The Road Not Taken

Getting a medical device from a napkin sketch to the operating room, examination room, or patient bedside isn’t always (seldom is, in fact) a high-speed, straight-line journey—particularly for a first-time entrepreneur or a doctor with a big idea. To carry the analogy a little further, it’s less like the autobahn and more like a long, winding country road filled with bumps, dips, detours, delays and wrong turns. But once you’ve learned your way or, more importantly, have had someone give you directions, the path is less riddled with potholes.

In the medical device development realm, finding that special someone with a planned route in hand can be even trickier than the trip itself.

To help provide innovators with a product development GPS, a collaboration recently has formed among the California Institute for Quantitative Biosciences (QB3), the University of California, San Francisco, (UCSF) Department of Surgery, the UCSF Department of Engineering and Therapeutic Sciences, and medical device professionals and investors.

Called the Rosenman Institute, the UCSF-based initiative is devoted to medical device innovation. The group is named for the late Daniel Rosenman, a biomedical engineer and medical device entrepreneur with UCSF ties. Rosenman spent 25 years in the medical device sector focused on areas including cardiology, cardiac surgery, urology, general surgery and ophthalmology. He led R&D efforts from the initial founding to financing and through commercialization in multiple startups. Rosenman was inventor or co-inventor on 40 U.S. patents and co-founded San Carlos, Calif.-based BioCardia, an interventional cardiology device company. His passion, according to his colleagues, not only was the rapid design of innovative products, but also bringing them to clinicians and patients within a short time period and in a way that focused on the human factors and clinical utility. Rosenman died in August while on a bike ride in Lake Tahoe.

According to the San Francisco Business Times, around the same time, representatives of UCSF’s surgery department approached QB3 Director Regis Kelly with an idea: Could QB3, an incubator known for helping startups form out of novel academic research or linking companies with researchers at UCSF, UC Berkeley, and UC Santa Cruz, help faculty members transform their ideas into actual products?

A few weeks later, Kelly witnessed a tight-knit group from the medical device community interacting at a memorial for Rosenman. At that moment, he realized “this is a good idea to tap into,” Rosenman’s widow, Christine Winoto, who also happens to be the assistant director for strategic planning at QB3, told the Business Times.

The institute initially will focus on bringing to market the innovations of engineers from UCSF. Researchers at UCSF aren’t exactly strangers to the medtech space, having recently been awarded $26 million in government funding to study neural implants for Parkinson’s disease and epilepsy.

As the creators of the Rosenman Institute explain: “Surgeons know what problems they need solved, but they often know little about bioengineering. Engineers are great at building products, but often don’t know whether a device is needed or wanted in the clinic.”

On June 4th, the institute opened with a symposium that was designed to bring together different stakeholders in the product development process.

Organizers said the goal of the first-time event was to inspire clinicians to innovate, introduce the resources available at the Rosenman Institute, and enable entrepreneurs to share their stories and perspectives on the future of medical device innovation. It provided an opportunity for networking with entrepreneurs, physicians, investors, biomedical engineers, mentors and representatives of major device companies.

Finding the fuel to power innovation will be increasingly important as the United States fights to maintain dominance in the sector. According to industry tracker DJX VentureSource, 2013 was the slowest year for medical device investing since 2005. Last year saw $2.5 billion invested across 261 deals, almost a return to the numbers from eight years ago, when $2.4 billion was invested in 251 deals. Medical device investing began to climb in 2006, then began dropping after 2011.

Organizations such as the Rosenman Institute are well-timed.  Bringing together experienced industry stakeholders—researchers, engineers, clinicians, investors and medtech professionals—to brainstorm, fund and commercialize transformational (and economical) healthcare solutions is a road map for success.

Right now, as medtech business development models go, such an organization may represent the road less traveled, but it’s shaping up to be a turn worth taking.

Christopher Delporte
Editorial Director
[email protected]