Revolutionizing Women's Health with Precision Medical Devices

Millions of women face the same health problem. The solution? Millions of custom medical devices.
 

There’s a women’s health problem so large that adult diapers now account for more landfill space than baby diapers. Cosm Medical is addressing it with a world’s first.

Derek Sham’s groundbreaking healthcare company was born from a panicked phone call he took while stuck in a boardroom. After screening several calls, Derek realized it was serious.

“My mom called me from my Grandma's house and said, ‘she's lying in the bathroom in pain,’” says Derek. His mother described grandma’s medical issue (in lurid detail) for Derek, who just happened to be the general manager of a urological products company. Derek immediately recognized the issue: Grandma was suffering from a pelvic organ prolapse, a common but non-life threatening problem.

Derek’s grandmother was referred to physicians who recommended surgery to correct the issue or to start using a pessary, an off-the-shelf prosthetic insert to support her pelvic floor. Grandma cited risks associated with her age and refused the surgery. Then, multiple doctors attempted to fit her with a pessary but she failed the fittings. And due to complications, she developed urosepsis, a life-threatening condition which required multiple emergency surgeries to address.

“Within a year, my grandma went from the lady who cooked Christmas dinner for over 20 of us to somebody who couldn't walk,” says Derek. “This would have been preventable if pessaries had made any real advancements in the last 50 years.”

She’s hardly alone. According to UCLA Health, over 50% of women will experience a pelvic floor disorder such as pelvic organ prolapse or incontinence in their lifetime. It’s associated with age, childbirth, physical activity, and other health factors such as smoking and obesity. The unmet need is quantifiably massive. Yet many female pelvic floor therapies, including devices and surgeries, can be uncomfortable, expensive, or risky.

The pessary is one of the oldest documented medical devices, dating back over 2,000 years to ancient Egyptians. This humble device has evolved and changed over time but has seen little innovation since the advent of medical silicone 50 years ago.

Typically, women with this issue will see a doctor or physical therapist for an exam. The medical professional estimates the ideal pessary type and size for the patient and performs a test. “A woman will walk around for a few minutes, do a jump, and cough to see if the pessary is comfortable and stays in place,” says Derek. “If not, it’s trial and error with other pessaries until they determine the best fit. It’s a clinical art.”

It can also be imprecise. Up to 30% of women fail the fitting process, about half will stop using the pessary within a year, and over 50% encounter complications from long term use. Derek saw the opportunity to advance the entire system by creating a platform for precision care and personalized pessaries with millions of fit options rather than about 100.

Cosm was born. The company began with its core expertise in the physiological measurement and biomechanics of the pelvic floor and surrounding organs. Still, Cosm lacked the advanced manufacturing expertise to execute on its vision and plans.

In 2021, NGen stepped in to fund a pilot program with Cosm to test a custom pessary product. NGen quickly recognized that the medical manufacturing solution needed the intersection of three different technologies. For increased precision, Cosm would need AI to replace some of the clinical art of diagnostics and measurement; to streamline workflows, Cosm would need software; and, to fabricate the precise, made-to-measure device, Cosm would need advanced 3D printing at scale. NGen helped facilitate collaboration with Cosm and category leaders in those technologies.