Being CEO is filled with challenges and lessons, and part of the job is learning along the way. Navigating the uncertainty of the burgeoning fertility field further sets the stage for many important lessons to share. At a recent SBAA tableside chat, Biodesign alumni had the opportunity to sit down and hear first-hand from Lissa Goldenstein, CEO of ARC Fertility, on the many lessons learned in her 12 years of experience as a CEO of 4 companies, both public and private. She answered questions about her path to the CEO role, the challenges of bringing a new technology to the fertility market and, in particular, her lessons on navigating the FDA clearance process.
In 2011, Lissa was CEO of Auxogyn, a fertility company she co-founded. At that time, Auxogyn was seeking FDA clearance for Eeva, a time-lapsed photography based technology to aid in the selection of embryos for IVF patients. As Lissa explained, by monitoring the timing of an embryo’s division through day 3 of incubation, Eeva enables an IVF lab to make a better prediction as to which embryo to transfer into a patient. The Eeva system was classified as a De Novo 510(k) by the FDA, and in hindsight, this led to three interesting challenges. First, the FDA would have to gain an understanding of a brand new technology unlike anything else on the market. This, coupled with the fact that the IVF industry is largely built on Class I devices, meant that both Auxogyn and the FDA had a great deal of learning to do. Second, at the time, aspects of the De Novo 510(k) process were still somewhat nascent, and both medical device manufacturers and the agency were learning how to navigate changes in the process. Finally, evaluating a novel technology in a new device field like fertility with no available predicates led to significant negotiation, and clinical measures and outcomes for clinical studies was the topic of many time consuming meetings and interactions.
Ultimately these challenges resulted in an extra year added to the FDA clearance process, and as Lissa explained, the loss of some momentum as a company. While Lissa and team labored with the FDA a year longer than anticipated on their day 3 embryo claims, they knew that there was an industry shift towards day 5 embryo outcomes. However, through it all she cited an important lesson on the value of cultivating relationships within the FDA and building credibility. Prompt response to the FDA’s concerns were a crucial ingredient in building a strong foundation. Later, in a surprising twist, Auxogyn found itself being audited by the FDA, even before being FDA cleared. As Lissa explained, she and the team managed to use this surprise interaction to deepen their relationship and convince the auditor to allay concerns coming from elsewhere within the FDA.
When Auxogyn later found itself going through a second 510(k) FDA pathway using its first application as a predicate, the relationship the company had established with the agency paid dividends again and dramatically shortened the process.
When asked about the importance of pre-submission meetings, Lissa replied that these were also useful to building that credibility, but to expect that the FDA will be hesitant to commit to an answer and would like to reserve the right to change its mind.
Though stressing the importance of this organic relationship, she also noted that relationships can be acquired through consultants, but the key point remained the same: build credibility.