CoolTech Part 2: Get through trials faster, with fewer tribulations.

Here, 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.

MiHelper is a drug-free way to treat migraines, cooling the patient with air. The design for the device was piggy-backed (pun intended, as they used a porcine animal model for the original device) onto an existing cooling platform –CoolStat– used for a totally different type of therapy. Even though the platform itself was proven, MiHelper still had to go through the twists and turns of trials because it was a de novo device in this application.

Need to know:

• Understand the commercial product requirements before you start
• To get from clinical trials to home trials as quickly as possible, develop platforms concurrently
• Drive value every step of the way
• Essentials to bridge the gap from trial to commercialization: market, pricing, and reimbursement models

The nitty-gritty:

Oxygen therapy has been used to treat migraines in the past, but devices were too bulky and complex for at-home use, until a prototype study at Johns Hopkins indicated that room temperature air could do the job. When CoolTech worked with their engineering partner to adapt their existing CoolStat evaporative cooling platform, the objective data panned out, and patients reported relief from migraines using the device. So MiHelper was born. That was the easy part, relatively speaking.

The thorny path is the road to clinical trials, in-home trials, regulatory approval and ultimately, commercialization. For clinical trials in this case, a subject had to develop a migraine, travel to the hospital, receive the therapy, and then report about relief – a lag time of several hours.

At-home trials require an additional level of device confidence, which is being achieved through design verification, biocompatibility testing, and electrical safety & EMC testing. There are more wild cards, starting with shipping the device to test subjects. (CoolTech found a contract manufacturer who could drop-ship and re-process them). Recruiting test subjects was done through social media, and because the data is digital, the study center doesn’t have to be local, allowing for larger sample sizes. Data tracking and security is another big issue that CoolTech solved with a one-way app.

To speed the whole process along, CoolTech developed the trial device and in-home platforms concurrently. To support at-home trials, CoolTech is using a “small-but-mighty” team of in-house people and contractors, which allows for flexibility and quick response. This way, they can channel resources into generating high-quality evidence and driving value.

The MiHelper trials have yielded a couple of valuable tips for any start-ups going into home trials.

1. Try to partner up with emerging companies using convergent technologies.

2. Partners could range from privately funded research to oversight by a clinic, or anything in between.

2. When evaluating data, it’s the quality of the evidence, not the name on the paper, that counts.

The market for in-home therapy is growing by leaps and bounds. And the profit potential is huge. But get your ducks in a row before you jump into the pond. That way, the path from drawing board to commercialization will be smoother and more straightforward.

There’s more. The whole story is right here, and well worth a listen.

HELPFUL LINKS:

https://www.cooltechcorp.com/

https://www.nih.gov/