Q&A: Helping start-ups address gaps in women's healthcare

Med-Tech Innovation News spoke to Derek Sham, founder and CEO of medical device company Cosm, about how he’s using technology to make women’s healthcare more equitable, and treatments for uterine prolapse.

First of all, tell us about Cosm and what made you start the company?

I founded Cosm after watching my grandmother go through a severe prolapse from a pelvic floor disorder (PFD). Watching my grandmother undergo treatment for her prolapse inspired me to create a better treatment solution that would help my grandmother and the 50% of women over 80 who suffer from PFDs. Using my experience in the medical device industry, I founded Cosm to provide patient-specific pessaries for those with pelvic floor disorders. As opposed to the standard sizing and trial-and-error fit method for traditional pessaries, Cosm makes a personalised pessary based on the unique anatomy and lifestyle needs of the patient. 

What options are there for treating uterine prolapse?

There are two main options for treating uterine prolapse. The first is with surgery; however, surgery is costly and often doesn’t yield permanent results. The more common treatment is the use of a pessary, a device inserted into the vagina to reduce prolapse and support pelvic tissues and organs or compress the urethra to stop urinary incontinence. Typically, the methods doctors use to fit patients for pessaries is an invasive trial-and-error process. With what’s currently available, one in three women fail pessary fittings, 50% will stop using their pessary in one year, 56% will develop complications with long term use such as bleeding, tissue abrasion, infections, and chronic pain. Although pessaries are one of the oldest documented medical devices, dating back to Egyptians in 1850 BCE, they have remained largely unchanged for the past 50 years since the introduction of medical-grade silicone. 

What goes into the development of a custom pessary? You use ultrasound, AI and 3D printing, give us a brief overview as to how these go into developing the finished product.

Cosm uses artificial intelligence (AI) and additive manufacturing to create custom pessaries we call Gynethotics. These gynaecological prosthetics are made-to-order and work to lower risks and enhance care for patients with pelvic floor disorders by increasing fitting success, increasing patient compliance and lowering complications rates Our proprietary technique includes scanning and moulding a patient’s pelvic floor and vaginal cavity using ultrasound, leveraging machine learning and AI to analyse the ultrasound images and extracting measurements to design a 3D-printed custom pessary for the patient. The patient’s measurements go into a parametric 3D CAD modelling software with eight to 12 measurements - including vaginal length, width, and curvature, as well as a patient’s treatment goals and activity level - to create a customised prosthetic design. Then Cosm uses a Formlabs Form 3B printer to print the design. Formlabs’ price point and user-friendly interface enable Cosm to deliver a customised prosthetic at scale for every patient.

Cosm discovered Formlabs after learning how their printers were used to make custom silicone ear moulds, where silicone is injected into a one-part cocoon mould. The Cosm team saw similarities in the custom ear moulds and their vision for custom pessaries. Embarking on silicone moulding was a challenge initially, but Cosm was able to achieve it easily with the Form 3B’s high surface quality and remote assistance and have clinical study investigational approvals for the devices.

Tell us about the manufacturing process… you’ve used 3D printing but what made you choose this particular route?

Mass customisation at scale is only possible with a 3D printer. When we discovered Formlabs, we knew they were the right solution to enable our vision of creating personalised pessaries. By using Formlabs printers for our manufacturing process, we can print a new mould for each patient's specific needs and anatomy. The Form 3B offers excellent prints, a surface quality requiring minimal post-processing, and a tolerance so tight that the discrepancies from CAD to the model are negligible. In-house production also enables flexibility for design and prototyping, which enables the team at Cosm to provide the highest quality products for our customers.

What trends do you see in this current market segment?

Cosm is within the larger emerging market of femtech - innovations that improve women’s health and wellness. It is a burgeoning industry driven by increasing consumer awareness about women's health, advancements of smart medical devices and the rising demand for digital health solutions. The women’s health market size is estimated to reach $1.19 trillion by 2027 globally. We plan on leveraging this growth alongside the growth of personalised medicine and age-tech, which are expected to become trillion dollar industries by 2025.

Anything else you would like to add? 

Every woman is different and pelvic floor disorders are common, growing, stigmatised, and underserved.

By replacing trial-and-error pessaries with the world’s first, data-driven personalised gynaecological devices, we will improve women’s pelvic health globally and the lives of 1,000,000 women by 2030.