Startup combats mask dilemma behavioral institutions face

Some local mental health care workers are experiencing a mask shortage, though not in the way you might think.

Karena Nielsen, Kallie Penchansky and Kathleen “Kathy” Romero work at a live-in mental health care facility in the Treasure Valley, and when COVID-19 concerns ramped up, masks becoming required, the three women quickly realized almost all of the traditional masks worn by themselves and the patients were unacceptable, because they were dangerous.

Nielsen, a clinical social worker, holds up a typical surgical mask and, in seconds, shows the ease of pulling the ear loop elastics out and turning them into a ligature apparatus. The metal nose could be used for cutting oneself or others.

Essentially, standard surgical masks cannot be used in the in-patient psychiatric units without increased staffing and observation levels. This is cost prohibitive to the facility. Closing the facility to new patients, if an outbreak should occur, and testing of units could also prove costly.

These concerns, Nielsen said, are also applicable to jails and prisons, and other places where people live communally. Patients come to the facility either by choice or committal, such as from law enforcement.

“We were up against this problem and figured it needed to be solved in order to protect our patients and to protect our staff,” Nielsen said.

After coming up with a prototype that includes the surgical, paper-like mask material and cardboard ear fasteners similar to glasses, Nielsen, Penchansky and Romero have founded a company, Happy and Harmless Global, and are seeking to mass-produce the product, called FeltSafe. A patent is pending, and the intent is to get the product to market as quickly as possible. More information is available at happyandharmless.com.

“I’m very sad to report there still is no existing solution to this problem,” risk manager Penchansky said. “We are beginning to engage not only with our own hospital system, (but) we are starting to reach out to other hospitals and other contacts in the industry to generate interest, generate contacts. And on the back end we are working very hard to secure manufacturing pathways and just get everything aligned for our business structure so that we are ready to launch with a supply sufficient to keep our initial customer base in masks at a pace that keeps up with the supply chain.”

So far, they have not found a local organization to help with the manufacturing, though several — like Southwest Idaho Manufacturer’s Alliance and TechHelp — are currently aiding in the search process, and another, SMHeuristics, is ready to help.

“I think they have a very unique product, the needs of which are not being met here in Idaho and elsewhere,” said Sheri Johnson, executive director at SWIMA. “It seems like a complete no-brainer and there’s a lot of demand [for it].”

Pros, cons of Idaho’s manufacturing industry

Idaho has strength in the manufacturing industry, particularly around technology, growing aerospace and food production. Many manufacturing organizations, such as ones with 3-D printing and other fabrication machines, helped create personal protective equipment early in the pandemic.

Now, industry experts say, much of Idaho’s personal protective equipment comes from overseas, especially Asia, due to lower production costs.

Some industry leaders, like Derik Ellis and Nicolas “Nic” Kawaguchi with SMHeuristics, believe there is opportunity for, and would love to see, Idaho manufacturers pursue manufacturing PPE long-term.

“I do think the demand is going to be a big demand in the U.S.,” Ellis, co-founder and CEO, said. “Five years, 10 years, or maybe it’s here to stay. All data we have coming in says the demand will be around.”

“It’ll be interesting if we go down that route,” he added. “It’d be our preference to source local.”

Ellis and Kawaguchi help connect multiple health care and medical sales companies with manufacturing resources — some local, some as far as Taiwan — for equipment such as COVID-19 PPE. They also help the companies, including ones pursuing more entrepreneurial avenues, develop their business and/or product plans.

SMHeuristics offers advice from figuring out a potential product’s viability to helping market it. First and foremost is ensuring the product is in alignment with what the customer wants, Kawaguchi said.

“There are a lot of expenses bringing a product to market, and it takes time,” Kawaguchi, co-founder and COO, said. “Idaho has a very strong presence in manufacturing and it comes down to cost right now. The cost of doing business in Idaho is phenomenal.”

The rub, though, could be accessibility to required materials. A challenge for individuals like Nielsen, Penchansky and Romero is proving the cost-effectiveness and otherwise viability of their proposed product, and aligning with Federal Drug Administration or other industry appropriate guidelines and regulations.

Johnson said SWIMA (soon to be Idaho Manufacturing Alliance) plans to launch a digital database/network of manufacturing businesses and resources, in partnership with the University of Idaho, something that would have been invaluable as COVID-19 gained traction in Idaho. Part of SWIMA’s goal is to assist individuals and companies with networking.

In the meantime, SWIMA is assisting Happy and Harmless Global in connecting with possible manufacturing partners and local leadership, such as through Congressman Russ Fulcher’s office, which, Johnson said, if it can help, it will. The Small Business Development Center is another resource Happy and Harmless Global could use.

“You can tell how passionate they are about this product and taking care of their patients,” Johnson said. “I don’t think they’re out for the money. I love the ingenuity of seeing something their patients need and they sought to fill it to take care of their patients. That’s a noble cause.”

What’s next for Happy and Harmless Global?

Happy and Harmless Global sees their mask as not only addressing immediate concerns around COVID-19 but also applying to future circumstances as well. These masks could also help slow the spread of flu and other airborne viruses

The company intends to look into using the business infrastructure for products that are safe for those who suffer from mental illness.

“That shortage exists whether there’s a pandemic or not,” Penchansky said.

Not having industry-appropriate masks, Penchansky added, could add to the stigma around mental health being a secondary population, and, sometimes, forgotten.

“That is really contrary to the mission of treating those who suffer from mental illness,” Penchansky said.

Despite the concerns around accessibility to appropriate masks at the facility, Romero, a nurse, encourages those considering seeking help not to be discouraged. Current safety protocols around COVID-19 include social distancing in the facility and outdoors. Testing also occurs as is appropriate. Everything possible is being done.

“Everybody that works in the hospital, from the nurses to the techs to the social services department, we’re there to help; we want this to be the safest environment possible,” Romero said. “We’re lucky our CEO encourages this, they want a solution to it, but they don’t want people to not get the help they need.”