After repeated incidents of contact with bodily fluids, a paramedic and an emergency room doctor put their heads together and invented a solution that, despite its effectiveness, encountered several barriers to market entry.
The Stal Shield and Stand is a diamond-shaped piece of hard, transparent plastic that covers a patient’s nose and mouth when airways are being cleared with a suction wand. The Stal – the first two initials of the inventors' first names – creates a barrier against visible and invisible excretions from the sick and injured.
A hole and grommet in the Stal’s centre allows a suction wand to be threaded through, as well as scalpels and saline bottles. And the Stal's bevelled edge keeps the wand from falling on the floor, risking contamination.
“Everyone we show it to, they see the benefits immediately,” says Al Wickheim, 52, an advanced life-support paramedic based in Victoria who has 28 years of on-the-job experience.
Two years ago, post-H1N1 and SARS, protection from inhaled pathogens became a priority. Mr. Wickheim was asked by the B.C. Ambulance Association to develop new protocols around infectious diseases.
Long-accustomed to unexpected discharges from coughing and gagging patients, the former salvage diver got an idea. He bounced it off Stephen Wheeler, 54, an emergency room physician at Victoria General, who has worked with the Canadian military and done annual emergency room stints in California.
Dr. Wheeler, like Mr. Wickheim, had used the Yankauer suction wand to clear patient airways and, to his amazement, no one had improved the device, which was invented in 1904.
The Stal – marketed by the two men through their company Prodaptive Medical Innovations Ltd. – helps prevent bodily fluids and bacteria from reaching medical personnel and potentially exposing them to serious illness. But getting the product into hospitals and ambulances has been stymied by reduced health-care budgets and slow-moving bureaucracy.
“The easy part was making it,” says Dr. Wheeler, a physician since 1987.
It took a year and four prototypes to create a safe, effective product – manufactured by Scott Plastics in Sidney, B.C. – but it has taken almost as long for Health Canada to issue a licence that allows Prodaptive to manufacture and distribute the Stal.
Prodaptive applied for a licence last fall and in June Health Canada finally reviewed the Stal, considered a low-risk medical device because it doesn't enter the body, it has no drug associated with it, and it is made of hypoallergenic plastic.
Approval should have occurred within 15 calendar days, according to Health Canada.
But because of funding cuts at the agency, there's a shortage of inspectors, Dr. Wheeler says. The person who reviewed the Stal specialized in drug inspections, not device reviews, he added.
Prodaptive received relatively quick approval from the U.S. Food and Drug Administration to sell the Stal south of the border.
With demanding day jobs and families, the founders are currently seeking distributors. They have secured medical suppliers in Calgary and Pennsylvania, and Prodaptive will be marketing the Stal at the Emergency Medical Services World Expo in August in Las Vegas, but for the moment sales have stalled.
“Like so many things in health care, you have to equate the dollar figure to future events,” says Mr. Wickheim, who also owns a wilderness cabin business.
Before purchasing a $5 Stal, customers of the single-use device want to be assured of net savings. That's a no-brainer, Mr. Wickheim insists, since fewer staffing resources are required for post-incident cleaning, and the risk of illness for doctors, nurses and paramedics is reduced.
Before a customer such as the Vancouver Island Health Authority would purchase Stals, the benefits must be crystal clear, says professor Geoff Archer, who teaches entrepreneurship in the management faculty at Victoria's Royal Roads University.
In Canada, health authorities are constantly under funding pressure. But in the United States, with its privately operated health-care system, a key selling point for new products involves tapping into the country’s litigious nature, adds Mr. Archer, an American who has worked for ExxonMobil and Yahoo.
Stal sellers should warn about potential lawsuits if someone catches Hepatitis C, for example, a situation that could be prevented through use of the device.
“The $5 cost probably pales in comparison to the lawsuits this will protect you from,” Mr. Archer says.
Scare tactics, he explains, deliver results. The Stal won a 2011 award from the U.S.-based Journal of Emergency Medical Services for most innovative product.
In Canada, Mr. Archer suggests Prodaptive connect with health-sector labour unions. “If a union of, say, ambulance workers demands this device be available then it is likely that will come to be. Similarly, working with regulatory bodies that ensure workplace safety might result in what is called ‘legislated demand.’ Government mandates that every medical institution use these things.
“Good examples of legislated demand would be Bluetooth headsets for talking on a mobile phone while driving or smoke alarms at home.”
Beyond sales, there's also a patent challenge. In December, 2010, on the advice of a patent lawyer, Prodaptive applied for an international patent after getting a provisional patent for North America in May, 2010. The group felt an international patent would provide more protection for the invention.
With a “patent pending,” Mr. Archer said the concern is that another company could produce its own version of the Stal. On top of that, “patents are only as valuable as your willingness to protect them,” Dr. Wheeler says.
Having spent about $70,000 of their own money to get this far, and with no guarantee that an upstart off-shore company won't steal their idea, the founders agree it's been a frustrating and challenging process. “But I get satisfaction knowing I'm bringing something beneficial to medicine,” Dr. Wheeler says.
Special to The Globe and Mail