Medtech company SI-BONE is constantly looking to develop and provide new technologies for surgeons’ and patients’ clinical needs.
Before the company can create those technologies and implants, the organization first has to generate high-quality clinical evidence through studies.
These studies and evidence are what breeds innovation throughout the industry, something that not every medtech company is necessarily working toward, according to SI-BONE CEO Laura Francis.
Ms. Francis recently connected with Becker’s to talk about why building strong clinical evidence is critical to advancing spine care, how SI-BONE stays connected to identify unmet clinical needs and how the company’s ongoing studies are helping move the field forward.
Note: Responses were lightly edited for clarity and length.
Question: Why is generating this clinical evidence so important for medtech companies?
Laura Francis: It’s especially important for companies that are tackling unmet clinical needs. In the spine market, it’s actually pretty unusual to see companies running randomized controlled trials or prospective studies. The reason is that there’s not a lot of innovation in the space.
For us, generating high-quality clinical evidence is how we build credibility with physicians, payers and regulators. It’s a core part of who we are as a company. Because of the strength of our evidence, many payers now have exclusive coverage policies on our iFuse technology for SI joint fusion, opening access to approximately 100 million covered lives.
To be clear, we don’t have contracts or formal relationships with these commercial payers. They made these coverage decisions independently, based on the uniqueness of our technology, the quality of our data and their confidence that it will be used appropriately.
Q: How do you go about identifying clinical needs for these new technologies?
LF: We try to stay as close as possible to both the surgeon and the patient. That’s really how we identify unmet clinical needs. By engaging directly with clinicians, we’ve uncovered major challenges, like pelvic fixation failure, and learned where current technologies fall short.
By being in the field, listening and working side-by-side with surgeons, we get a clear picture of the problems they face. That insight allows us to develop better solutions and over time, expands and diversifies our portfolio in meaningful ways.
Q: Looking to the future, where do you see SI-BONE’s clinical data efforts having the greatest impact on the field?
LF: We’re going to keep doing what’s always defined SI-BONE, which is staying focused on unmet clinical needs and generating high-quality data that shows our technologies are safe, effective and cost-efficient. That’s the foundation of everything we do. Most importantly, all this work does more than just validate our technology. It’s helping shape the future of the field, setting new standards of care, guiding best practices and creating a stronger foundation for innovation across medtech.
