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Andy Rogers and Jake Cowperthwaite continue their talk with Steve Schaefer, CEO at CoolTech, about the quest for data with MiHelper: a new in-home therapy device.
Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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We're back with Jake and Steve here,
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talking with CEO Steve Schaefer from CoolTech.
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So episode two of MedTech Speed to Data
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that we're going to be talking
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about this, the other product
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that CoolTech is developing, the MiHelper platform.
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So, Steve,
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do you want to describe the
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MiHelper for our audience, please?
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Sure.
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MiHelper is a non-drug
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therapy for migraines.
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It's something that people will be able to use at home
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when they feel a migraine coming on.
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Quick ten minute therapy to make it go away.
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So this is the sister product to the
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to the CoolStat platform.
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So I'm curious how did you discover
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and I know this was kind of discovered,
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after the CoolStat the clinic platform
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was being developed.
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How did you discover
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that it might be effective for migraines?
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Well,
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people have used oxygen
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therapy to treat cluster headaches
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and migraines in the past.
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And it's been pretty successful,
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a little bit difficult to deliver
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and not really feasible for at home therapy.
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But it had efficacy.
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And a prototype study was done at Johns Hopkins
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to compare oxygen therapy and just
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simple dry room air compared to a control group.
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And it showed a significant pain reduction
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in the dry air, over the control.
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What data specifically
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showed that?
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With the outcomes data.
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So with migraine, it's a subject reported
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pain and other bothersome symptoms.
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And they say what it was like in the beginning
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and whether it was reduced or went away
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Got it.
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Sounds pretty pretty clear cut there.
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Oh, so. So question for you.
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The MiHelper what is your regulatory pathway
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to get this product on the market?
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So a similar to CoolStat in
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that it's a 510K process,
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but like CoolStat that will probably be a
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De Novo process.
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Meaning you're not claiming a predicate,
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but you're also saying that it doesn't require a PMA,
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which is a longer more rigorous path
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So you've developed you're in trials now, sounds like,
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and you've developed a clinical trial device.
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So can you describe,
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what this trial device is more specifically?
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And then is this trial device, how is this trial device
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different from your commercial device?
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So we're actually for the current
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randomized controlled
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trial using a modified version, of CoolStat.
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So one of the great things about having an outsourced
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development partner is it makes you nimble.
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We were able to work with Key Tech to modify
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CoolStat to work for the migraine delivery.
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So instead of a closed loop
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temperature management system, it's an open loop
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specified flow rate for a specified time period.
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Similar patient interface.
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Except for that,
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we actually have incorporated
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and nebulized mist of saline for added comfort
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and tolerability because people have migraines.
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We want it to be a very pleasant therapy,
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so we were able to make those changes.
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What's exciting and coming right around the corner
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is a completely new product design for at home use,
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which Key Tech is also doing the development for
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and leveraging the background experience
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they've had with CoolStat.
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So that is a product that's going through
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a verification and validation process.
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We'll go to the FDA most likely and get an IDE
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and run studies with people at home.
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So they can have it at their bedside.
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So you have sort of an in clinic study
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sort of going now with a modified product
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and then in parallel,
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you've got your more,
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commercial ambulatory product.
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There will also need a trial,
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in parallel.
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But you'd be confident
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that the data from the first trial
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the platform will work in your in your second trial
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sounds like.
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Yeah, it'll be different
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because it's a different use case
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when you're in clinic you have to develop a migraine.
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You've got to travel in
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without taking any rescue medication.
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Hours later, get the therapy
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it's going to be a different
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use case and different patient population.
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So we expect the at home data look even stronger.
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Than the clinic data
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A lot of companies are looking to go from in clinic
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to at home.
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I have to ask,
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as your
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what considerations are you making
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in your product development plans now
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for eventually running a clinical trial at home?
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So not in a controlled environment.
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This is a this is a different world.
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So how are you planning for
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running a trial in the home environment?
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Well, it starts with the device requirements
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and the standards for at-home use,
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which are very different.
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And you also have to incorporate
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usability and other design considerations
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around the fact
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that you're not going to have
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someone administering the therapy.
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It has to be completely self-guided.
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Things have
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to be very obvious, very simple.
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You're not going to have an expert user.
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Everything you could imagine they shouldn't do,
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they'll probably try.
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And you have to make sure that it's always safe
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regardless of what they do.
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It's a lot more work.
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There's a lot more rigorous standards
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for at-home devices.
