Category Archives: Devices

eCOA in action: Podcast interview with iCardiac CEO, Alex Zapesochny

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Alex Zapesochny, CEO, iCardiac Technologies

Electronic clinical outcome assessment (eCOA) platforms collect data from patients, clinicians and caregivers to make clinical trials more efficient and accurate. iCardiac Technologies, an innovative core lab where I am a board member, just introduced its QPoint eCOA platform to complement its existing cardiac safety and respiratory function product lines.

In this podcast interview, iCardiac CEO Alex Zapesochny shares more about the launch.

  • (0:11) What are some of the key trends you are following in clinical drug development?
  • (1:04) You started with cardiac safety testing and then added pulmonary function testing. How do those fit together?
  • (3:00) Now you have a new platform, QPoint. What is it, and why is it the next logical service?
  • (4:44) For those who are less familiar with eCOA, what is it? And what are some of the challenges that are typically encountered?
  • (7:09) Compliance is often an issue with patient reported outcomes. Do you address compliance with QPoint?
  • (10:30) How important is eCOA for drug development? Is it a major change or incremental?
  • (12:20) You have explained the move from cardiac safety to respiratory to eCOA. What can we expect next from iCardiac?

By healthcare business consultant David E. Williams, president of Health Business Group.

Podcast interview with Dexcom CEO Kevin Sayer

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Dexcom “Warriors” surround CEO Kevin Sayer on World Diabetes Day 2016

Kevin Sayer is CEO of Dexcom, and on World Diabetes Day he had the privilege of ringing the NASDAQ bell at the start of the session. I caught up with him afterwards to ask about developments in Continuous Glucose Monitoring.

Here’s what I asked:

  • (0:10) What is World Diabetes Day and what does it accomplish?
  • (0:45) Your company is a pioneer in Continuous Glucose Monitoring (CGM). What is the impact on patients?
  • (1:48) Does CGM replace finger sticks or do you have to do both?
  • (2:23) Is CGM relevant only for those with insulin pumps? Is it useful for people who inject insulin?
  • (3:24) What is an artificial pancreas? How does CGM fit in?
  • (5:15) How do you model the financial impact of CGM for individual patients and for populations?
  • (6:49) How important are online patient communities and data registries, such as T1D Exchange? Do they play an important role in your R&D?
  • (8:11) As we look to 2017 and beyond, what are the next big things we can expect?

By healthcare business consultant David E. Williams, president of Health Business Group.

TytoCare: Comprehensive telehealth exam platform

TytoCare hopes to take telehealth to the next level by providing a solution that allows clinicians to conduct remote examinations. Patients (or caregivers) will use a TytoCare device to conduct an exam that can be interpreted by a physician over a cloud-based platform with video conferencing.

The company took a step forward recently by obtaining FDA clearance for its digital stethoscope. The approach looks pretty cool, but clearly it will be a challenge to get the devices out to patients ahead of need and to do so cost effectively.

CEO & Co-Founder Dedi Gilad answered my questions via email:

1. What was the inspiration for Tyto?

I founded TytoCare along with Ofer Tzadik, another lifelong leader in Healthcare IT, in 2012. The story is similar to that experienced by most families when at a young age, my daughter suffered from a series of earaches requiring constant medical treatment. With two working parents, it became increasingly difficult to travel in and out of the local physician’s office on a regular basis. The experience was not easy for my daughter either, waiting for hours in the crowded doctor’s office in considerable pain and discomfort. 

After consulting with my pediatrician, I recognized the strong need for change in the way primary care is delivered today. I collaborated with Ofer Tzadik to design a new medical experience, one that would not only mutually benefit both the doctor and the patient, but also serve to strengthen this vital relationship. The result of this endeavor is TytoCare, a company prepared to lower the load and cost of U.S. healthcare services, improve accessibility to healthcare services even from the comfort of home, and reshape day-to-day healthcare as we know it.

2.      Why a dedicated device instead of using a tool everyone already has, i.e., a smartphone?

 TytoCare’s examination tools and complete telehealth platform work with a smartphone or tablet and include a stethoscope, otoscope, tongue depressor, camera, and thermometer. While a smartphone can only offer video and audio technology, Tyto enables the patient to conduct actual exams of the heart, lungs, heart rate, temperature, throat, skin and ears. This cannot be done with video alone and more importantly, it requires an interface and technological infrastructure that simply wouldn’t be cost effective in a smartphone.

