Bringing a new medical device to market is a costly, time-consuming process. Innovations that seem like a slam dunk in the research lab often turn out not to work as intended during development. Clinical trials require minute, painstaking attention to detail. Federal regulators, understandably, demand proof that any new device is reasonably safe and works as its manufacturer claims. Each of these steps requires adequate funding and skilled manpower.
At the end of it all, Medicare, Medicaid and private insurance firms
must be willing to reimburse providers that use the device. With rare exceptions, devices that don’t qualify for reimbursement—a highly complex consideration—fail to find traction in the market.
“Even with unlimited funding, it can take two years or more to complete the process for relatively simple medical devices,” says
FocusStart founder and CEO Dr. Daniel Sigg.
Sigg and FocusStart co-founder Peter DeLange, who previously ran a successful medical device startup called
Devicix (recently purchased by
Nortech Systems, a local medical engineering company), had each spent years searching for a better early-stage device development model. When they met a few years back, they quickly realized their professional skills complemented each other.
So they founded FocusStart, a St. Paul startup that shepherds promising medical technologies through the tricky testing and development phase, refines validated devices for commercialization, and seeks strategic partners (typically multinationals) to complete the regulatory approval process and actually bring devices to market. FocusStart’s model is less capital-intensive than traditional medical device development models, though the company still assumes risk for technologies that don’t pan out during development.
FocusStart currently has four promising technologies in its portfolio: a cardiac product that may reduce blood clot risk following certain surgical procedures; a urological catheter that may reduce the risk of certain infections; a “smart” respiratory inhaler; and a “tissue tension sensor” that may promote better outcomes following partial and total knee replacement procedures.
Sigg and the team are devoting substantial energy and attention to the tissue tension sensor, which is capable of directly measuring ligament tension without requiring an invasive cut. Direct measurement enables surgeons to properly “balance” the knee during the replacement procedure, reducing the likelihood of complications or outright failure.
The sensor could potentially benefit other orthopedic procedures, such as rotator cuff and ACL surgeries, though FocusStart is concentrating on knee replacement for now. According to Sigg, it also has potential as a training tool for newer surgeons, who lack the intuitive “feel” of more experienced operators.
Although each technology is different, FocusStart’s development approach is fairly standardized. First, the company approaches a research institution to work out a licensing agreement for the technology. FocusStart works with the University of Minnesota, Mayo Clinic, the University of Zurich (in Switzerland) and an Israeli inventor.
“We quickly found that these agreements are fairly standard, with some variation,” says Sigg.
FocusStart generally would pay a royalty on future sales of the product, possibly with an equity component to sweeten the deal for the institution should the technology find its way into a marketable device.
“We find it easier to develop relationships locally,” says Sigg, adding that his Swiss background (he grew up in Switzerland and attended medical school at the University of Basel) probably helped with the Zurich partnership.
FocusStart’s lean model helps, too. “Once [our partners] understood our approach, we become more successful in finding very interesting technologies,” says Sigg. And the combined expertise of the firm’s principals—Sigg was a board-certified anesthesiologist and subsequently amassed almost two decades of medical research and development experience, while DeLange had the business chops to build Devicix into a successful concern and boasts insider knowledge of the medical device field—doesn’t hurt.
But that doesn’t mean swift success is assured. FocusStart has been “fortunate” to receive National Institutes of Health grants during the early going, but the company continues to seek government grants and private funding—a process that will likely continue as Sigg and DeLange seek out and develop promising new technologies.
There’s no such thing as a perfect batting record in the medical device business. “As we do our own work, we may find challenges or problems that weren’t apparent previously,” says Sigg. “Occasionally, you have to know when to say ‘that’s it’ and walk away [from a technology].”