STEWARTVILLE -- Automated machines quietly raise and lower trays of liquid silicone, water and a paraffin-like material in a Stewartville facility to create a new solution to an age-old medical condition that afflicts an estimated 2 percent of the world’s population.
Multiple, carefully monitored dips create trays of 400 silicone inserts with a small bubble of liquid in four minutes. The inserts then move on to packaging to eventually be shipped to Minnesota Medical Technologies' waiting customers in a growing number of countries.
Designed by and created by a local team led by brothers Jim and Philip Conway, the patented myMiracle device is a small, lubricated anal insert to be used as a simple and discreet way to treat fecal incontinence. The design allows the one-time use device to comfortably conform to a patient’s body to create a double seal to prevent leakage.
While fecal incontinence is a condition that few people want to think or talk about, it is a common one that is a primary reason for seniors moving from living independently to being cared for in a nursing home.
In the few months since European medical centers started using myMiracle, Jim Conway said that appreciation letters from patients have started arriving in Stewartville with people thanking Minnesota Medical for giving them a way to return to activities like horseback riding and dancing.
“If you have the issue, it's a really big deal,” said Philip Conway of the inserts.
Building a Stewartville facility to manufacture medical devices is familiar ground for the Conway brothers and their core team of Sarah Grinde, Lonnie Boe and David Jonas.
They created Rochester Medical, a silicone catheter maker which grew into one of Stewartville’s top employers with more than $60 million in annual sales. About 60 percent of those sales were in Europe. In 2013, the Conways sold it to industry rival C.R. Bard for $262 million. Bard closed the plant in 2016.
While they signed a non-compete agreement to not make urinary incontinence products, the Conways didn’t want to stop making things in Stewartville. After a couple years of research and design, plus the help of Mayo Clinic doctors, they came up with Minnesota Medical Technologies and the myMiracle insert.
Between the brothers, Jim’s primary role is product design, while Philip is the manufacturing expert.
“The joke is that Jim comes out and hands me one product and says, ‘Now make a million,’” said Philip Conway.
Jonas says each brother has a very unique mind that works differently from the other's and compared to the average person. Overall, the whole team is involved in the design process from the beginning, which the Conways say creates a smoother road from idea to product.
Philip Conway designed a 6,500-square-foot manufacturing facility in Stewartville’s Schumann Business Park. While the plant made “only” about 200,000 inserts in its first year with about 15 employees, the company is prepared to ramp up to produce 6 million devices a year for its next anticipated phase in a year or two.
Minnesota Medical is approved to sell its inserts in Europe and has a major contract with Sweden-based medical distributor Wellspect Healthcare.
The U.S. Food and Drug Administration has not yet considered myMiracle for use in the U.S. Regulators are awaiting the results of a clinical study being conducted by Dr. Adil Bharucha at Mayo Clinic. Dr. Bharucha is listed on the device's patent as an inventor with the Conways and Grinde.
The clinical trial process, like the standard sales in Europe, has been greatly slowed by the COVID-19 pandemic. During much of the pandemic, Mayo Clinic has conducted the clinical trial remotely to keep participants from needing to come to the hospital.
Looking to the future, Jonas and the Conways are optimistic that Minnesota Medical could grow much quicker and much larger than Rochester Medical. Unlike Rochester Medical, Minnesota Medical has very few competitors for patients in the fecal incontinence market.
"We are primarily competing with diapers and they can't do what our product does," said Philip Conway.
Roughly 2 percent of the U.S. is 6.5 million people. Minnesota Medical will have a very bright future if 100,000 of those people use its product.
“This has the potential to be much bigger than Rochester Medical,” said Jonas.