 3.    How will distribution to end users work? It seems like logistics will be difficult. For example, do you expect everyone to have a device in place before they need it?

 To begin, distribution will start with health institutions though a full consumer product is coming in 2017. We expect that consumers will see the value in being able to perform live, remote medical examinations at home, in place of rushing back and forth to the doctor’s office. 

 4.  What is the cost of the home and pro solutions?

 TytoPro will cost $999.00 plus a monthly fee based on usage, and TytoHome will cost $299.00.

5.  More broadly, what are the overall economics of the solution? Is there a financial return on investment? How do you think about calculating that? Is it more appropriate for certain segments of patients or providers?

Certainly, and our work with leading financial institutions has reinforced the financial ROI.

 The incredible benefit of the product is that its applications are endless because it simultaneously empowers doctors and clinicians while unlocking the full benefits of telehealth for patients. TytoHome can be beneficial in many different scenarios – for geographically isolated patients and those who lack easy access to medical facilities; those who are turning to urgent care because they cannot get an appointment in time at their regular establishment; patients with chronic illnesses or other conditions that require monitoring and frequent, tiresome trips to the doctor or hospital; school or traveling nurses; and of course, parents at home with kids.

 6. What is the lifecycle for this solution? Do you expect to upgrade the devices over time? Can that be done through software or will it require hardware to be replaced?

We will likely add additional examination capabilities over time, but the majority of upgrades can be made through software updates.

 7. What else should readers know?

TytoCare is a complete end-to-end telehealth platform that provides a telehealth experience comparable to in-person visits. It truly fills the missing link in telehealth between the in-office professional and the at-home patient by delivering comprehensive exam results – of the ear, nose, throat, heart, lung, stomach, skin – as part of a complete telehealth visit. The exam data can be delivered to a clinician via “live telehealth exams” or through the “exam and forward” function – sending the exam results on to be examined by the clinician later.

 TytoCare can be used anytime, anywhere and by anyone. Patented guidance technology directs and enables anyone to collect the right data so a clinician can make the proper diagnosis. The advanced digital exam tools use clinic-grade technology to capture high resolution images and sounds, allowing for more kinds of remote diagnoses and increased accuracy.

The secure cloud-based platform enables integration with existing HER systems and provides analytics for decision support with health alerts. TytoCare offers HIPAA compliance, and the modular product design also supports open APIs so other examination devices can be integrated within TytoCare.

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By healthcare business consultant David E. Williams, president of Health Business Group.

Justifying EpiPen pricing, once again

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Back with more

I enjoyed Medical hackers create $30 DIY EpiPen in defiance of corporate greed over at inhabitat. The Four Thieves Vinegar collective cobbled together an “EpiPencil” from an auto injector for insulin, a hypodermic needle, and epinepherine. It’s a pretty cool trick but it proves nothing about EpiPen pricing nor does it help real patients.

Actually, it unwittingly reinforces the points I made in my very unpopular EpiPen may still be too cheap post, which is that the pricing of EpiPen has almost nothing to do with the cost of its parts.

Consider these caveats about the DIY EpiPencil from the inhabitat post:

However, it is worth mentioning that many experts have voiced concern about the EpiPencil and warned that it’s not advisable to try to create a piece of medical equipment at home – it can be difficult to ensure the correct dose is being administered, the epinephrine inside is delicate and might lose its effectiveness if stored this way, and of course, if someone were to create the device without paying close attention to hygiene, it could become contaminated. A miscalibration of the device could even cause the medicine to be injected into a vein, which can have dangerous side effects.

To recap, here’s what you’re paying for when you buy a real EpiPen:

  • The ability to send your kids to school, playdates, summer camp, hikes, and restaurants with reasonable confidence that they’ll survive an allergic reaction
  • An auto-injector that works. Remember, Twinject was rejected by the market for being clumsy, Auvi-Q was recalled because it could administer the wrong dose, and Teva’s autoinjector was rejected by FDA for “major deficiencies”
  • A device that many, many people know how to use: school nurses, babysitters, passers-by. That means someone is likely to be there to help you if you need it. Good luck with getting someone to learn how to use your EpiPencil in an emergency, even if somehow it worked as advertised

EpiPen’s maker, Mylan has done a lot of sleazy things, which I don’t defend, and as a result they may well deserve the opprobrium that is being directed at them. But I stand by my argument that EpiPen is not $2 of epinephrine and a syringe. Instead its a differentiated solution that provides plenty of value to users.

