The debate over DTx product definitions has been ongoing since their arrival on the market less than a decade ago. In brief, DTx products use algorithms instead of molecules to deliver clinically-validated therapeutic effects. Robust evidence and regulation are the main ingredients. What makes this conversation even more interesting is that many roads can lead to the same ambiguous destination.
For what it's worth, I think that starting with a use case is far better than a definition (ive been a member of DTA, participated in AMCPs forums, etc etc) and I am convinced that what we have here is a positioning issue not a definitional one. If we have clarity around setting / site of care, stage of disease (1st line, second line intervention etc) it will help resolve a lot of the confusion. As part of this, saying something like "you can try X instead of Y" makes a clear case for subsitition. Many DTx products can be tried prior to starting a pharmacological approach for example.
For what it's worth, I think that starting with a use case is far better than a definition (ive been a member of DTA, participated in AMCPs forums, etc etc) and I am convinced that what we have here is a positioning issue not a definitional one. If we have clarity around setting / site of care, stage of disease (1st line, second line intervention etc) it will help resolve a lot of the confusion. As part of this, saying something like "you can try X instead of Y" makes a clear case for subsitition. Many DTx products can be tried prior to starting a pharmacological approach for example.