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and so you have to work with your
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development partner first.
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You hope to have all the experience in that.
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ours does, which is great.
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And you go from there.
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Is the device, the at-home device connected
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like paired with a smartphone or not?
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Or is it just direct to a cloud.
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No, it has a companion app with it.
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And eventually in the commercial product,
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that'll be a large aspect of it.
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And people who suffer from migraine
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which is the fifth leading cause of E.R. visits
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They deal with a lot of trauma.
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It's very disabilitating.
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And they need to track their triggers
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they need to diary things.
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And so having a companion app
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that ties along with the therapy is very important.
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Is it worth having the app in the trial?
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Like, why are you doing that?
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I know that complicates
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the development and, maybe safety testing
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to do leading up to the trial.
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Why are you using the app in the trial?
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Yeah, so that's my first question.
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Yes, it's great question.
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So we're intentionally
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making it unidirectional.
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So we're not allowing the app to
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to make any changes to the device.
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Not even, the potential for firmware changes.
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So the user's not going to they're going to press
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the button on the box,
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not press the button on their phone.
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And that eliminates a lot of the security issues,
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which you don't want to even deal with in the study.
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What we do want to get,
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and we have Bluetooth connectivity to enable it,
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is we want to be able to pull out the device data
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into the app and through the cloud securely to us
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so we can monitor the device performance.
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So what are you envisioning
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for the commercial device then?
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Because it makes sense in the trial that
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you don't want people programing the device
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with the app.
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But in the commercial product, how do you envision
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the app being used with the product?
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So we we expect there
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to be user controls on the app
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to be able to customize settings,
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to be able to
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track the number of treatments to be able to,
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diary their experience with their headaches.
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So we expect it to be
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a robust kind of self-care app.
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Also, they can
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order supplies through the app very importantly,
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and people want that.
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They want to make it simple, easy.
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They want everything recorded
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So, Steve, I'm going a little off script.
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I'm trying to get some sound bites on at home
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trial design.
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there's a lot
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I could talk about with that home trial design
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because it is completely different
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than the in hospital trials.
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So that's what I want to focus on.
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Like I want to,
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I want to convey the story
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of developing a product for effective at-home trials.
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And in the context
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of what you care about, which is what is that trial
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and what data are you getting from it?
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So we touched on
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we touched on on kind of a one way
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Bluetooth connection
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so that the phone
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is really just beaming the data to the cloud.
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Are there other like in-home trial,
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in-home medical device trial, considerations that.
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we haven't covered that
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that maybe aren't connected to the app,
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aren't related to the app, rather?
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Yeah, absolutely. So
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a modern thing in clinical
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trials at home is these decentralized clinical trials.
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So they're not going through an institution,
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not going through a hospital,
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but they're going through a central
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institutional review board.
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There's going to be PIs that,
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may be employed by the company or third party CRO,
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and those platforms start with recruitment.
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So you're going out not only through social media
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or through advocacy groups
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where patients are coming to looking for solutions.
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And you can cast a very wide net,
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very cost effectively.
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We use that even for our own clinic study
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and we had 5000 people apply for trials
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within just a 50 mile radius around
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three different centers.
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So imagine if you could
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broadcast that out to the entire U.S. population.
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You're not limited to
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the fact that someone lives in Iowa
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and the center is in California.
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It's very different and a lot of these new companies
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have developed platforms that have the apps.
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They can do the training, they can do the tracking
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the data collection.
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It's all on one platform.
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It’s a completely different way to manage clinical trials.
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You can get a lot of leverage out of it.
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And actually, you know, we're considering
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using their app
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clinical trial partners
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app to pull the data
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through on our Bluetooth with our design.
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So working with our design partner Key Tech,
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we've been able to
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to not duplicate efforts
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in that application development,
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which is a huge cost savings.
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Yeah, I guess I'm curious So,
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Steve, in a sense, these at-home clinical devices
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are really going out into the wild.
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Can you take us through the life of these devices
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so they're built.
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They have to get to users in their home,
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set up, used, and then back to you.
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Could you maybe,
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maybe step us through the process for doing that?
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Yeah.
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And it is a challenge because you're losing sight of it.
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You may be able to watch the therapy
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through an app while they're doing it.
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They actually have software that blurs out
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the subject's faces during that recorded time.
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But you are losing physical custody of the device.
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So you have to
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have fulfillment
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that ties to the clinical trial enrollment.
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To get the device to the user's home.
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You have to train them on use of the device.
