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Ep8 - Matching early animal model data to market needs - Steve Schaefer of CoolTech
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How to get from “data” to “device”: one cool story.
What data you need, where you get it – and most importantly – what you do with it, all determine whether a medical device will be successful. Of course, every technology has its own set of caveats, but it always helps to hear from people who have been there.
In this episode, VP of Business Development Andy Rogers, and Senior Electrical Engineer/Partner Jake Cowperthwaite, both of Key Tech, talk with Steve Schaefer, CEO at CoolTech, about the quest for data with CoolStat: a new way to manage patient temperature in fever that can develop following a stroke, traumatic brain injury, seizure, or metabolic encephalopathy.
There are other technologies that manage patient temperature, but CoolTech partnered with a engineering team to build a way build a better mousetrap. CoolStat generates filtered air that’s delivered to the patient via a nasal mask air tubing set. It cools through evaporative cooling, using room temperature air. CoolStat is smaller and lighter than existing devices; it reduces side effects like shivering which can lead to complications – and shortens treatment time.
Need to know:
● Understand the commercial product requirements before you start
● Your regulatory path depends on your specific device
● Go where the data leads
The nitty-gritty:
The initial data that drove CoolStat’s development was collected from tests on pigs, who have similar physiology to humans. In this case, because they were seeking objective data – rate of cooling, rate of air flow and efficiency of cooling – CoolTech was able to save time by using existing temperature probes and storage software.
The first results were okay, but less than optimal. For many companies, this can be a go/no-go point, where you decide to fish or cut bait. CoolTech opted to pause the study, make changes, and go back to the FDA with an improved device.
Finding human subjects for testing was another challenge. Patients are typically unconscious in the ICU, so getting family consent is laborious, especially during the COVID pandemic. Patient data is recorded on CRF’s and validated within 24 hrs. so engineers can quickly make changes based on this real-world info.
CoolTech found that partnering with outside resources, such as the National Institutes for Health (NIH) university hospitals, and end-user associations can help to expedite development. Clinical studies will be completed soon. Now the critical numbers for CoolStat are the savings that hospitals can reap using this exciting new technology.
Listen in for more data. And more details.
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