more than the false assurance of safety with the potential of a high, final and unconscionable human cost. Panic buttons for seniors must go (Mobihealthnews)
Update 7 Dec: Editor Steve, in his comments under the article, makes two points: self-reporting safety confirmations (response to automated calls and similar systems) adds another security layer for older people and disabled living alone; current accelerometer-based fall detectors often miss ‘soft’ or gradual falls, especially to the seated or slumped position
Also from Ed. Steve, continuing research in behavioral telecare’s quantification of the early detection of illness is being done by the University of Missouri at two locations in Missouri and Iowa. They are using Microsoft Kinect for gait assessment, which can predict propensity to fall, and are receiving NSF and other Federal funding for this (limited) ongoing research. Originally covered by us back in July [TA 3 July] and updated in this article from (UK) HealthCanal: Sensor Network to Protect the Elderly
Our onslaught of 2013 predictions starts with the Top Five from AT&T, cleverly timed for the mHealth Summit. From their press release supplying plenty of AT&T ForHealth focused examples (and our interpretation):
- A shift from stand-alone “unsponsored” apps to meaningful “sponsored” mHealth solutions (Here come the pharmas, insurance companies and care management companies–now if they will just pay for it and stick with it!)
- Hospitals and other healthcare institutions including payers will begin to move more and more healthcare data into the cloud (outrunning HIT’s ability to secure the cloud, secure internal systems, or backup when the cloud goes down)
- Remote patient monitoring will move from pilots to large-scale adoption (another pilot with telehealth provider Intuitive Health and Texas Health Resources is so 2006)
- Integrated mHealth applications will be created (increased interoperability–here there is some traction as hackathons to develop apps on platforms is becoming actually commonplace; the goal of Continua gets closer)
- Upswing on telehealth to bridge the significant gap between physician resources and patient demand (once again in example muddying telehealth with telemedicine, but overall there is some traction; we can only hope that finally we start getting there in 2013!)
mHealth is perceived as having the potential to be effective in changing behavior which will be effective in controlling chronic diseases such as diabetes, according to the mobile trade group GSMA in their latest white paper. The lead finding in this global study is that “89% of practitioners, 75% of patients and 73% of consumers believe that mHealth solutions can convey significant benefits.” While the finding may sound like the ‘perception is reality’ early-hype curve stuff, it’s being backed up by studies like the Clinical Therapeutics study earlier this year on how text (SMS) reminders significantly improved diabetics’ medication adherence and the just-published text4baby study of 90 women in a Fairfax County, Virginia Health Department program. Attitudes and behavior were measured among a primarily Hispanic new mother group, and text4baby had a significant effect on increased agreement with the attitude statement “I am prepared to be a new mother” and increased negative attitudes concerning alcohol consumption. GSMA: mHealth perceived globally as effective, Study: text4baby effectively helps new moms (FierceMobileHealthcare)
This past week, brain injury once again has made sad headlines in the US this weekend with the public suicide of an NFL linebacker, following his murder of the mother of his child. Reportedly, Jovan Belcher of the Kansas City Chiefs had been recently concussed, was on painkillers and had been drinking the prior evening. Thus the release of an academic research study on chronic traumatic encephalopathy (CTE), a progressive disorder that occurs as a consequence of repetitive mild traumatic brain injury such as experienced by contact sport athletes and soldiers, could not be more timely. Published in this month’s Brain: A Journal of Neurology (Oxford Journals), a research team drawn from the Boston VA, Boston University and the Mayo Clinic details the four progressive stages of CTE with symptoms progressing from headache and loss of concentration to dementia, depression, and aggression. This was based on (post-mortem) analysis of 85 brains — 64 athletes and 21 military veterans with a history of repetitive concussions. 68 had CTE and the group also had other neurological diseases. The study was funded by seven organizations, including the VA, the National Institute on Aging–and the NFL. Certainly this will be a key reference in the NFL-funded research being started by the FNIH and the US Army-NFL helmet sensor program to help detect cumulative injury [TA 7 Sept] CTE a Progressive Condition, Brain Study Shows (MedPageToday) The spectrum of disease in chronic traumatic encephalopathy (Brain): Abstract and full study (PDF)
Students at Brigham Young University in Utah have developed a prototype ‘smart sock’ for babies that alerts for low levels of blood oxygen, irregular heartbeat and stopped breathing during sleep. This is to help detect for early signs of SIDS (Sudden Infant Death Syndrome) or other dangerous situations. The information is sent to a smartphone app that serves as the alert monitor. The Owlet Baby Monitor won first place and crowd favorite awards, with cash prizes totaling $6,000, at the Student Innovator of the Year competition. The inventors have filed for a patent (pending), more prototypes and testing, and undoubtedly FDA, but if you’re an angel looking for a highly marketable telehealth item–and with adult uses in hospitals and nursing homes–a trip to Utah may be in order. “Smart Socks” Helps Parents Sleep Easier (Smart Phone Healthcare) BYU news release (video)
In general, systems coped and helped others out which were flooded or lost power; NS-LIJ took in patients from evacuated NY Health and Hospitals Corporation (NYHHC) facilities as well as NYU-Langone Medical Center. In opening remarks, NS-LIJ CEO Michael Dowling pointed out the large gap that had to be worked around–a torrent of new admissions, and being unable to access non-network EHRs. He also pointed out that what healthcare needs is the right data to make the right decisions, and that health care systems were liable to data overload–too much, not right and thus not actionable. Closing remarks by HHC’s CEO Alan Aviles returned to Sandy and were a blow-by-blow account of hospital disaster response, followed by what was being done (step by step) to restore services and lessons for the future.
