“You’ll be absolutely blown away in about 10 years by the things some of my clients are working on here,” says Carrie Scofield, founder of Surgical Training Solutions. She launched the Mendota Heights firm in 2005 to provide medical device companies with surgical staff, supplies, and instrumentation, as well as anatomical specimens, to fine-tune the next generation of lifesaving innovations.
Because of confidentiality agreements, Scofield can’t divulge what those potential breakthroughs are. She can say that her clients generally are at one of the two ends of the product-development cycle. Some are early-stage enterprises testing prototypes of their devices to submit with their applications to the U.S. Patent Office. Others are market-ready firms that have received FDA approval and are training surgeons—their prospective customers—in the proper procedure for inserting the devices in patients, or equipping salespeople with the hands-on experience they need to effectively market their products.
Scofield provides her clients with human cadavers—specifically, torsos—which she secures through organizations accredited by the American Association of Tissue Banks. Those groups match human tissue donated for research and medical education with users in the medical and scientific community. Scofield recovers the fee that she pays to the tissue banks, which prep and deliver the tissue, by dividing the cost of each specimen among three clients. Clients work primarily in three areas: the spine, the heart, and the combined fields of urology and gynecology. “We attempt to get three surgeries—one for each specialty area—out of one torso,” says Scofield, who keeps custody of the specimens.
Traditionally, she explains, medical device manufacturers have used university or hospital- or physician-associated cadaver labs. “I’m an independent,” she says. “I think there are very few of us—maybe 10 in the country—that are working on a private scale.” Many of Scofield’s clients have told her that it’s difficult to schedule lab time because of last-minute changes in doctors’ schedules. Labs generally are booked 30 days in advance.
Scofield has the distinctive background required to start such an unusual business. She worked as a surgical assistant in oral and maxillofacial procedures. She then moved to the American Red Cross, where she became a certified “human tissue banker”—trained to surgically remove human tissue (including bone, skin, connective tissues, and heart valves) from cadaver donors for surgical implantation into living patients. Part of her training included learning how to pack operating equipment in traveling cases and build surgical environments on the road for performing tissue recovery.
When Scofield struck out on her own in 2005 with the help of family funds, she offered a traveling service for medical device manufacturers, providing instrumentation, supplies, rentable surgical rooms and equipment. She soon opened a lab next to her office for local customers, while continuing to offer portable services.
Surgical Training Solutions has roughly doubled its first-year sales of about $100,000. In June, the company opened a new 4,100-square-foot teaching facility, which includes a 30-seat surgical lecture room and a surgical suite outfitted with closed-circuit video that can provide real-time feeds to instructional sites nationwide. The new facility is located close to the airport, “offering surgeons a quick trip in and out of the city,” Scofield says.
