Erez Meltzer, CEO & Acting Chairman of Nanox, is a prominent Israel business leader with 35+ years’ experience leading global companies.gettyThroughout my career leading medical technology companies across global markets, one of the questions I get asked most often is, “How do you get a health system to change?” The honest answer is that shifting what an entire field considers the clinical baseline is the hardest problem in medicine.​One of the clearest illustrations of this difficulty I’ve seen is the transition from 2D to 3D mammography. Digital breast tomosynthesis (DBT) received FDA approval in 2011, and showed 15% to 53% improved cancer detection and 15% to 37% fewer unnecessary callbacks versus traditional 2D mammography. And yet, it took the better part of a decade for 3D breast imaging to become dominant.​By 2023, 87% of U.S. certified facilities had at least one DBT system. Getting there was not a technology story, but rather a deployment story. In my experience, three forces determine whether an innovation actually shifts the standard of care or just stalls after regulatory approval or clinical validation.1. Internal Champions Are The Primary Deployment Mechanism​As important as advances in technology are, people ultimately have to make the collective decisions that result in systemic changes in clinical practices. A landmark 2014 JAMA study of 454,850 examinations showed a 41% increase in invasive cancer detection after the implementation of DBT, compared to standard mammography alone.​The study gave clinical champions the evidence to win the internal argument. Previously, adopting DBT felt like making a risky clinical bet, and afterward, not adopting DBT began to feel like a liability. That inversion, when not adopting feels riskier than adopting, is the mechanism of every shift in standard of care that I have seen.​I saw this pattern up close with an early-stage extremity imaging technology built to give clinicians additional diagnostic information at the point of care. The first institutional partner moved because the case was clear: Better "first-time-right" imaging meant fewer inconclusive reads and fewer patients sent home without answers. Clinicians found real value in cases involving subtle fractures in the knees, feet and other extremities, where conventional X-ray findings were inconclusive or missed the fracture altogether. The added information also helped clinicians more clearly document the need for follow-up CT when an X-ray left unanswered questions, and it proved especially useful in cases involving existing metal hardware, where X-ray images are notoriously hard to read. That clarity, delivered at the moment of clinical decision-making, is what gave the internal champions the confidence to move first.2. Evidence Alone Doesn’t Move The Standard​Not all evidence moves a standard of care. Guideline bodies, payers and clinicians respond to different proof on different timelines, and the gaps between them can cost years.​• Guidelines: While the American College of Radiology endorsed DBT for routine screening in 2017, the U.S. Preventive Services Task Force issued an "insufficient evidence" rating in 2016 and did not reverse that decision until 2024. For nearly a decade, this ambiguity contributed to hesitancy to adopt DBT among physicians.​• Reimbursement: Dedicated Current Procedural Terminology (CPT) codes for DBT did not exist until 2015, four years after the original FDA approval. No chief financial officer approves capital equipment with unresolved reimbursement. Regulatory clearance and commercial viability run on different clocks.​• Regulatory Variation: Approval of DBT in the U.S. did not translate across markets. Each market requires its own evidence and reimbursement pathway—a reality every company scaling medical technology globally learns quickly. For example, in 2015 in the U.K., the NHS ran its own independent evidence trial for DBT (TOMMY Trial), four years after FDA approval, before considering adoption into its national screening program.3. Patients Can Bypass The Clinical Hierarchy Entirely​As awareness grew of dense breast tissue as a risk factor, patients began requesting 3D imaging by name. In 2023, the FDA mandated national breast density notification for all facilities, enforceable from September 2024. Patient demand reached administrators directly, changing the institutional risk calculus in ways evidence alone could not.​Patient voice is underestimated. It is not a marketing tool; it is one of the most powerful forces in shifting clinical practice. When patients pull, the champion's job gets easier.​What This Means For The Next Standard Of Care​The challenges that slowed 3D mammography’s adoption—regulatory timelines across markets, reimbursement gaps, the long runway to shift clinical practice—are the same ones that every medical technology company continues to navigate. The difference is that today’s pace of change demands we learn from that timeline, not repeat it.​The 3D mammography standard of care was not born with FDA approval in 2011. It was built across the decade that followed in journals, boardrooms and the offices of clinicians who staked their credibility on a better approach. That is what shifting a standard of care actually looks like.Forbes Technology Council is an invitation-only community for world-class CIOs, CTOs and technology executives. Do I qualify?