Dan Cerutti of IBM’s Watson commercialization area presented the development of Watson’s deep Q/A in processing structured and unstructured data, and their tackling oncology first in partnership with WellPoint, and refining the decision making model through research with the Cleveland Clinic. [More in TA 27 Sept and 1 Nov] WellPoint’s CTO Rickey Tang extended the discussion into the wild and wooly world of utilization management, so dear to payers and so badly in need of streamlining in precertification, collection of missing information, cost transparency and post-service review. Both Watson and WellPoint are intent on redoing the UM process; eHealth developers should especially keep an eye on how this restructuring develops. A rather surprising factoid tossed out by Mr. Tang was that 81% of doctors spend less than 5 hours/month reading journals, which gave your Editor pause, especially with state and specialty continuing education requirements; does this account for how physicians are transitioning to consuming information via PCs and mobiles?
The Payers and Providers: Making Health Tech Work panel again returned to how to utilize data in moving to evidence-based care, and then moved forward into issues such as connectivity and patient engagement–extending care to the life of the patient outside the walls of the hospital and the doctor’s office. Managing massive amounts of data into workflow was also a major concern of the panel. Charles Saunders, M.D. of Aetna Emerging Businesses noted the fine line between Big Data and Big Brother. Aetna is developing a payer-neutral infrastructure with providers through Accountable Care Solutions to narrow population gaps in care and integrating its patient engagement application, iTriage [TA 24 Dec 2011], to fill what he termed the ‘white space’ between visits. In later remarks, he added case management and call centers to that mix; in total, more overlap, not less, between provider and payer. For providers, their approach is also affected by the composition of their patient population. Pamela Brier, CEO of Brooklyn’s Maimonides Medical Center, pointed out the special challenges of being both the largest Medicaid provider in the borough–now moving to a managed care vs. fee-for-service model–and having a major commitment to the seriously mentally ill, which are for now both roadblocks for Maimonides moving into an accountable care (ACO) model. Their focus is on the electronic transfer and integration of patient information between providers through the local RHIO (regional health information organization). Dr. Neil Calman of the Institute of Family Health and the Mount Sinai School of Medicine, from the primary care provider view, proposed that useful data is real time, alerting to patient status and responding to patients at the ER (ED), and will inevitably result in workflow changes. Marco Diaz, representing employers as VP Benefits for Thomson Reuters, thought the balance would come at the consumer level, in matching and integrating individual data, engagement and actions into records. In follow up questions from the floor, panelists were asked about their experiences with remote patient monitoring (telehealth) integration and the effect on same-cause readmissions. Ms. Brier’s experience has been about a 15% reduction, with a key factor the integration of care managers; Dr. Saunders claimed that the rate could be as high as 40% if transitions of care are managed effectively. A sobering note at the end concerned data tracking and a potential increase in liability, not only from the data capture but also from data breaches. However, Dr. Calman positioned this as more importantly, and inevitably, a manageable risk in an improved standard of care, with RHIOs and an ‘electronic trail’ being part of the security solution.
After a break, the shorter Innovations and the Market panel discussed what can be successful–and not–in health tech. David Blumenthal, M.D. of Partners Healthcare, which is heavily involved in innovative telehealth such as text reminders and startups such as Healthrageous [TA 17 Oct], told a cautionary tale about his encounter with a ‘Silicon Valley hotshot’ who thought his app was ‘the end’–it was, though not in the sense he intended. What is obvious to the developer is not necessarily that to the consumer. Patients don’t listen! Medivo, an early-stage monitoring/lab result tracking company founded by seasoned veteran Sundeep Bhan, has evolved its revenue model several times as it has grown. To Maria Gotsch, CEO of the NYC Investment Fund, the real revolution is coming with data analysis and the tools to make it actionable. Similar tools have been pioneered in the financial sector, and NY is rich in skilled people. However, the talent hasn’t yet migrated from financial to health tech–the VC mentality is still stuck in financial and shopping websites–but the outlook is improving. The panel agreed that for healthcare innovations, ROI in the traditional sense remains problematic, but is rapidly becoming part of a new standard of care delivery.
