Issue 106
Digital health research from Brian Dolan
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:
- The big deal this week: Novo Nordisk and Amalgam Rx announced a global expansion for their prescription-only, basal insulin titration SaMD, Dose Check. Dose Check is cleared in the US and Brazil and will launch in some European and Asian markets by the end of 2021. (More on that below.)
- Timed with the announcement above, Amalgam Rx also announced that its basal insulin titration SaMD, iSage Rx (and its white-labeled variants), recently secured a CE Mark that will allow it to launch in certain European countries this year.
- Surprised to see that Akili Interactive Labs bought a four-minute sponsored live interview during a local news morning talk show in Washington DC. Even though it’s positioned as a direct pitch to caregivers of kids with ADHD, it’s hard not to suspect anything marketed specifically to the DC area as an attempt to reach lawmakers and their staff. (Pretty clever if this is part of a soft lobbying effort.)
- 23andMe started trading on NASDAQ this week as “ME” marking the completion of its SPAC merger with a group backed by Sir Richard Branson.
- This is thin but I was surprised to see a job description for a “Global Brand Leader for Aspirin Pain” at Bayer included a line about developing a digital therapeutics strategy: “Lead development of transformational innovation programs across category related to digital therapeutics, new APIs and prevention.”
- Pharmaphorum has a helpful write-up on MIOTIFY’s recent announcement with AstraZeneca: “UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD).”
- A few weeks ago Roche posted a few more hints about its work with Samsung’s Harman group. The companies have worked together since May 2020. The duo is developing a VR-based digital therapeutic for autism spectrum disorder (ASD): “This partnership aims to use virtual reality (VR) to deliver the ‘therapeutic’ component that would hopefully help improve social communication skills. The VR headset can be used at home to ‘practice’ interactive scenarios. The data gathered by active and passive monitoring can then be shared with the healthcare provider and therapist to inform about a patient’s progress.”
- Curious to see two new general trademark filings from Headspace for its main brand and its Headspace Health sub-brand. Both describe Headspace’s services as “telehealth” instead of the list of meditation offerings spelled out in prior trademarks. Makes me wonder if Headspace is pulling back on its previous prescription digital therapeutic plans and moving more toward bolting on a Talkspace-like offering.
- One more thing… The other interesting trademark I happened upon was one from Happify. No further details on this but one of its future potential brands looks to be: “Glowe”.
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SaMD iteration workaround: More on MedRhythms’ usability study: Prelude
Two weeks ago I included a block quote from MedRhythms President and Co-Founder Owen McCarthy about an initiative that the company calls “Product Lab” internally, but is known to some of its patients as the “Prelude” study. One E&O reader asked for more details on this study so I hopped on a call with McCarthy a few days ago to discuss it.
Here’s the original thing I wrote about this two weeks back:
During a recent digital therapeutics-focused webinar put together by Ipsos, MedRhythms’ president and founder Owen McCarthy briefly mentioned how his company overcomes the disadvantage of being unable to iterate its products as nimbly as direct-to-consumer, OTC health tech companies like Mymee, Happify, and Noom:
“That is a big advantage. You don’t have to pour the foundation of the house before you know what the house is going to look like. In our case, we have some angst about that [because we are going the prescription route]. So, we have created a mechanism, which we call ‘Product Lab’ that is an under-IRB, clinical study that evaluates each protocol but more flexibly than we would in a large RCT — [so] we can test and iterate.”
The official name of the study is actually “Prelude” and it just got started at the end of May. MedRhythms is enrolling participants in batches. The participants will have access to the program for one to two months, according to the Prelude participant flyer.
Here’s a snippet of how the company positions this study to potential enrollees:
“While clinical trials are underway, the technology is being made available for trial use to identify ways to improve the patient experience. Participants will:
- Receive a device that is ready to use
- Walk with sensors attached to your shoes while listening to music that adapts to your speed
- ‘Walk-to-the-beat’ of the music for up to 30 minutes, a few times a week
- Share feedback through brief surveys with the study team
You may be eligible to participate if:
- Your stroke was 3 months ago or longer
- You have walking impairments caused by your stroke
- You are able to walk independently for at least one minute
- You live in the U.S.”
McCarthy considers the study to be a “workaround” for MedRhythms because it is unable to test and iterate its product with the public as a typical tech company would.
Prelude is IRB-approved but it’s not testing clinical protocols. Its protocol is broadly focused on usability. When MedRhythm decides to amend and tweak the study’s aims to add a new specific usability objective, the IRB typically approves those tweaks within a week or so. The timeline is based on a medical device’s safety-risk profile, however (along with variabilities among IRBs, I’m sure), but the turnaround time allows MedRhythms to iterate and ship tweaked versions of its digital therapeutic on a continuous basis to Prelude participants.
I’m curious how common this is — usability studies as iteration workarounds for SaMD companies with no legacy DTC business. Does your company do this too?
Clinical trial updates: Woebot, Happify Breather, DynamiCare, ResMed-Wellth
Woebot builds on its work with Stanford in Phase II study of substance abuse-focused DTx
A few months back Woebot published early findings in JMIR about its substance abuse digital therapeutic. This week Woebot posted details of its Phase II study:
“This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to an education-only control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.”
Happify study on Breather suspended for now as PI moves schools
A Happify study that started in late 2019 is suspended as the principal investigator at the University of Kentucky changed jobs and moved to the University of Texas at Arlington. The study was expected to finish up in May 2022. Because of the PI move and the pandemic, it’s suspended for now. Breather is an FDA-regulated device. Here’s a brief description:
“The main objective of this study is to assess the Breather app manufactured by Happify, Inc., as a tool for improving levels of depression and heart rate variability in college students. Happify Breather is a mobile app that provides users with HRV biofeedback aimed at improving mental health and wellness. Breather uses HRV sensors to help users control breathing, leading to calm and relaxation. The more relaxed users are, the more visually reinforcing scene elements will appear in the underwater environment of the game. Breather uses an optical sensor in a smartphone camera. During app use, users are cued by the app to breathe at 6 cycles/minute using a breath pacer. When the smartphone camera flash is illuminated, color signal changes are measured from the fingertip pressed to the camera lens.”
DynamiCare study on contingency management in substance use disorder
DynamiCare posted details on a new study of its app-based contingency management program vs a sham control group. More:
“This project will conduct a randomized evaluation of two types of dynamically adjusting incentive schedules for people with opioid use disorders or cocaine use disorders: ‘escalating’ schedules where incentive amounts increase with success to increase incentive power, and ‘de-escalating’ schedules where incentive amounts decrease with success to improve incentive targeting. Both schemes are implemented with a novel ‘turnkey’ mobile application, making them uniquely low-cost, low-hassle, and scalable. Effects will be measured on abstinence outcomes, including longest duration of abstinence and the percentage of negative drug tests.”
ResMed and Wellth study results
This week ResMed and Wellth posted the raw data results of an obstructive sleep apnea study, aka Project Dahlia, the partners started up back in early 2019. The study randomly assigned participants to standard of care or an intervention group that included standard of care plus an incentives program developed by Wellth:
“The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.”
Stanford study on a game-based therapeutic for children with autism
Another Stanford study: This one has no disclosed collaborator. This efficacy study is focused on a game-based therapeutic for autism spectrum disorder called GuessWhat (that is not described as an FDA-regulated device).
“[The study] aims to understand the efficacy of the mobile game platform, GuessWhat, in delivering behavioral therapy to children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 4 weeks.”
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