Ep11 - Designing In-Home Clinical Trials - Key Tech POV

MedTech Speed to Data

Clinical and in-home trials are different, but the essentials are the same –solid data, foresight, and flexibility.

Clinical trials are understandably rigorous, but in-home trials add a few wild cards into the mix. Andy and Jake spoke with Steve Schaefer, CEO of CoolTech, about this exact topic in the previous episode.

Here, Andy and Jake dig into in-home trial design and execution from a product development perspective.

Need to know:

• Approach trials with confidence in your device, backed up by data
• Know your user: clinical users are different from home users
• Evaluate the device against all applicable standards, and verify, verify verify.
• Stay lean, stay simple

The nitty-gritty
By now, it’s pretty clear that the future growth of med-tech points towards in-home testing and therapy. But you have to jump through more hoops from prototype to commercialization for in-home devices. As the Boy Scout motto says, “Be prepared.”

Plan for change. Start with a change control process in place so that you don’t make changes that could negatively affect performance down the road. Evaluate your device against all applicable standards at appropriate milestones.

Know your user. Clinical users are different from your home user, and each will need different training to use and evaluate the device correctly.

Keep it simple. A clinical device may not need all the bells and whistles of a commercial device, so keep it as simple as you can. With in-home trials, you don’t have trained clinicians and engineers on hand to monitor the process, so once again, make it simple for users to get it right the first time. For example, with the MiHelper in-home trials, CoolTech used disposable tubes and masks to simplify use and facilitate the trials; commercial products will be multiple use.

To get from trial to commercial success, you need to:

• Connect the dots. Make sure your core parameters match
• Lock down the software
• Review features and edit if needed
• Perform a gap analysis
• Understand impact of all changes
• Trace data back to clinical device

There are more details and more insight in the podcast. Check it out.