Tweetstream at #crainshealth. Many thanks to Crain’s event producer Courtney Williams for facilitating Editor Donna’s attendance.
Update 19 Nov: North Shore-LIJ–a healthcare behemoth in the making? Crain’s seems to think so here.
Carolyn Thomas, a Canadian writer, Mayo Clinic-trained advocate for women’s heart health and herself a heart attack survivor, observes the parade of self-monitoring and Quantified Selfing by ‘urban datasexuals’ at Stanford University’s Medicine X conference at end of September. Originally published in her blog Heart Sisters.
Shortly after arriving at Stanford University School of Medicine to attend the conference called Medicine X (“at the intersection of medicine and emerging technologies”), it hit me that I didn’t quite belong there. Maybe, I wondered, the conference organizers (like the profoundly amazing Dr. Larry Chu) may have goofed by awarding me an “ePatient Scholarship” – rather than a more tech-savvy, wired and younger patient in my stead.
Please don’t get me wrong – I was and still am duly thrilled and humbled to be chosen as one of 30 participants invited to attend MedX as ePatient scholars, generously funded by Alliance Health after we met selection criteria like “a history of patient engagement, community outreach and advocacy”.
But almost immediately, I started feeling like a bit of a fraud… (more…)
with Philippe Chambon of New Leaf Venture Partners. Other panelists included fellow entrepreneur Brett Shamosh of Wellapps (purchased by Medivo), Milena Adamian, MD of Life Science Angel Network, Esther Dyson of EDVenture, Donna Usiskin of a private investment team, and Alan Brody of the iBreakfast start-up forum.
Both the winner and runner-up were considered by the panel and audience to be ‘contendahs’:
The winner was not related to telehealth at all–BriteSeed’s SafeSnips technology is a near-infrared sensor which can detect blood vessels’ location, diameter size and blood flow, preventing catastrophic cutting into same during minimally invasive or robotic surgeries. This risk is estimated at 2.9% of these surgeries and SafeSnips would help surgeons avoid this at an average cost of $200/surgery. The technology was originally developed out of Northwestern University and they have an outstanding advisory board. And they already have a strong marketing tag: ‘SafeSnips puts the sense into surgical tools’. Congratulations to founder Paul Fehrenbacher on an excellent presentation which smartly included some rather graphic (to non-clinicals) surgical video to drive home the ‘catastrophic’ point. (Pictures do tell the ‘pain point’.) Editor Donna’s neighbor’s consensus was this was a high risk venture (with FDA approval and patent still pending)–but also high potential reward.
The runner-up is of interest to our readers who are concerned with older adults and their living arrangements, especially when that person can no longer live at home safely or needs a higher level of special assistance in everyday care, such as what we in the US call ‘memory care’. Silver Living is effectively a TripAdvisor(R) for senior communities. It independently reviews communities on factors such as care, appearance (independent photos), geography, residence availability, pricing, independent family and resident reviews, and state inspection reports. It also enables users (primarily younger family members) to compare communities much like an Edmunds.com does with cars. In the US, senior communities are a $200 billion market, but with a 46% turnover and onsite sales only; family members often cannot conveniently visit or compare desired communities, as they may live at a distance from the older adult at what is often a painful and emotional time. Bookings could be made directly on the site. Silver Living would also be a useful tool for hospital discharge planners, geriatric care managers, home care managers, doctors and social workers who generally do not have complete or updated referral resources. The revenue model is based on resident referrals (a potential limitation) but with the market size and need…the audience consensus was, ‘why hasn’t someone thought of this before?’ Congratulations to founder Tal Ziv on a strong and detailed presentation
The other presenters were Health2Social (patient empowerment using social media), Health Options Worldwide (automating care and treatment options for companies’ high cost patients) and Talk About Health (a platform for cancer questions, answers and support). All great ideas and developing in the heart of NYC, which is slowly but surely becoming friendler (albeit expensive) territory for healthcare-related startups.
Video will shortly be available on this link. Many thanks to the organizers, especially Alex Fair of FairCareMD and the first healthcare crowdfunder MedStartr. (TA 12 July; more on this to follow) and Steve Greene of Sperlingreene.
If the Lifewatch V does what it claims to do, hubs and connected devices may be on their way to obsolescence. Using sensors on and apps in an Android-based smartphone, it measures ECG (one lead), body temperature, blood glucose, heart rate, oxygen saturation, body fat percentage and stress levels (heart rate variability), delivering the test results to a cloud-based server accessible for analysis and sending to the monitoring physician or clinician. For blood glucose, your strips are actually inserted into the phone. There’s also a med reminder, a pedometer application, diet plans and logs for exercise and weight. Whew! The company is based in Israel and is actively seeking partners for launch into markets. Gizmodo calls it the smartphone that could save your life. Oh yes, it alerts a call center–and you can make phone calls, text and email too. Not FDA approved as of yet, but it is definitely in the whiz-bang category. Hat tip to one of our readers (at his request, anonymous.)