As they work to help heal those who are sick or injured, clinicians often develop insights into ways in which certain innovations, such as new devices and technologies, or enhancements to those that already exist, may significantly improve the care they provide to their patients.
But acquiring the knowledge and skills, and finding the time needed, to successfully bring a new product to market, may seem too daunting a challenge for busy clinicians to take on—unless there are resources and support in place to help them.
That’s the idea behind the SYNERGY Clinician-Entrepreneur Fellowship (S-CEF). Awarded by Dartmouth SYNERGY Clinical and Translational Science Institute, S-CEF is a one-year fellowship program (that runs from Oct. 1 to Sept. 30), providing fellows with one day per week of protected time, as well as resources, to develop and study the commercial potential of their ideas.
In addition to cultivating entrepreneurial skills among clinical faculty at the Geisel School of Medicine and Dartmouth-Hitchcock, the overall goals of the S-CEF are to develop and evaluate ideas and inventions designed to address specific patient care needs and to facilitate institutional processes that foster commercialization of faculty ideas, says Aaron Kaplan, MD, a professor of medicine at Geisel, who leads the Academic-Industry Core for SYNERGY and developed the S-CEF.
“The primary purpose is to educate the community here and increase its understanding of what’s involved in developing an early device or concept,” explains Kaplan, an interventional cardiologist at Dartmouth-Hitchcock and an active medical device entrepreneur who has authored more than 40 US patents.
Candidates for the fellowship go through a formal review process and pitch their ideas to a panel of experts. “If selected, the fellow puts together a board of advisors and develops an in-depth business plan, as well as a full understanding of the challenges involved in becoming a clinician-entrepreneur,” he says. “At the end of the fellowship, their ‘deliverable’ is to share what they’ve learned with their peers, and their ‘end-product’ is to able to determine, ‘Does this idea have legs or not?’”
Making Breast Conserving Surgery More Accurate
For Richard Barth, Jr., MD, the first recipient of the SYNERGY Clinician-Entrepreneur Fellowship in 2015, and whose fellowship is being extended for another year, the answer has been a resounding “yes.”
Working with colleagues from the departments of Radiology and Pathology at Dartmouth-Hitchcock and Geisel, and Dartmouth’s Thayer School of Engineering, Barth continues to make impressive progress on developing a new system for improving the accuracy of surgery on non-palpable breast cancers.
“When we can’t feel the cancers, surgeons currently have to rely on image localization techniques to find them and take them out, and this involves placing a wire into the breast and then removing tissue around the wire,” says Barth, a professor of surgery at Geisel and section chief of general surgery at Dartmouth-Hitchcock.
“The problem is, it’s just not that accurate a way to do surgery—about 30 percent of the time there is a ‘positive margin’ or cancer at the edge of the lumpectomy and we don’t find out until four or five days after surgery when the pathology report comes back,” he explains. “Patients then need to go through a second procedure to make sure that the cancer has been completely removed, which means more discomfort and anxiety for them, added costs, and increased risk of complications.”
Using MRI guidance and 3D printing technologies, Barth and his colleagues Venkat Krishnaswamy and Keith Paulsen have created the Breast Cancer Locater. A bra-like form that is customized to each patient, the device allows surgeons to more easily identify the borders of tumors and remove them with greater precision.
Through their company, CairnSurgical LLC, Barth and colleagues have received a small business innovation research grant from the federal government to test the effectiveness of their new invention in patients whose cancers can be felt. He hopes to secure additional funding for a multi-center randomized trial next year that will lead to FDA approval.
There’s a lot to learn and a lot to do when you’re moving into this sphere, whether it’s related to intellectual property, regulatory issues, or how to start a company. I’m thrilled to have the support to be able to do this.”
-Richard Barth, Jr., MD
Barth’s goal is to reduce the positive margin rate to 10 percent or less while optimizing the cosmetic result for patients. “So far, it’s working very well—it’s been highly accurate with the patients we’ve tested it on,” he says.
