Category: Devices

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

March 6th, 2017 by
from-rbj-article-headshot-21
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

November 15th, 2016 by
dexcom-bell-for-blog
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

November 3rd, 2016 by

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.

——-

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

Justifying EpiPen pricing, once again

September 30th, 2016 by
tumblr_mz72cd4fow1rfwfq9o1_500
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!

——-

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

MedSentry: Adherence for complex drug regimens (podcast)

September 16th, 2016 by

front-red-logo-1

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?

——-

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