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You have to record the events,
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and then you have to get it back.
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You also have to think about,
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what are the components of the device?
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Do I have a durable piece?
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That's going to be reusable.
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Is it okay for that
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to then be used for another subject,
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or is there any possibility
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of any form of contamination?
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And you have to have a kind of reprocessing
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and a re-sanitation procedure
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or sterilization,
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depending on what you're doing for us.
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is making sure that the device is weighed down.
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But we don't plan to use the tube sets,
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and the handsets
00:13:41:04 - 00:13:43:18
ever again, it will be single use.
00:13:43:18 - 00:13:46:09
And that not only for
00:13:47:03 - 00:13:49:00
subject, it'll be a
00:13:49:00 - 00:13:51:06
single subject will use it,
00:13:51:06 - 00:13:54:02
but we still are going to make it disposable.
00:13:54:02 - 00:13:55:01
And the same thing for it.
00:13:55:01 - 00:13:56:17
We have a desiccant cartridge
00:13:56:17 - 00:13:58:01
that drives an air
00:13:58:01 - 00:14:00:08
and that will be single use as well.
00:14:01:14 - 00:14:02:23
So the only thing that we
00:14:02:23 - 00:14:06:11
plan on reusing is the boxes
00:14:07:13 - 00:14:11:06
and that's to limit the amount of,
00:14:11:06 - 00:14:14:21
regulatory issues and safety issues.
00:14:15:18 - 00:14:17:13
But you want to get that box back
00:14:17:13 - 00:14:19:18
and a lot of them don't ever make its way back.
00:14:19:18 - 00:14:20:10
Sure.
00:14:20:10 - 00:14:21:23
So obviously you're not going to
00:14:21:23 - 00:14:25:07
whatever type of compensation
00:14:25:07 - 00:14:26:23
that you provide, you
00:14:26:23 - 00:14:29:01
provide that once you get your device back.
00:14:29:01 - 00:14:32:09
So eventually at home, users could clean
00:14:32:09 - 00:14:34:14
or disinfect their own devices and re-use them.
00:14:34:14 - 00:14:37:04
But you've completely eliminated that step
00:14:37:04 - 00:14:39:07
by making them disposable for the trial only,
00:14:39:07 - 00:14:41:02
which really sounds like a great idea.
00:14:41:02 - 00:14:44:10
Yeah, it's a lot faster
00:14:45:03 - 00:14:46:21
and easier and there's less risk.
00:14:46:21 - 00:14:48:21
To another question
00:14:48:21 - 00:14:52:04
to field that many devices at homes.
00:14:52:04 - 00:14:55:02
Did you partner with another company to help fulfill
00:14:55:02 - 00:14:57:03
those those shipments?
00:14:57:03 - 00:14:58:17
How did you make that work?
00:14:58:17 - 00:15:02:01
So we haven't done it yet, but we're planning on using
00:15:02:01 - 00:15:05:03
our contract manufacturer to do that.
00:15:05:03 - 00:15:08:08
So they'll drop ship it to the customer's home
00:15:09:13 - 00:15:12:15
and then we'll receive it back and reprocess
00:15:12:15 - 00:15:13:22
what needs reprocessing
00:15:13:22 - 00:15:16:01
and dispose of what needs disposing.
00:15:16:01 - 00:15:16:23
Got it.
00:15:16:23 - 00:15:19:08
It's pretty simple logistics.
00:15:19:08 - 00:15:22:10
What data are you pulling off the device specifically?
00:15:22:10 - 00:15:26:00
So turn on turn off runtime you know.
00:15:26:18 - 00:15:29:12
I know for a migraine study, it's
00:15:29:12 - 00:15:31:14
kind of a qualitative,
00:15:31:14 - 00:15:33:05
how did you feel?
00:15:33:05 - 00:15:35:02
But what are what are you collecting?
00:15:35:02 - 00:15:37:02
So for migraine, it's
00:15:37:02 - 00:15:38:23
all about just device performance.
00:15:38:23 - 00:15:41:21
So what was the target flow rate?
00:15:41:21 - 00:15:44:04
What was the actual flow rate?
00:15:44:04 - 00:15:46:05
What was the relative humidity
00:15:46:05 - 00:15:50:12
coming in to the device, going out of the device?
00:15:50:12 - 00:15:52:16
What was the temperature of the air?
00:15:54:06 - 00:15:56:03
All things like that.
00:15:56:03 - 00:15:57:15
Was there any back pressure?
