Eyal Shamir is the CEO of IceCure Medical, developer of cryoablation systems for the destruction of benign and cancerous tumors.
We are witnessing a wide range of new technologies that are dramatically changing the way we live and conduct business—such as AI, autonomous vehicles and robotics. Such disruptive technologies are everywhere, and healthcare is no exception. While the potential for bringing novel life-saving medical technology to the market is exciting, it is not without its challenges.
What drives disruptive technology in medical devices?
The motivation behind innovating new medical devices is simple yet powerful—it has the potential to save lives. In my nearly 25 years of experience in the medical device industry, I can say there is nothing more inspiring than the hope to improve someone’s quality of life—whether it be to maintain vision, better pain management or less invasive cancer care. And I’ve had the chance to work with the best and brightest minds in healthcare.
However, their innovative approaches to addressing health issues do not come without challenges. Proving your product to be safe and effective while also getting buy-in from the healthcare ecosystem that the benefits of your product outweigh the risks are only some of the barriers a company can face when bringing a disruptive technology to the healthcare industry.
Overcoming Barriers In Disruptive Healthcare Technologies
For medical device companies, having a clearly defined roadmap on what you will need to bring your innovation to market will be key to preparing for the challenges ahead. A solid product roadmap that incorporates a path to regulation, a well-defined methodology for gathering clinical evidence and a strategic business plan are the key factors to success in bringing a disruptive healthcare technology to life.
Regulation & Clinical Data
Bringing novel healthcare technologies to the market can be a unique challenge. When there are no predicate devices on the market, the regulatory bodies that govern medical devices can subject your product to deep scrutiny and demand a plethora of hard evidence to back up your claims. And they are right to do this. Ultimately, such an investigation is in the best interest of everyone, ensuring medical technologies are safe and reliable.
Your clinical data is your strongest selling point, not only for physicians and patients, but for the regulators that review your product. Your disruptive technology must be more than just a concept—it is crucial that clinical data support the device’s safety and effectiveness, while clearly demonstrating patient benefits. The key to success here is preparedness. Make sure you collect well-defined data points aligned with what regulators want to confidently provide evidence for your claims.
Clinical trials investigating novel innovations will often inspire other researchers to conduct similar studies. Not only is imitation in this regard a form of flattery, but such “copycat trials” can further strengthen your safety and efficacy claims with independent data.
For example, the ICE3 trial investigated the use of cryoablation for women with early-stage, low-risk breast cancer. Among the largest control studies of its kind, it was unique in that it did not excise the tumors afterward, unlike the ASOCOG Z1072 trial. Presenting the interim data in publications and at global conferences helped to inspire other physicians looking for an innovative minimally invasive choice for their breast cancer patients, including two ongoing independent studies: THERMAC and PRECICE. In this case, the repetition of the data helped to bolster our market strategy by seeing who was willing to adopt the disruptive technology.
As medical technology evolves, so does the regulation behind it.
Take, for example, the use of AI in the diagnosis of breast cancer. Based on breast imaging, AI tools can be used to better predict if a lesion is malignant and support clinical decision making. The first computer-aided dedication system with FDA approval was in 1998. Nearly 20 years later, 92% of U.S. mammography centers had adopted the use of this technology into their practice.
The majority of AI devices entering the market are doing so under a 510(k) application to the FDA, meaning the medical device in question is safe, effective and equivalent to another already cleared device. As AI use in healthcare grows, the FDA is developing more rigorous guidelines such as the Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.
My recommendation: Don’t go on the regulatory pathway alone. Get guidance from expert regulatory consultants. Not only do they have the knowledge necessary, but they also have the experience of daily interactions with the regulatory body personnel and insights into what they are actually looking for.
Go-To-Market Plan: Adoption & Reimbursement
Naturally, new and innovative technologies bring with them a certain amount of doubt. Even physicians can be apprehensive of something new, especially if it challenges the current standard of care. Work to actively engage physicians and make them part of the innovation story—engage them in studies or training sessions. Make sure they see the value of your disruptive solution clearly as you do.
And of course, we cannot forget the person at the center of this disruptive technology—the patient. As today’s patients are increasingly involved with their own healthcare decisions, work with patient advocacy groups to raise awareness about your innovation so that patients can request it from their physicians—a classic B2B2C strategy.
Adoption will be hard to come by without reimbursement by insurance or government healthcare. Some people will pay out-of-pocket for the right treatment, but this is uncommon. Building strong partnerships across the healthcare ecosystem is crucial to ensure successful technology adoption and implementation.
Continuing The Disruption: Opportunities For Better Patient Outcomes
MedTech is constantly pushing the barriers of what we know and how we treat illness. The changes (as the word “disruptive” infers) may raise questions at first. However, we must remember that disruptive technologies in healthcare translate into better patient experience and outcomes—and in time, a healthier population.
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Eyal Shamir