Four Specialties, Two Continents: Blinded, In-Person Testing of an Expandable Sheath Concept
Large-bore access is a problem in both aortic and structural heart procedures, so the sample had to cover both.
A manufacturer sought reactions to an expandable sheath concept, as well as physicians' experiences with large-profile devices and existing expandable sheaths.
Because large-bore access matters in both aortic and structural heart procedures, the recruit spanned four specialties, each with its own procedure threshold:
Vascular surgeons: more than 10 TEVAR procedures a year
Cardiothoracic surgeons: more than 10 TEVAR procedures a year
Interventional radiologists: more than 10 TEVAR procedures a year
Interventional cardiologists: more than 25 TAVR/TAVI procedures a year
All physicians had more than two and fewer than 30 years post-fellowship.
Interviews lasted about 75 minutes and were held in person at US Congress, then at research facilities in Munich and London.
Recruitment was blinded. The sponsor was not revealed until the concept was shown, so early discussion of current devices and pain points stayed unbiased.
The final sample was 29 physicians: 19 vascular surgeons, four cardiothoracic surgeons, four interventional cardiologists and two interventional radiologists.
A congress plus two European facilities delivered a spread across three markets within a few months.
The longer format allowed detailed feedback on features, value propositions and seven project hypotheses.