00:15:57:15 - 00:15:59:20
Noticed, every second
00:15:59:20 - 00:16:03:18
the device is logging all of its parameters
00:16:05:10 - 00:16:07:14
and if there was any errors
00:16:07:14 - 00:16:10:18
or events, it's going to track on all of that.
00:16:10:18 - 00:16:13:11
But the the information
00:16:13:11 - 00:16:16:03
that the endpoints are based on
00:16:16:03 - 00:16:19:18
are all reported by the subject
00:16:21:08 - 00:16:24:00
What scale is my headache pain
00:16:24:00 - 00:16:24:23
right after I started
00:16:24:23 - 00:16:28:04
right after the therapy at 2 hours, at 24 hours?
00:16:29:21 - 00:16:32:10
that is a subject subjective
00:16:34:10 - 00:16:36:11
reported event.
00:16:36:11 - 00:16:37:15
So Steve,
00:16:37:15 - 00:16:38:20
when you planned this study,
00:16:38:20 - 00:16:41:14
I'm sure you have to assume that there's some fallout
00:16:41:14 - 00:16:43:10
and not every at home
00:16:43:10 - 00:16:46:04
user is going to use the device correctly.
00:16:46:04 - 00:16:48:17
They may not write down their information as expected.
00:16:49:20 - 00:16:53:10
So do you enroll, more users than you would
00:16:53:11 - 00:16:54:14
you would need in the end?
00:16:54:14 - 00:16:55:13
Yes, you do.
00:16:55:13 - 00:16:57:10
And you follow up
00:16:58:03 - 00:16:59:09
your follow up.
00:16:59:09 - 00:17:00:09
Sure.
00:17:00:09 - 00:17:02:08
You're not just going to trust that they've done it.
00:17:02:08 - 00:17:04:05
You're going to see whether they've done it.
00:17:04:05 - 00:17:06:13
You're going to call them if they haven't,
00:17:06:13 - 00:17:09:04
you know, log their stuff.
00:17:09:04 - 00:17:12:10
But you do you do have to count for people
00:17:12:10 - 00:17:15:09
falling out of the study for one reason or another.
00:17:15:09 - 00:17:18:16
And are you getting in trial data
00:17:18:16 - 00:17:22:06
and are you, modifying the therapy like,
00:17:22:06 - 00:17:23:19
on the on the CoolStat platform?
00:17:23:19 - 00:17:25:14
You made some pivots here or there.
00:17:25:14 - 00:17:29:03
Just curious, how the trial's going or
00:17:29:03 - 00:17:31:11
what are you planning to kind of
00:17:31:11 - 00:17:33:22
potentially change as the trial rolls out?
00:17:33:22 - 00:17:37:07
Well, unless you have an adaptive trial design
00:17:37:07 - 00:17:39:07
where you've already
00:17:39:07 - 00:17:43:00
created variables to make changes in it
00:17:43:00 - 00:17:45:00
based on the data that you're accumulating
00:17:45:00 - 00:17:46:07
on the way,
00:17:46:07 - 00:17:47:10
you really can't do that.
00:17:47:10 - 00:17:49:19
You have to stick to your protocol
00:17:51:18 - 00:17:53:04
all the way through.
00:17:55:01 - 00:17:57:18
So it's a big investment
00:17:57:18 - 00:17:59:19
in getting it right in the planning
00:17:59:19 - 00:18:01:22
So let's let's touch on that just a little bit more.
00:18:01:22 - 00:18:06:00
So what what data did you collect pre-trial
00:18:07:02 - 00:18:09:18
to tell you what
00:18:09:18 - 00:18:13:19
parameters to use for this migraine therapy?
00:18:13:19 - 00:18:15:23
So we're in process of that right now.
00:18:15:23 - 00:18:20:02
We have a study in clinic called The Calm Study
00:18:20:02 - 00:18:22:19
cooling for the alleviation of migraine
00:18:22:19 - 00:18:25:22
and the data from that study, which has
00:18:27:05 - 00:18:30:10
very various flow rates
00:18:30:10 - 00:18:34:07
is going to inform the protocol for the at-home study.
00:18:35:14 - 00:18:38:04
And we're going to get as much possible
00:18:38:04 - 00:18:40:05
data as we can out of that study
00:18:41:05 - 00:18:42:21
in order to make assessments
00:18:42:21 - 00:18:45:10
on the length of the therapy,
00:18:45:10 - 00:18:48:22
the flow rate to our dose, what should that be
00:18:48:22 - 00:18:50:16
how do we design a sham
00:18:50:16 - 00:18:53:05
that has no activity in it, which is really important
00:18:53:05 - 00:18:54:05
and difficult?