The S-CEF experience has been Barth’s first foray into any kind of business venture. “There’s a lot to learn and a lot to do when you’re moving into this sphere, whether it’s related to intellectual property, regulatory issues, or how to start a company,” he says. “I’m thrilled to have the support to be able to do this.”
Barth adds: “The Dartmouth community has wonderful resources—from SYNERGY and Dr. Kaplan to Thayer to the Dartmouth Entrepreneurial Network (DEN) at the college to the Tuck School of Business, where five students have helped us to formulate our business plan as part of their first-year project. I’m taking advantage of as many of these resources as possible. In the end, I just want to make a difference in patient care, and I think this will.”
High Tech and High Touch: Transforming Mental Health Care
Like Barth, the 2016 recipient of the SYNERGY Clinician-Entrepreneur Fellowship, William Hudenko, PhD, is passionate about applying innovation to his field of clinical expertise, psychiatry, to enhance the care process for both patients and practitioners.
Through their company, Incente, LLC, Hudenko and his colleagues have created a novel software product called Proxi, which serves as a digital toolbox for mental health clinicians and has modules that are designed to address the three major barriers they perceive to mental health treatment.
“The first problem is lack of collaboration,” says Hudenko, an assistant professor of psychiatry at Geisel. “Mental health treatment is very complex and usually involves a number of different parties to coordinate care, and right now the alternatives for people to accomplish that are to use email, which isn’t HIPPA-compliant, or to use the phone, which is inefficient and results in a lot of communications being lost.”
Using Proxi-Connect, patients are able to choose who will be part of their care team and their clinicians can create a team around them that can openly communicate in a secure fashion on the system’s platform, which can be accessed from a web browser on any internet-capable device, and soon will include a mobile product.
Patients are encouraged to include those closest to them as care team members. “We believe that leveraging a patient’s natural support system is one of the most under-utilized parts of care and key to helping them get better,” Hudenko explains. “That’s why we’ve created a feature in the system called Proxi-Reach that allows friends and family members to quickly and easily send messages to the patient to let them know they’re thinking about them.”
Hudenko and his colleagues have added Proxi-Assess, a suite of open-source assessment tools, into their platform to make the challenge of monitoring patients’ progress—a second barrier to treatment—more efficient and cost-effective. “We can release the assessment to anyone on the care team, including the patient, and can share results with care team members so that everyone can follow along with the progress.”
It’s very exciting to have this opportunity. To be able to devote time to this that previously was unavailable to me will make a tremendous difference for our company and our ability to really make progress.”
-William Hudenko, PhD
A third module, Proxi-Learn, confronts the problem of isolation of practitioners. “The large majority of mental health clinicians work in small practices and because of time constraints are often unable to interact with one another and stay up-to-date with best practices,” he says. “We’re able to provide information about the latest and greatest research in mental health, while keeping therapists connected, so they can continually learn from one another.”
With support from resources such as Dartmouth’s Dali Laboratory, which helped develop the prototype for Proxi, DEN, and now the S-CEF, Hudenko is focused on transitioning Proxi from its beta testing phase into a commercially viable product with paying customers.
“It’s very exciting to have this opportunity,” he says. “To be able to devote time to this that previously was unavailable to me will make a tremendous difference for our company and our ability to really make progress.”
Building Knowledge, Capacity for Entrepreneurship
As commercially promising as these two projects are, the success of the S-CEF program isn’t being measured by funding awards or out-licensing of technologies. “It’s really based on the fellows’ developing their entrepreneurial skills and sharing what they have learned with the broader community,” explains Kaplan. “It’s been very gratifying to see the progress that both are already making.”
“We’re very pleased to be able to offer fellowships for these two important projects and are excited about their potential to directly benefit our patients,” says Alan Green MD, principal investigator and director of Dartmouth SYNERGY. “They reflect the kind of culture we have here at Dartmouth, one that nurtures innovation and facilitates the translation of ideas into clinically impactful procedures and products.”