One of the reasons that supported the formation of Bongiovi Medical was that there was no known company focused on the advancement of using acoustic data in medicine. The field was wide open. As the company was formed, it was also discovered that a lot of research procedures and techniques that exist in other areas had not been developed for medical acoustics. For example, how does one make high-quality, digital recordings of biological sounds effectively and efficiently in a clinical setting?
The Bongiovi Medical team, using off-the-shelf commercial hardware and software, along with some internally developed hardware and software, quickly developed a system to record biological sounds, but it needed to be validated and verified in a clinical environment. At the same time, Bongiovi Medical was examining what opportunities might be available in the $50B+ annually US veterinarian medicine market. With these to convergent events, and the regulatory and cost advantages of animal vs human studies, the Small Animal Study was born.
Bongiovi Medical teamed with Brighton Animal Clinic, a small animal clinic in Lexington, KY. As stated, “The purpose of this phase is to perfect our techniques in making high quality digital recordings of heart and lung sounds.” To ensure that we learned as much as possible, we conducted the study under the standards that would be required for a human study, (from consenting the subject (owners) to anonymizing the data, to data security and HIPAA requirements). The study concluded after four months and over 50 subjects.
While we were unable to make any significant or publishable findings with the recordings, we were able to perfect our processes. We learned numerous lessons on the difficulty of conducting a study while conducting clinical services. We were able to make major improvements to our processes and procedures during the study and validate those improvements. The lessons learned have been invaluable to BMHT. These processes and procedures have become the cornerstones for our VASTS and CARDS studies. Bongiovi Medical now possesses this unique know-how.