00:18:55:18 - 00:18:56:23
So all of that,
00:18:56:23 - 00:19:01:04
we are still getting educated on
00:19:01:04 - 00:19:03:03
from the data from the current study
00:19:03:03 - 00:19:06:16
What steps are you taking to know that the MiHelper
00:19:06:16 - 00:19:09:17
is ready to go to homes for clinical trials?
00:19:09:17 - 00:19:12:04
Because I'm sure with an expensive study like this,
00:19:12:04 - 00:19:13:08
the last thing you want
00:19:13:08 - 00:19:15:01
is to ship a bunch of devices
00:19:15:01 - 00:19:17:08
and then find out that you have bugs.
00:19:17:08 - 00:19:18:04
That would be a nightmare.
00:19:18:04 - 00:19:19:21
So maybe you could talk us through
00:19:19:21 - 00:19:22:18
how you know you'll be ready to go.
00:19:22:18 - 00:19:25:02
Well, from a device
00:19:25:02 - 00:19:26:20
preparation standpoint,
00:19:26:20 - 00:19:29:08
we're working with our development partner
00:19:29:08 - 00:19:32:20
to do all the verification and validation work
00:19:32:20 - 00:19:38:05
external lab testing, the biocompatibility work,
00:19:38:05 - 00:19:41:18
the aging testing for disposables,
00:19:41:18 - 00:19:44:07
so all of that's being done
00:19:44:07 - 00:19:49:06
by the prescribed methods and regulations.
00:19:49:06 - 00:19:51:18
That's going to give us incredibly high
00:19:51:18 - 00:19:54:21
confidence that the device is going to perform.
00:19:54:21 - 00:19:58:06
It's going to perform safely, and it's operating
00:19:58:06 - 00:19:59:23
to its specifications.
00:19:59:23 - 00:20:01:00
Understood. Yes.
00:20:01:00 - 00:20:04:05
It sounds like you're under full design control,
00:20:04:05 - 00:20:06:22
following relevant standards, all that sort of stuff
00:20:06:22 - 00:20:09:13
so that, you know, that it's a robust design.
00:20:09:13 - 00:20:10:00
Got it.
00:20:10:00 - 00:20:10:20
Yeah, exactly.
00:20:10:20 - 00:20:13:06
And it meets all the at-home standards.
00:20:13:06 - 00:20:13:22
Sure.
00:20:13:22 - 00:20:15:09
So, Steve,
00:20:15:09 - 00:20:18:02
it's slightly different question, but I think it's
00:20:18:02 - 00:20:19:13
a really important one. So
00:20:21:07 - 00:20:22:09
what does your team
00:20:22:09 - 00:20:27:02
structure look like there at CoolTech
00:20:27:02 - 00:20:27:20
to support
00:20:27:20 - 00:20:31:16
and at home, you know, start up medical device trial?
00:20:31:16 - 00:20:34:08
You mentioned an outsourced product development partner,
00:20:34:08 - 00:20:35:23
but what does your team look like?
00:20:35:23 - 00:20:40:13
So I say it looks small but mighty.
00:20:40:13 - 00:20:42:09
We have
00:20:42:09 - 00:20:44:13
a total of
00:20:44:13 - 00:20:49:09
this many, four people, that are full-time employees.
00:20:49:09 - 00:20:51:23
There's myself.
00:20:51:23 - 00:20:54:17
There is a Senior Product Engineer
00:20:54:17 - 00:20:57:23
and there's a Director of Clinical Operations
00:20:57:23 - 00:21:00:14
and aClinical Research Associate,
00:21:00:14 - 00:21:04:09
and they work together with a regulatory consultant
00:21:04:09 - 00:21:07:06
our clinical advisory board
00:21:07:06 - 00:21:11:06
our Chief Science Officer, all of which are,
00:21:11:06 - 00:21:15:00
on a contract basis with us.
00:21:15:00 - 00:21:17:15
And that allows us to just use
00:21:17:15 - 00:21:20:17
the expertize that we need when we need it
00:21:20:17 - 00:21:23:05
and not carry a huge overhead
00:21:23:05 - 00:21:28:08
allows us to be flexible and nimble to make changes.
