Eyal Shamir is the CEO of Icecure Medical, the developer of the frozen bud version system for the destruction of benign and cancerous tumors.
We are witnessing a wide range of new technologies, including AI, self-driving cars, and robotics, which are dramatically changing the way we live and do our business. Such disruptive technologies are everywhere, and medicine is no exception. The possibility of bringing new life-saving medical technologies to the market is exciting, but it is not without challenges.
What drives the disruptive technology of medical devices?
The motivation behind new medical device innovations is simple yet powerful. It could save lives. Of my nearly 25 years of experience in the medical device industry, there's nothing more exciting than hopes of improving someone's quality of life. And I had the opportunity to work with the best and brightest mind in healthcare.
However, their innovative approach to addressing health issues does not come without challenges. Proving that product benefits outweigh risks while obtaining buy-ins from the healthcare ecosystem that product benefits outweigh risks is just some of the barriers businesses can face when bringing disruptive technology to the healthcare industry.
Overcoming the barriers of destructive healthcare technology
For healthcare companies, having a well-defined roadmap of what needs to be brought to market is key to preparing for future challenges. A robust product roadmap that incorporates the path to regulation, a well-defined methodology for gathering clinical evidence, and a strategic business plan are key factors for success in achieving disruptive healthcare technologies.
Regulation and clinical data
Introducing new healthcare technologies into the market can be a unique challenge. If there is no predicate device on the market, regulatory bodies that manage medical devices can expose the product to deep scrutiny and demand large quantities of harsh evidence to support the claim. And they are right to do this. Ultimately, such research is the greatest benefit of everyone and ensures that medical technology is safe and reliable.
Clinical data is the ultimate selling point not only for doctors and patients, but also for regulators who review products. Your disruptive technology must be more than just a concept. It is important that clinical data clearly demonstrate the patient's benefits while supporting the safety and efficacy of the device. Preparation is the key to success here. Collect well-defined data points that are in line with what regulators want to confidently provide evidence of your claims.
Clinical trials examining new innovations often encourage other researchers to carry out similar research. Not only is imitation a form of flattery in this regard, but such “imitation tests” can further strengthen your safety and effectiveness claims with independent data.
For example, the ICE3 trial examined the use of cryoprotective ablation in women with early stage low-risk breast cancer. Among the largest control studies of this type, unlike the AsoCog Z1072 trial, it was unique in that the tumor was not subsequently removed. Presenting preliminary data in publications and global conferences has helped inspire other physicians looking for innovative minimal options for breast cancer patients, including two ongoing independent studies, Thermac and Precice. In this case, data repetition helped to strengthen market strategies by looking at who was willing to adopt disruptive technologies.
As medical technology evolves, so does the regulations behind it.
For example, consider the use of AI in the diagnosis of breast cancer. Based on breast imaging, AI tools can be used to better predict whether the lesion is malignant and support clinical decision-making. The first computer-aided dedication system to be approved by the FDA was in 1998. Almost 20 years later, 92% of mammography centers in the US were using the technology.
The majority of AI devices entering the market do so under the 510(k) application to the FDA. This means that the medical device in question is safe, effective and equivalent to another device that has already been cleared. As AI use increases in healthcare, FDA is developing stricter guidelines, such as AI-enabled device software capabilities. Recommendations for lifecycle management and marketing submission.
My recommendation: Don't go through regulatory routes alone. Get guidance from an expert regulatory consultant. Not only do they have the necessary knowledge, they also have experiences of daily interactions with regulatory organization staff and insight into what they are actually looking for.
To-Market Plan: Recruitment and Refunds
Naturally, new and innovative technologies bring some doubt to them. Even doctors can worry about something new, especially if they are challenging the standard of care they are currently in. Participate in research and training sessions to actively engage physicians and make them part of their innovation stories. Just like you, make sure you see clearly the value of your disruptive solution.
And of course, we cannot forget the patient, the heart of this disruptive technique. As patients today are increasingly involved in their healthcare decisions, they are working with patient advocacy groups to raise awareness about your innovation so that patients can request it from their doctors. This is a classic B2B2C strategy.
Adoptions will be difficult to obtain without insurance or government medical rebates. Some people will pay their own self-pay for proper treatment, which is unusual. Building strong partnerships across the healthcare ecosystem is critical to successful technology adoption and implementation.
Continuing Confusion: Opportunities for Better Patient Outcomes
MedTech is constantly pushing the barriers to what we know and how to treat illnesses. Changes (the term “disruptive” can first raise questions, but we need to remember that disruptive techniques in health care lead to better patient experiences and outcomes, and eventually a healthier population.
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