If someone can come up with something better and cheaper, please do!

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By healthcare business consultant David E. Williams, president of Health Business Group.

MedSentry: Adherence for complex drug regimens (podcast)

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Medication adherence is a tough challenge, especially for high-risk patients, whose complex drug regimens often feature more than a dozen pills. MedSentry is rolling out an end-to-end closed loop adherence system for this population. Although it’s not a large group, it is responsible for a disproportionate share of medical costs.

In this podcast interview, CEO Adam Wallen and I discuss the following:

    1. (0:11) Adherence is a big problem in healthcare. What does it mean? What’s the nature of the problem?
    2. (0:57) Are there multiple reasons for lack of adherence?
    3. (4:05) There are a number of adherence solutions in the market. How well do they work?
    4. (7:46) What is the MedSentry approach? How is it different?
    5. (11:57) What evidence is there that this approach is effective?
    6. (13:17) You have focused on the most complicated patients. Will that continue to be your niche as your commercialize?
    7. (14:55) Do you have a scale-up plan?

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By healthcare business consultant David E. Williams, president of Health Business Group.

Amazon Echo for healthcare

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Alexa, what can you do for healthcare?

I bought an Amazon Echo this week and have been enjoying using it in the kitchen. I can ask, “Alexa, what time is it in Germany?” and it will tell me. Or I can say, “Alexa, play music by the Beatles,” or ask, “Alexa, how many ounces in a cup?” and it will let me know. It’s remarkably easy –and not at all frustrating– to use. The whole family is enjoying it.

Naturally I started almost immediately to think of healthcare uses, so I wasn’t at all surprised to pick up the Boston Globe yesterday and see that my friends from Boston Children’s Hospital are a step or two ahead. Chief Innovation Officer John Brownstein, PhD and clinical innovation director Michael Docktor, MD have launched a KidsMD app for the platform and are testing out uses for Echo in the OR, ICU and bedroom.

Although the article lays out some of the potential for Echo, overall I find it too dismissive, highlighting a software glitch, voice recognition problem, and asserting that “another layer of technology might frustrate staff.” The article ends with a quote from a Children’s engineer whose own kids aren’t interested in speaking with Alexa. None of this reflects my family’s experience.

What the article misses is that Echo represents the latest example of physicians bringing cutting edge consumer technology into the hospital and running circles around the standard tools offered by the IT department. In the real world, physicians are early and enthusiastic adopters of tools like the iPad and iPhone, and through the bring your own device (BYOD) movement they have upended the traditional, clunky hospital IT environment.

Here are some thoughts about what could make Echo so useful for healthcare:

  • It’s the rare tool that can be used equally well by doctors and patients
  • It’s a handsfree device, which makes it easy to use when one’s hands are occupied, dirty, or injured
  • The voice recognition is really good, and works just fine in a noisy environment
  • It enables continuity of care because a patient could use the same device at home that was used at the hospital
  • It gets smarter all the time as new intelligence and apps are added to the cloud
  • It can entertain as well as inform

I can foresee apps that help patients remember their customized care instructions, “Alexa, how often am I supposed to change my dressing?” or “Alexa, am I supposed to take my medication with food?”

I also think it will be useful for hospitalized patients who are trying to remember questions they want answered the next time their doctor or nurse comes around. There is a built in ability to say, “Alexa, add butter to my shopping list.” So there’s no reason it couldn’t compile a list of doctor questions as well.

These are the veritable tip of the iceberg, and I look forward to seeing a thousand (or more) flowers bloom as the healthcare field embraces Echo. “Alexa, I love you.”

By healthcare business consultant David E. Williams, president of Health Business Group.

 

Listen app: ResApp diagnoses respiratory ailments

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I’m intrigued by an Australian company, ResApp that has developed a smartphone app to diagnose respiratory diseases by analyzing the sound signatures of coughs. The company has just completed an oversubscribed fundraising round, so I guess I’m not the only one who finds it interesting.

I interviewed the CEO, Dr. Tony Keating via email, and his answers are below. Meanwhile, check out the demo for their consumer-facing product.

What is ResApp? from ResApp Health on Vimeo.

Q1. What unmet need does ResApp serve? How big is the need?

