HospitalsRegulatory

Silony Medical’s Process Advisory Board

by Elizabeth Hofheinz, M.P.H., M.Ed., April 24, 2020

What can a scrub tech tell you about instrument design? Quite a bit, says Constantin Schön, Managing Director of Silony Medical, a manufacturer of medical instruments that has put the horse before the cart.

“We start from the premise that the ones driving instrument design should be those who use the products,” says Schön.

To that end, Switzerland-headquartered Silony has enacted a formal approach to instrument consultation—the Process Advisory Board (PAB).

“We watched as industry was developing implants with the help of surgeons,” states Schön. “And while this is certainly important and laudable, we saw the need for another perspective.  We expanded the range of individuals who might provide a clinical perspective, i.e., nurses and scrub techs. In addition, we sought out professionals who might enhance our understanding of procedures and processes outside of the OR, including people in storage, logistics, and sterilization.”

Established 2014, Silony’s PAB began with a flurry of meetings focused on accelerating things on the regulatory front. It has evolved, says Schön, into a quarterly meeting where 2-3 individuals focus on specific projects.

Constantin Schön: “What we bring to the PAB is often an R&D-related issue. For example, to reduce tray sizes and amounts, we engaged with nurses, OR techs, and sterile processing department (SPD) people to ensure that what we are considering also works for them. The result was color-coded implants and custom-equipped trays that brought much-needed clarity to the operating theater as well as special instrument designs to enhance assembling and disassembling of instruments in regard to function and cleaning feasibility.”

Citing the work of the PAB on a screwdriver project, he says, “Our goal was to have a product that works for the German operating room and SPD processing, where everything has to be 100% dismantlable. We called upon a PAB member, a nurse, who told us, ‘All the other companies have screwdrivers that don’t come apart properly. Silony will really stand out if you can provide one that can easily be broken down into just a few parts.’”

“That was easy on its own,” states Schön, but when coupled with the requirement that we have one screwdriver for short screws and another for long head screws, this PAB member said, ‘I would prefer to have the ability to disassemble it as opposed to having just one screwdriver.’” Her input helped us prioritize which problem to solve for.”

When it came time for a large project focused on the sacrum, the OIC had three PAB members as consultants. Schön: “Based on an idea conceived by four trauma surgeons, we are launching an SI fracture product this year. Silony also involved an ER nurse from the PAB team, who told us how these cases come about. We were able to discern the types of accidents that cause these injuries and the common problems that occur postoperatively. We also spoke with surgeons and said, ‘Why is this happening?’ to which they responded, ‘We have a problem with the current system.’ The ER nurse then said, ‘If they want to treat this fracture this way, then the ER workflow has to look like this.’ Then when another PAB member—a scrub tech—said, ‘I don’t know what the hell they are talking about,’ we went back to the drawing board.”

“To further simulate real use the complete procedure was performed by surgeons and nurses in OR condition using human specimen. Especially in regard to instrument handling the scrub nurse was instructed just 10 Minutes on the complete system. The goal is to observe any user errors, which may occur during surgery. Identified changes and requirements were implemented in the design and the OR simulation was repeated until the usability testing was completed successfully. The input of a nurse is crucial.”

Even packaging gets the special PAB treatment. “Our entire packaging line was designed by OR nurses and hospital staff from logistics. They were very specific, saying that we need X number of labels in every package, that we must have a label on every side of the box, we have to put in big window so they can control what they are opening up, etc. We ended up making it flip open like a box of cigarettes with a mild perforation so that the user doesn’t need to push hard and thus run the risk of popping a glove. This design eliminates any concerns about sterility while unpacking.”

PAB members rotate, depending on the needs of the company. And to ensure a diversity of thought, Silony attempts to engage consultants from different geographic areas and in different age groups.

“These people bring us a vast pool of ideas when it comes to resources for finding solutions to problems. We show them a prototype and once they handle it, if it doesn’t feel right or is somehow difficult to manipulate, then we don’t do it.”

And the fundamental philosophy underlying all of this?

“From experts for experts,” says Constantin Schön.

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Elizabeth Hofheinz

Two time winner of the MORE award Ms. Hofheinz was the first writer employed by Orthopedics This Week. The MORE award is granted annually by the American Academy of Orthopaedic Surgeons to recognize excellence in journalism. Ms. Hofheinz is currently the Director of Communications for Ortho Spine Partners (OSP).

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