Sword Health | Bloom Pod
Medical device (Class II exempt) developed under ISO13485. Bluetooth intravaginal sensor detects pelvic floor muscle contractions and delivered real-time feedback during remote physical therapy sessions. Clinical-grade, asynchronous care delivery at home greatly expanded treatment access, while preserving the dignity and privacy of each patient.
Built the entire hardware team responsible for this design over the course of development, including hardware, software, quality, and manufacturing functions. From napkin concepts to fully-approved market launch in ~18 months.
Our engineers were fortunate to work closely team of dedicated physical therapists dedicated to treating pelvic conditions. They were instrumental in guiding the development device geometries, materials and user interactions, often testing pre-production devices to allow us to iterate quickly.
Early prototype built in-house to validate mechanical concepts and in-house. End-to-end development involved 9 separate pre-production builds with overseas teams.
In addition to normal engineering development product validation, many pre-production units were devoted to clinical trials and 3rd-party regulatory testing.
Led a challenging CM selection process. Because of the unique requirements of this device, we settled on a silicone processing specialist. We worked with their Quality team to bring them up to medical device standards.
All in-line and inspection QC tools used in production were developed by Sword engineering in conformance with internal standards under ISO13485.
Proud to have played a small role in expanding pelvic health treatment access to over 100k new patiences every year.