IceCure Medicalis a developer of cryoablation system for the destruction and removal of cancerous and benign tumors.

We’re witnessing a wide array of new technologies which are changing the way people live and do business. Examples include AI, autonomous vehicles, and robotics. Healthcare is not an exception to such disruptive technologies. The potential to bring novel life-saving technology to the market can be exciting, but it is not without challenges. What drives disruptive technologies in medical devices?

The motivation for innovating new medical products is simple, yet powerful: it has the potential to save a life. I have worked in the medical devices industry for nearly 25 years and can say that nothing is more inspiring than the desire to improve someone’s life, whether it’s to maintain vision, manage pain better or provide less invasive cancer treatment. I’ve also had the opportunity to work with some of the brightest minds in the healthcare industry.

But their innovative approaches to addressing healthcare issues are not without challenges. When bringing disruptive technologies to the healthcare industry, a company may face challenges such as proving that their product is safe and effective and gaining the buy-in of the healthcare ecosystem to ensure the benefits outweigh the risk.

Overcoming Obstacles In Disruptive Healthcare Technologies

A clearly defined roadmap will help medical device companies prepare for the challenges that lie ahead. A solid product roadmap, which includes a path towards regulation, a method for gathering clinical evidence that is well-defined and a business plan with a strategic focus are key factors in bringing disruptive healthcare technologies to life.

Regulation & Clinical Data

Bringing new healthcare technologies to market can be a challenging task. When there are no predicate medical devices on the market yet, regulatory bodies can scrutinize your product and demand that you provide a multitude of hard evidence in support of your claims. They are right to do so. This is ultimately in everyone’s best interest, as it ensures that medical technologies are reliable and safe.

Your data are your best selling pointnot only to physicians and patients but also to regulators who review your product. Your disruptive technology is more than a concept. It’s important that clinical data supports the device’s effectiveness and safety, while clearly demonstrating benefits to patients. Preparation is the key to success. To confidently support your claims, ensure that you collect data points that are aligned to what regulators require.

Clinical studies that investigate novel innovations often inspire other researchers conduct similar studies. In this case, imitation is not only flattering but can also strengthen your safety and effectiveness claims by using independent data.

The ICE3 trial examined the use of cryoablation in women with low-risk, early-stage breast cancer. It was one of the largest control trials, but it was unique because it did not remove the tumors afterwards, unlike the ASOCOGZ1072 trial. The interim data presented in publications and at international conferences inspired other physicians to look for innovative minimally invasive options for their breast cancer patients. This included two ongoing independent studies, THERMAC (19459065) and PRECICE (19459065). In this case the repeated data helped us to strengthen our market strategy, by determining who was willing and able to adopt the disruptive technology.

The regulation of medical technology is evolving at the same time.

For example, AI can be used to diagnose breast cancer. AI tools can be used based on breast imaging to better predict whether a lesion will be malignant and help support clinical decision-making. In 1998, the FDA approved the first computer-aided dedication system. Nearly 20 years after the FDA approved the first computer-aided dedication system, 92% of U.S. Mammography Centers were using this technology in their practice.

Most AI devices that enter the market do so under a510(k), which means the medical device is safe, effective, and equivalent to an already cleared device. The FDA is developing more stringent guidelines as AI usage in healthcare increases. These include the Artificial Intelligence – Enabled Device Software functions: Lifecycle management and Marketing Submission Recommendations.

Don’t take the regulatory path alone. Expert regulatory consultants can provide guidance. They have the necessary knowledge, but also the experience of working with regulatory bodies and insight into what they want.

Adoption & reimbursement

New and innovative technologies are always accompanied by a certain amount doubt. Even physicians may be wary of new technologies, especially when they challenge the current standard of healthcare. Engage physicians in training or studies to make them part the innovation story. Make sure that they understand the value of your disruptive technology as clearly as you.

We cannot forget that the patient is at the heart of this disruptive technology. As patients are becoming more involved in their healthcare decisions, you can work with patient advocacy groups to increase awareness of your innovation. Patients will then request it from their doctors–a classic B2B2C approach.

Without reimbursement from insurance or government healthcare, adoption will be difficult. Rarely, people pay out of pocket for the right treatment. To ensure successful adoption and implementation of technology, it is important to build strong partnerships across the entire healthcare ecosystem.

Continuing the Disruption : Opportunities for Better Patient Outcomes.

MedTech constantly pushes the boundaries of what we understand and how we treat illnesses. The changes (as “disruptive” implies) may initially raise questions. We must not forget that disruptive technologies in health care translate into improved patient outcomes and experience, and over time, a healthier populace.

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