My work with gynecologists, nurse practitioners, physical therapists, other healthcare providers and their patients since 2002 in the treatment of female urinary stress and mixed incontinence made me keenly aware of how urinary incontinence reduces the quality of patients’ lives. Despite the high efficacy of the pelvic floor exercise device we rented to them, patients with mild dementia could not remember the protocol, those with MS and paraplegia could not contract their pelvic floor muscles (PFM) and younger women busy with work and family responsibilities did not have the time to exercise. Cheri Grantham, an experienced medical assistant, and I began developing a medical device which blocks unwanted urine leaks and does not require exercise or the cooperation of the patient. I bring to this task over fifty one years of medical device experience, both in academia, private industry and consulting. I have the leadership and technical skills, industry contacts and FDA experience to take this device all the way into the market so that we can greatly improve the quality of life of not just incontinent women, but of their caregivers and families, as well as saving third party payers such as Medicare a significant sum now paid to institutionalize some of these patients due to their incontinence, as well as funds paid for surgery and absorbent products. In previous positions I designed and ran local and international clinical trials of medical devices that diagnosed or treated eye diseases and skin conditions. Our team is currently navigating the difficulties COVID-19 has created for running a clinical study, both indirectly by keeping subjects home and directly by infecting one of our team members.