00:21:28:08 - 00:21:29:15
And then, of course,
00:21:29:15 - 00:21:30:23
having an outsourced development
00:21:30:23 - 00:21:34:01
partner gives us incredible flexibility
00:21:34:01 - 00:21:37:17
and access to resources that we could never afford to
00:21:37:17 - 00:21:39:00
have on staff.
00:21:39:00 - 00:21:40:08
So keep it lean.
00:21:40:08 - 00:21:41:18
It sounds like.
00:21:41:18 - 00:21:44:08
As lean as you can for as long as you can.
00:21:44:08 - 00:21:45:13
Until you get to the point
00:21:45:13 - 00:21:49:09
where you're out there really generating the revenues
00:21:49:09 - 00:21:51:05
and you want to create scale
00:21:51:05 - 00:21:53:08
and you want to create more control.
00:21:53:08 - 00:21:56:07
But when you're in that earlier stage,
00:21:56:07 - 00:21:58:15
until you get to a growth stage,
00:21:58:15 - 00:22:01:14
it's better to be as lean as possible
00:22:01:14 - 00:22:04:20
and to get all the resources channeled into what
00:22:04:20 - 00:22:07:00
drives the most value.
00:22:07:00 - 00:22:08:20
And that’s hitting product
00:22:08:20 - 00:22:12:03
development milestones, it's hitting regulatory
00:22:12:03 - 00:22:14:17
milestones, and most importantly,
00:22:14:17 - 00:22:17:18
it's generating high quality evidence
00:22:17:18 - 00:22:19:21
for everything that you'll need down the line.
00:22:19:21 - 00:22:20:15
Got it.
00:22:20:15 - 00:22:22:03
So I think we're ready for
00:22:22:03 - 00:22:23:12
for the lightning round.
00:22:23:12 - 00:22:27:10
But this time, the lightning round is
00:22:27:10 - 00:22:31:10
is framed for startup medical device companies
00:22:31:10 - 00:22:34:07
embarking on in-home clinical trials.
00:22:34:07 - 00:22:36:18
Let's keep that lens on on this lightning round.
00:22:37:11 - 00:22:38:02
So, Steve,
00:22:38:02 - 00:22:39:08
what advice would you have
00:22:39:08 - 00:22:41:02
for another startup CEO
00:22:41:02 - 00:22:43:22
who's looking to run an in-home clinical trial?
00:22:43:22 - 00:22:46:20
I would say go out to the market
00:22:46:20 - 00:22:50:00
and find these emerging companies
00:22:50:00 - 00:22:53:23
that are using a convergence of new technology
00:22:53:23 - 00:22:56:03
to operate in the at home world.
00:22:56:03 - 00:22:59:18
It's completely different than the old traditional
00:22:59:18 - 00:23:01:23
on-premise studies.
00:23:01:23 - 00:23:04:19
And you really have got to break the mold and go
00:23:04:19 - 00:23:07:01
with a whole new set of people and partners.
00:23:07:01 - 00:23:10:13
Which partners, if you don't mind my asking,
00:23:10:13 - 00:23:11:20
if you don't want to answer that, that's fine.
00:23:11:20 - 00:23:13:19
I'm just you know, we're
00:23:13:19 - 00:23:15:03
we're a media company here, Steve.
00:23:15:03 - 00:23:17:15
So we're looking to create good content.
00:23:17:15 - 00:23:19:10
Controversy
00:23:20:09 - 00:23:21:19
we're in RFP process.
00:23:21:19 - 00:23:22:15
There are a number of.
00:23:22:15 - 00:23:23:15
Okay, all right.
00:23:23:15 - 00:23:26:00
Yeah, yeah. Okay.
00:23:26:00 - 00:23:28:20
You can go for an all in one or you can
00:23:28:20 - 00:23:32:00
look for a clinical trial recruitment company.
00:23:32:00 - 00:23:36:00
You can look for an ABC company, you can look for
00:23:36:00 - 00:23:37:08
a CRO,
00:23:38:16 - 00:23:41:17
you can you know, rent a PI.
00:23:41:17 - 00:23:44:06
You can go to there are,
00:23:44:06 - 00:23:47:14
professional research, private institutions
00:23:47:14 - 00:23:50:22
that work with these vendors,
00:23:50:22 - 00:23:53:07
but they provide the clinical oversight.
00:23:54:11 - 00:23:55:23
You don't have to own any of that.
00:23:55:23 - 00:23:57:04
You can go out and use that.
