Dr. Fred St. Goar shares lessons as co-founder of Evalve

Recently 9 biodesign alums had the unique opportunity to share a meal with Fred St. Goar, co-founder of Evalve, Inc. Over the course of the evening, Fred shared candidly about his 10 year journey developing a percutaneous approach to treat mitral valve disease, from the early days at The Foundry^® to the recent acquisition by Abbott (NYSE: ABT; Press Release, PDF).

Several interesting and insightful points emerged from the dialogue:

• Never lose sight of your end user: Dr. St Goar reiterated the core Biodesign tenet of maintaining close relationships with physicians in the field. Having open lines of communication with end-users is an obvious key to success but can often (and somehow easily) get lost in the design process. Never hesitate to engage physicians from a variety of settings throughout the process. Most are willing to take time out of their busy schedules to provide feedback and perspective.
• Acquisition caries risk, not only reward: Despite the obvious benefits to investors and founders that flow from a favorable exit, managing the culture of the company is critical when it comes to merging the enterprises. “If you don’t do this carefully and strategically, you run the risk of a significant brain drain.”
• Clinical trial landscape is changing: Driven largely by scrutiny from large payers (i.e., Medicare), there is an increasing call for clinical trials to show comparative efficacy to an existing therapy as opposed to simply beating placebo. “While such trials will be more expensive and time consuming, they will allow you to kill 2 birds with 1 stone (approval from the FDA and reimbursement from payers).”  (Prioritizing Comparative-Effectiveness Research — IOM Recommendations, NEJM)
• The need doesn’t always have to be latent: General public domain discussion of a percutaneous solution for mitral regurgitation was important to consider, but did not impede Fred from moving forward.
• Failure is OKAY: Fred pointed out that although his first company (HeartPort^®) suffered several missteps, his career in medtech was not derailed.  A good reminder that: “Failure doesn’t have to be a black mark onyourtrajectory within the small medtech community in the Valley.”
• Avoid conflicts of interest: Dr. St. Goar chose not to be involved in the early clinical work with Evalve’s MitraClip^® (as a direct practitioner).  “As a physician-inventor, be careful to avoid the perception of conflict of interest, especially once you have the early proof of concept work behind you.”
• Reserve for the unexpected: Fred described how a change in an FDA reviewer mid-way through the submission process cost the company 6 months simply because the new staffer was young and inexperienced in the space. “Clinical timelines and budgets continue to require more and more padding in light of the increasing scrutiny and requirements from The Agency.”

Cheers to Dr. St. Goar for his insight and encouragement!