You have a promising new medical technology at hand and the means to build it. But how do you prove it works?

This is a frequent problem. Everyone instantly thinks "large randomized clinical trial" but that really should be the last step - if it is needed at all. Before that happens you need to show safety and effectiveness at various levels, gather information about when your technology will work and when not, identify how it will fit into clinical care, and many other data points you will need for regulatory submissions, or marketing, or to raise more money.

I can help you figure out what you need at the stage you're in and then work with you to develop the research strategy you need. And if a large randomized clinical trial is part of that, we will get there - together.

You have spent a long time on developing your technology and now are the leading experts on it. You may ask yourself why you would want to ask someone for research advice who likely knows much less about your technology than you do.

It is exactly that closeness that makes it harder to see what your needs might be. I have listened to many pitches for promising technologies where the developers had spent a lot of time and effort generating data they believed to be convincing and relevant. In some cases that was an accurate assessment. In many cases, it was not.

I believe the term “thinking outside the box” is overused. But I also believe that looking at “the box” from the outside can bring clarity that is hard to achieve from within. If you have worked on a technology for an extended time, you are in that box. My goal is to help you take a look from the outside and then map a path forward based on that insight.

You are looking at a technology that someone else has developed. It looks promising and comes with its own research.

If you don't have the experience (or the time) to do the diligence on those research results, I can help you with the interpretation of the research and with identifying any open questions that are left. I can also make recommendations for additional work that may be needed before the new technology makes it to the patient.