00:23:57:04 - 00:23:58:22
And I would say
00:23:59:20 - 00:24:03:19
don't get hung up with using an academic center.
00:24:03:19 - 00:24:05:22
Despite the appeal,
00:24:05:22 - 00:24:09:14
the patina of the thought leader that's there,
00:24:11:02 - 00:24:14:20
it's all about the quality of the evidence
00:24:14:20 - 00:24:16:22
and not the name on the paper.
00:24:16:22 - 00:24:18:03
That's a great soundbite.
00:24:18:03 - 00:24:20:09
Yeah. We might have to turn that into a t-shirt.
00:24:20:09 - 00:24:21:16
Steve
00:24:23:17 - 00:24:28:01
We have not talked about product development,
00:24:28:01 - 00:24:29:01
Mainly just because it's
00:24:29:01 - 00:24:30:13
Key Tech doing the development.
00:24:30:13 - 00:24:33:23
But I guess Steve, as a CEO
00:24:33:23 - 00:24:36:00
of a startup company, going into
00:24:36:00 - 00:24:38:02
an at-home clinical trial,
00:24:41:22 - 00:24:45:14
What advice do you have for other startup CEOs
00:24:45:14 - 00:24:50:16
as it relates to selecting product development
00:24:50:16 - 00:24:53:16
teams, whether it's an internal and external team
00:24:53:16 - 00:24:56:20
and getting the right device in that trial?
00:24:56:20 - 00:24:58:15
Yeah, that's a great question.
00:24:58:15 - 00:25:00:18
I think that
00:25:02:07 - 00:25:04:03
having capability
00:25:04:03 - 00:25:07:10
in the requirements phase
00:25:08:16 - 00:25:12:08
having an understanding of the regulations
00:25:12:08 - 00:25:16:04
that will apply that are very different early on,
00:25:17:17 - 00:25:20:06
that's important because you're not likely
00:25:20:06 - 00:25:25:22
to have any clue what those ATOMS standards are.
00:25:25:22 - 00:25:28:07
You're not going to have a clue in terms
00:25:28:07 - 00:25:31:03
of the usability requirements
00:25:31:03 - 00:25:33:11
and all the things that an outsourced
00:25:33:11 - 00:25:35:14
firm has seen over the years
00:25:35:14 - 00:25:39:10
and years and years of what can go wrong.
00:25:39:10 - 00:25:40:18
They've seen it.
00:25:40:18 - 00:25:44:19
So it's it's very important,
00:25:44:19 - 00:25:47:20
I think, to leverage that
00:25:51:12 - 00:25:54:17
The other thing I would say is
00:25:55:21 - 00:25:56:22
understanding what
00:25:56:22 - 00:26:00:00
the product development firm is good at
00:26:00:00 - 00:26:03:22
and where they want to or should hand it off
00:26:03:22 - 00:26:06:12
to a contract manufacturer.
00:26:06:12 - 00:26:08:03
And a lot of that's about,
00:26:08:03 - 00:26:10:17
costs and efficiency,
00:26:10:17 - 00:26:11:11
which are important.
00:26:11:11 - 00:26:14:23
Like every dollar counts if you're in a startup phase,
00:26:14:23 - 00:26:17:10
So you're going to take MiHelper to trials.
00:26:17:10 - 00:26:19:19
Let's say that the data looks great,
00:26:19:19 - 00:26:23:15
everything goes well next step is commercialization.
00:26:23:15 - 00:26:26:09
What things have you done to set yourself up
00:26:26:23 - 00:26:28:03
to bridge that gap
00:26:28:03 - 00:26:30:14
from the trial devices to the commercial devices?
00:26:30:14 - 00:26:31:12
Well, aside
00:26:31:12 - 00:26:34:06
from doing a lot of research, we haven't done anything
00:26:35:13 - 00:26:38:03
and nor should we,
00:26:38:03 - 00:26:41:00
because there's going to be ample time in order
00:26:41:00 - 00:26:42:08
to ramp that up.
00:26:43:11 - 00:26:45:08
Understanding the market,
00:26:45:08 - 00:26:48:06
understanding the pricing and business models
00:26:49:01 - 00:26:51:10
there's a lot, at when you get to at-home
00:26:51:10 - 00:26:54:22
and direct to consumer marketing, it's very different,
00:26:56:01 - 00:26:58:05
including the reimbursement models
00:26:58:05 - 00:26:59:22
so you may have a device
00:26:59:22 - 00:27:02:10
which ends up on a drug formulary
00:27:02:10 - 00:27:05:21
and as part of a PBM,
00:27:05:21 - 00:27:09:07
that's very different because it's like a dose.
