Sword Health | Bloom Pod
Medical device (Class II exempt) developed under ISO13485. Bluetooth-connected 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 and led the hardware team including hardware, software, quality, and manufacturing functions. From napkin concepts to fully-approved market launch in ~18 months.
Fortunate to work closely with a team of dedicated physical therapists specialized in treating pelvic conditions. They were instrumental in guiding the development device geometries, materials and user interactions. Their feedback throughout development enabled 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 worked with a silicone processing specialist to develop and refine a specialized manufacturing process for this device. Our QARA team worked closely with the CM to ensure regulatory compliance throughout.
A product's potential is unlocked by design, but its success is defined by its quality. All in-line and automated 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.