ResApp is developing digital health solutions for the diagnosis and management of respiratory disease (e.g. pneumonia, bronchiolitis, asthma, COPD). We estimate that every year more than 700 million doctor visits result in the diagnosis of a respiratory disease within the OECD, in the US the number is 125 million visits. Pneumonia in particular costs the US hospital system $10.5 billion annually. The World Health Organization estimates that nearly 1 million children die of pneumonia in the developing world every year, with a large portion attributed to the lack of availability of a low cost diagnostic tool. 

Current diagnosis of these disease is costly and time consuming (consider that an x-ray for pneumonia diagnosis in the US costs more than $200 and can take up to an hour in an emergency department), and there are also many areas where current diagnostic tools are unavailable. Our initial focus is to provide an accurate remote diagnostic capability to telehealth where even the stethoscope is not available to physicians. 

Q2. How does the system work?

ResApp’s technology is based on the premise that cough and breathing sounds carry vital information on the state of the respiratory tract. We use machine learning algorithms that analyze the sound of a patient’s cough. Our algorithms are able to match signatures that are within a patient’s cough with a disease diagnosis. An analogy might be how speech recognition algorithms match speech to text, or how Shazam’s algorithms look for signatures in music to identify the artist and title. 

Q3. Who came up with the idea? How?

The technology was developed by Dr Udantha Abeyratne and his team at The University of Queensland. Dr Abeyratne and his team have been engaged in the R&D of the technology since 2009. They were initially funded by a grant from The Bill and Melinda Gates Foundation to investigate if mobile phones could be used to diagnose pneumonia in the developing world. The initial idea was to take the latest advances in speech recognition technology and couple them with physicians’ in-depth knowledge of cough and breathing sounds to develop a diagnostic test that could be delivered at low cost to patients in the developing world. 

Q4. You started as a telehealth app but are now looking to serve physicians for in-person visits, such as in the emergency room. Why?

Our focus remains on providing a remote diagnostic test to be used alongside a telehealth consultation. However we have seen great interest from physicians for use in in-person visits, such as in the ER. The potential of our technology to provide an instant and highly accurate differential diagnosis of respiratory disease is seen as a way to greatly improve the diagnosis and treatment of their patients. In addition, healthcare payers could potentially realize significant cost savings versus traditional diagnostic tests (such as chest x-ray). 

Q5. The app doesn’t require any additional hardware. Is a smartphone really good enough to serve as a medical device?

Our clinical study, run out of two major Australian hospitals, has demonstrated very high levels of accuracy (both sensitivity and specificity) in diagnosis from recordings taken using the microphone on the smartphone. We are simply using the smartphone as an efficient platform for delivering a clinical-quality medical diagnostic device. The FDA has approved over 100 mobile medical apps, including a number that diagnose a disease. 

Q6. Your initial focus is on diagnostics. Do you also plan to offer tools for ongoing management? 

Yes, our recent fundraising allows us to accelerate our plans to develop tools for ongoing management of the chronic respiratory diseases asthma and COPD. We see an opportunity to potentially measure the severity of these conditions on a more regular basis than what is done today. We also see the opportunity to deliver these management tools to all smartphone users who suffer from these conditions, without the need to purchase additional hardware (or perhaps also just as importantly, without the need to carry a second device). 

Q7. What geographic markets are you serving? Are you worried you are spreading yourself to thin?

Our focus is the US telehealth market, although our recent funding extends our US market into the in-person use by a physician. In both of these instances, we are still providing the diagnostic result to the physician, not directly to the patient, so our clinical studies and FDA submissions are essentially unchanged. We have recently seen growth in telehealth, in particular in Europe and Australia and will be working through the regulatory process in those regions in parallel to the US regulatory process.

Q8. What’s to prevent someone else from copying what you are doing?

The university has filed a patent application (which ResApp has a worldwide exclusive license to) describing the method and apparatus of respiratory disease diagnosis using sound. The machine learning algorithms that we use also require a significant amount of high quality clinical data, which we have generated from our multiple clinical studies. 

Q9. Anything else to add?

ResApp’s technology, originally developed by a world-class team at one of the world’s leading universities, provides an opportunity to deliver a clinical-quality medical diagnostic test for respiratory disease to everybody who has a smartphone in their pocket. While we’ve talked a lot about the opportunities in the US, Europe and Australia, we must remember that there are also billions of people in the developing world who do not have access to quality healthcare. We have recently partnered with a leading global humanitarian organization to help bring a high accuracy, low cost diagnostic test for pneumonia to those people and to try to reduce the number of children who die from pneumonia and other respiratory diseases every year in the developing world. 

By healthcare business consultant David E. Williams, president of Health Business Group.