00:27:09:07 - 00:27:12:04
And you might want to set up your device
00:27:12:04 - 00:27:16:23
to be a per use device under software controls
00:27:16:23 - 00:27:18:06
and not necessarily
00:27:18:06 - 00:27:22:03
physical controls of the old razor razorblade model.
00:27:22:03 - 00:27:23:10
So you don't necessarily
00:27:23:10 - 00:27:25:12
sometimes you want a disposable,
00:27:25:12 - 00:27:27:13
well, maybe you don't
00:27:27:13 - 00:27:30:02
because you can do it a different way in an at-home
00:27:30:02 - 00:27:34:01
setting under a formulary reimbursement model.
00:27:34:01 - 00:27:37:04
So it's thinking through all of that stuff.
00:27:37:04 - 00:27:39:01
But not spending a lot of money
00:27:39:01 - 00:27:42:09
until you have the evidence,
00:27:42:09 - 00:27:44:21
you're farther down the regulatory pathway
00:27:44:21 - 00:27:47:05
it's better to keep your powder dry.
00:27:47:05 - 00:27:48:22
Would you advise
00:27:48:22 - 00:27:50:11
for startup companies
00:27:50:11 - 00:27:53:22
that are ultimately going to be an in-home product to
00:27:53:22 - 00:27:55:10
to do what you're doing,
00:27:55:10 - 00:27:59:05
which is trying to kind of like,
00:27:59:05 - 00:28:02:12
a smaller study with a modified
00:28:02:12 - 00:28:04:08
maybe existing product
00:28:04:08 - 00:28:06:18
to get to get the data for confidence?
00:28:06:18 - 00:28:08:15
Or do you think in certain situations
00:28:08:15 - 00:28:11:17
it makes sense just to try to develop the actual
00:28:11:17 - 00:28:13:00
get close to the commercial product
00:28:13:00 - 00:28:15:00
and just go right to in-home trials?
00:28:15:00 - 00:28:20:01
So if you're going to have an at-home product,
00:28:20:01 - 00:28:22:09
the sooner you can get it into the at-home study,
00:28:22:09 - 00:28:23:13
the better.
00:28:24:15 - 00:28:26:12
It takes awhile to develop
00:28:26:12 - 00:28:29:02
the device that lets you get there.
00:28:29:02 - 00:28:31:20
So you might want to be doing some in-clinic work
00:28:31:20 - 00:28:33:13
along the way.
00:28:33:13 - 00:28:37:08
And it depends on the nature of the product,
00:28:37:08 - 00:28:40:23
whether it's a device or therapeutic,
00:28:40:23 - 00:28:42:16
if it's a therapeutic
00:28:42:16 - 00:28:46:10
and you don't know exactly the mechanism of action,
00:28:46:10 - 00:28:49:02
you just have a theory on it, which is
00:28:49:02 - 00:28:51:11
pretty much it's most
00:28:52:10 - 00:28:54:11
therapeutic medical devices.
00:28:54:11 - 00:28:58:17
Then you've really got to think of the outcomes study
00:28:58:17 - 00:29:01:20
and you should try to iterate
00:29:01:20 - 00:29:05:17
through dose escalation studies.
00:29:05:17 - 00:29:10:03
Do adaptive trial designs, smaller studies
00:29:10:03 - 00:29:13:08
to gain different foundations of understanding
00:29:13:08 - 00:29:16:07
before you jump into a big pivotal study.
00:29:16:07 - 00:29:18:20
So even when we go to the Adams study,
00:29:18:20 - 00:29:21:06
we plan to do
00:29:21:06 - 00:29:24:17
some more dose ranging work at-home
00:29:24:17 - 00:29:27:17
to confirm where we want to run our pivotal study.
00:29:27:17 - 00:29:29:14
All right, Steve,
00:29:29:14 - 00:29:33:12
thanks for sitting in today for two episodes.
00:29:33:12 - 00:29:36:08
Episode two here, focusing on the MiHelper.
00:29:36:08 - 00:29:38:20
Jake, thanks for being such a great co-host
00:29:38:20 - 00:29:40:06
and everybody that concludes
00:29:40:06 - 00:29:42:20
episode two of Speed to Data here at Key Tech.
00:29:42:20 - 00:29:43:15
Thank you.